Category: Biotech News

The biotechnology and pharmaceutical industries have significantly underperformed the S&P 500 so far this year – by 25.7% and 12.6%, respectively – but there are many opportunities for investors willing to assume some risk. Microcap biotech firms are largely under-the-radar of institutional investors, which means that individual investors have an opportunity to capitalize on discounted opportunities and generate alpha for their portfolios.

Innovus Pharmaceuticals Inc. (OTCBB: INNV) is an emerging pharmaceutical company that delivers safe, innovative, and effective over-the-counter medicine and consumer care products designed to improve men and women’s health, respiratory disease, and vitality. In addition to completing the acquisition of Beyond Human™, the company may be on the verge of an FDA approval of its FlutiCare™, Fluticasone Propionate Abbreviated New Drug Application (ANDA) for over-the-counter allergy relief medication.

In this article, we will take a look at the company’s upcoming FDA decision, robust commercial portfolio, and improved cash reserves and financial condition. 

FDA Decision on the Horizon

The single most important catalyst for Innovus Pharmaceuticals is the pending FDA decision regarding the approval of the Fluticasone Propionate ANDA for FlutiCare™, which has rights to market as an over-the-counter product worldwide. As a leading prescription brand with 40 million units sold in 2014, management believes that the over-the-counter version of FlutiCare™ is capable of generating in excess of $100 million per year in revenue once full market penetration is achieved.

The FDA decision is expected between July and the end of September, which means that the company could begin marketing the drug as early as late this year or early next year. Since ANDA decisions are for generic drugs based on an existing approved drug, they tend to have relatively high approval rates compared to New Drug Applications (NDAs) that have entirely new safety profiles and mechanisms of action when treating a given indication.

FlutiCare™ would be competing with GlaxoSmithKline plc’s (NYSE: GSK) Flonase®, which generated nearly $100 million in its first 16 weeks on the shelf, according to IRI figures. If the company is successfully in leveraging FlutiCare’s™ prescription brand strength, it could become a viable competitor to Flonase® and others in the corticosteroid nasal spray market.

Vitality Portfolio Drives Growth

Innovus Pharma has a growing pipeline of 13 commercial products, including those that it acquired from Beyond Human™ in March. Leveraging the portfolio, management has signed ten commercial partnerships that have over $500 million in sales milestones plus royalties across 60 different countries. Zestra®, Vesele® and EjectDelay® are the cornerstones of the portfolio with clinically proven efficacy in addressing sexual health issues with very large markets.

Zestra® is the only clinically proven and commercially available consumer care product tested in FSA/ID (Female Sexual Arousal Interest Disorder) in women. With over 10 million women affected by the disorder, the company believes that there’s a $2 billion market for the treatment. Meanwhile, EjectDelay® has been shown to improve intra-vaginal ejaculation latency time by 6.4 minutes for the nearly one-in-three men suffering from premature ejaculation.

The Beyond Human™ acquisition brings six commercial products to its portfolio, including the Beyond T Human® Testosterone Booster supplement and the natural Human Growth Agent HGA®. These products generated $400,000 in profit during FY 2015 and management expects them to be immediately accretive to the company.

Improving Financials

Innovus Pharma’s cash position improved drastically with $2.25M raised from institutional investors in July. This is an important signal for Innovus investors as its shows the institutional funds are beginning to take interest in the Company and want to be involved with the company at the early stages of growth.

The Company also reported that its revenues jumped 14.5% during the first quarter of 2016, despite its Beyond Human™ acquisition having an “insignificant” impact on revenue due to the timing of the transaction, and it is expecting between $3-5M in revenues for 2016. With organic revenue growth in place, investors could see strong results during the second quarter and beyond as the Beyond Human™ acquisition appears in its results. The potential approval of FlutiCare™ looms as a possible game-changer long-term.

During a CEOLIVE.TV interview, CEO Dr. Bassam Damaj suggested that the company is on track to reach a cash flow breakeven point by the end of the year and potentially a positive net income by the end of next year. The company’s auditors also removed the “going concern” statement from its financials, which suggests that it remains on solid financial footing. Management believes it has enough cash to last through Q1 2017 at the moment.

Looking Ahead

Biotech investors interested in an under-the-radar micro-cap opportunity may want to consider Innovus Pharma given its numerous upcoming catalysts and improving fundamentals. In terms of upside potential, SeeThruEquity recently issued an update on May 23 giving the stock a $0.91 per share price target, which represents a significant 127% premium over the current price of $0.40.

For more information, visit the company’s website at www.innovuspharma.com or download our free Company Analysis.

Biotricity, Inc. (OTCQB:BTCY), a healthcare technology company dedicated to delivering innovative, medically relevant biometric remote monitoring solutions, has appointed financial professional Norman Betts to the company’s board of directors. An accomplished accountant and professor, Betts also currently serves as a board member for the Bank of Canada, the country’s central bank and the Canadian equivalent to the Federal Reserve. He is the second board member, and first independent, to join Biotricity with others expected to be added during the second quarter.

“Biotricity’s clinical-grade devices are set to disrupt the healthcare paradigm, and the company is on the verge of a significant inflection point as its first product is soon to be submitted for FDA clearance,” said Betts. “The significant dialogue around wearables and their potential to revolutionize healthcare presents a tremendous opportunity for Biotricity. I look forward to working with Waqaas and the entire management team as the company continues to pursue its strategic and financial objectives.”

Betts, an expert in accounting regulations, audits, risk management, governance and oversight, was appointed to the board of directors of the Bank of Canada in June 2014 and currently serves as a member of the audit and finance committee and the pension committee. Betts holds a Fellow Chartered Accountant designation and is also a professor at the University of New Brunswick in Fredericton.

Additionally, Betts was a member of the New Brunswick Legislative Assembly from 1993 to 2003 and held three different cabinet posts, including minister of finance from 1999 to 2001. Prior to entering politics, Betts received a Ph.D. in management with a concentration in accounting and finance from Queen’s University School of Business. He served as assistant dean of the MBA program and professor at the University of New Brunswick. He also was a partner in the accounting firm Shannon, Betts & Buffett.

“I am thrilled to welcome someone of Norman’s caliber to Biotricity’s Board,” said Waqaas Al-Siddiq, founder, president and CEO of Biotricity. “Norman’s financial expertise will be a tremendous asset to Biotricity as we prepare to market our next-generation medical devices and transform how clinical grade data is captured, used and tracked by individuals and health care professionals alike.”

TWEET THIS: @normbetts elected to @biotricity_inc board of directors to help guide company as they prepare to launch revolutionary biometric devices #wearables #medicaldevices

About Biotricity Inc.

Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Biotricity’s R&D continues to focus on the preventative healthcare market, with a vision of putting health management into the hands of the individual. The company aims to support the self-management of critical and chronic conditions with the use of innovative solutions to ease the growing burden on the healthcare system. To learn more, visitwww.biotricity.com.

Important Cautions Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization ofbioflux or any of the Company’s other proposed products or services, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of its products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

Biotricity Inc. (OTCQB: BTCY), a developer of remote patient monitoring solutions with a focus on the cardiovascular market, recently presented at the Microcap Conference that took place on April 11^th and 12^th in Toronto, Canada. At the event, experts touted the importance of a strong management team, strong media traction, and innovative/disruptive technology as the three primary elements for success in the microcap marketplace.

There were 40 different companies that presented at the conference, representing some of the most exciting opportunities in the market today. While many companies focused on the tech sector, Biotricity was highlighted as a company to watch company bridging the gap between healthcare and technology by offering up medical device technologies.

Read more coverage of the event on InvestingNews here:

http://investingnews.com/daily/tech-investing/cybersecurity-investing/the-microcap-conference-notes-from-the-floor/

Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Recently, the company announced that its devices would be used in a study designed to identify early warning signs for illness and promote overall wellness with Rockyview General Hospital.

For more information, visit the company’s website at www.biotricity.com.

Biotricity Inc. (OTCQB: BTCY), a healthcare technology company dedicated to delivering innovative, medically-relevant biometric remote monitoring solutions, recently announced that researchers at Rockyview General Hospital would be using its biometric device in a study to identify early warning signs for illness and to promote overall wellness. In particular, the study will look at heart rate variability to predict the onset of illness in ICU patients.

With many mobile heart rate monitoring having up to a 40% margin of error, Rockyview General Hospital required a medical-grade, high-resolution ECG device with wireless communication capabilities. Biotricity’s device is able to detect small fluctuations in heart rate, which can indicate the onset of a variety of conditions. The four-month study will conclude in April of 2016 and is made possible by the National Research Council of Canada.

Investors in micro- and small-cap wearables companies, such as Lifelogger Technologies Corp. (OTC: LOGG) or Biotelemetry Inc. (NASDAQ: BEAT), may want to take a closer look at the stock given these recent developments as it moves closer to launching its bioflux technology.

Read the entire press release here:

Biotricity, Inc. (BTCY), a healthcare technology company dedicated to delivering innovative, medically relevant biometric remote monitoring solutions, announced that researchers at Rockyview General Hospital are using the company’s biometric device in a study designed to identify early warning sign for illness and to promote over-all wellness.

Researchers at Rockyview General Hospital (RGH), a large 650 bed hospital which is administered by Alberta Health Services (AHS), is using biotricity’s small portable monitors to determine the effectiveness of monitoring heart rate variability (HRV) to predict the onset of illness in intensive care unit (ICU) patients, where patient conditions can change quickly.

Today, the majority of devices that claim to measure heart rate only sample heart rate at intervals, and then produce an average over time. To accurately measure HRV, an electrocardiogram (ECG) is required because this technology is capable of measuring milliseconds between heart beats.

“Most mobile heart rate monitors in use today are extremely inaccurate with a margin of error of up to 40 percent. Because of this, AHS will utilize biotricity’s medical grade, high-resolution ECG and wireless communication capabilities as a perioperative wellness and recovery monitor which we believe will improve outcomes and reduce complications,” said Dr. David Liepert, a University of Calgary professor, anesthesiologist at AHS’ Rockyview General Hospital and lead investigator in the study. “The highly detailed data provided by biotricity’s unique technology is a key factor in our research as it is being used to detect small fluctuations in heart rate, which can indicate the onset of a variety of conditions including cardiovascular disease, stroke, diabetes or sepsis.”

Dr. Liepert research aims to use biotricity’s perioperative wellness monitor in order to follow a patient from pre-surgery, through the procedure, and throughout the recovery process among other uses.  The research team believes the monitor could result in a reduction of post-surgery complications including wound infections and blood clots.

“Monitoring a patient during the 30 days after surgery is very important to ensure a patient’s return to full wellness, getting back to normal activity, and getting back to normal life,” said Liepert.

The four-month study, which concludes in April 2016 and is made possible by a grant from theNational Research Council of Canada, will track HRV and health outcomes in 20 healthy people and 40 intensive care unit patients.

“I decided to participate in the study because it was a unique opportunity to look at how healthy I actually am,” says Anthony Cook, one of the 20 healthy participants in the study. “I like to consider myself a healthy guy but using this heart rate variability device will provide the data to prove it.”

Government and healthcare organizations are focused on driving costs down by shifting to evidence-based healthcare where individuals, especially those suffering from chronic illnesses, engage in self-management and preventative care.

“Our research with Dr. Liepert will drive the development of our next-generation medical devices that provide more detailed, medical grade data while being easy to wear,” Waqaas Al-Siddiq, founder, president and CEO of Biotricity Inc. “biotricity will disrupt how clinical grade data is captured, used and tracked by both sick and healthy people and will be instrumental in helping health care professionals reduce costs and support the move to evidence-based healthcare.”

TWEET THIS: @biotricity_inc helps scientists uncover link between heart rate ECG and onset of illness #wearables #medicaldevices

About Biotricity Inc.

Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. To learn more, visitwww.biotricity.com.

Important Cautions Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization ofbioflux or any of the Company’s other proposed products or services, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of its products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

OxySure Therapeutics Inc. (OTCQB: OXYS), a global leader and medical device innovator of life-saving, easy-to-use emergency medical oxygen and other products, recently announced that BUYINS.NET has updated their coverage and released the latest short sale data through March 11, 2016. The data shows that approximately 34.05% of daily trading volume is short selling and the SqueezeTrigger price for all shares shorted is $0.47, where a short squeeze could occur.

Regulation SHO requires bona-fide market-making activities to include making purchases and sales in roughly comparable amounts. Furthermore, market-making activities are not to include activity related to speculative selling strategies for investment purposes of the broker-dealer. BUYINS.NET continuously monitors the stock’s market-makers for daily compliance with the Fair Market-Making Requirements in order to ensure everything is above-board.

A short squeeze occurs when the price of a stock begins to rise above the short sale point, which creates losses for those short selling the stock. Since short selling must repurchase the stock they borrowed and sold, they are exposed to unlimited losses as the stock price rises. Short sellers must buy stock in order to cover their positions, which tends to increase the stock’s price and accelerate losses for other short sellers – causing a squeeze.

Read the entire press release discussing the report here:

OxySure Therapeutics, Inc. (OXYS) (“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative emergency medical solutions, today announced BUYINS.NET (http://www.buyins.net), a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has updated coverage on OxySure Therapeutics (OXYS) after releasing the latest short sale data through March 11, 2016. The total aggregate number of shares shorted since June 2012 is approximately 16.75 million shares. Approximately 34.05% of daily trading volume is short selling. The SqueezeTrigger price for all OXYS shares shorted is $0.47. A short squeeze is expected to begin when shares of OXYS close above the $0.47 SqueezeTrigger price.

Click for original Report: http://www.buyins.com/reports/oxys6-8-15.pdf

Click for updated SqueezeTrigger: http://www.buyins.com/images2/oxysstr3-13-16.jpg

Click for updated Friction Factor: http://www.buyins.com/images2/oxysff3-13-16.jpg

Click here for detailed explanation: http://www.buyins.com/brochure.pdf

Friction Factor calculates if a fair market is being made in the shares of OXYS. 39% of the previous 38 trading days have been positive or bullish-biased and 61% have been negative or bearish-biased.

Regulation SHO requires bona-fide market-making activities to include making purchases and sales in roughly comparable amounts. The Commission has stated that bona-fide market-making DOES NOT include activity that is related to speculative selling strategies for investment purposes of the broker-dealer and is disproportionate to the usual market making patterns or practices of the broker-dealer in that security. Likewise, where a market-maker posts continually at or near the best offer, but does not also post at or near the best bid, the market-maker’s activities would not generally qualify as bona-fide market-making. Moreover, a market-maker that continually executes short sales away from its posted quotes would generally not be considered to be engaging in bona-fide market-making.

BUYINS.NET monitors OXYS market-makers daily for compliance with Fair Market-Making Requirements.

About BUYINS.NET

BUYINS.NET (http://www.buyins.net) monitors trading in all US stocks in real time and maintains massive databases of short sale and naked short sale time and sales data, short squeeze SqueezeTrigger prices, market-maker price movements, shareholder data, statistical data on earnings, sector correlation, seasonality, hedge fund trading strategies and comparable valuations.

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products. www.OxySure.com

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

DISCLAIMER:

BUYINS.NET is not a registered investment adviser and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Company has paid a non-affiliate $1,117 per month for the first month of data provided in this report. OXYS has not approved the statements made in this release. Please read our report and visit our web site,http://www.buyins.net, for complete risks and disclosures.

Leveraging a fitness trend that started in the late 1980s, Fitbit Inc. (NYSE:FIT), maker of wristband devices to track exercise with an eye toward personal activities like walking, climbing, caloric burn and sleep quality, has been top in its category of wearable technology for individual health. After an IPO in June 2015, already with several products commercialized, Fitbit premiered in the public market with a first-day trading stock price that closed more than 50% above its original price.

In the months that followed, Fitbit performed exceptionally well. Sales from the year ended December 31, 2015 grew 150% over the prior time period, to $1.8 billion. Adoption of products was widespread. People between the ages of 25 and 45 years yearned to monitor their personal progress to defined fitness goals.

Much of this allure came from investors’ view of Fitbit as the perfect device to convey to physicians their ongoing preventative care efforts, through indications of potential heart trouble. Expectation of Fitbit’s success in medical monitoring brought shares to over $50, recognizing the large market for cardiovascular conditions and how possibly avoided, dropping healthcare costs to a reasonable level.

Although Fitbit may see future revenue and stock price gains given a global demand in health and fitness, recent events to harness heart disease did not pan out. Investors, realizing Fitbit’s wristband metrics were inadequate to correctly gauge such a dangerous and tenuous illness, fled from the stock in droves. Shares fell from a high of $51.90 on August 5th, 2015, to its current price of around $13, a market capitalization cut of over $2 billion. Price targets and revenue estimates fell. Class action lawsuits began to pile up, citing inaccurate heart tracking leading to hazardous health conditions.

Demand for more sophisticated heart rate measurements, and other vital medical metrics, has been supplied by Biotricity Inc. (BTCY), a company whose medical remote monitoring systems follow and record heart events in real-time, easily and effectively used by doctors and hospitals. As a global killer, cardiovascular disease affects 30 million people in the US alone. Onset of diabetes and rise in obesity, two demographic offenses, make this worse.

