Andara OFS (Oscillating Field Stimulator) Therapy for Acute Spinal Cord Injury repair

March 9, 2007 We’ve written before about Cyberkinetics Neurotechnology Systems’ BrainGate, a brain-implant device designed to control a computer, assistive devices and eventually, limb movement. The company’s focus is neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system. Cyberkinetics' product development pipeline includes: Andara OFS (Oscillating Field Stimulator) Therapy for acute spinal cord injury, an investigative device designed to stimulate nerve repair and restore sensation and motor function; the; and a pilot program in the detection and prediction of seizures due to Epilepsy. Cyberkinetics has now filed to market its Andara OFS Therapy for Acute Spinal Cord Injury under Humanitarian Device Exemption. Cyberkinetics recently submitted a Humanitarian Device Exemption (HDE) to the Food and Drug Administration (FDA) to obtain market clearance for the implantable Andara OFS System, a nerve growth stimulator. If approved, Andara would be the first commercially available neurotechnology device designed to partially restore sensation and motor function in acute spinal cord injuries by stimulating nerve repair. The company sees it as its first step toward building a Nerve Repair Franchise.

"The Andara HDE-filing is a major milestone achievement for Cyberkinetics because it represents our first therapeutic product and the first step in our strategy to build a valuable nerve repair franchise," said Tim Surgenor, Cyberkinetics' President and Chief Executive Officer. "We are driven by the opportunity to provide this product to people whose lives have been impacted by spinal cord injuries.

"While we await FDA response to our application, we are preparing to launch the Andara OFS Therapy for acute spinal cord injury in an initial group of centers of excellence. If approved, we expect to commercialize the product as early as the fourth quarter of 2007 and generate significant revenues over the next few years. In the coming months, we plan to build out our core sales and marketing team and complete development of the Andara OFS surgeon training materials, reimbursement systems and patient registry program."