GeNO LLC Gets FDA OK for Nitric Oxide Delivery System
8/10/2012 7:17:25 AM
WALTHAM, Mass., Aug. 9, 2012 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held pharmaceutical company developing a line of inhaled nitric oxide drug products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) to market its inhaled nitric oxide (NO) delivery system (GeNOsyl MV-1000).
The GeNOsyl MV-1000 delivery system incorporates four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer. The GeNOsyl MV-1000 injects a constant flow of nitric oxide gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient. It provides continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves two functions: 1) as a mixing chamber, and 2) to chemically convert to NO any nitrogen dioxide which may be present, so as to deliver NO with extremely low levels of nitrogen dioxide, a toxic byproduct.
The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings.
"This marketing clearance is a major milestone for our unique NO delivery technology," said GeNO Founder and President Dr. David Fine. "The MV-1000 is GeNO's first delivery apparatus to receive marketing clearance from FDA. We welcome this first approval from FDA as we move all of our platforms forward through clinical development."
GeNO is developing three unique nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit use, and a pocket-sized ambulatory system for chronic outpatient use. All of the platforms are designed to deliver extremely low levels of the toxic byproduct nitrogen dioxide that are undetectable by conventional means, while also addressing the cost, complexity and lack of portability of approved inhaled nitric oxide treatment systems. GeNO's nitric oxide gas has the potential for treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients.
GeNO recently completed a Phase 2 pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH). The company is currently performing a dose-escalation trial for the Treatment of Pulmonary Hypertension in patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF). Additional study details can be found on http://clinicaltrials.gov/-- ClinicalTrials.gov Identifier NCT01265888. At present, GeNO's other delivery technologies are investigational and are not approved by regulatory authorities.
The first human data on this technology was presented in April 2012 at the ISHLT Conference, studying the safety of the GeNO system for delivering inhaled NO to patients being evaluated for cardiac transplant. The GeNO device reproducibly provided NO with low levels of NO2 in air or O2. The NO2 levels were considerably below the FDA limit of 3 PPM and OSHA limit of 5 PPM even in the presence of oxygen which is known to rapidly convert NO to NO2.
ABOUT GENO LLC
GeNO LLC, founded in 2006, is a privately held pharmaceutical company that is developing innovative nitric oxide (NO) generation and delivery chemistry and platforms to enable the true potential of inhaled nitric oxide to be realized for the treatment of a multitude of diseases. The company is focused on applying its technology to delivering inhaled NO to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment. GeNO will provide stand-alone medical devices and combination products that include the base delivery system and GeNO's nitric oxide gas. GeNO's systems 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 INDs. The combination products will be regulated by the FDA as new drugs with their own NDAs.
SOURCE GeNO LLC