Cyberkinetics Neurotechnology Systems, Inc, a medical device company, and NeuroMetrix, Inc. have formed PNIR, LLC (Peripheral Nerve Injury Repair), a joint venture to develop and commercialise a therapeutic product for peripheral nerve injury based on Cyberkinetics' Andara Oscillating Field Stimulator (OFS) neurostimulation technology platform. Each company will have equal ownership in PNIR.
Under the 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 Therapy platform and provide technical and scientific expertise to the joint venture. 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 joint venture.
"With our soldiers returning from combat, there has been a dramatic increase in the number of multiple, severe injuries to the arms, legs, head and neck," commented James M. Ecklund, M.D., chairman, Neurosciences at Inova Fairfax Hospital in Falls Church, Virginia. "These injuries, which often involve severe nerve damage, highlight the profound clinical need to develop therapies to repair and restore sensory and motor function." Dr. Ecklund is the prior Chairman of the National Capital Consortium Neurosurgery Program and retired Colonel, United States Army. He also previously served as Professor and Chief of the Division of Neurosurgery at the Uniformed Services University in Bethesda, Maryland.
According to industry estimates, each year approximately 800,000 people in the United States alone sustain peripheral nerve injuries that require surgical intervention and that can result in disabilities that permanently impair sensory and motor function. Of these, Cyberkinetics and NeuroMetrix estimate that as many as 100,000 people with laceration, stretch and compression injuries could benefit from nerve fiber growth repair treatment using Andara(TM) OFS(TM) Therapy.
Cyberkinetics' Andara OFS System is currently under review by the US Food and Drug Administration (FDA) for Humanitarian Device Exemption (HDE) approval for the treatment of acute spinal cord injuries. 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 Therapy in patients with recent spinal cord injuries were published in the January 2005 issue of the Journal of Neurosurgery: Spine, and indicated statistically significant improvements in sensory and motor function at 12 months after treatment. Four additional patients were subsequently enrolled in a phase Ib the trial.