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.
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.
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.
Our entire sales team is fired up and the race has already begun.
We are looking forward to a bumper month and everyone will have fun in the process.
You miss 100% of the shots you don’t take.
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.
We have already closed several deals under leasing programs with MedOne and our customers love the easy, fast and flexible approach. In addition, our customers can now enjoy several other benefits when they purchase their lifesaving medical equipment from us, including conservation of capital and tax advantages.
We are delighted to have Zach join our team, and we very much look forward to working together to grow our business, enhance shareholder value, improve medical outcomes with our innovative products, and save lives.
I am pleased to join the OxySure Advisory Board and I look forward to assisting Julian and his team as they develop this business globally. I believe OxySure is a game changer and a no-brainer as a companion product to Automated External Defibrillators (AEDs) for post-resuscitation usage by lay rescuers in cardiac arrest events. I also believe patients with unstable angina, asthma, pulmonary fibrosis and severe anaphylactic reactions like peanut allergy could benefit from OxySure prior to the arrival of first responders.
This has been a good building quarter for us. We were able to bring strong management to the opportunities and challenges along the way and we are pleased with the exemplary results.
Looking forward, we remain on track with the launch of at least one new solution in 2015,” added Ross. “Also, we have started working with our medical advisors on laying the ground work for our direct to consumer campaign addressing “At Risk” markets such as Asthma and Immunology markets.
We expect to continue our efforts to grow our direct sales force. We have made additional progress and will be continuing our work on the Nasdaq uplisting process. Finally, our growth plan is working and our investments are paying dividends. We are especially excited about working towards one of our next key milestones, which is to reach the $10 million revenue run rate number and break even some time in 2016.
Said Al Ford, Cardiac Science General Manager and Senior Vice President of Sales / Marketing: “We are excited about our relationship with OxySure. The OxySure Model 615 is a great companion product to our AEDs, and we intend to work together closely to address the significant market need to improve outcomes in sudden cardiac arrest, which is the nation’s No. 1 killer, claiming approximately 369,000 lives every year.”
Speaking at a joint sales launch of the new Cardiac Science Powerheart® G5 AED in Frisco, Texas, recently, Clark Hood, Vice President of Resuscitation Sales for OxySure, stated: “We are pleased with the mutual cooperation we have enjoyed with Cardiac Science so far; and we look forward to the continued strengthening of this relationship as we market and sell our lifesaving products together.”