As Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) awaits a Humanitarian Device Exemption (HDE) from the FDA for its implantable Andara OFS (Oscillating Field Stimulator) System for acute spinal cord injury, it’s taking the same technology to a different, broader market with the formation of PNIR (peripheral nerve injury repair), a joint venture with NeuroMetrix (Waltham, Massachusetts).

The two companies will develop and commercialize Andara OFS for a variety of peripheral nerve injury indications. Each company will have equal ownership.

“We are just totally focused right now, as a small company, on the HDE approval. We are in our third round of submissions to the FDA and if we are successful, that will be the first product FDA has approved for spinal cord injuries,” Cyberkinetics’ president/CEO Timothy Surgenor told Medical Device Daily. “NeuroMetrix had a need to broaden their product portfolio, which is why they formed PNIR with us. The spinal cord injury indication would be for a potential $100 million market. But the market for peripheral nerve injury repair might be a $1 billion market.”

Under terms of the joint venture agreement, NeuroMetrix will fund the first $2 million of the development costs at PNIR during the next two years and will provide PNIR with biomedical engineering and neurophysiology expertise.

Cyberkinetics will contribute intellectual property related to its Andara OFS platform and provide technical and scientific expertise to the joint venture.

The Andara OFS technology is designed to restore sensory and motor function through the use of low voltage, direct current, electrical stimulation that promotes and directs the nerve fibers to grow across the area of injury.

Results from a Phase Ia, 10-patient clinical trial of the Andara OFS in patients with recent spinal cord injuries were published in 2005 and indicated statistically significant improvements in sensory and motor function at 12 months after treatment.

After the initial $2 million investment by NeuroMetrix, the two companies will each contribute equally to future development costs. As part of the agreement, NeuroMetrix will distribute and Cyberkinetics will manufacture any products developed by the j-v.

Some initial uses of the device include treating war-injured soldiers. “Their injuries create deficits that are hard to recover from,” Surgenor said. “In the military, they can do reconstructions on patients, but they may not get their full feeling back in legs or hands. It’s very frustrating for these people.”

Cyberkinetics and NeuroMetrix estimate that as many as 100,000 people with lacerations, stretch and compression injuries could benefit from nerve fiber growth repair treatment using Andara OFS Therapy.

Cyberkinetics received a letter from the FDA requesting additional analyses and data last fall (Medical Device Daily, Dec. 13, 2007). Surgenor estimates that the company’s formal response will be submitted by the end of March.

In the short term, Surgenor said Cyberkinetics’ joint venture with NeuroMetrix helps the company to progress its technologies without spending its own cash, but that Cyberkinetics is, “Exploring additional avenues” to raise more funding.

There are currently no approved treatments for spinal cord injury that offer the possibility of returning sensory or motor function, according to Cyberkinetics. Spinal cord-injured patients generally face poor prognosis — several surgical procedures and extensive rehabilitation programs.

Cyberkinetics acquired Andara (Indianapolis), developer of the Oscillating Field Stimulator (OFS) device, in a stock exchange deal (MDD, Feb. 16, 2006). Andara’s technology derives from research concerning the repair and regeneration of neural tissues at the Center for Paralysis Research at Purdue University (West Lafayette, Indiana).

Other companies developing spinal cord stimulation devices include Advanced Neuromodulation Systems (ANS; Plano, Texas), which recently received CE-mark approval for its Rapid Programmer 3.0, an advanced therapy for managing chronic pain. ANS, the neuromodulation business of St. Jude Medical (St. Paul, Minnesota) also has launched an upgraded version of its rechargeable spinal cord stimulation device, the Eon, used to treat patients suffering from chronic intractable pain (MDD, Feb. 23, 2007).