According to the company, IriSys successfully formulated the GeNOsys tablets into a product that could be manufactured in high quantities yet maintain the necessary tablet hardness, appropriate generated Nitric Oxide concentration and volume. Further, the completion of the contract with IriSys Pharmaceuticals represents a major milestone in the process toward submitting the company’s portable nitric oxide generator to the FDA. The work completed at IriSys was completed on time and under budget.
Clark Mower, director of GeNOsys, said: “We are moving rapidly toward a 510 (k) FDA approved device submission. We look forward to being able to customize the tablets for a specific disease, which represents a final step prior to FDA submission.”