Biotricity developed a new type of remote heart rate monitor that stands technologically far above what Fitbit could produce; its design is supported by years of biomedical and wireless engineering talent. Its scientific and advisory board is world-class. Biotricity makes a new generation device for mobile cardiac telemetry, where a cardiac patient is freed from the confines of a hospital or clinic to monitor for dangerous arrhythmias, heart beats that can kill if not detected.

Much progress has been made by Biotricity in the past year: Software and monitor are FDA-approved with official launch into commercial markets this summer. Partnerships have been formed to facilitate US entrance with almost 500 embedded customers. Reimbursement is set, under a strategic solution where Biotricity creates its monitoring devices around current reimbursement codes.

Not stopping there, Biotricity plans a ‘life-style’ device to incorporate telemetry with more human interaction, via social networking, to affect improvement in the patient non-compliance multi-billion dollar market. This blends nicely with Biotricity’s vision of participating in preventative care.

Marketing of Biotricity’s devices and software will commence next year, targeting thousands of users – doctors and hospitals seeking better ways to monitor patients toward optimal health. Unlike competitors, Biotricity will seek partnerships with remote heart rate monitor providers to produce revenue, expected as early as third quarter this year.

Fitbit trades at a high valuation; albeit lowered significantly in recent months because its promise of medical monitoring is not deliverable. Biotricity will fill that burgeoning market need and its stock should rise accordingly as client base can be viewed as essentially equal – individuals who care about their health.

OxySure Therapeutics Inc. (OTCQB: OXYS), a global leader and medical device innovator of life-saving, easy-to-use emergency medical oxygen products, recently announced the launch of an e-commerce website focused on cardiac safety products. These products include its AEDs, emergency oxygen devices, and related accessories and supplies that can be quickly and easily purchased online rather than through in-person channels or distributors.

The move marks the first step in its e-retail strategy designed to complement its offline solutions and institutional customers. With companies like Amazon.com Inc. (NASDAQ: AMZN) and Shopify.com Inc. (NYSE: SHOP) reporting tremendous growth in online shopping, the move could help the micro-cap company expand its offerings to a much wider customer base over time.

Analysts believe that OxySure could be valued at between $1.90 to $2.30 per share, which is significantly higher than its current valuation of just $0.12 per share. With growing revenue and plans to up-list to a national exchange, investors in companies like SANUWAVE Health Inc. (OTCQB: SNWV) or Biomerica Inc. (OTCQB: BMRA) may want to take a closer look at the stock as it launches another initiative designed to enhance its revenue growth.

Read the entire press release here:

OxySure Therapeutics, Inc. (OXYS) (“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative emergency medical solutions today announced the launch a new cardiac safety e-commerce retail website.

The website is located at www.AED-Oxygen.com and allows for the quick and easy purchase and checkout of Automated External Defibrillators (AEDs), OxySure emergency oxygen devices and all related accessories and supplies.

“Our customers, partners and stakeholders have spoken, and we have listened,” stated Julian Ross, CEO of OxySure. “There has been a steady call for a website that offers a way for retail customers to buy our innovative and lifesaving products from a website that is simple, easy to navigate and quick to check out. We are excited about AED-Oxygen.com and we plan to drive enormous amounts of traffic to this site.”

AED-Oxygen offers all the major AED brands, including Philips, Cardiac Science, Physio Control, Defibtech, and HeartSine. Customers can also easily buy accessories for these AEDs, such as batteries, pads and AED wall cabinets. In addition, the site offers the OxySure Model 615 emergency oxygen device to place as a companion product next to an AED, as well as display wallboxes, resuscitation bags, pulse oximeters and other related medical items. Other features and benefits offered by the site include:

• Free shipping for orders shipped to all addresses in the contiguous USA
• Shipping to international destinations
• Acceptance of all credit cards and Paypal
• Secure shopping with SSL encryption
• Mobile friendly

The Company also announced a launch discount to the first 100 customers to purchase from the website. The discount is obtained by applying coupon code LAUNCH10 upon checkout.

Ross added: “This is the first in a series of steps we are executing relative to the implementation of our e-retail strategy. And our e-retail strategy complements our distribution and sales operations very well as they focus on developing offline solutions for our institutional customers. We are already working on our next stellar online property.”

According to Statistica.com the growth in online shopping will rocket in the next several years. In 2013, global e-retail sales amounted to 839.8 billion U.S. dollars and projections show a growth of up to 1.5 trillion U.S. dollars by 2018. The U.S. is currently the largest regional market for online shopping, with sales worth some 126 billion U.S. dollars reported in 2013, more than double the amount in 2008.

About AED-Oxygen.com

AED-Oxygen.com is a division of OxySure Therapeutics, Inc. (OXYS). AED-Oxygen is a premier online store focused on cardiac and respiratory medical safety and resuscitation equipment and supplies at highly competitive prices. The website offers all AED brands, including Philips, Cardiac Science, Physio Control, Defibtech, and HeartSine. In addition, customers can purchase OxySure Model 615 emergency oxygen device, OxySure cartridges, pulse oximeters, display wallboxes (including double wallboxes designed to house both an AED and an oxygen device), wall signage, batteries, pads, resuscitation bags, and many more. www.AED-Oxygen.com

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products.www.OxySure.com

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

Right now there is hypochlorous acid, or HOCl, on the immunological front lines in the bodies of people fighting infections, doing its job as an inorganic bactericidal compound of the innate immune system to destroy a wide spectrum of pathogens. Although still not used as a pharmaceutical drug, the important role of hypochlorous acid in biology is only recently emerging, in addition to its well-documented germicidal properties.  For example, research by Serhan Sakarya, MD, et al. shows that HOCl in stable form is an ideal wound care solution with a powerful and rapid killing effect on different types of microorganisms, biofilms and microbicidal effect within the biofilm.

This and other research squares with what distinguished dermatology experts recently had to say about the Microcyn-based products of Oculus Innovative Sciences (NASDAQ: OCLS).  The Microcyn-based franchise includes products generated through a patented electrochemical treatment of dilute saltwater, which creates a pH neutral solution of hypochlorous acid that is similar in nature to the potent natural HOCl in the human body.  These products, branded as Alevicyn and Celacyn, have FDA clearance for use as treatments for wound healing, scar management and more.

Speaking at a virtual round table hosted by Maxim Group discussing breakthroughs in dermatology, Dr. Adam Friedman explained that hypochlorous acid has historically been acknowledged for its antiseptic properties, “But the truth is, it’s much more than that” and it “can have a very important role in modulating and regulating the immune system.”  Dr. Friedman is an Associate Professor of Dermatology at the George Washington School of Medicine and author of more than 140 published papers and two textbooks with an emphasis on emerging medical technologies.

He detailed the ability of hypochlorous acid to directly interact with proteins to minimize inflammation and itch, including activating alpha-2-macroglobulin from an inactive state to “a sponge gobbling up numerous inflammatory mediators as well as pro-itch mediators.”  Published in the peer-reviewed journal The Journal of Clinical Investigation, Thomas Leung, et al. discovered that hypochlorite, the sodium salt of HOCl, reversibly inhibited the expression of CCL2 and SOD2, two Nuclear factor-?B (NF-?B)–dependent genes, a culprit in inflammatory diseases.  In conditions such as atopic dermatitis (eczema), controlling inflammation and itch is critical.  In some eczema cases, the itch can be so intense that the sufferer can’t sleep, while skin lesions caused by scratching can lead to infection.

A natural pathogen destroyer, hypochlorous acid has been an unsung hero for its multiple roles in treating dermatological conditions.  Even though not designated as an antibiotic, the unique mechanism of action of hypochlorous acid to swiftly and thoroughly destroy bacteria makes it virtually impossible for resistance to develop, according to Dr. Friedman.  Drug resistance has become a hot button topic with governments and global agencies, including President Barack Obama and the World Health Organization, calling for immediate action to combat antibiotic resistance before the world returns to the antibiotic dark ages.

“[It’s] not just about killing bacteria, but it’s actually modulating the dysregulation of these various pro-itch, pro-inflammatory mediators,” explains Dr. Friedman.

Dr. Neal Bhatia, Associate Clinical Professor and Interim Program Director in the Department of Dermatology at Harbor-UCLA Medical Center in Los Angeles, says both dermatologists and non-derms often have a knee-jerk reaction to use topical steroids as adjunctive treatments for itch and symptomatic relief of conditions such as actinic keratosis.  These practices “unfortunately, will undo the inflammatory benefits that we’re trying to accomplish,” according to Dr. Bhatia.  Dr. Bhatia is a prescriber of Alevicyn and has been published on the product and its efficacy.

Dr. Bhatia sees many tie-ins as to the benefits of Microcyn products by addressing basic symptoms while tackling issues with drug resistance and the lack of good topical antibiotics in the derm space to provide “a long-term benefit without any sort of consequence.”

Derm doctors may have been realizing the benefits of hypochlorous acid without actually recognizing it, as natural hypochlorous acid is, in a rudimentary sense, similar to diluted bleach, though diluted bleach is unstable and more reactive in nature.  “Bleach baths,” soaking in a tub with diluted common bleach, are frequently used to treat moderate to severe eczema, but are inefficient and carry risk because if not mixed properly, the bath can further irritate already sensitive skin.  To get the greatest benefit and capitalize on hypochlorous acid, the right set up and delivery system of a stable molecule is necessary, such as that with Microcyn-based products.

Dr. Firas George Hougeir, a board certified Dermatologist as well as Fellow of the American Society for Mohs Surgery, elucidated on additional benefits of Oculus products in his areas of expertise in both surgical and non-surgical applications.

Adoption of new products in wound healing and scar management is of particular importance today considering the American Academy of Dermatology is calling for patients to avoid antibiotics following biopsies, Mohs surgery and even standard excisions.  Dr. Hougeir, who already avoids antibiotics as much as possible, shares this sentiment, stating, “there’s absolutely no proof that using an antibiotic decreases the rate of infection any more than using, for example, Vaseline.”

In Mohs micrographic surgery, layers of skin are removed one by one to eradicate cancerous tissue, leaving only healthy cells intact.  Mohs is the most effective technique for removing Basal Cell Carcinoma and Squamous Cell Carcinoma and its use is widening into other types of skin cancer.  The surgery is often done on the face and the wounds are left open, so decreasing the odds of infection developing and promoting optimal healing is paramount.  Dr. Hougeir, who commented that he doesn’t believe hypochlorous acid is bleach in any way, thinks that once dermatologists and surgeons start to understand the multiple facets to hypochlorous acid (antipruritic, anti-inflammatory, debridement, increased oxygenation, safety, etc.) that it will be used “very, very much more commonly.”

Part of broader acceptance could be driven by the Microcyn-based products serving as a viable option to steroids or, at the very least, an adjunct therapy to reduce steroid use.  On the wound sealing front, results from Celacyn, a hypochlorous acid combination with a modified silicone dimethicone, are shown to be comparable to more expensive full silicones with added benefits that full silicones lack.

As early adopters, Dr. Friedman believes that once dermatologists and surgeons are educated on the underlying mechanisms of hypochlorous acid that they will “connect the dots very quickly.”  Dermatologist are faced with endless substitutions for things that don’t work and more “me too” drugs than novel technology at a ratio that can’t even be described, according to Dr. Friedman.   Oculus’s products are an answer to these challenges, and at a reasonable price.

Potential uses go well outside the parameters of dermatology and surgical centers, expanding into wound healing centers and for itch related to indications such as renal failure, liver disease, hematologic problems and malignancy.  Many people discount pruritus (severe itch of the skin) and the reality that it is an actual disease as defined by the American Academy of Dermatology and associated with primary skin disease, underlying medical problems and side effect of medications.  Yet, there are very few effective options for patients.  Dr. Friedman says he uses Alevicyn for many different types of itch and sees that it works “across the board” because of its mechanism of action to attack the problem from every angle.

Dr. Friedman’s passion shone in his concluding statement, “If you could stop the patient’s pruritus, you stop their itch, which is driving them crazy, to changing their day-to-day; change their ability to interact with people, work, sleep just that one person, you’ve made a huge difference and that’s why we need products like this and it’s great that we have it available to us.”

Investors in companies that have been pursuing approvals in the dermatology space, such as Vitae Pharmaceuticals (NASDAQ: VTAE), Vanda Pharmaceuticals (NASDAQ: VNDA) and Aquinox Pharmaceuticals (NASDAQ: AQXP) may want to perform some due diligence here. Oculus Innovative Sciences has developed a platform technology with applications across indications, and dermatology experts have been seeing very positive results with their patients.

OxySure Therapeutics Inc. (OTCQB: OXYS) has grown its revenue for an impressive 15 consecutive quarters. While several analysts have taken note, setting price targets ranging from $1.90 to $2.30 per share, the stock has traded largely under-the-radar at just $0.17 per share.

The company trades at just 1.8x trailing 12-month revenue and 2.7x book value. By comparison, Cardica, Inc. (NASDAQ: CRDC), a larger company but one that has similar revenues in the medical equipment manufacturer space, trades at 82.5x trailing 12-month revenue and 10.5x book value.

In this article, we’ll take a look at some of the company’s recent progress and where it may be headed over the coming years.

Paving the Way

OxySure doubled its production capacity in early February in order to address its rapidly increasing backlog of orders. During the third quarter of 2015, the company’s net receivables jumped to $1,234,000 from $1,159,000 during the second quarter and $878,000 during the first quarter. These net receivables have been growing at a 10.3% compounded growth rate over the past four quarters and appear positioned to continue growing ahead.

“Through recent investments in infrastructure and additional manufacturing staff, we were able to reduce our current backlog from two months to one month,” said OxySure Production Manager Richard Bryant in a February 10^th press release. “We plan to further add additional production capacity by adding some anticipating process changes, as well as further acquisitions of equipment and additional manufacturing staff.”

These investments have been supported through the City of Frisco’s Economic Development Corporation and Sinacola Commercial – its landlord. This year, the company received the fifth of five incentives from the city designed to boost capital investment and job growth. These incentives helped management build up a multi-million dollar company that employs a growing number of people in the emergency medical industry.

Focus on Profits

OxySure’s revenues jumped nearly 40% during the third quarter of 2015, putting it on track for a $5 million run-rate moving into the new year. According to Julian T. Ross, Chairman and CEO, this run rate will accelerate to $10 million in 2016 and facilitate a breakeven on a cash flow basis.

On the product level, the company’s growing client base is having a positive effect on its revenue mix. One-time unit sales may provide a nice boost to total revenue, but recurring revenue from the sale of replacement cartridges provider higher margins. In addition, the company’s efforts to cross-sell products manufactured by other companies could have a similar impact on margins and bolster overall profitability over the long-term.

In early February, the company signed a supply agreement with ORS Nasco to offer complementary products to its institutional customers seeking a single source for their medical emergency preparedness. These products include first aid supplies, respiratory products, heat stress protection, eye protection, and many other product lines. Through this agreement, there are ample opportunities for revenue and margin expansion.

Looking Ahead

OxySure has made significant progress in building up its revenue over the past several years, but recent developments could accelerate this growth over the coming quarters. Investors in small-cap biotech stocks, like Allied Healthcare Products Inc. (NASDAQ: AHPI) and Akers Bioscience Inc. (NASDAQ: AKER), may want to take a look at the company given these recent developments.

For more information, visit the company’s website at www.oxysure.com.

Antibiotic resistance is the phenomenon where microorganisms adapt to antibiotic drugs, rendering the drugs ineffective in destroying the bacteria they were designed to kill.  The World Health Organization has called antibiotic resistance a “global health crisis” and “one of the greatest challenges for public health today.”  In November, WHO launched the first World Antibiotic Awareness Week in a bid to better educate people worldwide on how to best slow the growth of antibiotic resistance.

Antibiotics are used to treat a vast array of bacterial infections, such as skin/wound infections, pneumonia, strep throat, urinary infections and meningitis.  For more than 50 years, antibiotics have also been used to treat skin conditions like acne and rosacea, perhaps more than people realize.  In fact, even though dermatologists make up only one percent of U.S. physicians, they account for five percent of all antibiotic prescriptions.  This lengthy exposure, in combination with overuse and misuse, has the potential to contribute to the antibiotic resistance problem, a fact dermatologists are much more mindful of today.

Acne, For Example

A known cause of acne is the bacteria Propionibacterium acnes (P. acnes), an anaerobic, gram-positive bacterium that is part of the skin flora.  In a ten-year study in England, researchers discovered that the percent of patients carrying P. acnes strains that were resistant to commonly used anti-acne antibiotics, such as erythromycin and clindamycin, rose from 34.5 percent in 1991 to 55.5 percent in 2000.  The implications can run deep, considering that anti-acne drugs like clindamycin and doxycycline are also used to treat serious forms of Methicillin-resistant Staphylococcus aureus (MRSA) infections.

As noted in a recent article in Dermatology Today, antibiotics remain a staple in skin care, but dermatologists are also employing alternatives and combination therapies, a proactive approach to improve outcomes and help limit the development of antibiotic resistance.  Combinations often involve topical and systemic treatments that leverage both antibiotic and anti-inflammatory properties of products to treat skin conditions.  Long-standing drugs like erythromycin and clindamycin are available in topical formulations and are known to be effective acne treatments.  However, as noted in the Acne Guidance of the American Academy of Dermatology, “the use of these agents alone can be associated with the development of bacterial resistance.”

