FOXBOROUGH, Mass.–(BUSINESS WIRE)–Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Company”; “Cyberkinetics”), announced that the Company provided its Andara(TM) Oscillating Field Stimulator (OFS(TM)) System to a Spanish motorcycle racer who recently suffered a spinal cord injury during a high speed crash. After the accident, the patient was taken to the Hospital Universitari Vall d’Hebron in Barcelona, Spain, for treatment at its spinal cord injury unit by a vertebral-column surgery team led by Carlos Villanueva, M.D., Ph.D. The treatment was organized by Heinz Kinigadner, Executive Director and Founder of the Wings for Life Foundation, a European Spinal Cord Injury Foundation based in Austria.
“As a result of his severe spinal cord injury, my patient has lost all sensation and is paralyzed below his waist with limited chances of spontaneous recovery,” said Dr. Villanueva. “The patient was extremely pleased to be able to obtain the Andara(TM) OFS(TM) System from Cyberkinetics in the hope that he might regain some Functional benefit from the technology. The implantation procedure was successfully completed and we look forward to monitoring his progress.”
“Our scientific advisors recommended that the basic science and early clinical results behind the development of the Andara(TM) OFS(TM) System support its safety and potential to restore some sensation and movement in the lower body,” added Heinz Kinigadner. “This case highlights the compelling need for access to new treatments for spinal cord injury.”
“We were pleased to be able to accommodate the patient and Dr. Villanueva’s request under the custom-made device exclusion in the European medical device regulations,” stated Timothy R. Surgenor, Cyberkinetics’ President and Chief Executive Officer. “However, we are committed to providing broader access to this important technology in the near term. We have recently filed a Humanitarian Device Exemption to market the Andara(TM) OFS(TM) Therapy in the United States and have also begun the regulatory process to support introduction of the device in the European markets in 2008. We are driven by the opportunity to provide this product to people whose lives have been impacted by spinal cord injuries.”
The most severe spinal cord injuries result in devastating and permanent loss of sensation and movement, with little prospect for spontaneous improvement. The loss of sensation alone can result in a range of serious health and quality of life problems. Of the estimated 11,000 US and 15,000 European spinal cord injuries each year, Cyberkinetics anticipates that less than one third of these individuals are likely to be the primary beneficiaries of Andara(TM) OFS(TM) Therapy. There are currently no approved treatments for spinal cord injury that offer the possibility of returning sensory or Motor function. Patients with spinal cord injuries generally face poor prognosis — several surgical procedures and extensive Rehabilitation programs, which are extraordinarily expensive.
About Wings for Life
The Wings for Life Spinal Cord Research Foundation is a privately funded, non-profit organization that aims to promote research worldwide to expedite scientific and clinical progress towards a putative cure for Spinal Cord Injury (SCI) Paralysis. Additional information is available at the Wings for Life website at http://www.wingsforlife.com.
About the Andara(TM) OFS(TM) Technology Platform
Cyberkinetics’ Andara(TM) OFS(TM) Therapy is based on initial research by the Center for Paralysis Research at Purdue University and 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(TM) device must be implanted within 18 days of a severe spinal cord injury. Andara(TM) OFS(TM) Therapy has been shown in published randomized controlled preclinical studies to restore sensation and some motor function in a large animal model. Results of a ten-patient clinical study were published in the Journal of Neurosurgery: Spine in January of 2005 and reported statistically significant improvements in assessments of ability to move and feel at 12 months after treatment compared to baseline.
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(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 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. 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.
Cyberkinetics Neurotechnology Systems, Inc.
Elizabeth A. Razee, 508-549-9981, Ext. 109
Manager, Corporate Communications
Source: Cyberkinetics Neurotechnology Systems, Inc.