Patient treated with Andara(TM) OFS(TM) Therapy for acute spinal cord injury will discuss his progress and the need to support promising new therapies for spinal cord injuries with U.S. legislators
Meeting is part of AdvaMed “Progress You Can See” event on Capitol Hill to raise awareness of advances in medical technology
FOXBOROUGH, Mass.–(BUSINESS WIRE)–Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Cyberkinetics”; “Company”), a medical device company focused on developing novel implantable products to treat neurological diseases and injuries of the Central Nervous System, announced that the Company’s Andara(TM) OFS(TM) Therapy for acute spinal cord injury has been selected for inclusion in the 2007 Advanced Medical Technology Association’s (“AdvaMed”) “Progress You Can See” events on Capitol Hill. Cyberkinetics is one of several companies that will be represented at the event by a physician and patient pair.
On Wednesday, June 20, 2007, Beverly C. Walters, M.D., a neurosurgeon and consultant to Cyberkinetics; Brandon Ingram, one of the first patients treated in the clinical trial of Cyberkinetics’ Andara(TM) OFS(TM) Therapy following his spinal cord injury; and other representatives of Cyberkinetics will speak with members of Congress concerning the critical importance of making available innovative treatments, such as the Andara(TM) OFS(TM) Therapy, which is designed to restore function and improve long-term medical outcomes in people with spinal cord injuries.
“Immediately after my injury, my doctors told me I’d never have any movement or sensation below my waist again,” commented Brandon Ingram, founder of Positive Images, a foundation to provide inspirational programs to youth and adults. “The Andara(TM) OFS(TM) Therapy has helped me regain some ability to move my legs and toes and to have some return of sensation. I’m now happily married and have a job. We need to make sure that new treatments like the Andara(TM) OFS(TM) Therapy are available to people who can benefit from them.” Mr. Ingram was injured in a car accident in 2002 in which he suffered a spinal cord injury that left him paralyzed from the waist down.
“Cyberkinetics is emblematic of the type of entrepreneurial, highly-innovative company that develops novel technologies, such as the Andara(TM) OFS(TM) Therapy, we want to highlight to Congress,” added Stephen J. Ubl, President and Chief Executive Officer of AdvaMed. “I believe that the Andara(TM) OFS(TM) Therapy is positioned to become a viable treatment for patients with spinal cord injuries.”
“We are very pleased that AdvaMed has selected the Andara(TM) OFS(TM) Therapy as an example of the value of medical device technology,” stated Timothy R. Surgenor, Cyberkinetics’ President and Chief Executive Officer. “The potential benefit for our Andara(TM) OFS(TM) System to restore some sensation and Motor function in people with spinal cord injuries represents an important advance.”
The Andara(TM) OFS(TM) System 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. 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.
About the Andara(TM) OFS(TM) System
Cyberkinetics’ Andara(TM) Oscillating Field Stimulator (“OFS(TM)”) System is designed to be implanted in patients within 18 days following a spinal cord injury. The Andara(TM) OFS(TM) System applies an oscillating field of low-voltage, direct electrical current to the area surrounding the spinal cord to stimulate the regrowth of nerve tissue across the area of injury to restore sensory and motor function. Published data from randomized, controlled preclinical studies indicate that the Andara(TM) OFS(TM) System aided in the restoration of sensation and some motor function in naturally injured dogs. Results of the first ten-patients enrolled in a clinical study of the Andara(TM) OFS(TM) System were published in the Journal of Neurosurgery: Spine in January of 2005. Subsequently, four additional patients enrolled in the clinical study.
Results from all 14 patients, including 13 for whom extended follow-up data were available, that participated in the clinical trial were reported at the 29th Annual Meeting of the Bioelectromagnetics Society in Kanazawa, Japan, on Tuesday, June 12, 2007. Based on reported results, 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 historical data indicate that spontaneous recovery rarely occurs. In addition, 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.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, Inc., a leader in the neurotechnology industry, is developing neural stimulation, sensing and processing technology designed 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 Andara(TM) OFS(TM) 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 Epileptic seizures. Additional information is available at Cyberkinetics’ website at http://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.
Elizabeth A. Razee, 508-549-9981, Ext. 109
Manager, Corporate Communications
Berry & Company Public Relations
Bill Berry, 212-253-8881, Ext. 21
Source: Cyberkinetics Neurotechnology Systems, Inc.