Studies show that resistant strains of P. acnes can emerge in as little as eight weeks of topical antibiotic monotherapy.  Utilizing complementary drugs with different mechanisms of action can deliver a clinically meaningful effect on slowing resistance development.  Ideally, it makes sense for dermatologists to use a multimodal approach, prescribing different drugs initially and then transitioning to non-antibiotic topicals.

Retinoids

Topical retinoids, drugs that are related to Vitamin A, are important as a front-line treatment for acne.  They work by unplugging clogged hair follicles that are at the root of acne, which also allows other medicines, such as topical antibiotics, to be more effective.   Topical retinoids include Nestle subsidiary Galderma’s Differin (adapalene), Allergan’s (NYSE: AGN) Tazorac (tazarotene) and tretinoin, which is marketed under many brand names and listed on the World Health Organization’s List of Essential Medicines.

Retinoids, as an oral therapy for severe acne, came under scrutiny through isotretinoin, an effective, albeit sometimes controversial, drug. The drug was developed by Roche Pharmaceuticals (OTC: RHHBY) and eventually marketed as Accutane before Roche pulled it from the market over safety concerns in 2009, namely related to birth defects and inflammatory bowel disease.  However, follow-on studies painted a clearer picture as to the potential side effects and led to increasing usage today.  Roche’s patents on isotretinoin expired in 2002 and the drug is now available under multiple brand names, including Absorica by Mylan (NASDAQ: MYL) and Claravis by Teva (NYSE: TEVA).  Because of systemic toxicity and potential side effects, isotretinoin is still only meant to be used once other treatment options have been exhausted.

New Approaches

New medicines are available, or coming down the pipeline, that take a different route in treating acne.  Derm companies in this space are looking to provide better and safer treatment options and take a piece of a market forecast by Research and Markets to reach $3.02 billion in 2016.

Oculus Innovative Sciences (NASDAQ: OCLS) has built a portfolio of dermatology products founded upon its Microcyn® Technology to treat conditions by reducing infections, itch, pain, scarring and harmful inflammatory responses.  These are all responses that need to be addressed in many skin conditions, including acne.  The science of Microcyn centers on manufacturing a pH neutral solution of hypochlorous acid (HOCl), a natural bactericidal acid created on demand by the body’s white blood cells or neutrophils.  Published research shows that in an 89-patient clinical study Microcyn outperformed the commonly used acne treatment benzyl peroxide in reducing inflammation of lesions, although the improvement was not considered statistically significant and a larger trial is needed.

Importantly, HOCl has demonstrated to be potent and fast acting through targeting non-specific biomolecules on bacterial cell membrane. It is widely documented that HOCl readily reacts with a wide range of biomolecules including DNA strands, RNA strands, fatty acid groups, cholesterol and proteins amongst others. It is a highly reactive compound and upon reaction it is completely rendered neutral. Unlike antibiotics, and specifically the use of topical antibiotics, the potency of HOCl and the damage delivered to bacterial cell membranes without specificity, as reported by McKenna in 1988, infer a lack of resistance. Oculus strongly believes HOCl’s mechanism of action, as opposed to the mechanism for antibiotics, drastically reduces the potential for emergence of new superbugs.

Oculus’ GramaDerm Solution and GramaDerm Hydrogel have been approved for use in Europe, with both products commercialized overseas in November as a new topical treatment of mild-to-moderate acne.  GramaDerm’s marketing literature hammers three messages: (1) terrific kill times against P. acne, (2) reduction of inflammation with solid supporting clinical evidence and (3) no resistance issues due to HOCl’s unique mechanism of action.

Stateside, the FDA has so far given its blessing to Oculus products for atopic dermatitis (eczema), scar and advanced wound management and animal healthcare applications.  Oculus also markets doxycycline monohydrate capsules, indicated “to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules (commonly used for moderate-to-severe acne) and other antibacterial drugs” used to treat bacterial infections.

Oculus and Maxim Group are teaming up to host a conference call with dermatology experts on Thursday, Feb. 25 to discuss these and other derm treatment issues. Details can be found here. One of the experts, Dr. Adam Friedman, recently penned an interesting piece in The Lancet, further discussing the drug resistance issue.

Dermira (NASDAQ: DERM) has in its pipeline DRM01, a novel, topical sebum production inhibitor currently in clinical development for the treatment of acne.  Sebum is an oily matter produced by sebaceous glands in the skin that when overproduced are known to play a key role in the pathogenesis of acne.  Sebum inhibition is known to improve acne, but the only approved drug that does this is the aforementioned oral version of isotretinoin.  DRM01 targets acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, which represent an essential component of sebum.  Because the drug acts in a dose-dependent manner, Dermira is attempting to determine the optimal dosing level in a Phase 2b trial currently.

Also in this space, the company has completed early clinical research on a topical PDE4 inhibitor dubbed DRM02 for the treatment of inflammatory skin diseases, such as atopic dermatitis, psoriasis and rosacea.  DRM05 is Dermira’s novel, topical photodynamic therapy in preclinical development for the treatment of acne.

One of the lead products of Foamix Pharmaceuticals (NASDAQ: FOMX) is FMX101, a novel topical foam formulation of minocycline for treating moderate-to-severe acne.  FMX101 delivers minocycline directly to the acne-infected sebaceous glands in the skin.  A 150-patient, 12-week Phase 2 trial showed clinically and statistically significant efficacy for patients taking FMX101 compared to the control group (taking either Solodyn, Epiduo or Aczone).  The data on FMX101-treated patients showed sharp improvements in both inflammatory and non-inflammatory lesions at six and 12 weeks, respectively, without any drug-related systemic side effects.  Larger, Phase 3 trials are expected in 2016.

In October, a Phase 2 trial began evaluating FMX103 in people with moderate-to-severe papulopustular rosacea.  Israel-based Foamix is also planning to initiate Phase 3 research of FMX102 as a new treatment for impetigo, a contagious bacterial skin infection that primarily affects young children and is typically caused by staphylococcus aureus, including MRSA.

Acne is a convenient example to demonstrate the importance of developing new drugs to avoid a post-antibiotic world, as even a common condition like acne highlights how often used drugs become ineffective.  Because it is not life-threatening like cancer or heart diseases, it is a condition that most probably don’t consider when pondering the problem of antibiotic resistance.  It also serves to show the changing dynamic to tackle the issue through innovation and combination therapies that utilize different pathways to lessen the dependence on antibiotics, a tactic that needs to make its way into other dermatological conditions.

Pressure BioSciences, Inc. (OTCQB: PBIO), a developer of proprietary laboratory instrumentation and associated consumables based on its game-changing Pressure Cycling Technology (“PCT”) platform, recently announced an exclusive co-marketing deal with SCIEX, a wholly-owned subsidiary of the $60B Danaher Corporation (NYSE: DHR), and a global leader in life science analytical technologies.  SCIEX and PBIO plan to jointly promote PBIO’s PCT-based sample preparation systems and SCIEX’s top-of-the-line mass spectrometry equipment to generate superior insights for the life sciences industry, particularly in the proteomics (protein) discovery field.

With initial orders from this agreement already coming in the door, the company appears well positioned to grow its revenue and recurring cash flow over time. Management’s plans to up-list from the OTC Markets to the NASDAQ or NYSE exchange during the first half of this year could help bring retail and institutional investor attention to the stock at the same time. Institutional investor support, something the company has been without since its inception, could create a significant and compelling catalyst for all investors.

Fast Initial Sales

SCIEX recently announced an alliance with Children’s Medical Research Institute (“CMRI”) to equip The Australian Cancer Research Foundation International Centre for the Proteome of Cancer (“ProCan™”) facility with state-of-the-art protein profiling instruments and other tools and solutions required for the advancement of their large-scale proteomic profiling studies. The studies will profile thousands of tumor samples per year, enable discoveries around the causes of cancer, provide guidance on cancer treatment options, and work to produce standard operating procedures in cancer testing worldwide.

With the co-marketing agreement in place, ProCan™ will access Pressure Bio’s PCT-based technology for increased protein quantitation and reproducibility. The exact terms of the deal weren’t disclosed, but the agreement could generate the first major sale of PCT technology as a part of the co-marketing agreement just weeks after it was put into place. With both upfront investment in the company’s proprietary instruments and ongoing disposable purchases in the tens of thousands of units, the company’s PCT product line generates attractive recurring revenue for shareholders, at historically excellent gross margins.

Pressure Bio’s PCT platform maximizes proteome coverage in samples, particularly when dealing with the small tissue biopsies associated with clinical tumor samples. In the past, these small sizes limited the use of mass spectrometry-based proteomics in clinical research. However, the addition of PBIO’s PCT platform to SCIEX’s SWATH mass spectrometry system (PCT-SWATH) will enable these researchers to use very small amounts of tissue, accurately process them in a couple of hours, and generate large amounts of actionable data that was not attainable before by mass spectrometry. With increased depth and reliability, researchers may be able to significantly expand their knowledgebase in these critical areas of cancer research.

Setting the Stage

The CMRI alliance clearly illustrates the SCIEX co-marketing agreement’s enormous potential to expand PBI’s sales over time. In just a few weeks, the company has already generated orders and significant press coverage that it has struggled to achieve in the past. SCIEX’s team of sales and marketing personnel and worldwide distribution network has created a virtual sales force for the company’s products without the heavy costs associated with building and running such a worldwide sales and marketing team.

CMRI is also likely to be just the start of something much bigger. In a January 12^th SCIEX press release, Professor Ruedi Aebersold, Director of the Institute of Molecular Systems Biology at the ETH in Zurich, Switzerland, and a worldwide expert in the field of proteomics, said that PCT-SWATH “should increase the chance for biomarker discovery, potentially leading to significant improvements in healthcare, including personalized medicine.”

The increased attention could also spur competitors like Thermo Fischer Scientific Inc. (NYSE: TMO) and Waters Corporation (NYSE: WAT) to pursue their own agreements with Pressure BioSciences down the road to enhance their own product offerings. Other companies like Qiagen NV (NASDAQ: QGEN) and Agilent Technologies Inc. (NYSE: A) also have an interest in new sample preparation technologies that could benefit their own businesses. With a modest market cap of $7 million, the company could become a buyout target in some of these cases.

Upcoming Catalysts

Pressure BioSciences plans to up-list to the NASDAQ or NYSE in the first half of this year, which could significantly expand its visibility in the financial markets. Since many retail and institutional investors aren’t permitted or aren’t willing to buy over-the-counter securities, the up-list move could open the door to greater liquidity and a wider investment base. The simultaneous increase in revenue and visibility in its customer end-markets could amplify these effects throughout the remainder of the year and into 2017, and ultimately help generate significant value for PBIO shareholders.

Investors in companies like NanoString Technologies (NASDAQ: NSTG), which specializes in genomic sampling technology; NeoGenomics (NASDAQ: NEO), which provides cancer-focused genetic and molecular testing; and Protea Biosciences Group (OTC: PRGB), which provides small molecule and tissue analytics services, may want to keep an eye on this unique opportunity.

For more information, visit the company’s website at www.pressurebiosciences.com.

OxySure Therapeutics Inc. (OTCQB: OXYS), a global leader and medical device innovator of life-saving, easy-to-use emergency medical products with its “oxygen from powder” technology, recently announced that it has received the fifth of five economic incentives from the City of Frisco through the Frisco Economic Development Corporation. These incentives and assistance with from its landlord were instrumental in building out its production and distribution facility.

During its third quarter financial results, the company reported its 14th consecutive quarter of revenue growth with a run rate approaching $5 million. Management also announced a number of significant milestones including progress towards an uplisting to the NASDAQ that’s expected this year and the launch of new products through key partnerships. Its Quickclot® product launch, for example, could compete with Arch Therapeutics Inc.’s (OTCBB: ARCH) AC5™.

Biotech investors may want to take note, including companies like Invivo Therapeutics Holdings Corp. (NASDAQ: NVIV), as analysts see the stock reaching $1.90 to $2.30 per share. With the stock trading at just $0.19, this could mean significant upside for investors.

Read the entire press release here:

OxySure Therapeutics, Inc. (OXYS)(“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative emergency medical solutions, today announces that the Company has received the fifth of five economic incentives from the City of Frisco through the Frisco Economic Development Corporation (“FEDC”).

The FEDC has provided OxySure a significant incentive over five years, designed to incentivize capital investment and job growth in the City. Through these incentives and with the assistance of the Company’s landlord Sinacola Commercial, OxySure has developed a multi-million dollar, purpose built production and distribution facility in the City of Frisco, where the Company produces the innovative OxySure Model 615 emergency oxygen device.

Julian Ross, CEO of OxySure, stated: “We are grateful for the support we have received from the FEDC and we are proud of the manufacturing capability our facility now has to offer. We look forward to leveraging our platform as we continue to expand our business.”

“The Frisco EDC is glad to see the continued growth of OxySure Therapeutics, Inc. as a home-grown company that graduated from Frisco’s NTEC business accelerator,” said Jim Gandy, President of the Frisco EDC. “We wish OxySure continued success in growing the company.”

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products. www.OxySure.com

About the Frisco EDC

The Frisco Economic Development Corporation (FEDC) was created in 1991, when Frisco voters approved a half-cent sales tax to fund economic development in the city. The FEDC operates as a Texas non-profit corporation and is governed by a seven-member board of directors appointed by the Frisco City Council. Job number one is creating jobs, as the FEDC’s mission is to improve the economic opportunities and quality of life for all Frisco residents. Since its establishment, the FEDC has facilitated every major economic development project in the city of Frisco, resulting in more than 340 projects that have the potential to occupy over 44 million square feet of commercial space, generate new capital investment in excess of $7.6 billion, and create or retain more than 77,000 potential direct jobs in the city of Frisco.

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-lookingstatements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

OxySure Therapeutics Inc. (OTCQB: OXYS), a global leader and medical device innovator of easy-to-use emergency oxygen products leveraging its “oxygen from powder” technology, recently announced that it has doubled its production capacity in response to a rapidly increasing backlog. By adding capacity, changing processes, acquiring equipment, and staffing up, the company hopes to reduce its backlog from two months to one month.

The move comes shortly after the company appointed a new territory sales managers in South Florida and partnered with MedOne Capital to provide leasing options to its customers. Through efforts like these, the company has been able to expand its revenue base and reach new customers with its innovative technology. The company also signed an agreement with ORS Nasco to diversify its product offering when it comes to related solutions.

Investors in the small- and micro-cap medical device space, including Wright Medical Group Inc. (NASDAQ: WMGI) and Mediwound Ltd. (NADSAQ: MDWD), may want to take a closer look at the stock. With revenue scaling higher, analysts are projecting that the stock could soar to between $1.90 and $2.30 per share from its current price of less than $1.

Read the entire press release here:

OxySure Therapeutics, Inc. (OXYS) (“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative emergency medical solutions, today announced that the Company has doubled its production capacity in response to a rapidly increasing backlog.

Said Richard Bryant, OxySure’s Production Manager: “Through recent investments in infrastructure and additional manufacturing staff we were able to reduce our current backlog from two months to one month. We plan to further add additional production capacity by adding some anticipated process changes, as well as further acquisitions of equipment and additional manufacturing staff.”

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products. www.OxySure.com

 Forward-Looking Statements

 Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

2016 has been brutal for many sectors, but perhaps none so much as for biotechnology and pharmaceutical companies.  For instance, the Nasdaq Biotechnology Index has been clubbed from 3,550 at the end of December to around 2,550, for a loss of roughly 28 percent.  A wider view shows that this sector has been languishing since NBI hit an all-time high of 4,195 in July 2015.  Given a $200 million market cap minimum for the index, components are diverse in size, ranging from a giant like Celgene (NASDAQ: CELG) to much smaller companies, such as NeuroDerm (NASDAQ: NDRM) and Flexion Therapeutics (NASDAQ: FLXN), demonstrating how broad the sell-off has been.

Investors have been hitting the sell button with little discrimination, employing the adage of the baby being thrown away with the bath water.  So what’s driving the epic sell-off?  A portion can likely can be attributed to rhetoric on Capitol Hill over pricing power of biotechnology companies, which has many traders on the sidelines until elections provide some clarity.  Analysts also cite sluggishness in innovation as a possible culprit.  Amid this environment, the case can still be made that investors who stay calm can discern companies that will grow through this weakness in the coming months and years.

About two years ago, Oculus Innovative Sciences (NASDAQ: OCLS) made the decision to restructure its business model.  By spinning off its biotechnology unit into and subsequently cashing-out on its investment, Oculus put some money in the bank to execute a new strategy focused on its Microcyn-based dermatology products.  Less than a year later, the plan started moving forward with an old distribution partner dismissed and a direct sales force hired, deployed to target select U.S. markets and tasked with improving sales with three unique dermatology products in their bag.

Since then, three more products have entered the market following clearance from the U.S. Food and Drug Administration and additional sales members were added to the team to cover more target markets in the U.S.  As it stands, Oculus now has products approved for sale in either in the U.S. or internationally (or both) for atopic dermatitis (eczema), severe acne, scars, seborrheic dermatitis, and advanced wound care.

