FOXBORO, Mass. – Cyberkinetics Neurotechnology Systems Inc. (OTCBB: CYKN) today announced it has applied to the U.S. Food and Drug Administration for permission to market its implantable Andara OFS nerve-growth stimulation system, under a humanitarian waiver.
Approval would make the Andara the first such device on the market. Its oscillating electrical field is designed to encourage healing in patients with acute spinal cord injuries, helping them to regain movement and sensation.
The filing “is a major milestone … because it represents our first therapeutic product,” said Timothy R. Surgenor, the company’s president and CEO.
Cyberkinetics already is gearing up to begin sales through an initial group of medical centers. If the FDA accepts its application, Surgenor said, “we expect to commercialize the product as early as the fourth quarter of 2007 and generate significant revenues over the next few years.”
Cyberkinetics Neurotechnology Systems Inc., founded in 2001 based on the research of a team led by Brown University neuroscientist John P. Donoghue, signed a collaborative research and licensing agreement with Brown in September 2005. For additional information, visit www.cyberkineticsinc.com.