FOXBOROUGH, Mass.--()--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Company;” “Cyberkinetics”), a medical device company focused on developing novel implantable products to treat neurological diseases and injuries of the central nervous system, announced that Richard Ben Borgens, Ph.D., an inventor of Cyberkinetics’ Andara™ Oscillating Field Stimulator (OFS™) Therapy, presented at the Electromed Plenary Session entitled, “Electrical Stimulation of Severed Spinal Cord Repair in Humans,” at the 29th Annual Meeting of the Bioelectromagnetics Society in Kanazawa, Japan, on Tuesday, June 12, 2007. Dr. Borgens’ talk included clinical results from the 14 people with acute spinal cord injuries that participated in the Phase I clinical trial of the Andara™ OFS™ System.
“We believe that the data reported today continue to support the probable benefit of the Andara™ OFS™ Therapy for patients with acute spinal cord injury”
Dr. Borgens’ presentation included results from the first ten patients in the trial, results of which were published in the January 2005 issue of the Journal of Neurosurgery: Spine, as well as results from four additional patients that received the device subsequent to publication of results in the journal. Dr. Borgens reported that:
- The Company believes that the device has experienced an excellent safety profile, with only one minor infection reported;
- In the 13 patients for whom one-year data were available, the Company observed improvement in neurological outcomes as measured by ASIA assessment of motor function, sensation of light touch and pinprick, which was comparable to the results first published in the Journal of Neurosurgery; Spine report;
- The Company’s testing indicated that 12 of 13 patients had improvement in sensory or motor function that met a “response to therapy” definition related to improvement several levels below the level of injury where spontaneous recovery rarely occurs;
- None of the 13 patients reported moderate or severe pain at one year, despite the common occurrence of neuropathic pain in spinal cord-injured patients, with average pain scores on the Visual Analog Scale less than 1 on scale of 0 to 10.
“We believe that the data reported today continue to support the probable benefit of the Andara™ OFS™ Therapy for patients with acute spinal cord injury,” stated Timothy R. Surgenor, Cyberkinetics’ President and Chief Executive Officer. “If approved, we look forward to being able to provide The Andara™ OFS™ Therapy to neurosurgeons as a tool to treat patients with spinal cord injuries.”
The Andara™ OFS™ System, currently under review by the U.S. Food and Drug Administration (“FDA”) for Humanitarian Device Exemption (“HDE”) approval, is designed to restore sensory and motor function in patients with acute spinal cord injuries. The HDE approval process, similar to the Orphan Drug designation, is an expedited approval process designed by the FDA to encourage companies to develop products that address significant medical needs in patient populations of less than 4,000 patients annually.
Dr. Borgens is the founder and Director of Purdue’s Center for Paralysis Research and the Mari Hulman George Professor of Applied Neurology in the School of Veterinary Medicine at Purdue University.
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: Andara™ OFS™ Therapy 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 seizures due to epilepsy. Additional information is available at Cyberkinetics’ website at http://www.cyberkineticsinc.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. 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.