The efforts are taking shape for Oculus as measured by increasing product sales.  The company recently released the results from the third quarter of fiscal 2016, ended December 31, 2015, showing total revenue improved 19 percent to $3.8 million from $3.2 million in the year prior quarter.  Total revenue includes money from product sales, as well as product licensing fees and royalty revenues.  Product sales make up the majority of revenues and are the point of focus as a proxy for growth.

Product sales climbed 40 percent from Q3 fiscal 2015 to $3.5 million, boosted by gains in the U.S.  Sales in the U.S. represent the greatest growth opportunity for Oculus, not only because of higher profit margins, but also because they took a substantial hit as part of the new sales model.  In the latest quarter, product sales in the States totaled $1.0 million, versus $647,000 in the year earlier quarter.  In the first three quarters of fiscal 2016, product sales in the United States were $2.99 million, compared to $1.36 million in the same period of fiscal 2015, an increase of 120 percent.

In Latin America, new distribution partner Laboratorios Sanfer SA continues to show its reach, as sales rose $185,000 (+18%) year-over-year to $1.3 million.  Some shine was taken off of the increase due to a 22 percent decline in the value of the peso compared to a year earlier.  Stripping out that effect, sales were up by 43 percent.  Sales were up 60 percent to $1.2 million in Europe and the rest of the world.

Total revenues for the first nine months of fiscal 2016 of $11.6 million increased by $1.7 million, or 17%, as compared to $9.9 million for the nine months ended December 31, 2014.  Product revenue of $9.8 million increased $3.1 million (+47%), with strong growth in all major segments, paced by the U.S.  Latin America’s revenue was up 22 percent, despite a 21 percent decline in the peso and rest of world’s revenue was up 38 percent with strong growth in Asia.

Gross profit as a percentage of revenue declined as license and royalty revenue was phased out, with the decline only being partially offset by the higher product revenue.  In the nine-month period, Oculus reported gross profit of $5.5 million, or 47 percent, compared to $5.3 million, or 54 percent.

Oculus is still operating with a net loss, to the tune of $3.15 million, or 19 cents per share, in the third quarter, compared to $5.91 million, or 69 cents per share, in the year earlier quarter.  For the nine-month period, net loss was $7.25 million, or 45 cents per share, this year, versus $6.7 million, or 79 cents per share, in the fiscal 2015 period.  The company also reported $6.1 million in cash at the close of the quarter. Shares of OCLS moved lower following the report, suggesting traders lamented the loss and disregarded the corporate development and sales growth.  In the investor call discussing the latest quarter, Oculus management noted that it “conservatively” expects annual sales to rise to a range of $28 million to $35 million in the next 18 to 30 months, a point at which they believe they will be breakeven.  Extrapolating from available data and guidance, Oculus management is forecasting a very strong growth pace (mid-double digits) over the next couple years.

This is an early growth story in the making, only four quarters into its dermatology direct sales efforts in the U.S.  Looking ahead, Oculus has two more products, Ceramax and SebDerm Gel, which are being commercialized this spring and summer, respectively.  Further, management has regularly expressed their goal to bring a new product to market every quarter, which will fuel future sales.  To meet these goals, the scientists at Oculus are developing new products in-house and the company has gone outside its own walls to in-license new products from European pharmaceutical companies.  Much of the information on new products – including plans for proof of concept clinical trials – is being kept close to the vest right now by Oculus.  However, the company advised it will be releasing more details when the timing is correct.  Given the fact that the turnaround plan is still holding the expected course and Oculus management remains transparent, there’s no reason to suspect that they won’t deliver on these initiatives as well.

OxySure Therapeutics Inc. (OTCQB: OXYS), a global leader and medical device innovator of life-saving emergency oxygen products based on its “oxygen from powder” technology, recently announced a new supply agreement with ORS Nasco, a division of Essendant Inc. (NASDAQ: ESND), which is a global distributor of workplace essentials with $5.4 billion in sales that trades with a market capitalization of about $1.09 billion.

With the new agreement in place, the company will be able to offer first aid safety, respiratory protection, heat stress protection, eye protection, and a wide range of other medical emergency preparedness products to become a single source solution. The company’s sales team can not only help customers by providing everything they need in one place, but also accelerate revenue by upselling them on distributed products without the associated overhead production costs.

Investors in the medical supply space, including Alphatec Holdings Inc. (NASDAQ: ATEC) or Sharps Compliance Corp. (NASDAQ: SMED), may want to take a closer look at OxySure given this new agreement that could enhance customer value and revenue at the same time. According to several analysts covering the stock, shares could be worth between $1.90 and $2.30 per share, which is a significant premium to the current price of just $0.13 per share.

Read the entire press release here:

OxySure Therapeutics, Inc. (OXYS) (“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative emergency medical solutions today announced that the Company has established a supply agreement with ORS Nasco, a division of Essendant, a global distributor of workplace essentials with $5.4 billion in sales.

“This agreement allows us to offer additional, complimentary offerings to our institutional customers seeking a single source solution for their medical emergency preparedness, therapeutics and medical risk management needs,” stated Julian T. Ross, CEO of OxySure. “In addition to our OxySure Model 615 and related therapeutics and medical emergency offerings, our sales teams can now offer expanded solutions for first aid safety, respiratory protection, heat stress protection and eye protection, to name just a few options.”

OxySure plans to develop a new, enhanced catalog of products which will be expanded to include first aid kits, antiseptics, CPR masks and eye wash solutions in the first aid safety category; disposable and escape respirators in the respiratory protection category; and hydration and cooling solutions in the heat stress protection category.

“We remain committed to developing and selling innovative, patented products in the medical device and therapeutics areas,” said Clark Hood, VP of Sales for OxySure. “At the same time we also recognize we can grow faster by satisfying our institutional customers’ need for a single source solution with highly differentiated service as they seek to continually enhance workplace safety.”

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products. www.OxySure.com

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus on developing technoloiges and solutions for individuals with neurological disorders, recently announced that it would be presenting at the 18^th Annual BIO CEO & Investor Conference on Monday, February 8, 2016 at 1:30pm EST in New York, NY. The presentation will include an update on ARKE™ and its strategic growth strategy.

As the world’s largest trade association representing biotechnology companies and others in the sector, the BIO CEO conference is the largest independent investor conference in the space. The company will be presenting alongside many other biotech micro- and small-caps, including companies like StemCells Inc. (NASDAQ: STEM) and RegeneRx Biopharmaceuticals Inc. (OTCQB: RGRX), as well as speakers from Biogen, Novartis, Gilead Sciences, and other large firms.

Investors may want to take a look at Bionik Labs given its ongoing progress in bringing ARKE™ to market. According to management, the company anticipates presenting key verification and clinical data on ARKE™ from testing in Canadian rehabilitation centers by the middle of this year. The company plans to launch the product into Canada and Europe by the first half of 2017 and in the U.S. nine months later.

Read the entire press release here:

Bionik Laboratories Corp. (BNKL), a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders (“Bionik” or the “Company”), announced today that Peter Bloch , Chief Executive Officer and Chairman of the Board, will present at the 18^th Annual BIO CEO & Investor Conference on Monday, February 8, 2016 at 1:30 p.m. EST in New York, NY .

Mr. Bloch will present a corporate overview and provide an update on the progress of its primary product, ARKE™, a robotic lower-body exoskeleton device designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. Bionik expects to report key verification and clinical data on ARKE from testing in Canadian rehabilitation centers in mid-2016. The Company’s growth strategy focused on acquiring, licensing and partnering synergistic products and technologies to enhance its internal product pipeline will also be discussed.

A live webcast of the presentation will be available on Bionik’s IR Calendar in the Investor Relations section of the Company’s website (www.bioniklabs.com). The webcast replay will be available approximately two hours after the presentation ends and will be archived for 30 days.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The 18^thAnnual BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies. Each year the conference provides a neutral forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotechnology industry. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

About Bionik Laboratories

Bionik Laboratories (BNKL) is a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders. The Bionik team has researched, developed and tested its primary product, ARKE^™, a robotic lower-body exoskeleton device designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. For more information, please visitwww.bioniklabs.com and connect with the Company on Twitter, LinkedIn, Facebook, andGoogle+.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company’s raw materials, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company does not undertake to update these forward-looking statements.

Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders, recently announced a collaboration with IBM (NYSE: IBM) to leverage machine learning algorithms to improve the outcomes of neurological rehabilitation. The first phase of the project – data collection for processing – is expected to be completed this year.

The agreement comes after a meeting a year ago where management discussed the importance of big data. Through its Big Data University initiative, IBM identifies promising entrepreneurial and emerging technology companies and provides them with access to its programming expertise and engineering talent. The technology should help improve the ARKE™’s performance, patient data, and ultimately the rehabilitation efficacy.

Investors in the robotic exoskeleton space, including companies like Ekso Bionics (OTCQB: EKSO) and Rewalk Robotics Ltd. (NASDAQ: RWLK), may want to take a closer look at Bionik given this new collaboration and its promising ARKE™ technology.

Read the entire press release here:

Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders (“Bionik” or the “Company”), announced today that it is working with IBM to develop a unique analytics system and apply sophisticated machine learning algorithms to improve the outcomes of neurological  rehabilitation.

Michal Prywata, Co-Founder and Chief Operating Officer of Bionik, stated, “This collaboration is the genesis of a meeting nearly a year ago where we discussed the universal importance of big data. During our follow-on conversations we began to realize synergies and started to discuss potential ways in which we could work together to develop an intelligent analytics platform for ARKE.”

ARKE is Bionik’s proprietary robotic lower-body exoskeleton device that is designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. Use of IBM’s cognitive computing infrastructure would enable access to the exoskeleton’s performance, patient data, and results of ARKE rehabilitation from multiple sites, including rehabilitation centers, physicians’ offices, physiotherapists’ offices, patients’ homes, research centers or any other location at any time. Phase one of the IBM development project for ARKE is expected to be completed in 2016.  Phase one will include the full backend required to capture the information needed for future use.

The collaboration is a result of IBM’s Big Data University initiative designed to identify promising entrepreneurial and emerging technology companies and provide access to the programming expertise and engineering talent at IBM.

Leon Katsnelson, Director and Chief Technology Officer of IBM Analytic Platform Emerging Technologies, commented, “Our entrepreneurial access program focused on adoption of cognitive computing is perfectly suited for a pioneering robotics company such as Bionik. IBM recognizes the potential of Bionik’s ARKE exoskeleton and is eager to assist Bionik in their quest to provide advanced data analytics to rehabilitation specialists anywhere, anytime, through IBM Cloud.”

Peter Bloch, Chief Executive Officer and Chairman of the Board of Bionik, commented, “We are honored to be collaborating with the innovative technology partners at IBM. We believe that ARKE, when used with the solution being developed together with IBM, will have the potential to significantly improve physicians’ and physiotherapists’ access to analytics related to use of ARKE.”

Mr. Prywata added, “Importantly, this proprietary system will enable us to develop a better understanding of the data collected during ARKE patient sessions and, most importantly, advance the correlation between patient regimens with patient results and strategically work to improve overall outcomes for these individuals. We believe that these advancements have the potential to be a key differentiating factor for not only ARKE, but other medical devices as well, with the goal of providing improvements in the quality of life for individuals and their families as well as a broad socioeconomic impact.”

As part of phases two and three of the project, Bionik engineers together with data scientists at IBM are expected to develop machine-learning algorithms designed to analyze large volumes of sensor data generated by ARKE. The analytical program is expected to be an important tool in identifying the correlation between different rehabilitation regimens using the ARKE exoskeleton and understanding the therapeutic results from these physio-protocol programs over certain measures of time.

 About Bionik Laboratories

Bionik Laboratories (BNKL) is a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders. The Bionik team has researched, developed and tested its primary product, The ARKE^™, a robotic lower-body exoskeleton device designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. Bionik recently successfully raised approximately US$13.1 million which enables the company to advance its development and growth strategy. For more information, please visit www.bioniklabs.com and connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company’s raw materials, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company does not undertake to update these forward-looking statements.

SCIEX, a global leader in life science analytical technologies, and a wholly-owned subsidiary of Danaher Corporation (NYSE: DHR), recently announced an exclusive co-marketing agreement with Pressure BioSciences, Inc. (OTCQB: PBIO).  PBIO is a worldwide leader in the development and sale of pressure cycling technology (PCT)-based sample preparation systems to the life sciences research market. Under the agreement, the companies will jointly promote PBIO’s PCT-based sample preparation systems and SCIEX’s mass spectrometry equipment, with a focus on improved sample preparation, a crucial step performed by hundreds of thousands of research laboratories worldwide. This combination of technologies could result in superior biological insights and discoveries in the life sciences industry, and in rapid and dramatic revenue growth for PBIO.

The deal is significant given SCIEX’s leadership position in the proteomics (the study of proteins) subset of an industry that Research and Markets expects will reach $7.2 billion by 2020. After the Danaher acquisition in 2009 for $1.1 billion, SCIEX was able to leverage Danaher’s 47,000 associates serving customers in more than 125 countries to significantly grow its market share. The company is now one of the “Big Six” mass spectrometry companies worldwide and a clear leader in proteomics with its impressive “SWATH” based next generation proteomics mass spectrometry instruments.

The combination of PBIO’s PCT Platform with SCIEX’s SWATH mass spectrometry is now being referred to by some of the leading protein experts in the world as “PCT-SWATH”.

Why the PCT Technology Platform Matters

Pressure BioSciences’ PCT Platform solves a critical problem in the mass spectrometry industry – the speed, accuracy, and overall quality of sample preparation.

Traditional sample preparation is accomplished primarily by breaking cells (whether normal or abnormal, regardless if from plant, animal, or human tissue) using mechanical means to obtain proteins, lipids, nucleic acids (DNA/RNA), or other cellular components (“biomolecules”) for analysis.  These mechanical methods, such as battering the cell with dozens of tiny beads as it spins in a centrifuge or a vortex, can actually damage or even destroy some of the biomolecules that scientists are trying to release from the cell for their investigative studies. PCT works in a completely different way.  By subjecting the cell to alternating cycles of hydrostatic pressure between ambient and high/ultrahigh levels, the company’s PCT platform quickly, safely and reproducibly controls the cell lysis (breakage) process, while it squeezes out important cellular components with minimal or no damage whatsoever (like squeezing a sponge).

In the January 12^th SCIEX press release, Professor Ruedi Aebersold, Director of the Institute of Molecular Systems Biology at the ETH in Zurich Switzerland, and a worldwide expert in the field of proteomics, said that PCT-SWATH “should increase the chance for biomarker discovery, potentially leading to significant improvements in healthcare, including personalized medicine.”

As a result of the co-marketing arrangement, the combination PCT-SWATH offering will be capable of producing a proteome analysis within 12 hours from the start of tissue processing, mush faster than current methods, as well as a more comprehensive protein quantitation from complex samples. As an example, PCT-SWATH could be used in the context of personalized medicine to analyze thousands of proteins in tissue biopsies, compared to just the hundreds of proteins currently analyzed in these important samples using traditional methods, and to generate very important quantitative digital proteome maps.

Leveraging SCIEX’s Distribution

SCIEX is a global leader in mass spectrometry with a focus on capillary electrophoresis and liquid chromatography, empowering labs working in basic research, drug discovery and development, food and environmental testing, forensics, and clinical research. With over 40 years of experience in the space, the company has been a leader in understanding the evolving needs of customers and finding answers to complex analytical challenges in the field.

As a worldwide market leader in mass spectrometry, SCIEX has dozens of sales and marketing personnel and a worldwide distribution network.  Consequently, this co-marketing agreement will act to introduce Pressure BioSciences’ entire PCT instrument and consumables line to hundreds of existing SCIEX customers worldwide, each of which could benefit from the PBIO PCT platform.  Compare this to PBIO’s current sales and marketing team of two personnel, and one can quickly understand why the company’s revenue could dramatically and significantly increase in 2016, and beyond.

Interestingly, as word spreads, mass spectrometry competitors of SCIEX like Thermo Fischer Scientific Inc. (NYSE: TMO) and Waters Corporation (NYSE: WAT) may also be interested in signing agreements of their own with Pressure BioSciences to improve sample preparation in front of their instruments, which should ultimately make their platforms more desirable.  Even if they don’t, the exposure that PBIO is about to receive through the SCIEX co-marketing deal will most likely expose the PCT sample preparation product line to thousands of non-SCIEX mass spectrometry customers that today do not know of either PBIO or PCT. Either way, PBIO is the big winner.

There’s also the potential for eventual M&A in the space. Markets and Markets projects that the sample preparation industry could reach $5.6 billion by 2018 and it’s a market that many mass spectrometry companies already target. For example, Danaher, Thermo Fischer, Qiagen NV (NASDAQ: QGEN) and Agilent Technologies Inc. (NYSE: A) all have interest in new sample preparation offerings. If Pressure BioSciences’ PCT technology platform catches on, its modest $7 million market cap could make it a buy-out target.

