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FDA Clears GeNO IND Application For Nitric Oxide Delivery System

GeNO, a privately held, advanced development-stage technology company, has received FDA clearance for its investigational new drug (IND) application of stand-alone gas cylinder Nitrosyl Delivery Platform (NDP).

GeNO’s stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen. The gas is allowed to flow through our proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy.

David Fine, founder and president of GeNO, said: “Having our IND application accepted in the 30-day period is an accomplishment for GeNO, given that we are working on a inhaled nitric oxide generation and delivery system. This marks an critical milestone for the company and completes our rapid transition to a clinical-stage organization. Furthermore, this milestone enables us to move our other patent-protected technology development programs toward clinical trials.”

Lewis Rubin, professor of medicine and head of the pulmonary hypertension program at University of California, San Diego and a medical advisor at GeNO, said: “There are hundreds of clinical studies and thousands of published papers that have evaluated the use of inhaled nitric oxide in treating patients with a variety of indications.

“But despite its promise, widespread use of inhaled nitric oxide has been limited by cost, complexity and lack of portability of the delivery equipment. The GeNO Nitrosyl Delivery Platforms offer an elegant solution, and if shown to be effective, could greatly expand the use of inhaled nitric oxide to treat a larger patient population.”