Apnex Medical : FDA Approval for Pivotal Clinical Study for Obstructive Sleep Apnea

Aug. 2, 2011 - Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA). Data from this clinical study are intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.
"Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA," said the study's co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women's Hospital.
Sponsored by Apnex Medical, the Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate to severe OSA. To be enrolled in the study patients must not have received lasting benefit from CPAP or other OSA treatments... [PDF] Apnex Medical's Press Release -

Apnex Medical : Additional $14 Million

December 2, 2009 - Apnex Medical, Inc., a private medical device company, announced that it has completed a second round of private equity financing totaling $14 million. The funds will be used to complete a clinical study and develop a second generation of its proprietary implantable technology designed to treat obstructive sleep apnea (OSA).
Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman. The current board includes Robert Atkinson, CEO, and Michael Berman, Chairman, together with Brian Chee, John Nehra and Nimesh Shah representing Polaris, NEA and Domain, respectively. This financing brings the total investment in Apnex Medical to $30 million.
“We are very excited about the early results with the Apnex Hypoglossal Nerve Stimulation (HGNS™) System in our clinical study. Our technology really has the potential to change the lives of people suffering from OSA. This round of financing will allow us to finish our initial clinical study and get us that much closer to market,”... [PDF] Apnex Medical's Press Release -