Looking Ahead

Pressure BioSciences stands at a tipping point in its corporate history. After spending years developing its PCT technology platform, and growing mostly by word-of-mouth, the company’s co-marketing agreement with SCIEX could quickly spread the word to hundreds, perhaps thousands of potential customers, and drive PBIO’s near-term revenue to unprecedented levels.

Last quarter, the company reported a 55.8% increase in revenue and a 13.4% decrease in operating costs, despite scaling up its marketing and sales efforts. The SCIEX agreement could boost these figures significantly further in 2016. Management also cleaned up the company’s finances by eliminating all of its variable rate convertible notes, which had been a significant overhang on the stock over the past 2-3 years, opening the door to easier, less expensive, and much safer financing.

Finally, the company has disclosed that it plans to up-list to the NASDAQ or NYSE in the first half of 2016, which would expand the visibility of its stock in the financial markets. Since many institutional investors are not allowed to buy over-the-counter securities, the move could open the door for more liquidity and a wider investment base.

Investors in companies like NanoString Technologies (NASDAQ: NSTG), which specializes in genomic sampling technology; NeoGenomics (NASDAQ: NEO), which provides cancer-focused genetic and molecular testing; and Protea Biosciences Group (OTC: PRGB), which provides small molecule and tissue analytics services, may want to keep an eye on this small company. The combination of catalysts noted above could make the stock worth watching over the coming quarters as Pressure BioSciences scales up revenue, drives the installed base of its instruments, becomes a much more recognizable player in the large and growing mass spectrometry field, and attracts more investment.

For more information, visit the company’s website at www.pressurebiosciences.com.

Chemotherapy compounds like paclitaxel and docetaxel have been used for years to treat cancer, but the caveat is that they indiscriminately kill both cancerous and normal cells. In order to solve this problem, researchers have tried a number of different approaches. The most common approach has been conjugating anti-cancer agents to antibodies or functional fragments, but even then, there are significant numbers of normal cells affected.

Since 2010, Seattle Genetics Inc.’s (NASDAQ: SGEN) Adcetris and ImmunoGen Inc.’s (NASDAQ: IMGN) Kadcyla have offered some hope taking this approach, but response rates have been low and toxicity issues remained. Some companies reported high response rates, but those results came with a high toxicity price in retrospectively determined subsets in a small number of patients. New classes of drugs are attempting to solve these problems, but success remains limited thus far.

OncBioMune Pharmaceutical Inc. (OTCQB: OBMP), a clinical-stage biopharmaceutical company that’s primarily focused on a vaccine-based technology, recently filed a new patent covering a new, targeted cancer treatment leveraging its transferrin transport technology. Since the serum iron transport protein transferrin is overexpressed in a broad range of cancers, the company aims to bind chemotherapeutic agents to that protein to deliver the drugs in a targeted manner.

In the past, researchers linking paclitaxel or docetaxel to transferrin experienced difficulties with cellular uptake due to the linking of the agent and the protein. The company’s approach solves this problem by effectively trapping the agent within the protein. By doing so, the company solves the problem of cellular uptake and experiences magnitudes of order greater inhibition activity.

“This patent is a very important addition to our intellectual property portfolio, as we believe our targeted therapeutics represent the next generation of taxane and taxoid-based cancer treatments,” said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. “Although their ability to slow cell proliferation is well known, taxanes are particularly insoluble, providing a unique set of challenges to drug developers. With our paclitaxel-gallium-transferrin composition, we have overcome this challenge. Lab studies support the thesis that we can deliver cytotoxic agents targeted selectively to the cancer cell, resulting in robust activity to inhibit cellular proliferation without damaging normal cells.”

The company’s patent covers drug development across a wide spectrum of cancers, including but not limited to sarcoma, lymphoma, leukemia, prostate, lung, and breast cancer. With Celgene Corporation’s (NASDAQ: CELG) Abraxane®, albumin-paclitaxel, generating over $1 billion per year in revenue last year alone, the company’s technology could increase efficacy and safety for patients and ultimately “latch on” to these revenue streams over time.

Investors in the oncology space, including monoclonal antibody developers like Peregrine Pharmaceuticals (NASDAQ: PPHM) or other ADC firms like Sorrento Therapeutics Inc. (NASDAQ: SRNE) , may want to keep a close eye on OncBioMune given the recent patent filing and its potential to reinvent the way cancers are treated with taxane and taxoid-based therapies. In addition to this potential, investors may also benefit from the company’s other clinical programs, including its ProscaVax™ cancer vaccine that’s scheduled to commence a Phase II clinical trial in early 2016.

For more information, visit the company’s website at www.oncbiomune.com.

Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus on developing technologies and solutions for individuals with neurological disorders, recently announced that it will present at the 2016 Colloquium on Sports and People with Disabilities at l’Universite de Poitiers in Poitiers, France on February 5, 2016. The presentation will include the first live demo of its second-generation ARKE™ exoskeleton.

With a much lower anticipated price point than the competition, the ARKE™ technology includes a number of innovative features including a cloud-based system that receives data from the device’s sensors, analyzes them, and displays the data to the physiotherapist in real time. The company plans to launch the technology in Canada and Europe by the first half of 2017 before rolling it out into the U.S. nine months later due to the stricter regulatory environment.

ReWalk Robotics Ltd’s (NASDAQ: RWLK) meteoric rise following the VA’s reimbursement program demonstrates just how significant the demand for these technologies could become over the coming years. Less advanced companies like Ekso Bionics Inc. (NASDAQ: EKSO) also generated $3 million last year at a 37% gross margin after launching in 2012. With a market cap of approximately $82 million, investors may want to keep an eye on Bionik Labs.

Read the entire press release here:

Bionik Laboratories Corp. (OTCQX: BNKL), a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders (“Bionik” or the “Company”), announced today that the Company will present at the 2016 Colloquium on Sports and People with Disabilities at l’Université de Poitiers being held February 5, 2016, in Poitiers, France.

Michal Prywata, Chief Operating Officer, will discuss the development of Bionik’s primary product, ARKE™, a robotic lower-body exoskeleton device designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. Bionik expects to report key verification and clinical data on its second generation exoskeleton, ARKE GEN2, from Canadian rehabilitation center testing in mid-2016.

“Bionik is honored to be invited to participate in this important event highlighting the latest scientific developments related to adaptive living, technology, equipment, materials, prosthetics and connected devices intended to enhance physical and motor abilities of people with disabilities,” stated Mr. Prywata.

The Bionik team will present an onsite demonstration of ARKE GEN2, the first comprehensive lower body exoskeleton with tablet control. Following its clinical development and the appropriate health agency approvals, ARKE will initially be used in a rehabilitation environment, with the eventual goal of being made available for home use.

“Robotic exoskeletons like ARKE have the potential to transform the future for mobility impaired patients by significantly improving rehabilitation stimulation,” added Mr. Prywata. “We purposefully reengineered ARKE for a lighter mechanical profile and significantly improved control, adaptability, safety and electronics to allow users to walk more easily and efficiently. I look forward to joining this distinguished group in France to for the first live demonstration in Europe of ARKE GEN2’s capabilities.”

The 2016 Colloquium on Sports and People with Disabilities, the Health of Aging People with Disabilities: Physical and Athletic Activities and Technological Innovations focuses on aging people with disabilities. The colloquium addresses a variety of healthcare topics including physical, health, educational and social issues as well as the latest technological innovations in rehabilitation, autonomy and adaptive sports. Participants include professionals in healthcare, education, social work, sports, and culture, along with athletes and other individuals with disabilities, their families, and organizations engaged expanding awareness and advancement of resources and technologies related to the support of people with disabilities.

About Bionik Laboratories

Bionik Laboratories (BNKL) is a pioneering medical device and robotics company with a focus in developing technologies and solutions for individuals with neurological disorders. The Bionik team has researched, developed and tested its primary product, The ARKE^™, a robotic lower-body exoskeleton device that is designed to allow paraplegics as well as other wheelchair users the ability to rehabilitate through walking and other motion. Bionik recently successfully raised approximately US$13.1 million which enables the company to advance its development and growth strategy. For more information, please visit www.bioniklabs.com and connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain additional financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company’s raw materials, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. The Company does not undertake to update these forward-looking statements.

BioLargo, Inc. (BLGO) recently announced that its subsidiary, Clyra Medical Technologies, secured a $5.75 million financing package for Its Advanced Wound Care Products.  Cash of $750,000 is earmarked for FDA Application and approval, and a $5 million line of credit is dedicated to commercialization once FDA approval is complete.

Wound Care refers to the promotion of effective healing and the prevention of infections in post surgery and trauma wounds, diabetic ulcers, pressure ulcers (bed sores), and any chronic wound that has difficulty healing. CLYRA Medical Technologies boasts that its products feature the most potent, broadest spectrum, antibacterial, antifungal & antiviral advanced oxidation system known and yet are gentle and cost effective.

The National Center for Health Statistics reports that 51.4 million inpatient surgical procedures were performed in the United States in 2010, followed closely by 31.5 million outpatient surgeries.  Estimates for the size of the Wound Care market range widely from $6 billion to as high as $25 billion, but whatever the number is, the need for post-surgical wound care is large and sharply on the rise.

A further complication of Wound Care is that since over 50 million surgical procedures are performed in hospitals each year, and since an open wound is a known pathway for transmission of infection, hospitals are the focus of a national effort to reduce Hospital Acquired Infections such as MRSA and Clostridium difficile, and the economic burden caused by them.

The CDC tells us that each year there are over 1.7 million Hospital Acquired Infections and more than 100,000 deaths.  Reducing infections in wound care could result in significantly fewer deaths as well as a reduction in government healthcare spending that is estimated by the CDC to be close to $20 billion annually.  An article published by the U.S. National Library of Medicine, “Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy”, details the acute need for more effective Advanced Wound Care.

In the first week of 2016, Frost & Sullivan awarded BioLargo, Inc. (BLGO) its 2015 North American Frost & Sullivan Award for New Product Innovation.  This coveted award recognizes BioLargo’s game-changing iodine-based technology in the water treatment industry. The Award was limited to the water industry and did not even attempt to address BioLargo’s robust and award winning technologies for disinfection, decontamination, odor control, and wound care.

In August 2015, a team of researchers at the University of Alberta unveiled BioLargo’s AOS Filter/Reactor that uses one of the company’s three different platform technologies based on iodine.  Findings from over 100 studies on the AOS Filter for water disinfection were presented and demonstrated its ability to disinfect pathogens 100 times more effectively than chlorine, at 10 times the speed, and at only 1/20th of the cost of the closest competitor.  One year earlier, the AOS Filter/Reactor received the Technology Star Award from New Technology Magazine, known as the First Word on Oil Patch Innovation.

University of Alberta Professor Lynn McMullen, evaluated test results and commented, “At the foundation of the AOS Filter is its efficiency in generating a highly oxidative state.  Extremely high levels of performance [disinfection] were achieved during testing and we are excited to expand the work with BioLargo to other applications targeting food safety concerns.”  The tests demonstrated unprecedented effectiveness in destroying highly concentrated contaminants in sample water, including Listeria and Salmonella. Test results at the University of Alberta demonstrated that the iodine based AOS Filter killed 10,000,000 salmonella cells in 2 minutes compared to the industry standard chlorine dioxide that killed 100,000 cells in 60 minutes. That is 100 times more effective and 30 times faster than the industry standard methodology. And the energy requirements are negligible.

Formulations of CLYRA’s antimicrobial hydrogel and liquid wound cleanser products have passed rigorous third party laboratory testing validating both efficacy and safety.  Independent testing has verified both rapid and effective control against a host of dangerous pathogens commonly encountered in the wound care field.  Testing of the company’s liquid formula verified efficacy against antimicrobial resistant species referred to by the CDC as the “ESKAPE” pathogens – enterococcus faecium (VRE), staphylococcus aureus (MRSA), klebsiella species, acinetobacter baumannii, pseudomonas aeruginosa, and enterobacter. The next step is to now prepare these products for FDA application.

BioLargo is targeting early 2017 for its new Advanced Wound Care products to be commercially available.

The business of Wound Care is highly fragmented with several dozen companies competing for a share of this fast growing market.

Smith & Nephew (NYSE: SNN) is one of the current leaders in Wound Care and offers a wide range of products for the treatment of acute and chronic wounds, including leg, diabetic and pressure ulcers, burns, and post-operative wounds. The company also provides traditional and single-use negative pressure wound therapy and hydrosurgery systems; and biologics and other bioactive technology products for debridement and dermal repair/regeneration. The company primarily serves the providers of medical and surgical treatments and services.  Smith & Nephew reported annual sales of $4.6 billion for the year ending December 2014.

Derma Sciences (NASDAQ: DSCI) is a tissue regeneration company providing products for the management of acute and chronic wounds, and burns. Their portfolio provides a broad product line including MEDIHONEY®, XTRASORB®, BIOGUARD®, ALGICELL® Ag, TCC-EZ®, AMNIOEXCEL®, and AMNIOMATRIX®.  Derma Science’s products are intended to help advance healing for patients suffering from complex chronic or acute wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and burns.  Derma Sciences reported sales of $84 million for the year ending December 2014.  Annual sales of $84 million in a $6 billion market, indicates the absence of a breakthrough product yet.

Osiris Therapeutics, Inc. (NASDAQ: OSIR) uses allogeneic stem cell technology in their line of Advanced Wound Care products that include Grafix, a cryopreserved placental membrane for treating hard-to-treat acute and chronic wounds, venous leg ulcers and other products for bone healing.  Osiris reported 2014 year-end revenues of $60 million.

Vericel Corporation (NASDAQ: VCEL) Vericel Corporation is a stem cell company developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. It markets two autologous cell therapy products in the United States, including Carticel (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee; and Epicel (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of total body surface area.  Vericel reported annual revenues of $29 million for the year ending December 2014.

With the new $5.75 million funding package in place, and what appears to be a very valuable technology, BioLargo’s Subsidiary Clyra Medical Technologies now has the financial resources to complete the preparation work and apply to the FDA for approval to market its Advanced Wound Care products and when successful, has the potential to gain a meaningful portion of a large and fast-growing market that is in need of better products and technologies. The depth and breadth of the BioLargo technology portfolio looks to have multiple game changers in the wings.

With oil cratering and miners struggling amid depressed metal prices, there is no shortfall of “turnaround” talk on Wall Street for resource and energy companies that have suffered a beat-down in valuations in recent years.  Broadly, you don’t have to look around very many corners to hear turnaround speculation for companies in an array of sectors.  GoPro (NASDAQ: GPRO) was a darling of Wall Street with its IPO in June 2014, taking shares as high as $98.47 in October.  The stock has since plunged almost 90 percent since, with analysts promulgating changes that need to be effected to right the action camera maker’s ship.  Underscored by the onset of the digital age, several retailers have languished against online competition, including small caps Bebe Stores (NASDAQ: BEBE) and Destination XL Group (Nasdaq: DXLG), leading to talk about requisite moves to restore shareholder confidence.

While certainly a challenge, turnarounds do happen.  Sure, there have been high profile, “too big to fail” companies that have garnered the most attention.  But, don’t forget that even Apple (NASDAQ: AAPL) in its early days fired and re-hired founder Steve Jobs to get the company on track as the stock floundered before becoming the tech behemoth it is today.  Many were writing off struggling NutriSystem (NASDAQ: NTRI) until Dawn Zier became president and CEO in 2012, reviving corporate spirit and reverse a trend of shrinking revenue and profitability.

There is no exact secret sauce to a successful turnaround, but there are certainly specific actions are often part and parcel, including a management change, a focus on core business, and turnaround milestones giving investors a proxy to measure success.  After years of sliding share value, Oculus Innovative Sciences (NASDAQ: OCLS) has adopted these themes and so far is holding the course and trading higher subsequent to an all-time low of 65 cents last May when the turnaround efforts were starting to take shape.

The Winds of Change at Oculus

In 2013, it was time for a change.  Oculus spun off its novel biotechnology business, Ruthigen, Inc., into a new public entity, sending with it Oculus board members and its chief executive.  With the spin out, then-COO and director Jim Schutz took the position of Oculus CEO.  Schutz was tasked by a re-vamped board with executing a clear plan on a re-focused business model centered on developing and marketing the company’s core portfolio of Microcyn-based dermatology products.  Microcyn is Oculus’ flagship technology utilizing a patented small molecule oxychlorine formulation to generate a family of products containing a hypochlorous acid that is similar to the natural hypochlorous acid produced by the body.  The steroid-free products are used for a range of dermatology applications for humans and animals, leveraging their benefits in treating skin conditions, scar management, wound healing and microbial eradication without cytotoxicity.

To house and develop these and other products, a new division, called IntraDerm Pharmaceuticals, was formed early in 2015.  As promised, new products were coming down the pipeline.  Intraderm rolled out its first two initial products in the U.S.: Alevicyn Antipruritic Gel, which is used to manage pain, burning, and itching associated with various dermatoses; and Alevicyn Dermal Spray, which is used in the management of debridement of surgical wounds from dermatological procedures.  Those were followed shortly after by the launch of Alevicyn Antipruritics SG, a spray gel formulation that has the advantage of being administered as a spray, but adheres as a gel, and Celacyn Prescription Scar Management Gel, the only prescription product on the market for treating scars.

