Cyberkinetics' Andara combination product shows positive results in spinal cord injury preclinical study

By Lisa Kerner

Erie, Pa., April 25 - Cyberkinetics Neurotechnology Systems, Inc. researchers presented study results demonstrating that the company's combination product, the Andara Oscillating Field Stimulator (OFS) PLUS System, induced nerve regeneration and functional recovery in a preclinical model of chronic spinal cord injury.

Previously, a phase 1a clinical trial of 10 participants demonstrated the ability of the Andara OFS, used alone, to restore sensation and some function in participants who received the device within 18 days of their injuries.

The latest results were achieved in a preclinical study examining the use of the Andara OFS Device in combination with local delivery of a naturally occurring small molecule called inosine, together known as the Andara OFS PLUS System.

Researchers used an animal model of chronic spinal cord injury to evaluate the application of the Andara OFS PLUS System versus inosine alone at 91 days post injury. Results were measured in part by the ability to restore the cutaneous trunchi muscle reflex (CTM).

Both the Andara OFS PLUS System and inosine groups exhibited recovery of the CTM reflex at 60 days post-treatment. All but one subject exhibited recovery of the CTM reflex one month post treatment in the Andara OFS Device PLUS group.

The Andara OFS technology platform uses low-voltage, direct current of electricity to stimulate neural fibers surrounding the spinal cord to grow across the injury to restore sensory and motor function.

Cyberkinetics said the device, about the size of a lipstick tube, is implanted and the electrical leads are attached onto the bone above and below the area of injury.

"The Andara OFS Device is currently under Food and Drug Administration review as a Humanitarian Device for use in patients with acute spinal cord injuries and that indication represents a promising near-term revenue opportunity," president and chief executive officer Timothy R. Surgenor said in a company news release.

"We believe that the exciting preclinical results reported today provide the basis for expanding the Andara OFS market potential by using it as a delivery vehicle, not only for inosine, but for other neural repair factors as well."

The results were presented at the Annual Meeting of the American Association of Neurological Surgeons in San Francisco.

Cyberkinetics, located in Foxborough, Mass., is developing neural stimulation, sensing and processing technology for those with severe paralysis.

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