Spinal Cord OFS System

For victims of spinal-cord injuries, any significant recovery of sensation or movement can make a huge difference.
A person who regains mobility in a few fingers may be able to use a fork or operate a computer mouse. Increased sensation also may help a person avoid injuries, because he or she can sense pain. In some cases, enough sensation returns to restore sexual function.
Dr. Scott Shapiro, a professor of neurological surgery at Indiana University, said he has seen those sorts of results from his research of a medical device called the Andara OFS System.
"The science behind it is well-founded," said Shapiro, who has studied the device in 14 patients. "It's a simple device."
Shapiro, though, said the business of medicine does not always mesh with the science of medicine: "It may make sense for the patient, but it may not make a lot of money for the company."
Indeed, the Andara OFS -- for Oscillating Field Stimulator -- is a homegrown Indiana innovation that illustrates the potential rewards -- and risks -- of commercializing cutting-edge medical technology.
About the size of an old-fashioned cigarette lighter, the Andara OFS must be implanted surgically in a patient's back within 18 days of a spinal-cord injury and kept in place for 15 weeks. The battery-powered device uses six leads attached to the spinal column to create an electrical field around the injury in an effort to stimulate nerves to grow and form new connections.
The device was invented by Dr. Richard Ben Borgens, a professor of biomedical engineering at Purdue University. In 2005, the university helped create a startup, Andara Life Science, based on the device.
That company then was purchased by Massachusetts-based Cyberkinetics Neurotechnology Systems.
Now Cyberkinetics is depending on the Andara OFS gaining regulatory approval for its own financial viability. The company lost $8.1 million in the first nine months of 2007. Its stock, traded on the Nasdaq Over the Counter Bulletin Board, has lost more than 80 percent of its value in the past 52 weeks.
"We're going to need more funding to get through the whole year," said Chief Executive Timothy Surgenor. Once on the market, the Andara OFS would carry a price of about $50,000 per unit, he said.
Cyberkinetics is seeking approval for the Andara OFS under the Food and Drug Administration's Humanitarian Device Exemption, a less burdensome regulatory process designed for medical devices that have no competing products on the market and that serve a patient population of fewer than 4,000 a year.
However, the company said last month it received a response letter from the FDA asking more questions about the device and its probable benefits to patients.
Cyberkinetics had expected the device to be approved in 2007, but that estimate now has been pushed back until at least the first half of 2008.
Still, management seems determined. Mark Carney, an Indiana-based executive vice president for Cyberkinetics, said, "We're enthusiastic about completing the process."

Source - Indianapolis Star

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