FDA requests more data from Cyberkinetics

Cyberkinetics Neurotechnology Systems Inc. of Foxborough announced today that it has received a letter from the Food and Drug Administration requesting additional analyses and data regarding its treatment of acute spinal cord injury.

Based on the FDA's request, the company said it now expects that approval of its Andara System, a nerve growth stimulator, may be delayed until at least the first half of 2008.

The company said it had applied for a Humanitarian Device Exemption, or HDE, marketing application for the Andara.

The Andara System is intended as a treatment option for people with acute spinal cord injuries; the device is designed to be implanted in patients within 18 days following a spinal cord injury to stimulate nerves to grow across the area of injury, the company said.

"We believe that we can provide the information that the FDA has requested in an additional amendment to our HDE application in early 2008," Timothy R. Surgenor, Cyberkinetics' president and chief executive said in a statement.
(By Chris Reidy, Globe staff)