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FDA Clears GeNO LLC Investigational New Drug Application for Nitric Oxide Delivery System


3/9/2010 8:06:20 AM

COCOA, Fla., March 9 /PRNewswire/ -- GeNO LLC (www.genollc.com) a privately held, advanced development-stage technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its stand-alone gas cylinder Nitrosylâ„¢ Delivery Platform (NDP). The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl delivery system is as a diagnostic agent for administration as an adjunct to right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. No agents are currently approved for this indication. Prior to conducting a pivotal study later this year, GeNO LLC will first conduct a 10 patient Pilot Study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via this GeNO Nitrosyl delivery system.

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.

"Having our IND application accepted in the 30-day period is an important accomplishment for GeNO, given that we are working on a novel inhaled nitric oxide generation and delivery system," said GeNO LLC Founder and President David Fine. "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 novel, patent-protected technology development programs toward clinical trials."

"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," said Dr. Lewis J. Rubin, M.D., Professor of Medicine, and ,head of the Pulmonary Hypertension Program at University of California San Diego and a medical advisor to GeNO. "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."

ABOUT GENO LLC

GeNO LLC, founded in 2006, is a privately held, advanced development-stage technology company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized. The company is focused on applying the new technology to deliver inhaled nitric oxide to patients in a wide variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO's nitric oxide delivery platforms will be regulated by the FDA as new drugs with their own NDAs. GeNO's platforms have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer for GeNO's initial IND. GeNO plans to submit a second IND application to FDA later this year to begin evaluation of its ambulatory platform. The company has five US patents with additional patent applications pending.

Media Contacts: Carla Burigatto, 610-457-2178 cburigatto@gmail.com

Brian Heffron, 781-799-9568 bheffron@ctpboston.com

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