Healthcare Industry News:  Stereotactic 

Devices Neurology

 News Release - June 5, 2006

Cyberkinetics Reports First Data from Non-Speaking, Paralyzed Participant in Ongoing Study of BrainGate Neural Interface System - Expanded Evidence of Brain Computer Interface Utility Presented at ASSFN Meeting in Boston

FOXBOROUGH, Mass.--(HSMN NewsFeed)--June 5, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Cyberkinetics") announced at the American Society of Stereotactic and Functional Neurosurgery (ASSFN) Biennial Meeting on Sunday, June 4, 2006, in Boston, Massachusetts, that clinical investigators provided an update on Cyberkinetics' ongoing BrainGate Neural Interface System (BrainGate) pilot clinical trials. Their presentations included new data from the surgical, neurological and scientific efforts that have led to the use of the BrainGate System by those with quadriplegia to control computer interfaces using thought.

"The results from the third participant are particularly significant because we have begun to replicate the intuitive control of a computer mouse," stated John P. Donoghue, Ph.D., a founder and Chief Scientific Officer of Cyberkinetics and Director of the Brain Science Program at Brown University. "Such control, including the ability to 'stop' the computer cursor, for example, is directly related to a person's ability to stop other electronically controlled devices, such as a motorized wheel chair. The new data expands our previous results showing that we are able to obtain neural signals in additional participants. We believe these findings are leading to a day when this technology can be used to improve the lives of those who are paralyzed."

The preliminary performance data reported at the meeting included initial results from the third trial participant, who is unable to speak as a result of a brainstem stroke. Specifically, the third participant has been able to control a cursor with significantly greater stability, to stop cursor movement at will, and to 'click' on icons using imagined movements with the aid of an enhanced BrainGate interface. In addition, among other new developments, the third participant has also used the enhanced BrainGate operating system to type messages using assistive software.

"This pilot trial continues to indicate that an implantable brain-computer interface can one day provide an operating system for patients with severe disabilities", added Tim Surgenor, President and Chief Executive Officer of Cyberkinetics. "What is most exciting is that we have recently developed several proprietary techniques for making our neural computer interface much more intuitive and controllable - which could ultimately lead to significantly greater patient utility for controlling communication devices and other computer-controlled robotics. Based on our work with these first three participants, we now have a clearer idea of the hardware and software challenges involved in moving forward, including those needed to overcome variability in the quality and quantity of signals the BrainGate System recovers and transmits, as well as moving toward more compact, fully implantable, wireless devices."

Gerhard Friehs, a founder of Cyberkinetics and a neurosurgeon involved with the BrainGate System clinical trial, also presented data from four implantation procedures and one explant procedure. To date, there have been no unanticipated adverse events associated with any of the procedures. In addition, from the explant procedure, which was completed after 16 months in vivo, Dr. Friehs reported that no clinically significant damage to the neural tissue was observed at the time of explant. Dr. Friehs also discussed the future of Cyberkinetics' neural sensing technology, including the NeuroPort(TM) Neural Monitoring System, which is designed to detect abnormal brain activity; multi-sensor implantation; the development of a long-term, wireless system and the potential for using BrainGate-based sensor technology to both sense and respond in a number of therapeutic applications, such as seizure prediction and tremor control.

Leigh R. Hochberg, M.D., Ph.D., a Principal Investigator in the BrainGate System pilot clinical trial, provided a performance update on three participants in the pilot trial for those with spinal cord injury, stroke and muscular dystrophy. He indicated that preliminary results include:
  • Neural signals have been obtained from all three participants;
  • All three participants have been able to achieve volitional modulation of the neural signals detected by the BrainGate sensor.
  • All three participants have been able to achieve control of a computer interface using the BrainGate System.
Preliminary data from a fourth participant enrolled in a pilot trial of the BrainGate System for those with ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig's Disease) and other Motor Neuron Diseases is expected to be presented at a scientific conference later in 2006.

In addition to his role as Principal Investigator in the BrainGate clinical trial, Dr. Hochberg is a member of the neurology staff at Massachusetts General Hospital, Brigham and Women's Hospital and the Spaulding Rehabilitation Center. He is also Associate Investigator, Rehabilitation Research and Development Service, Center for Restorative and Regenerative Medicine, Department of Veterans Affairs, Providence, Rhode Island, as well as an Investigator in Neuroscience at Brown University. Dr. Friehs is an associate professor of clinical neurosciences at Brown Medical School. As director of trauma and functional neurosurgery at Rhode Island Hospital, Dr. Friehs specializes in diseases that interfere with patients' daily functioning.

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 NeuroPort(TM) System, a cleared-to-market 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 investigative device designed to stimulate regeneration of the neural tissue surrounding the spinal cord; and the BrainGate System, an investigative device designed to provide communication and control of a computer, assistive devices, and, ultimately, limb movement. 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.


Source: Cyberkinetics Neurotechnology Systems

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