Researchers report that people with spinal cord injuries treated with Cyberkinetics’ Andara™ OFS™ System showed significantly greater neurological improvement than those in a separate study who received no therapy for their spinal cord injuries.
FOXBOROUGH, Mass.–(BUSINESS WIRE)–Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Cyberkinetics”) today announced that the Company’s Andara™ Oscillating Field Stimulator (OFS™) System was the subject of two presentations at the 24th Annual Meeting of the AANS/CNS (American Association of Neurological Surgeons/Congress of Neurological Surgeons) Section on Disorders of the Spine and Peripheral Nerves in Orlando, Florida. The Andara™ OFS™ System, which uses electrical stimulation to promote the growth of nerve fibers, is currently under review by the U.S. Food and Drug Administration (FDA) for Humanitarian Device Exemption (HDE) approval for the treatment of acute spinal cord injuries.
“Results from each of these studies continue to support the probable benefit of the Andara™ OFS™ System for people with acute spinal cord injuries,” said Timothy R. Surgenor, President and Chief Executive Officer at Cyberkinetics. “We now have data that show two or three times the level of sensory improvement compared to results from people that did not receive therapy following their injuries in a prior study.”
Surgenor continued, “Reported results also indicate that 90 percent of patients treated with the Andara™ OFS™ System were responders to the therapy. Those patients also believe the treatment they received greatly improved their quality of life.”
In a presentation Thursday, February 28, 2008, entitled, “Neurological Recovery and Patient Satisfaction Following Early Treatment of Spinal Cord Injury with Oscillating Field Stimulation,” Richard B. Rodgers, M.D., reported findings for 13 people with spinal cord injuries who participated in clinical trials of the Andara™ OFS Device. One patient in the study was lost to follow-up at one year. Dr Rodgers reported that the findings indicate that the Andara™ OFS™ System can produce improvements in neurological function and diminish pain. Based on the data, improvements in the Functional recovery of the patients were statistically significantly improved more than two spinal levels below “the zone of partial Preservation,” the maximum level at which spontaneous recovery of Motor and sensory function is generally preserved. These results are consistent with results from the first ten patients in the trial that were published in the January 2005 issue of the Journal of Neurosurgery: Spine.
Dr. Rodgers also reported that the majority of the trial participants regarded their treatment with the Andara OFS System beneficial and would elect to undergo the treatment again.
Authors of the study include: Scott Shapiro, M.D., Principal Investigator for the clinical trials of the Andara™ OFS™ System and the Robert L. Campbell Professor of Neurosurgery at the Indiana University School of Medicine; Richard B. Rodgers, M.D., Assistant Professor, Department of Neurological Surgery and Director, Neurotrauma and Neurocritical Care, Indiana University School of Medicine; Robert Pascuzzi, M.D., Vice Chairman and Professor, Department of Neurology, Indiana University School of Medicine; Philip Yoder Smucker, M.D., Department of Neurological Surgery, Indiana University School of Medicine; and Richard B. Borgens, Ph.D., founder and Director of Purdue’s Center for Paralysis Research, where initial research for the Andara™ OFS™ technology was performed under Dr. Borgens’ direction, and the Mari Hulman George Professor of Applied Neurology in the School of Veterinary Medicine at Purdue University.
In a presentation on Saturday, March 1, 2008, entitled, “Comparison of Outcomes of Oscillating Field Stimulation in AIS A Patients to Spontaneous Recovery Alone,” Beverly C. Walters, M.D., reported findings that compared neurological improvements for the 13 people with spinal cord injuries that participated in the clinical trials of the Andara™ OFS™ System for whom one-year data were available to the placebo group from a previous large multicenter trial. Patients were matched with respect to the level of injury, baseline sensory and motor scores, age and gender. The purpose of the comparison was to determine if improvements reported by participants in clinical trials of the Andara™ OFS™ System were greater than would be expected by spontaneous recovery alone. According to the study analysis, people treated with the Andara™ OFS™ System demonstrated statistically significantly more neurological improvement than those in the placebo group in the previous study. People that responded to Andara™ OFS™ Treatment were reported to have double or triple the level of improvement compared to those that had no treatment.
Authors of the study include: Beverly C. Walters, M.D., Consulting Medical Director, Cyberkinetics; William P. Coleman, Ph.D., Consulting Statistician, Cyberkinetics; Scott Shapiro, M.D.; Richard Borgens, Ph.D.; and Fred H. Geisler, M.D., Ph.D., founder of the Illinois Neuro-Spine Center and founding member of the Institute for Spine Care at the Chicago Institute of Neurosurgery and Neuroresearch.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing products to restore function for people with spinal cord and other nerve injuries, as well as disorders and conditions of the nervous system. Cyberkinetics’ product development pipeline includes: the Andara™ Oscillating Field Stimulator (OFS™) System for acute spinal cord injury, an investigative device designed to stimulate nerve repair and restore sensation and motor function; the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement; and a pilot program in the detection and prediction of epileptic seizures. PNIR (Peripheral Nerve Injury Repair), LLC, a joint venture of Cyberkinetics and NeuroMetrix, Inc., is working to develop a product to treat peripheral nerve injury based on Cyberkinetics’ Andara™ OFS™ Therapy platform. Additional information is available at Cyberkinetics’ website at www.cyberkinetics.com.
Forward-Looking Statements This announcement contains forward-looking statements, including statements about Cyberkinetics’ product development plans and progress, potential development of proprietary inventions and benefits that may be realized by certain research programs. Such statements may be considered “forward-looking” within the meaning of the United States Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of words like “may,” “will,” “could,” “should,” “project,” “believe,” “anticipate,” “expect,” “plan,” “estimate,” “forecast,” “potential,” “intend,” “continue” and variations of these words or comparable words. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Forward-looking statements include, but are not limited to, statements concerning our future expectations, plans, prospects and future operating results as well as projections of cash and marketable securities and sufficiency of funding for capital expenditures. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors including risks related to: our ability to secure regulatory approval for our products; our access to additional capital; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales and distribution of our products; our development of products; our ability to obtain and maintain patent protection for our discoveries and products; and our limited operating history; as well as those risks more fully discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-KSB filed with the SEC on April 2, 2007, and our other public documents filed with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
Cyberkinetics Neurotechnology Systems, Inc.
Elizabeth A. Razee, 508-549-9981, Ext. 109
Manager, Corporate Communications