FOXBOROUGH, Mass.--(BUSINESS WIRE)--Oct. 8, 2004--
Initial results of the BrainGate(TM) Neural Interface
System pilot clinical study will be presented today at the annual
meeting of the American Academy of Physical Medicine and
Rehabilitation in Phoenix, Arizona. The preliminary results represent
the first demonstration of a quadriplegic person controlling a
computer using thoughts and the BrainGate System. The BrainGate System
is being evaluated by Cyberkinetics Neurotechnology Systems, Inc.
(Cyberkinetics) (OTCBB: TGRV) in an ongoing pilot study under an
Investigational Device Exemption from the U.S. Food and Drug
Administration.
The poster presentation of these initial results from the pilot
(feasibility) study will be made by Jon Mukand, M.D., Ph.D. of Sargent
Rehabilitation Center. The ultimate goal of the BrainGate development
program is to create a safe, effective and unobtrusive universal
operating system which will allow physically disabled people to
quickly and reliably control a wide range of devices using their
thoughts, including computers, assistive technologies and medical
devices.
Jon Mukand, M.D., Ph.D., the investigator for the study based at
Sargent Rehabilitation Center commented, "While these results are
preliminary, I am extremely encouraged by what has been achieved
to-date. We now have early evidence that a person unable to move their
arms, hands and legs can quickly gain control of a system which uses
thoughts to control a computer and perform meaningful tasks. With
additional development this may represent a significant breakthrough
for people with severe disabilities."
"The preliminary results presented today are an important next
step in the development of the BrainGate System," said John Donoghue,
Ph.D. Chief Scientific Officer of Cyberkinetics and Chairman of the
Department of Neuroscience and Director of the Brain Science Program
at Brown University. "Our ultimate goal is to develop the BrainGate
System so that it can be linked to many useful devices, including for
example, medical devices such as muscle stimulators, to give the
physically disabled a significant improvement in their ability to
interact with the world around them."

Summary of Preliminary Results

The poster titled, "Feasibility Study of a Neural Interface System
for Quadriplegic Patients," includes preliminary data from one patient
with a three-year-old spinal cord injury. The reported results were
recorded over a two-month period in approximately 20 study sessions.
The surgery to implant the BrainGate sensor was performed in June 2004
at Rhode Island Hospital, Providence, R.I., by Gerhard M. Friehs,
M.D., Ph.D., director of functional neurosurgery at Rhode Island
Hospital, and associate professor of clinical neurosciences at Brown
Medical School. Dr. Friehs said of the surgery, "The procedure went as
planned and took about 3 hours to perform. We are pleased that so far
the first patient has not experienced any side-effects and that the
healing and recovery process has been uneventful."
The signal processing function of the BrainGate System was
confirmed by its ability to detect, transmit and analyze brain
(neural) signals. The first patient was able to immediately modulate
their neural output in a controllable and meaningful fashion in
response to directional commands. A computer interface was developed
successfully using the patient's thoughts, thus enabling the patient
to perform tasks and operate basic computer functions repeatedly. The
patient's control of the cursor was immediate and intuitive, and the
patient was able to perform multiple tasks at the same time, without
disruption. For example, in early research sessions the patient was
been able to control his TV using the BrainGate System, while
simultaneously talking and moving his head.
These results are preliminary and represent the early outcomes
from a single patient. While the first patient will continue in the
study, Cyberkinetics plans to expand the pilot (feasibility) study to
additional clinical sites and will enroll additional patients.
Cyberkinetics expects to announce additional preliminary results and
scientific observations from the pilot study at the upcoming annual
meeting of the Society for Neuroscience in San Diego.

About the BrainGate(TM) Pilot Study

The ongoing pilot (feasibility) study will enroll up to five
quadriplegic (unable to use the arms and legs) individuals between the
ages of 18 and 60 who meet the study's selection criteria, which
include that the patient be able to verbally communicate. The two
primary goals of the pilot clinical study are to characterize the
safety profile of the device and to evaluate the quality, type, and
usefulness of neural output control that patients can achieve using
thoughts. Participants will undergo surgery to implant the sensor
portion of the BrainGate neural interface on the area of the brain
responsible for movement. During the study, they will perform tasks
with the device such as attempting to control the movement of a cursor
on a screen toward a specific target with their thoughts. The study is
expected to last for about 13 months for each patient. At the end of
the study, each participant will undergo another surgery to have the
device removed or may have the option to participate in future
studies.

About the BrainGate(TM) System

Cyberkinetics' BrainGate Neural Interface System is a proprietary,
investigational brain-computer interface device that consists of an
internal neural signal sensor and external processors that convert
neural signals into an output signal under the person's own control.
The sensor consists of a tiny chip about the size of a baby aspirin,
with one hundred electrode sensors each thinner than a hair that
detect brain cell electrical activity. The sensor is implanted on the
surface of the area of the brain responsible for movement, the primary
motor cortex. The sensor is connected by a small wire to a pedestal
which is mounted on the skull, extending through the scalp. The
pedestal is in turn connected by a cable to a cart containing
computers, signal processors and monitors which enable the study
operators to determine how well a study participant can control their
neural output.

About Cyberkinetics Neurotechnology Systems, Inc.

Cyberkinetics is a leader in neurotechnology, an emerging field
driven by advances in neuroscience, computer science, and engineering
that promises to revolutionize the medical treatment of nervous system
dysfunction. Cyberkinetics' first product, BrainGate(TM), is designed
to give severely paralyzed individuals a long-term, direct
brain-computer interface for the purpose of communication and control
of a computer. Cyberkinetics' intellectual property features key
technologies licensed from Brown University, the Massachusetts
Institute of Technology, Emory University, and the University of Utah.
Cyberkinetics is publicly traded on the Over the Counter Bulletin
Board under the ticker symbol, TGRV. The Company is headquartered in
Foxborough, Massachusetts and conducts engineering and research in
Salt Lake City, Utah. More information is available at www.cyberkineticsinc.com. For specific information about the
BrainGate(TM) clinical trial please send an email to
braingateinfo@cktrial.com.

Forward Looking Safe Harbor Statement:

This press release contains forward-looking statements. By their
nature, forward-looking statements and forecasts involve risks and
uncertainties because they relate to events and depend on
circumstances that will occur in the near future. There are a number
of factors that could cause actual results and developments to differ
materially. For a discussion of those risks and uncertainties, please
see our filings with the Securities and Exchange Commission.

Pilot Study Information:

If you are interested in information about the BrainGate pilot
study please contact:
Jon Mukand, M.D., Ph.D.
(401) 886-6600

Media Note: Reprints of the AAPM&R poster, digital photos and
illustrations of the BrainGate System are available. B-roll is
currently unavailable, but can be requested for future delivery by
contacting Kari Lampka.

KEYWORD: NORTH AMERICA MASSACHUSETTS UNITED STATES
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES PHARMACEUTICAL PRODUCT/SERVICE
SOURCE: Cyberkinetics, Inc.

CONTACT INFORMATION:
MacDougall BioCommunications, Inc.
Kari Lampka, 508-647-0209
klampka@macbiocom.com
or
Sargent Rehabilitation Center
Joanne Gemma, 401-886-6600
or
Cyberkinetics, Inc.
Barbara Morse, 508-549-9981 Ext 100
or
Rhode Island Hospital
Nicole Gustin or Nancy Cawley, 401-444-5327
ngustin@lifespan.org

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