Thursday, November 30, 2023
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Firm takes giant step

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FOXBORO – Patients with acute spinal cord injuries could regain partial movement and sensation with the first step of what could be a giant leap forward in Star Trek-like technologies designed to regenerate nerves.

Cyberkinetics Neurotechnology Systems announced Tuesday that it submitted a Humanitarian Device Exemption to the Food and Drug Administration to obtain market clearance for an implantable nerve growth stimulator.

If approved, the Andara Oscillating Field Stimulator would be the first commercially available device designed to partially restore sensation and Motor function in patients with recent spinal cord injuries.

The humanitarian device exemption would allow Cyberkinetics to expedite sending its product to market, possibly as soon as this fall.

“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,” Cyberkinetics President and CEO Timothy R. Surgenor said. “We are driven by the opportunity to provide this product to people whose lives have been impacted by spinal cord injuries.”

Surgenor said the company expects the product, if approved, to generate significant revenues.

Cyberkinetics develops medical devices aimed at restoring sensation and motor function to patients whose neural activity is affected by spinal disorders or by illness such as muscular dystrophy.

The company’s BrainGate Neural Interface System, currently being tested in clinical trials, allows severely injured patients to use brain impulses to control computers, household devices and robotic arms.

Cyberkinetics received a notification of a patent allowance from the U.S. Patent and Trademark Office in December covering the Andara device.

The therapy, based on initial research by the Center for Paralysis Research at Purdue University, has been shown in clinical trials to be capable of restoring sensation and motor function. The device, about the size of a man’s little finger, must be implanted into muscle tissue beside the spinal column within 18 days of an injury.

It applies oscillating, low-voltage direct current to areas above and below a spinal cord injury. The device is designed to stimulate the neural fibers surrounding the spinal cord to grow across the injured area. The technology is the product of more than 20 years of research.

The most severe spinal cord injuries result in profound, permanent loss of sensation and movement with little chance of improvement. Of the estimated 11,000 spinal cord injuries in the United States each year, company officials anticipate that fewer than 4,000 are prime candidates for Andara therapy.

Currently, there are no approved treatments for spinal cord injury that promise the return of sensory or motor function.

Surgenor said the new technology is not intended to restore full function, but views it as an important step forward.

“We’re only just beginning to understand what it takes to get these nerve fibers to re-grow,” he said

Ultimately, restoring higher levels of function may require a combination of medical devices and cellular therapies, he said.

Cyberkinetics officials said they expect to expand the use of the stimulation therapy to include the treatment of Peripheral nerve injuries, strokes and traumatic brain injuries.


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