Healthcare Industry News: neurostimulator
News Release - April 25, 2006
Cyberkinetics' Andara(TM) Combination Product Yields Nerve Regeneration and Functional Recovery in Model for Chronic Spinal Cord InjuryAndara(TM) OFS PLUS SYSTEM Data Debuted at AANS Annual Meeting
FOXBOROUGH, Mass.--(HSMN NewsFeed)--April 25, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Cyberkinetics") today announced that the Company's research collaborators at Indiana University and the Center for Paralysis Research at Purdue University presented study results that demonstrate - for the first time - that Cyberkinetics' Andara(TM) Oscillating Field Stimulator (OFS) PLUS System, a combination product, induced nerve regeneration and functional recovery in a preclinical model of chronic, or long-term, spinal cord injury. These new findings build on the previously demonstrated ability of Cyberkinetics' Andara(TM) OFS Device, used alone, to restore sensation and some function in a Phase Ia clinical trial of ten participants who received the device within 18 days of their injuries.
In his presentation yesterday at the Annual Meeting of the American Association of Neurological Surgeons in San Francisco, California, Scott Shapiro, M.D., explained that these promising results were achieved in a preclinical study that examined use of the Andara(TM) OFS Device in combination with local delivery of a naturally occurring small molecule called inosine (together, the "Andara(TM) OFS PLUS System"). This system is the subject of a patent filing to which Cyberkinetics holds an exclusive, worldwide license. Dr. Shapiro is the Principal Investigator for the ongoing Phase Ib clinical trial of the Andara(TM) OFS Device and the Robert L. Campbell Professor of Neurosurgery at the Indiana University School of Medicine. Richard Borgens, Ph.D., inventor of Cyberkinetics' Andara(TM) OFS Device technology, founder of Purdue's Center for Paralysis Research, and the Mari Hulman George Professor of Applied Neurology in the School of Veterinary Medicine at Purdue, and Scott Purvines, M.D., a neurosurgeon affiliated with The Brain and Spine Center at St. Luke's Hospital in Chesterfield, Missouri, and former intern at the Indiana University School of Medicine, were co-authors on the study.
"The need for effective treatments for spinal cord injury is urgent and we are currently studying the Andara(TM) OFS Device with the goal of making a promising treatment for acute spinal cord injuries available to surgeons as soon as possible," stated Dr. Shapiro. "The findings reported today suggest that the Andara OFS PLUS System may eventually make it possible to also restore function in the large number of chronically injured patients who suffered injuries in the past."
"The Andara(TM) OFS Device is currently under FDA review as a Humanitarian Device for use in patients with acute spinal cord injuries and that indication represents a promising near-term revenue opportunity. We believe that the exciting preclinical results reported today provide the basis for expanding the Andara(TM) OFS market potential by using it as a delivery vehicle, not only for inosine, but for other neural repair factors as well," said Timothy R. Surgenor, President and Chief Executive Officer at Cyberkinetics. "We are also actively exploring how to move beyond the treatment of spinal cord injuries to address the other potential neurostimulator markets for the Andara(TM) OFS Device such as repair of peripheral nerve injuries, strokes and traumatic brain injuries."
"The results reported today are a significant step in our efforts to develop novel biological approaches to the medical treatment of paralyzed people. While many emerging treatments for spinal cord injury, such as stem cells, are still in early stages of development, the Andara(TM) OFS platform could potentially bring benefit to paralyzed people sooner. We believe that there is great promise in combining OFS with a variety of neurotrophic factors, and we look forward to further investigating this approach," said Richard Borgens, Ph.D., inventor of the Andara(TM) OFS Device technology platform and co-investigator for the study.
About the Study
Researchers used an animal model of chronic spinal cord injury (SCI) to examine the usefulness of applying the Andara(TM) OFS PLUS System versus inosine alone at 91 days post injury. The results were referenced to a sham device control group and to historical data from using the Andara(TM) OFS Device alone. Efficacy was evaluated by measuring the ability to restore the cutaneous trunchi muscle reflex (CTM) and by analyzing for regenerating axons histologically after complete spinal cord injuries. The researchers found that the Andara(TM) OFS PLUS System and inosine groups both exhibited recovery of the CTM reflex at 60 days post-treatment, vs. no CTM recovery in the control group. Notably, the CTM recovery obtained in the Andara(TM) OFS Device PLUS group occurred in all but one subject by one month after treatment. Furthermore, the Andara(TM) OFS Device PLUS group showed statistically superior regeneration of ascending and descending nerve fibers across the injury site vs. inosine (p0.03 and p0.02, respectively) and both groups regenerated more than the controls (p0.0001 and p0.0004, respectively).
About the Andara(TM) OFS Device and Andara(TM) OFS PLUS System
The Andara(TM) Oscillating Field Stimulator technology platform is based upon the application of oscillating, low-voltage, direct current of electricity to the areas above and below a spinal cord injury. The Andara(TM) OFS Device stimulates the neural fibers surrounding the spinal cord to grow across the injury in order to restore sensory and motor function. Only about the size of a lipstick tube, the device is implanted and the electrical leads are attached onto the bone above and below the area of injury. The Andara(TM) OFS PLUS System includes a drug pump which delivers inosine to the area of injury. The Andara(TM) OFS Device is designed to treat acute injuries and the Andara(TM) OFS PLUS System, which is designed to be used with a number of neurotrophic factors, is being developed for long-term (chronic) injuries. The proprietary therapeutic devices are both designed to stimulate repair of central nervous system tissue and to restore sensation and motor function.
The Andara(TM) OFS Device has already been demonstrated in Phase Ia clinical trials to regenerate neural fibers and improve or restore tactile sensation and movement in those with quadriplegia and tetraplegia due to spinal cord injury when the device is implanted within 18 days following injury. Cyberkinetics is seeking to obtain Humanitarian Use Device (HUD) Designation from the FDA to support the filing of a Humanitarian Device Exemption (HDE) in mid 2006. If approved, Cyberkinetics could begin marketing the Andara OFS Device on a limited basis as early as 2007.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system. Cyberkinetics' product development pipeline includes: the FDA cleared-to-market NeuroPort(TM) System, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity; the Andara(TM) Oscillating Field Stimulator (OFS) Device, an investigational device designed to stimulate regeneration of the spinal cord; and the BrainGate(TM) System, an investigational device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement.
Additional Information about Cyberkinetics is available at Cyberkinetics website at www.cyberkineticsinc.com.
A photo of the Andara(TM) OFS Device, a fact sheet about the Andara(TM) OFS technology and a copy of the abstract for Dr. Shapiro's talk, Inosine Versus Oscillating Field Stimulation Plus Inosine in Treating Experimental Chronic Spinal Cord Injury, are available via "Media Room" at http://www.cyberkineticsinc.com. An animation about the Andara(TM) OFS Device is available on the homepage of Cyberkinetics' website at www.cyberkineticsinc.com.
This announcement contains forward-looking statements, including statements about Cyberkinetics' product development plans and progress. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate" or other comparable terminology. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements and reported results shall not be considered an indication of our future performance. Factors that might cause or contribute to such differences include our limited operating history; our lack of profits from operations; our ability to successfully develop and commercialize our proposed products; a lengthy approval process and the uncertainty of FDA and other governmental regulatory requirements; clinical trials may fail to demonstrate the safety and effectiveness of our products; the degree and nature of our competition; our ability to employ and retain qualified employees; compliance with recent legislation regarding corporate governance, including the Sarbanes-Oxley Act of 2002; as well as those risks more fully discussed in our public filings with the Securities and Exchange Commission, all of which are difficult to predict and some of which are beyond our control.
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