got a few more jus now..think im goin to start dabbling down here again in the nearterm here and there jus in case this gets the big news we been waiting on!FDA clearance for their nitrous oxide system would be the ticket!
from last 10q..
Nitric Oxide Gas for Inhalation
We are a medical research and development company specializing in pharmaceutical, bio-technical and medical gas generating systems. The primary gas our systems will generate is medical grade nitric oxide, along with other various combinations of beneficial medical gases suitable for the treatment of human conditions and diseases. The gases also have other potential uses, such as the treatment of animals by veterinarians and the sterilization of equipment and devices.
Non-medical grade nitric oxide gas is produced and sold commercially by major gas companies as a specialty gas mixture and calibration gas. Nitrogen dioxide is present in all nitric oxide gas currently produced. Its presence limits the size of the dose of nitric oxide gas that can be administered for prospective uses in both humans and animals.
We have developed a proprietary compound formulation that will be utilized to produce medical grade nitric oxide gas in our desktop and portable generators. Management believes that with the further refinement of our proprietary formulation, we can make or filter medical grade nitric oxide gas with minimal amounts of nitrogen dioxide, and that this process can produce medical grade nitric oxide gas in ample quantities for any current or prospective use and at a price substantially less than that of all currently available technologies.
Our current generator models are capable of delivering sufficient quantities of nitric oxide gas for individual laboratory desktop use. We are continuing to further develop our generators and our proprietary compound formulation for high production quantities and consistency. The product must have a known shelf life and be available in various configurations to produce known concentrations and volumes of gas. Packaging is another critical developmental process that we are addressing. Management plans to rely on outside contractors to achieve these objectives.
We estimate that non-clinical laboratory sales could take place earlier than United States Food and Drug Administration (“FDA”) approval. Management anticipates that selling our desktop generator earlier into the market as laboratory equipment will pave the way for sales of our medical generators and proprietary tablets and compounds, but expected financial contributions from non-medical generator and tablet sales will not be sufficient to fund the substantial costs of the FDA approval process for human medical uses. We expect that contributions from laboratory sales will be able to cover all or part of our manufacturing and set-up costs and contribute to our overall profitability in due time, but believe that we will also require additional funding, which we are currently working to secure.
All human medical uses of nitric oxide gas require FDA approval prior to initiating sales in the United States, and the approval of similar international agencies in their respective countries. Approval can be a long and expensive process, with no assurance that any such approval can or will ever be obtained. Management hopes to reduce the time for regulatory approval by certain strategic approaches that are proprietary.
Our objectives are to establish GeNOsys (generated nitric oxide systems) as the premier nitric oxide generating pharmaceutical company and to:
-manufacture and sell medical grade nitric oxide generators and tablets and compounds for use in the relief of human diseases;
-offer value added services such as custom generators adapted for the treatment of various diseases
-hire staff both currently identified and unidentified to implement our business model; and
-obtain FDA approval of our generating systems.
Nitric Oxide Producing Topical Products
We have developed a group of nitric oxide producing products for topical use. Patent applications have been filed for these products, which will be available as a cream, gel or wash, depending on the desired application and use.
There are significant markets for topical nitric oxide producing products, including use on non-healing wounds (diabetic ulcers, etc.) and skin care (acne, rashes, abrasions, etc.). For use on non-healing wounds, nitric oxide producing topical products will, with their vasodilator properties, support blood flow to the wound area and support collagen growth, with their anti-inflammatory properties they will reduce inflammation in the wound area, and with their antibacterial properties, support the body in clearing the wound area of infection. We are currently working with a wound care clinic to finalize the procedures for use on non-healing wounds. It is anticipated that revenues will begin to be generated from these topical nitric oxide producing products during the fourth quarter of 2011.
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