Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) in seeking a Humanitarian Device Exemption (HDE) from the FDA to obtain market clearance for its implantable Andara OFS (Oscillating Field Stimulator) System, a nerve growth stimulator.
Cyberkinetics said that its Andara OFS System would be, if approved, the first commercially available neurotechnology device designed to partially restore sensation and motor function in acute spinal cord injuries by stimulating nerve repair.
According to the National Institutes of Health, people who survive a spinal cord injury will most likely have other medical complications including chronic pain, bladder and bowel dysfunction, and increased susceptibility to respiratory and heart problems. These issues not only affect the person’s health, but they also take a toll on their quality of life.
Timothy Surgenor, company’ president/CEO, told Biomedical Business & Technology that the Andara HDE filing represents Cyberkinetics’ “first step in building a valuable nerve repair franchise.”
“We are driven by the opportunity to provide this product to people whose lives have been impacted by spinal cord injuries,” Surgenor said.
Surgenor said that while Cyberkinetics waits for the FDA’s response to its HDE application, the company is preparing to launch the Andara OFS Therapy for acute spinal cord injury in an initial group of centers. “If approved, we expect to commercialize the product as early as the fourth quarter of 2007 and generate significant revenues over the next few years. In the coming months, we plan to build out our core sales and marketing team and complete development of the Andara OFS surgeon training materials, reimbursement systems and patient registry program,” Surgenor said.
There are currently no approved treatments for spinal cord injury that offer the possibility of returning sensory or motor function, the company said. Spinal cord injured patients generally face poor prognosis -- several surgical procedures and extensive rehabilitation programs. The company expects its Andara OFS Therapy will make a significant difference in the course of these patients’ lives.
Of the estimated 11,000 spinal cord injuries in the U.S. each year, Cyberkinetics anticipates that fewer than 4,000 of these individuals are likely to be the primary beneficiaries of Andara OFS Therapy.
“We’re really working on the worst of the worst [spinal cord injury cases],” Mark Carney, executive VP of Cyberkinetics, told BB&T.
Carney described a primary beneficiary of the device as “a patient with a complete spinal cord injury, complete behavior loss below the injury.”
Cyberkinetics’ Andara OFS Therapy is based on initial research by the Center for Paralysis Research at Purdue University (Lafayette, Indiana). The technology is intended to improve or restore tactile sensation and some movement in those with quadriplegia and tetraplegia due to recent spinal cord injuries by promoting nerve fiber repair. The OFS device must be implanted within 18 days of a severe spinal cord injury.
Andara OFS Therapy has been shown in published randomized controlled preclinical studies to restore sensation and some motor function in a large animal model, the company said.
Recognizing that many of the patients who will need the Andara OFS have suffered some type of trauma and may also have a brain injury or other serious aliment that needs immediate medical attention, Carney said the 18-day limit gives the surgeon the opportunity to “do what needs to be done to stabilize the patient” before having to implant the device.
Cyberkinetics expects to expand the use of the OFS Therapy to include the treatment of peripheral nerve injuries, strokes and traumatic brain injuries. The company’s goal is to develop Andara OFS Therapy into a platform applicable to a wide range of nervous system injuries. device is currently The device is being tested in preclinical studies in combination with a nerve growth factor.