Oculus’ decision to focus on dermatology, or derm, was the best move to point the company in the direction of profitability.  Amongst other things, derm products have shorter developmental timelines, lower clinical trial expenses, strong margins and insurance coverage and fast sales ramps.  Oculus already had an international presence (distribution partners in Europe, Middle East, India and China) that it could lean on for short-term growth, while restructuring its domestic operations to bolster sales while it worked to achieve marketing clearance to launch new products for long-term growth.

To achieve this, Oculus moved sales in-house with new dermatology management and a seasoned sales force.  They launched a new animal healthcare division, cut ties with animal health care partner, Innovacyn, and partnered with a leading sales firm to foster expansion on that front.  With the new partnership, Oculus originally rolled out six new MicrocynAH advanced all-animal healthcare products in the U.S. and Canada to treat wounds, skin and eyes.  With the recent addition of two animal healthcare SKUs for the treatment of dermatological conditions in animals, the MicrocynAH portfolio now includes 13 products.

In Mexico, historically the largest revenue-generating market for Oculus, Laboratorios Sanfer acquired its former distribution partner.  Sanfer’s much larger size expanded Oculus’ market opportunity from Mexico to across Mexico, Latin America and Caribbean.

Meeting Turnaround Milestones

Instead of being a mile wide and an inch deep, Oculus made substantive changes to create a company more fundamentally sound with a better foothold than ever before.  Coming off an inflection point, the company forecast more regulatory approvals as milestones to continue to grow momentum.  As 2015 came to a close and 2106 got underway, Oculus made good on these projections.

OCLS promised an FDA approval or clearance in the first calendar quarter of 2016 and came in early by a quarter.  On November 30, Oculus received a FDA 510(k) premarket notification for Ceramax, a skin barrier cream intended as a topical skin preparation to relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis (eczema), irritant contact dermatitis, radiation dermatitis and other dry skin conditions.  A product launch should be coming late this quarter or early in Q2.

Oculus guided that the prescription product SebDerm Gel would garner the FDA’s blessing in the spring of 2016.  This milestone was met earlier than expected, with a 510(k) clearance from the FDA on December 17.  The gel is intended to manage and relieve the burning, itching, erythema, scaling, and pain experienced with seborrhea and seborrheic dermatitis, also known as “cradle cap” in infants and “dandruff” in adolescents.  Oculus plans to launch SebDerm Gel in June 2016.

Oculus also promised to secure their eleventh CE mark next month and this too came ahead of schedule.  On January 14, the company disclosed approval for MucoClyns, a solution intended for use in emergencies on mucous membranes, cuts, abrasions, burns and body surfaces to treat immediately after exposure to infection risk.  Oculus says it is currently negotiating with potential partners in Europe about distribution.

Show Me

Regardless of plan, every turnaround is a “show me” story.  Investors want to hear the plan and see the execution.  Oculus has shown that there has been little impeding their turnaround so far as they meet their milestones.  As expected, sales are picking up in the U.S., showing the plan is being effective.  In the latest quarter reported, ended September 30, 2015, product revenue in the States was $1.2 million, versus $356,000 in the year prior quarter, a 233 percent improvement.  In spite of a 26 percent plunge in the value of the peso, year-on-year gains in Latin America were 8 percent at $1.3 million during the quarter.  Oculus still posted a net loss during the quarter, but it’s relatively unrealistic to expect anything different until the turnaround is a little longer in the tooth.  With no debt and roughly $8 million in cash and cash equivalents as of the end of September, the company has the resources to continue to execute and move toward the black as it rolls out more products through its improved sales force and larger distribution network throughout 2016.

The 2015 drama Concussion starring Will Smith follows the story of Dr. Bennet Omalu’s battle with the National Football League to acknowledge research on the brain damage suffered by professional football players. After examining the brains of many deceased NFL players, Dr. Omalu coined the term chronic traumatic encephalopathy (CTE) to represent the large accumulation of tau protein on the brain causing a wide range of mental problems.

Aside from the long-term problems caused by CTE, professional football players must deal with the immediate potential for a brain hemorrhage following a concussion. Bleeding within the brain can rapidly increase intracranial pressure and cause respiratory depression or inefficient respiration. That is because the pressure buildup places pressure on the brain stem where the respiratory center resides. Emergency oxygen could be a life-saver in these cases by temporarily providing much-needed oxygen to compensate for respiratory depression or inefficient respiration until a CAT scan can be done following the concussion to rule out hemorrhaging.

The best standard of care after a concussion may be immediate emergency oxygen, an emergency room evaluation, to include a CAT scan, and 24 hours of observation if there are any doubts. Over the long-term, technologies are being developed that may be able to predict when concussions are causing major problems and ultimately prevent CTE and related issues.

Oxygen from Powder

The only way to ensure that the effects of possible hemorrhaging are ameliorated following concussions in not just football especially, but in all sports is to have emergency oxygen ubiquitously available at all games and all practice sessions. However, historically this has been a challenge because traditional oxygen tanks are not ideal for this purpose. In addition to safety hazards, and the high costs and maintenance requirements, these oxygen tanks require very specific training in order to operate. However, a new technology has come along to make it possible to have emergency oxygen available at all sporting events, creating a great emergency response tool for concussions and other medical emergencies.

OxySure Therapeutics Inc. (OTCQB: OXYS), an innovative medical device maker, has developed an FDA-cleared portable emergency medical oxygen solution called the OxySure Model 615. OxySure creates medical oxygen by combining two dry and inert (proprietary) powders. With a simple turn of a dial these powders come together to create the oxygen instantly, obviating the need for oxygen storage in compressed form (such as in a tank), and thus the device is ideal for emergency situations. Moreover, it is easy to use and can administered by any lay rescuer. The OxySure Model 615 is literally a game changer in the availability and accessibility of emergency oxygen at any football venue or practice session, or more generally for any sporting event.

While the movie Concussion focuses on football, concussions can be inflicted in many other sports. In March 2009 actress Natasha Richardson (daughter of Vanessa Redgrave and wife of actor Liam Neeson) suffered a concussion after a skiing accident. In a tragic turn of events, the concussion caused an epidural hemorrhage and Ms. Richardson died with 24 hours of the concussion.

The OxySure Model 615 costs just $349 “rescue ready.” The system uses replaceable oxygen cartridges costing only $149 each, which makes it a low-cost, high-impact tool for the NFL and college football as well as other sports organizations. In addition, a growing number of schools are adopting the technology with brain injuries affecting more than 775,000 children and adolescents treated in hospital emergency rooms for sports-related injuries each year – often athletes aspiring to reach the likes of the NFL.

Instant Testing for Concussions

Detecting a concussion can be difficult in many cases, especially when there are few physical signs of a problem, which means that many cases go undiagnosed. Even if a problem is diagnosed, confirmation requires a neurological examination, CAT scan, MRI, and/or PET scan that requires a trip to the emergency room. Many professional athletes likely return to the field – especially with so much at stake – without making a diagnosis.

Chembio Diagnostics Inc. (NASDAQ: CEMI) has developed a point-of-care diagnostic test for traumatic brain injury, including sports-related concussions. Through an agreement with Concussion Science Group, the company is leveraging a patented biomarker in combination with its DPP® platform to develop semi-quantitative or quantitative point-of-care tests. Rapid intervention could lead to lower risk and reduced incidence of secondary injuries.

The DPP® platform is a unique, rapid, point-of-care testing platform that’s ideal for multiplexing antigen and/or antibody detection. With an independent delivery mechanism for test samples and easy visual interpretation, the device interfaces with a hand-held or phone-based reader to send data to the cloud and receive an objective interpretation in a short period of time. The CSG agreement represents just one application for the unique technology.

Long-term TBI Treatment Options

MYnd Analytics Inc. (OTCQB: CNSO) is a clinical decision support company with a patented commercial neurometric platform to predict drug response for the treatment of brain disorders. Using its PEER technology, the company commenced a reimbursed 2,000 patient trial at Walter Reed National Military Medical Center and Fort Belvoir Community Hospital focused on patients with depression PTSD, and mild traumatic brain injury.

The PEER Online platform uses a statistical analysis of EEG outputs and other patient information to generate a report that indicates the statistical likelihood of a patient’s responsiveness to classes of CNS medications, such as antidepressants, SSRIs, and fluoxetine.  Since the database is “practice based evidence” supported, doctors can be confident in their decisions with data from over 37,000 clinical endpoints across 9,900 patients.

In addition to the decision support systems, companies like Neuralstem Inc. (NASDAQ: CUR) and StemCells Inc. (NASDAQ: STEM) are working on regenerative medicine treatments for neurological diseases that could eventually be applicable to conditions like TBI.

Looking Ahead

There are many different opportunities in the concussion space as professional organizations like the NFL are forced to deal with longstanding issues. From immediate solutions like OxySure Therapeutics Inc.’s (OTCQB: OXYS) Model 615 to long-term treatment options with MYnd Analytics software, investors have a number of different options when it comes to treating concussions and dealing with the long-term impact of CTE and TBI.

BioLargo Inc. (OTCQB: BLGO), a developer of technologies designed to solve some of the world’s most important problems that threaten water, food, agriculture, health and energy, recently announced that it secured financing to support the FDA approval and commercial launch of its wound care products. Sanatio Capital purchased 40% of the company’s Clyra Medical Technologies in exchange for a $750,000 investment and $5 million line of credit.

The move represents a key milestone for the company and its mission to make life better with sustainable, disruptive, patented technologies. With wound care being a $6 billion annual market, the FDA approval and commercialization of its innovative product could unlock significant long-term shareholder value. The product also adds to a growing list of promising technologies, including its water purification technology that’s in development.

Investors in the wound care space, including companies like Chemtura Corp. (NYSE: CHMT) and Polypore International Inc. (NYSE: PPO), may want to take a closer look at the stock given this development and its many other prospects moving forward.

Read the entire press release here:

BioLargo, Inc. (OTCQB: BLGO) subsidiary Clyra Medical Technologies, Inc. has successfully concluded a financing from Sanatio Capital LLC for $750,000 in equity and a forward commitment to provide a $5,000,000 operating line of credit, to support the FDA approval and commercial launch of Clyra’s advanced wound care products.

Clyra Medical Technologies holds the exclusive license to commercialize BioLargo’s technology in the Advanced Wound Care industry. Effective December 30, 2015, Sanatio purchased 40% of the issued and outstanding shares of Clyra in exchange for its investment and its commitment to fund the operating line of credit. Details of the transactions are set forth in the Form 8-K filed by BioLargo, Inc. with the Securities and Exchange Commission and can be viewed at www.SEC.gov:click here.

Dennis P. Calvert, President & CEO of BioLargo, commented, “This is another important milestone for BioLargo and Clyra as we continue to advance our mission to ‘Make Life Better’ with our sustainable, disruptive, patent-protected technologies. We believe our Clyra products represent a technical advancement in the way wounds can be better managed to promote healing and that they will reduce human suffering around the world.”

Steve Harrison, President of Clyra Medical Technologies, commented, “We believe that this financing will provide the capital needed to help Clyra secure the appropriate regulatory approvals and launch what we believe will become a game changer for the Advanced Wound Care industry. This segment is a $6 billion market and we believe we will be able to offer better technical solution to this market.”

About Sanatio Capital

Sanatio Capital was created around the goal of identifying and supporting game-changing, high-impact technology. This vision is driven forward by powerful management teams focused on addressing challenges facing humanity and relieving human suffering around the world by creating innovative products. The company was founded by the Strommen family, the founders and leaders of PD Instore. With 75+ years of experience in product development, they bring product expertise and a network of relationships to leading retail companies around the world, helping ‘big brands dream big.’

About BioLargo

BioLargo, Inc. (BLGO) makes life better by delivering sustainable technology-based products that help solve some of the most widespread problems threatening the world’s supply of water, food, agriculture, healthcare and energy. More information can be found about the company and its subsidiaries at www.BioLargo.com. Its subsidiary BioLargo Water, Inc. (www.BioLargoWater.com) showcases the Advanced Oxidation Systems, including its AOS Filter — a product in development specifically designed to eliminate common, troublesome, and dangerous (toxic) contaminants in water in a fraction of the time and cost of current technologies. It is the winner of the Technology Star award by New Technology Magazine for its breakthrough innovation for the oil industry and is named the Technology Innovation Leader in the water treatment market by Frost & Sullivan. BioLargo also owns a 50% interest in the Isan System, which was honored with a “Top 50 Water Company for the 21st Century” award by the Artemis Project now being commercialized under a license to Clarion Water, Inc. BioLargo’s subsidiary Odor-No-More Inc., features award-winning products serving the pet, equine, military supply and consumer markets, including the Nature’s Best Solution® and Deodorall® brands (www.OdorNoMore.com). BioLargo’s subsidiary Clyra Medical Technologies, Inc. (www.ClyraMedical.com) focuses on advanced wound care management and is preparing to make FDA 510(k) applications in 2016.

Safe Harbor Statement

The statements contained herein, which are not historical, are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, the risks and uncertainties included in BioLargo’s current and future filings with the Securities and Exchange Commission, including those set forth in BioLargo’s Annual Report on Form 10-K for the year ended December 31, 2014.

Even though the root cause of atopic dermatitis (AD), or eczema, remains a mystery, this is an exciting time in the dermatology space with innovation driving substantial advancements for the first time in decades.  As Peter Lio, MD, assistant professor of clinical dermatology and pediatrics-dermatology at Northwestern University Feinberg School of Medicine, explained in the October edition of The Dermatologist, part of the challenge rests in the fact that a range of factors play a role in the immunopathogenesis of AD, a chronic, itchy inflammation of the skin that can range from mild to severe.

Addressing the dynamics and prominence of AD is a prime initiative of companies like Oculus Innovative Sciences (NASDAQ: OCLS) and Vitae Pharmaceuticals (NASDAQ: VTAE).  The AD business is forecast to experience significant growth in the next 10 years and a company with safe and effective products could be part and parcel to the expansion.  Aquinox Pharmaceuticals (NASDAQ: AQXP) was hoping to capitalize on the opportunity, but last month disclosed that its Phase 2 trial of AQX-1125 in AD patients missed its primary endpoint, resulting in Aquinox deciding to discontinue the program.

AD, which most often presents in infants and children, accounts for up to 20 percent of all referrals to dermatologists.  More than 10 percent of all infants and young children are affected by AD and about 60 percent of those people continue to have some symptom of AD in adulthood, equating to in excess of 15 million people in the U.S. feeling some symptom of the disease.

According to research and consulting firm GlobalData, the global atopic dermatitis treatment market will more than double in value from $3.6 billion in 2014 to an estimated $7.3 billion by 2024.  In line with comments of Dr. Lio, GlobalData sees new drugs coming to market as one of the catalysts for the growth as better alternatives in a saturated generics market.

Oculus Innovative Sciences was also mentioned in the October edition of The Dermatologist because of its recent FDA approvals of Alevicyn Antipruritic Gel and Alevicyn Antipruritic SG (spray gel).  Antipruritics, which can include antihistamines and corticosteroids, have been difficult for the industry to successfully advance due in part to side effects, especially with corticosteroids.  Oculus broke through this problem with topical solutions that were approved as non-steroidal, antipruritic products utilizing the company’s Microcyn Technology to manage and relieve the burning, itching and pain experienced with several types of dermatoses, including atopic dermatitis and radiation dermatitis.

The efficacy and safety of the Microcyn-based technologies is centered on the principles of hypochlorous acid, an antimicrobial solution produced by the body to fight invading pathogens.  The scope of hypochlorous acid activity is wide, as it is also known to rapidly destroy many resistant pathogens, including MRSA, E.coli, HIV, and the avian influenza virus, to name a few.

Employing a patented electrochemical manufacturing process, Oculus creates a pH neutral solution of hypochlorous acid and its sodium salt called hypochlorite.  The recently approved Alevicyn products for dermatoses join a portfolio of Microcyn-based products used in advanced wound management and animal healthcare.  Because Alevicyn products are water-based, they create a moist environment to treat the skin barrier function and rehydrate the skin.  Importantly, across more than 30 clinical trials and thousands of applications, there are zero known serious adverse events and no interactions or contraindications with the Microcyn-based products.

The most recent Alevicyn AD products were launched in the third quarter.  Oculus didn’t break down sales of their products during the recent quarter, but total product sales in the U.S. were up a strong 233 percent year-over-year to $1.2 million for the quarter.  Look for rising sales figures in coming quarters as the company’s sales team continues to ramp introduction to dermatologists.

Vitae Pharmaceuticals announced recently that it began dosing patients in a Phase 2a clinical study evaluating the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of VTP-38543, a topical LXR (liver X receptor) selective agonist, in patients with mild to moderate AD.  The four-week, approximately 100 patient study is a jump in developmental pathway, as Vitae originally was planning to start clinical work on VTP-38543, which has yet to be tested on a human, for the indication in a Phase 1 trial.  Top-line results from this trial are expected in the second half of 2016.

