Frisco, Texas, March 31, 2016 – 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 provided a stockholder update.
The Company provided an updated advisory to stockholders indicating that it expects to file its audited financial statements for the fiscal year 2015 during the week of April 11, 2016.
The Company’s legal team also addressed a recent FDA safety notice regarding the OxySure Model 615. Said Mazin Sbaiti, Esq., attorney with Friedman & Feiger LLP and OxySure’s litigation counsel: “OxySure strongly disagrees with both the content and import of the FDA's March 29, 2016, safety notice about the OxySure Model 615 device. We are sure that the thousands of people saved over the years with our product also disagree. Notably, the notice cites no evidence that shows that the OxySure Model 615 device does not perform up to FDA standards, or that it fails to perform as intended -- indeed, the record of usage to save lives would suggest otherwise. We continue to stand by our product, its innovativeness and the value it brings to society. FDA's sudden and unprompted notice is not only full of inaccuracies; it is plainly arbitrary and capricious.”
“The Board is reviewing all strategic and operational options at its disposal,” said Julian Ross, Chairman of the Company.
“From a strategic standpoint, we like the idea of using this opportunity to take a step back, take Model 615 offline and accelerate our plans for Generation 2. We are evaluating this approach being done in combination with an outsourcing strategy. Outsourcing can provide the benefits of immediate scale, efficiency and approvals such as ISO 13485, which is needed for markets such as Canada and others. At the same time, it can lower cost and it makes manufacturing cost more variable.”
The Company’s plans for Generation 2 of the device include improvements that provide user convenience and additional precautions against user error and intentional or unintentional abuse of the product.
“We plan to conduct focus groups regarding what this Generation 2 version will be called, but we expect it to be ready some time during the mid-summer of 2016,” Mr. Ross added.
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
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.