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news.Cyberkinetics Neurotechnology Systems has received a letter from the FDA requesting additional analyses and data regarding its humanitarian device exemption marketing application for the Andara OFS system, a nerve growth stimulator designed as a treatment for acute spinal cord injuries.
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Based on the FDA’s request for additional data and analyses, the company now expects that approval of its Andara OFS system for the treatment of acute spinal cord injury may be delayed until at least the first half of 2008.
The Andara OFS 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.
Timothy Surgenor, president and CEO of Cyberkinetics, 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.”