Vitae, who is pre-revenue and most advanced product is in a Phase 2 trial for Type 2 diabetes, is looking to assess the ability of its compound to activate LXR in skin keratinocytes, the predominant cell type in the outer layer of the skin, constituting about 90 percent of the cells in the epidermis.  Activating these cells in lab studies showed increase formation of corneocytes (which comprise most of the stratum corneum, or portion of the skin that touches the environment) and lamellar lipids (another unique and essential component of the stratum corneum).  LXR activation has also been shown to reduce inflammation in the skin to a similar level as a high potency corticosteroid.  By repairing damage and reducing inflammation, two key components of AD, Vitae hopes to improve outcomes in AD patients.

Vanda Pharmaceuticals (NASDAQ:VNDA) is also worth mentioning in the AD drug development space.  The company is generating revenue with other products, but hit a setback in the first quarter this year in development of tradipitant, a neurokinin 1 receptor antagonist being developed for chronic pruritus in patients with AD.  A meaningful improvement on the 100mm unit Visual Analog Scale for itch was shown, but a large placebo effect was too, resulting in no statistically significant improvement for the drug compared to placebo.  Additional pharmacokinetic analysis showed a strong correlation between outcomes and patients with higher exposure to tradipitant, leaving interested parties as to what the developmental path holds for tradipitant going forward.

Cesca Therapeutics Inc. (NASDAQ: KOOL), an autologous cell-based regenerative medicine company, recently announced that it’s hosting the first annual Symposium on Haploidentical Stem Cell Transplantation in Delhi, India on January 7^th. At the event, experts will discuss current protocols and challenges for immune-oncology therapeutic approaches from a half-HLA matched (haploidentical) related donor – a treatment option that’s gaining popularity.

The company’s MarrowXpress™ platform is a device and disposable system that isolates and concentrates stem cells from bone marrow. As a self-powered microprocessor-controlled technology, the MXP contains flow control and optical sensors to concentrate white blood cells from bone marrow to a user-defined volume in just 40 minutes, while retaining over 90% of mononuclear cells (MNCs) that provide therapeutic benefits.

The use of haploidentical transplantation will greatly increase the options for patients in need of bone marrow transplant, particularly in India where there is a great unmet need due to a lack of public bone marrow banks. Investors in the cell therapy space, including companies like StemCells Inc. (NASDAQ: STEM) and Pluristem Therapeutics Inc. (NASDAQ: PSTI), may want to take a closer look at the stock as it continues to target India’s growing market.

Read the company’s entire press release here:

Cesca Therapeutics Inc.(KOOL), an autologous cell-based regenerative medicine company, today announced that it is hosting the first annual Symposium on Haploidentical Stem Cell Transplantation in Delhi, India on January 7, 2016. The symposium will bring together National and International experts in the field of pediatrics and hematology/oncology to discuss current protocols and challenges for immune-oncology therapeutic approaches from a half-HLA matched (haploidentical),  related donor. The program will include panel discussions on the latest clinical data and the merits of this treatment option in the current health care scenario. Haploidentical transplantation is a treatment option gaining global acceptance as it increases the possibility and practicality of finding an acceptable donor match, known as an HLA (genotype) match. Parents are always a half-match for their children and siblings have at least a 75% chance of a match (full match and half match). Until recently, use of closely related donor sources such as the patient’s parents came with a high risk of potentially fatal Graft versus Host disease, where donor immune cells attack the recipient’s cells. New protocols that involve ex-vivo selection or removal of specific sub-types of T lymphocytes, a service provided in Cesca’s TotipotentRX cell processing laboratory in Delhi, India, are now providing a good therapeutic option for patients in need of a life-saving bone marrow transplant for treatment of leukemia and genetic blood disorders such as sickle cell anemia. Other protocols for haploidentical transplantation incorporate drugs that suppress the recipient’s immune system in-vivo to promote acceptance of the donor’s immune system.

Use of haploidentical transplantation will greatly increase the options for patients in need of bone marrow transplant, particularly in India where there is a great unmet need due to a lack of public bone marrow banks. Dr. Venkatesh Ponemone, Ph.D., Executive Director, Clinical affairs at TotipotentRX, India, stated “We are very pleased to sponsor this symposium and excited to have Dr. Rupert Handgretinger, Professor of Pediatrics at the Children’s Hospital, University of Tubingen, Germany to share his clinical experience in treating children with various cancers using haploidentical stem cell transplantation. This symposium is a welcome platform to bring together leading hemato/oncology physicians to review and discuss standards of practice and emerging protocols for bone marrow transplantation. We are committed to supporting the practice of bone marrow transplantation and enhancing the ability of India to meet the growing need for this therapy.”

The one-day symposium will be held on January 7, 2016, in the Hotel Leela, Gurgaon, New Delhi, and is expected to be an annual event.

 About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products.  These include:

• SurgWerks™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:

• Cell harvesting
• Cell processing and selection
• Cell diagnostics
• Cell delivery
• CellWerks^TM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
• The AutoXpress^® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
• The MarrowXpress^™ (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
• The BioArchive^® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. 

Forward Looking Statement

The statements contained herein may include statements of future expectations and other forward looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Descriptions of other risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. Cesca may, at its discretion, choose to publish on-going interim notifications, but as a general policy only makes announcements regarding material or significant information, such as filing of applications, approvals, initiation of studies, and conclusions.

OxySure Therapeutics Inc. (OTC: OXYS), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other solutions, recently announced that it would be presenting at the 34^th Annual JP Morgan Healthcare Conference in San Francisco. Chairman and CEO Julian Ross will provide a corporate overview on January 11th at noon at the SeeThruEquity Microcap Investor Event.

At the event, the company will have a lot to talk about given its significant progress across many different fronts. The company’s third quarter financial results showed its 14^th consecutive quarter of growth as it ramps up operations to pursue an uplisting to a national exchange. Revenue soared 39% to $1,138,308, gross profit jumped 12% to $558,254, and shareholders’ equity more than doubled to $2,180,918 following a $3 million financing transaction.

Biotech investors may want to take note of how companies like CytoSorbents Corp. (NASDAQ: CTSO) successfully transitioned to a national exchange – a potential upcoming catalyst for OxySure – while the company could be an attractive company to watch for investors in other micro- and small-cap medical device companies like Sharps Compliance Corp. (NASDAQ: SMED) or Biomerica Inc. (OTC: BMRA) given its rapid growth and upcoming catalysts.

Read the entire press release here announcing the upcoming event:

OxySure Therapeutics, Inc. (OXYS) (“OxySure,” or the “Company”), a global leader and medical device innovator of life-saving, easy-to-use emergency oxygen products with its “oxygen from powder” technology and other innovative medical solutions will be presenting at the 34th Annual J.P. Morgan Healthcare Conference in San Francisco. Mr. Julian Ross, Chairman and CEO will provide a corporate overview at 12:00 noon on Monday, January 11, 2016 at the SeeThruEquity Microcap Investor event at The Fairmont Hotel, 950 Mason Street, San Francisco, CA 94108.

About OxySure Therapeutics, Inc.

OxySure Therapeutics, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. In addition to oxygen products for public/lay responder usage, OxySure also markets emergency medical solutions including AEDs (Cardiac Science, Philips, Zoll, Physio Control, Defibtech, and HeartSine), Quickclot Bleeding Control solutions, resuscitation products and pulse oximetry products. www.OxySure.com

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Therapeutics, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Therapeutics, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014.

There are many different approaches to treating cancer. While surgery was undoubtedly the first approach to treating cancer, Dr. William B. Coley noticed that cancer patients went into remission after developing a bacterial infection and began the first immunotherapy regimens back in the late 19^th century. Scientists noticing the effects of mustard gas in the early 20^th century began developing the first chemotherapy regimens by the 1940s.

According to the American Cancer Society, the five-year relative survival rate for all cancers diagnosed in 2004-2010 increased to 68% compared to just 49% between 1975-1977. These favorable trends have been driven by a combination of better treatments and earlier diagnoses thanks to improved awareness. Of course, breast cancer has seen some of the biggest strides in terms of early detection and treatment that has dramatically improved survival.

Companies have taken a wide array of different approaches since the early days of cancer therapeutics. Celgene Corporation’s (NASDAQ: CELG) Abraxane is a leading chemotherapy drug; Peregrine Pharmaceuticals Inc.’s (NASDAQ: PPHM) bavituximab removes cancer cells’ immunosuppressant abilities; and, Lion Biotechnologies Inc. (NASDAQ: LBIO) is focused on adoptive cell therapies to infiltrate tumors and destroy them.

Unlike many of these companies, OncBioMune Pharmaceuticals Inc. (OTC: OBMP) is focused on developing cancer vaccines that treat the patient at an early stage with little or no toxicity. By building up immunity early on, patients’ bodies are better equipped to combat the cancer on their own. The company’s lead product, ProscaVax™ is set to begin Phase 2 clinical trials early this year after seeing promising signs in its Phase 1 clinical trial results published late last year.

Innovative Approach

OncBioMune is focused on developing cancer vaccines designed to boost the immune system’s natural ability to protect the body.

In many types of cancer, the immune system produces white blood cells called lymphocytes as a natural response to the threat. Two key types of lymphocytes – B cells and T cells – are especially effective in combatting cancer. B cells produce antibodies that can inactivate cancerous cells, while T cells can prompt them to self destruct through a process called apoptosis. Normal cells are left unharmed by these processes, which makes it preferable to chemotherapy approaches.

The company’s cancer vaccines introduce molecules known as antigens into the body that stimulate an immune response and get the process started before a disease becomes too advanced to combat. For example, a patient with  rising PSA levels – an early indication of possible prostate cancer – may get the vaccine to put their body on alert to their prostate cancer in order to more effectively fight it and prevent progression of their disease.

The cancer vaccine approach is not only a smart way to combat cancer, given its low toxicity and early support to the immune system, but the early-stage approach creates a larger potential end market than most cancer therapeutics that only target late-stage patients. Patients benefit from being proactive in treating their cancer early on, while shareholders benefit from a greater number of potential vaccination patients.

Promising Clinical Data

OncBioMune presented results from its Phase 1 clinical trial in October at the International Cancer Immunotherapy Conference. While the trial wasn’t expected to be completed until December, 70% of patients that received three vaccines had increased immune responses to PSA and none of the 12 patients that received at least one vaccine had a dose limiting adverse event (DLAE). These results were more than enough to justify a Phase 2 clinical study early this year.

The lack of toxicity is among the most promising elements of the early-stage clinical trial results, since toxicity is a concern that typically derails many cancer therapeutics. With safety concerns out of the way, the company may be able to expedite its Phase 2 clinical trial and focus on proving efficacy. The excellent safety profile could also help expedite future clinical trials that leverage the same technology and approach across different types of cancer.

Many Near-term Catalysts

OncBioMune has a number of near-term catalysts that investors may want to watch over the coming quarters. With a Phase 2 clinical trial set to commence early this year, the company could have interim data out to investors later this year that could provide some additional insights into efficacy with a planned 120 patients enrolled. The clinical trial’s lead site will be Harvard Medical School’s affiliate Beth Israel Deaconess Medical Center and its Dana-Farber Cancer Institute.

The company also continues to move forward with its other clinical programs. Using the same concepts as its prostate cancer vaccine, the company plans to target ovarian cancer as its next most advanced indication by moving into a Phase 1 clinical trial. The company is taking different approaches to target both breast cancer and renal cancer as well, which both remain in the preclinical stage of development as of early 2016.

Looking Ahead

OncBioMune represents an attractive play in the oncology space, with a cancer vaccine that has shown early promise and is moving into a Phase 2 clinical trial. In the past, the company received funding from the Department of Defense for its Phase 1 clinical trial and signed an agreement with Lincoln Park Capital Fund to provide an additional $10 million in funding through equity purchase agreements, which will help finance its Phase 2 program.

For more information, visit the company’s website at www.oncbiomune.com.

Improved Balance Sheet Paves Way for Increased Revenue, Potential Uplisting and Stronger Shareholder Value

Pressure BioSciences Inc. (OTCQB: PBIO) has delivered on its promise to shareholders to remove all of the variable rate debt from its balance sheet by the year’s end. In a recent press release, the company announced that it raised an additional $730,000 of its $5 million PIPE, which brings the total capital raised in the financing to $4,755,000. The move clears the way for the Company to begin to concentrate its efforts on increasing its revenue through additions to its currently small sales and marketing team, improving its operating functions, and for a potential uplisting in early 2016 to a national exchange.

Uplisting to a National Exchange

Pressure Bio’s management team has made it clear that they intend to make it a priority in 2016 to relist on a national exchange in an effort to build shareholder value.

“We are looking at the possibility of an uplist at some time next year, when the time is right.  We will know when the time is right when we believe the value of the company based on its stock price is fair to shareholders and the market is appropriate,” said CEO Richard Schumacher during the company’s third quarter conference call in November. “Our goal is to eliminate all variable rate debt on our balance sheet on 12/31/15. We think that is going to go a long way to helping us get back on a national exchange, and we believe that getting back on such an exchange will bring value to PBIO.”

The prospect of an uplisting provides a strong catalyst for investors next year. Since many institutional investors are forbidden from investing in over-the-counter stocks, or are deterred from doing so because of massive red tape, the uplisting to a national exchange would open the door to a significant number of additional investors. The Company’s now clean balance sheet and the marketing/sales investments Mr. Schumacher has indicated are coming, could make the stock even more attractive to these investors, especially if the stock is trading at a discount to its peers.

Investing in Sales & Marketing

Pressure Bio plans to spend the rest of its PIPE proceeds on expanding its sales and marketing infrastructure. According to the PIPE’s provisions, the offering can be up to 25% oversubscribed, which could bring in a total of about $1.25 million in additional capital.

“We’ve already started to buff-up our capabilities in sales and marketing, but we’re going to expand this important area much more once the last bit of debt is paid off,” said Mr. Schumacher during the company’s Q3 conference call.

The company has also been in co-marketing discussions with at least one large mass spectrometry manufacturer. Since PCT can be used to break up samples faster and with higher quality than current methods prior to mass spectrometry analysis, a co-marketing agreement with a large, multi-national mass spec instrument provider could provide valuable access to key target markets and existing mass spec customers. There are more than 7,000 labs in the U.S. alone that have at least one mass spectrometer, which equates to an enormous target market that is ripe for the taking.

These future efforts come in addition to the Company’s already strong organic revenue growth seen over the past several quarters, following a number of publications from Key Opinion Leaders (KOLs) from around the world featuring the PCT platform.

“We have brought on new important customers who are using, publishing, and presenting on our PCT technology platform.  Others in the field are beginning to hear the good comments and see the great data offered by the KOLs.  These researchers are calling us and saying, ‘I’d like to see the PCT system that Dr. so-and-so and so-and-so have been using’, so please send me a quotation for a purchase,” added Mr. Schumacher during the conference call.

Potential Opportunity

Pressure Bio represents a unique opportunity within the biotech industry. While companies like Harvard Biosciences Inc. (NASDAQ: HBIO) are focused on sample prep and others like NanoString Technologies Inc. (NASDAQ: NSTG) are developing molecular identification technologies, these companies are mostly focused in a specific area of the life sciences.  Conversely, Pressure Bio represents a unique and somewhat different investment than these other companies, as its PCT platform is more universal and can help scientists broadly while being applicable to many vertical markets.

In addition to its compelling market opportunity, the company’s razor-razorblade business model generates predictable and recurring revenue over time as new labs are added. These dynamics, especially now that the Company has a balance sheet completely void of variable rate convertible debt, could lead to a higher valuation, and soon, as investors gain more confidence in cash flow projections into the future compared to companies selling one-off instruments and other devices.

For more information, visit the company’s website at www.pressurebiosciences.com.

As 2015 winds to a close, a little reflection shows it was a huge year for biotechnology.  Of course, this year featured the biggest tax inversion deal ever with Pfizer (NYSE: PFE) and Allergan (NYSE: AGN) agreeing to combine companies in a whopping $160 billion deal.  That mega-merger pushed the total for health and pharmaceutical mergers over $550 billion in 2015, up 17 percent from a year earlier, as big pharmas look to buy companies rather than risking resources on their own research and development.  As with every year before it, 2015 was a time for new drugs to come to market, including Novartis’ (NYSE: NVS) heart failure drug Entresto, and clinical trials advancing to offer hope for those in need in the future.   Below are some companies that will be initiating key trials in 2016.

Synthetic Biologics, Inc. (NYSE MKT: SYN) recently provided encouraging topline data from its 63-patient phase 2 study using SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C).   SYN-010 is a proprietary modified-release formulation of lovastatin lactone.  In the short (4 week) trial, SYN-010 was shown to lower breath methane, which is thought to be a cause of constipation, in a dose-dependent fashion at both day 7 and day 28, in IBS-C patients, thus meeting the trial’s primary objective.  The treatment also improved stool frequency in IBS-C patients.

A second phase 2 trial in IBS-C is ongoing evaluating the 42 mg dose of SYN-010 during an eight-week period in patients carried forward from the first trial.  Topline data from this study is expected in the first quarter of 2016 as Synthetic prepares a larger phase 3 trial.  About 45 million people in the U.S. alone are affected by irritable bowel syndrome.

OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) is aiming to wrap up a phase 1 study assessing its cancer vaccine ProscaVax for the treatment of prostate cancer and start a phase 2 trial in the first quarter of 2016.  The phase 1 trial received substantial support from the U.S. government, with $5 billion in funding coming from the Department of Defense.  The phase 2 trial, as described in the video below, will be hosted at “a major university” in the Northeast United States.  Companies are often coy about using names of institutions in public statements, but a 10-Q filing with the Securities and Exchange Commission shows that “the lead site will be Harvard’s Beth Israel Deaconess Medical Center, with additional other hospitals in the Harvard Health System.”  Harvard’s health system is arguably one of the best in the world for cancer research and includes the venerable Dana-Farber Cancer Institute.  The phase 2 trial will be under the direction of Dr. Glenn Bubley, who serves as an Associate Professor of Medicine at Harvard Medical School and Director, Genitourinary Medical Oncology, at Beth Israel.

With about 221,000 men estimated to be diagnosed with prostate cancer this year (and 27,500 deaths from it), there is a tremendous area of unmet medical need as effective drugs are scarce and accompanied by unpleasant side effects.

In-house clinical research and the phase 1 study have showed several important characteristics for ProscaVax.  One, levels of PSA (prostate specific antigen, a protein produced by the prostate that’s typically elevated in prostate cancer patients) were driven down in early stage patients with biopsy-confirmed prostate cancer and rising PSA levels without any other therapy.  Long-term follow up and additional biopsies in four patients showed significant reduction in tumors following ProscaVax therapy.  Further, the vaccine had almost no toxicity, a key in any monotherapy or those used in an adjuvant setting.  In prostate cancer patients with advanced disease there was a significant decrease in the rise of the PSA for half the patients following ProscaVax therapy.

The phase 2 study  will use ProscaVax alone to treat patients at presentation who are in active surveillance.  This is an important distinction as most therapies are focused on late stages of the disease where prognosis is poor.  There are currently no therapies available for treatment in the active surveillance period, a time when treating the disease could provide the greatest therapeutic benefit.  Should ProscaVax reduce tumor volumes at this early stage without toxicity, OncBioMune will be in an enviable position to leverage accelerated FDA pathways in a bid to bring its product to market, as well as expanding its platform technology into other indications, such as ovarian cancer.

InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV), a company focused on treating traumatic acute spinal cord injuries (SCI), got some good news early this month when the FDA gave a conditional approval to a study protocol amendment that will convert an ongoing pilot study into a pivotal probable benefit study.  The “conditional” approval only has to do with a slight change in the informed consent form, which has already been modified and sent to the FDA.  Full approval is expected in the next few weeks.  The five-patient feasibility pilot study is evaluating the company’s Neuro-Spinal Scaffold (NSS) under an Investigational Device Exemption application for the treatment of complete traumatic acute spinal cord injury (SCI).

The NSS is an investigational bioresorbable polymer scaffold designed for implantation at the site of injury within a spinal cord contusion.  It provides structural support to the spared spinal tissue and a supportive matrix to facilitate endogenous repair processes as it degrades over several weeks.

InVivo has provided compelling data so far showing NSS to have a positive safety profile and a meaningful effect on spinal cord injuries, injuries that have a long history of being notoriously difficult to treat.  One patient in the trial with a high thoracic injury even had an AIS conversion (an improvement in the impairment scale of the American Spinal Injury Association) from AIS-A to AIS-B in one month, an occurrence that happens less than 4 percent of the time in patients with a T4 injury.  Another patient has improved from AIS-A to AIS-C in one month, which happens in less than 5 percent of patients with a T10-T12 injury.

The pivotal probable benefit study, dubbed the INSPIRE study, is planned initially to enroll 12 patients, with expectations to be expanded to 20 patients after a review of 6-month safety data of the first five patients.  The inclusion criteria are also being widened to a new range of injuries and the age criteria has been significantly expanded to people between the age of 16 and 70.  The number of U.S. sites has been increased to 40 and InVivo further intends to initiate the study in Canada and the United Kingdom.

Suppose that you’re at a sporting event and someone in the crowd suffers a heart attack and goes into cardiac arrest. A nearby fan responds quickly and calls for help, but stadium employees aren’t quite sure where the nearest AED is located. Once a device is finally located, emergency responders attempt to utilize it, but the battery has died. The person ends up dying at the event and the sporting event is sued for their lack of an appropriate response.

OxySure Therapeutics Inc. (OTCQB: OXYS), a leading provider of emergency medical solutions, recently launched its OxyTrac™ technology to make sure these scenarios never occur. Through a cloud-based solution, the technology helps rapidly locate all emergency response devices on the premises, facilitates availability of extra help via a contact database, and ensures that devices are properly inspected, while tracking expiration dates for batteries or other consumables.

The OxyTrac™ Solution

OxyTrac™ is compatible with a wide array of emergency response devices, ranging from OxySure’s in-house Model 615 emergency oxygen solution to AEDs produced from a variety of different manufacturers. At a price as low as $25 per device per year, the solution is a cost effective way to ensure appropriate emergency responses and legal compliance necessary to avoid lawsuits and other issues stemming from the lack of an appropriate response.

“We are excited about OxyTrac and the way it will make our customers’ lives easier by consolidating the tracking, inspections, maintenance, and monitoring of all their emergency medical devices on one single platform,” said Julian Ross, CEO of OxySure. “We are able to track any device with an expiry date on it, and OxyTrac can provide the confidence of knowing the filing, registration, and submission of the required compliance paperwork has been documented properly.”

Investor Implications

OxyTrac™ addresses a large potential end market – including its existing customer base – with a high margin recurring revenue service. The company has sold thousands of its own devices over the past several years, creating a strong initial market for the service, while there are millions of commercial AED installations around the world. Capturing even a fraction of these customer segments could generate significant recurring revenue for shareholders.

In addition to generating recurring revenue from the yearly subscription fee, the technology could improve the consistency of consumable revenue from its other products. The OxySure Model 615 has reusable oxygen cartridges that must be regularly replaced to remain effective and the reminders generated from OxyTrac™ could ensure a steady stream of orders for new cartridges from its existing customer base over the long-term. The system automatically generates email reminders regarding upcoming expiry dates and an even create autoship options with automatic invoicing for customer convenience.

Looking Ahead

OxySure reported its 14^th consecutive quarter of growth during its fiscal third quarter, with revenue growing at a nearly 40% clip to $1,138,380 for the quarter. With plans to reach a $10 million run rate by the end of the year, the company’s products continue to gain traction in the market, while new product launches like OxyTrac™ promise to create new growth opportunities. Combined with an anticipated cash flow breakeven next year, investors may want to take a closer look.

The company also plans to pursue an uplisting to a national exchange like the NASDAQ or NYSE MKT, having appointed new board members and taken actions to meet other requirements. Upon a successful uplisting, the move could encourage institutional investors to take a closer look at the stock and potentially improve both liquidity and share price. Analysts like SeeThruEquity have assigned a $2.30 per share price target on the stock given these upcoming catalysts.

Investors in micro- or small-cap medical device companies, such as Sharps Compliance Corp. (NASDAQ: SMED), Sanuwave Health Inc. (OTC: SNWV), or Biomerica Inc. (OTC: BMRA), may want to take a closer look at the stock given these numerous catalysts.

For more information, visit the company’s website at www.oxysure.com.

Cesca Therapeutics Inc. (NASDAQ: KOOL), an autologous cell-based regenerative medicine company, recently announced receiving Medicare coverage approval for the FDA approved clinical study “Critical Limb Ischemia Rapid Delivery by SurgWerks^TM-CLI Kit and VXP System (CLIRST III)” from the Centers for Medicare and Medicaid Services (CMS). The approval extends coverage across all Medicare administrative regions.

SurgWerks-CLI Medicare reimbursement is a significant milestone as it’s structured to provide reimbursement of certain partial costs of Cesca’s CLIRST III pivotal trial for Critical Limb Ischemia and potentially initiates a path toward Medicare coverage following the conclusion of the clinical trial and a positive regulatory result from the US FDA. SurgWerks^TM is a proprietary platform stem cell therapy point-of-care kit system for treating vascular and orthopedic indications that integrates cell harvesting through delivery.

Investors in the cell therapy space, including medical device approaches like Zimmer Biomet Holdings Inc. (NYSE: ZBH) and Harvard Apparatus Regenerative Technology, Inc. (NASDAQ: HART) or pure-play cell-based approaches like Capricor (NASDAQ: CAPR) and Pluristem Therapeutics, Inc. (NASDAQ: PSTI) or StemCells Inc. (NASDAQ: STEM), may want to take a closer look at Cesca given its ongoing progress in bringing a unique technology to market.

Read the entire press release here:

Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced that it has received approval for Medicare coverage for the investigational device exemption (“IDE”) clinical study protocol entitled: “Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System (“CLIRST IIIII”)” from the Centers for Medicare and Medicaid Services (“CMS”), a federal agency within the United States Department of Health and Human Services. According to the official correspondence from CMS, Cesca’s IDE study was consistent with conditions specified in the IDE regulations and was therefore approved for Medicare coverage. This approval extends coverage across all Medicare administrative regions.

“We are very pleased with the CMS’s decision to approve our potentially life changing, pivotal clinical study in critical limb ischemia (“CLI”) for Medicare reimbursement,” said Robin Stracey, Chief Executive Officer of Cesca. He added, “Achieving Medicare reimbursement is a significant milestone. Medicare reimbursement will further the Company’s efforts to find an effective treatment for CLI, the most severe form of peripheral arterial disease (“PAD”). Often associated with chronic foot and leg ulcers and leading to approximately two hundred thousand major and minor amputations per year, Medicare reimbursement will help the Company reduce the cost of our clinical trial as the team at Cesca works toward fulfilling a major unmet medical need.”

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:

• SurgWerks^TM Platform, proprietary stem cell therapy point-of-care kit systems for treating vascular and orthopedic indications that integrate the following indication specific systems:

• Cell harvesting
• Cell processing and selection
• Cell diagnostics
• Cell delivery
• CellWerks^TM Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
• AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP^® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
• The MarrowXpress Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
• The Res-Q^TM 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
• The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.

Forward Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

ARCA biopharma (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, recently announced its third quarter financial results and provided a business update. While the results were largely in-line with expectations, there were two key takeaways that shareholders and potential investors should note – its $41.5 million cash runway and the successful rollout of its revised trial protocols.

Cash to Catalyst

“Cash and cash equivalents totaled $41.5 million as of September 30, 2015, compared to $15.4 million as of December 31, 2014. The Company believes that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, through at least the end of 2017. ARCA had approximately 9.0 million outstanding shares of common stock as of September 30, 2015.”

ARCA biopharma disclosed $41.5 million in cash and cash equivalents, as of September 30, 2015, which management believes will be sufficient to fund its operations through at least the end of 2017. This cash runway is significant given that Phase 2B efficacy data is expected to be released during the first half of 2017, according to Dr. Bristow’s comments earlier in the press release, which means that investors could see a big catalyst ahead of any future dilution.

The company’s cash burn has increased during the quarter due to the opening of additional GENETIC-AF clinical trial sites, but these costs should begin to even out as the company reaches its target of 65 clinical trial sites by the fourth quarter of this year.

For investors, the cash runway removes a significant overhang in the stock caused by the potential for dilutive financing before a major catalyst.

On-going Enrollment

“Additional investigative clinical sites were approved, trained, and began adopting the revised protocol, with all of the client sites now operating under the revised protocol.”

ARCA biopharma introduced a revised trial protocol to expand its patient population that has been rolled out to all 58 clinical trial sites across the U.S. and Canada. While the revised protocol was announced back in March of this year, the implementation across all of its clinical trial sites suggests that patient enrollment could accelerate. The other key benefit is that the treatment now addresses a much larger commercial end market, if approved.

Under the new protocol, patients in sinus rhythm who have experienced symptomatic A-Fib in the past 120 days are eligible to be included in the trial. The trial was previously restricted to only patients with A-Fib episodes lasting seven days or less, which was a substantially more limited patient population. With these revised criteria, the company anticipates enrolling 200 patients in its Phase 2B trial and an additional 420 patients in a Phase 3 trial.

De-Risked Trial

ARCA biopharma’s GENETIC-AF clinical trial is premised on a DNA sub-study of a BEST trial of 2,708 heart failure patients, which showed a 74% improvement in A-Fib for a specific genotype compared to a 41% improvement in the broader population. In addition, the genotype is present in approximately half of the population. This means that the treatment in the appropriate genotype has a higher potential of seeing efficacy, while addressing a large patient population.

Gencaro‘s classification as a beta-blocker also means that it’s likely well-tolerated with relatively low risk for patients with advanced A-Fib. Given this class of drug’s established safety profile, the company likely has a low risk of failing to secure regulatory approvals due to its safety profile – a big concern and regulatory hurdle for many new classes of drugs.

The combination of likely efficacy and a strong safety profile yield a relatively de-risked clinical trial compared to many other novel cardiovascular therapeutics.

Looking Ahead

Investors may want to take a closer look at ARCA biopharma following its third quarter financial results given its cash runway, on-going trial enrollment, and de-risked clinical trial. In addition, investors interested in the cardiovascular therapeutics space, including companies like Cardiome Pharma Corp. (CRME) and Cytokinetics Inc. (CYTK), may want to take a look at the stock given its upcoming catalysts.

For more information, visit the company’s website at www.arcabiopharma.com

Earnings season is in full swing, with about 350 S&P 500 companies having disclosed their results from the latest quarter through Friday.  Considering the headwinds from soft global economies and sluggish growth in the United States during the third quarter, analysts didn’t set expectations too high and about 68 percent of companies beat earnings estimates, keeping Q3 in line with long-run averages.  Some S&P 500 components hit it out of the park, including real estate firm Prologis (NYSE: PLD) crushing analyst expectations by a stunning 133 percent with adjusted profits of 49 cents per share.  Shares of First Solar (NASDAQ: FSLR) spiked 12 percent on Friday as the solar energy solutions provider blew past predictions with earnings of $3.38 per share, versus $1.55 expected.

Earnings will still be in focus this week, with some popular smaller companies in the spotlight, including game developer Glu Mobile (NASDAQ: GLUU) and specialty pharma Oculus Innovative Sciences (NASDAQ: OCLS).

Analysts expected Glu, who makes free-to-play games for smartphones and tablets, to have a tough second quarter, forecasting a net loss of 4 cents per share on revenue of $51.5 million.  The company outstripped those expectations, surprising with a profit of 1 cent per share and sales of $56.2 million.  Looking to the recent quarter, expectations are again for Glu to report a net loss of 4 cents per share, although for the full year, the consensus is that Glu will report a profit of 3 cents per share.  If Glu can confound analysts again, the beaten down stock might find some legs to move towards the $8.15 consensus price target analysts currently have on the stock.

Oculus began a turnaround effort late in 2013, which has included spinning out its biotechnology unit, shuffling executives, replacing board members, winding down its legacy animal health operations and rebuilding them under a better business model, launching new Microcyn-based dermatology products and creating a new derm division called IntraDerm Pharmaceuticals.  As with any turnaround, it took time to get the parts in motion, but they now all are in sync as evidenced by growing year-over-year sales and a stock price that has basically doubled after hammering out a bottom at 65 cents in May.

In the first quarter of fiscal 2016, ended June 30, 2015, total revenue was up 8 percent from Q1 fiscal 2015 to $3.68 million.  Net loss was 15 cents per share.  Product revenue climbed 37 percent, including a 122-percent jump for US product sales to $787,000, which put US sales back in front of sales to the rest of the world ($571,000).  In Mexico, Oculus’ largest market, product sales were ahead 43 percent to $1.6 million, even though negatively impacted by an unfavorable currency exchange.  This surge in sales in Mexico is attributable to Laboratorios Sanfer, a large distributor with channels throughout Latin America, acquiring More Pharma, Oculus’ previous distribution partner, in January 2015.  Given the considerably larger sales territory of Sanfer, the buyout should continue to grow Oculus’ footprint south of the U.S. border.

At the end of the first quarter, Oculus had $8.8 million in cash and cash equivalents and no material debt outstanding.

Looking to the second quarter of fiscal 2016, ended September 30, analysts are expecting similar figures to Q1.  Maxim is forecasting $3.602 million in revenue and a net loss of 8 cents per share.  Stonegate expects $3.767 million and a net loss of 14 cents per share.  Dividing the annual expectations of Dawson James puts Q2 revenue at $3.8 million and a net loss of 8 cents per share.  Yahoo Finance has the consensus at $3.69 million and a net loss of 11 cents per share.

In the same quarter of fiscal 2015, Oculus reported total revenue of $3.264 million and a net loss of 8 cents per share.  Therefore, analysts are expecting little quarter-over-quarter growth and 13 percent year-over-year revenue growth.  It is possible that Oculus will exceed the consensus revenue due to the expected continuing sales ramp of the dermatology business, as shown in the company’s posted investor presentation.

Oculus remains an underappreciated value play with valuation measures that trail industry peers in nearly every metric, including a market capitalization and enterprise value of about $20.7 million and approximately $11.3 million, respectively. If the company continues to show consistent growth quarter-over-quarter as well as in consecutive quarters, both the appreciation for and the value of the stock could be on the upswing.