Medical Device Daily
In the most severe cases, spinal cord injuries result in devastating and permanent loss of sensation and movement. 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.
These interconnected difficulties support 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.
If approved, Cyberkinetics said that its Andara OFS System would be the first commercially available neurotechnology device designed to partially restore sensation and motor function in acute spinal cord injuries by stimulating nerve repair.
Timothy Surgenor, company president/CEO, told Medical Device Daily 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.
And the company is not wasting any time.
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 MDD.
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. For example, the Andara OFS device is currently being tested in preclinical studies in combination with a nerve growth factor.
This Andara OFS device-drug combination product may one day be used to treat nerve injuries that are months or years old, the company noted.
Surgenor discussed the company's neuromodulation technology during the 2006 Medical Innovation Summit of the Cleveland Clinic in November (Medical Device Daily Nov. 9, 2006). At that time, the device was already a candidate for a HDE, having been designated as a Humanitarian Use Device by the FDA a couple months earlier (MDD, Sept. 7, 2006).
Cyberkinetics has also received a fair bit of attention lately for its Braingate Neural Interface system, designed to improve the independence, mobility, and communication of patients with advanced amyotrophic lateral sclerosis (ALS) — commonly known as Lou Gehrig's disease or Motor Neuron Disease — or other motor impairments. The Braingate is an investigational brain/computer interface consisting of an internal sensor to detect brain cell activity and external processors that convert brain signals into a computer-mediated output under the person's own control (MDD, Oct. 17, 2006).
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. These devices — known as "pacemakers for pain" — interrupt the pain signals' pathway to the brain by delivering low-intensity electrical pulses to selective nerve fibers along the spinal cord (MDD, Jan. 19, 2007).
In addition to treating chronic pain, some companies in the neurostimulation market are now using neurostimulation devices to treat movement disorders like Essential Tremor or Dystonia and psychological disorders including depression and obsessive-compulsive disorder. Companies involved in the neurostimulation space for these conditions include ANS, Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts), Northstar Neurosience (Seattle) and Cyberonics (Houston).