GeNO LLC Receives Four Additional Patents for Inhaled Nitric Oxide Delivery

WALTHAM, Mass., Aug. 21, 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 been awarded four (4) additional US patents on its proprietary nitric oxide (NO) generation chemistry and delivery technology. This brings to sixteen (16) the number of US patents that have been awarded to GeNO, with additional patents pending.

US patent number 8,211,368, which expires in 2028, describes the conversion of nitrogen dioxide (NO₂) to nitric oxide (NO) where the nitrogen dioxide is stored as a liquid in a permeation tube.  US patent number 8,221,800, which expires in 2023, describes the use of a nitrite salt to release NO within the GeNO NO delivery system.  US patent number 8,226,916, which expires in 2025, relates broadly to the conversion of a liquid NO₂ to NO using an antioxidant. US patent number 8,246,725, which expires in 2025, covers a method of making a device that converts NO₂ to NO, with the option of using one or more surface-active materials in the conversion-based device, as well as one or more reducing agents.

"These four new patents follow FDA clearance earlier this year of GeNO's 510(k) premarket notification to begin commercialization of its acute inhaled nitric oxide (NO) administration apparatus, as well as orphan drug designation for its nitric oxide (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of Persistent Pulmonary Hypertension in Newborns (PPHN)," said GeNO LLC President and Founder Dr. David Fine. "These four new patents, together with GeNO's existing patent portfolio, position GeNO to be a major player in the inhaled NO drug market."

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 nitrogen dioxide impurity that is 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 use in the 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), and 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.   Other than the 510(k) clearance of GeNO's MV-1000 nitric oxide delivery system, GeNO's delivery technologies are investigational and are not approved by regulatory authorities.

ABOUT GENO LLC                                        
GeNO LLC, founded in 2006, is a privately held pharmaceutical company that is developing innovative nitric oxide (NO) generation and delivery 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.

Media Contacts:                                                                    
Carla Burigatto
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Brian Heffron
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SOURCE GeNO LLC