COCOA, Fla., April 11, 2012 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, today announced that data on the NITROSYL Delivery System during Right Heart Catheterization (RHC) in subjects being evaluated for Orthotopic Heart Transplantation (OHT) and Left Ventricular Assist Device (LVAD) implantation has been selected for oral presentation at the International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting in Prague, Czech Republic on April 19, 2012.
This is the first human data to be presented with the Company's novel inhaled nitric oxide (NO) delivery system that converts nitrogen dioxide in either air or oxygen to nitric oxide. The gas is allowed to flow through a proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy.
Dr. Andrew Boyle, Medical Director of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Aurora St. Luke's Medical Center in Milwaukee is scheduled to present the abstract, "An Open Label Non-Randomized Pilot Study To Evaluate the Safety of the GeNO Nitrosyl Delivery System in Patients Being Evaluated for Heart Transplantation."
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO NITROSYL Delivery System during RHC. Secondary considerations are to confirm that inhaled NO generated by the system reduces pulmonary vascular resistance (PVR) in patients with reversible pulmonary hypertension and contains levels of Nitrogen Dioxide (NO2) well below the upper level of acceptable exposure.
GeNO's NITROsyl Delivery System could add valuable options for clinicians treating a range of serious pulmonary and cardiac diseases with inhaled nitric oxide. GeNO's plans for both in-hospital and ambulatory inhaled nitric oxide systems will help address the cost, complexity and lack of portability of current treatment regimens, and potentially reach a much larger group of patients. At present, GeNO's delivery technologies are investigational and are not approved by regulatory authorities.
GeNO 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.
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 NITROSYL Systems will be will be regulated by the FDA as new drugs with their own NDAs. These 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.
ABOUT AURORA HEALTH CARE
Aurora Health Care is a not-for-profit Wisconsin based health care provider and a national leader in efforts to improve the quality of care. Aurora provides care at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois.
SOURCE GeNO LLC