|
BOSTON and FOXBOROUGH, Mass. –
The Spaulding Rehabilitation Hospital (Spaulding) and Cyberkinetics
Neurotechnology Systems, Inc. (OTCBB:CYKN) (Cyberkinetics) today announced
the addition of Spaulding as a new clinical site for the BrainGate™
Neural Interface System pilot study. Spaulding, a teaching affiliate
of Harvard Medical School, is one of the premier rehabilitation facilities
in the United States and is the second rehabilitation center to participate
in the study.
“The successful development of the BrainGate System, which
may allow patients to control computers and other devices using thought,
has tremendous potential to improve the mobility and independence
of people with severe physical disabilities. We look forward to recruiting
patients to participate in this unique study,” commented Leigh
R. Hochberg, M.D., Ph.D., a principal investigator for the study who
is a Consultant in Neurology at Spaulding and is on the Neurology
staff at Massachusetts General Hospital and Brigham and Women’s
Hospital.
“We are very excited to join this important study which has
the potential to make a groundbreaking contribution to the advancement
of rehabilitation science,” said Joel Stein, M.D., Chief Medical
Officer and Medical Director of the Stroke Program at Spaulding and
a co-investigator for the study.
“The addition of Spaulding, one of the most prestigious rehabilitation
institutions in the country, is a key step toward our goal of continuing
enrollment in the BrainGate pilot trial,” said Tim Surgenor,
President and CEO of Cyberkinetics. “We are very enthusiastic
about the preliminary progress achieved in our BrainGate development
program as a result of enrolling the first patient in our study. This
progress has enabled us to initiate development of the next generation
of software applications for use with the BrainGate System earlier
than we had originally planned.”
About the BrainGate Pilot Study
Cyberkinetics received regulatory clearance from the U.S. Food
and Drug Administration (FDA) in March of 2004 to study the BrainGate
Neural Interface System under an Investigational Device Exemption
(IDE). In the first several weeks of the study, the first patient
enrolled through the Sargent Rehabilitation Center in Rhode Island
has successfully been able to use his thoughts and the BrainGate System
to operate a computer, environmental controls and a robotic limb.
The pilot (feasibility) study protocol provides for the enrollment
of up to five individuals with quadriplegia (unable to use their arms
and legs) who are between the ages of 18 and 60 and who meet the study’s
selection criteria. 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. Initial clinical and scientific findings
from the study were recently presented at the annual meetings of the
American Academy of Physical Medicine and Rehabilitation in Phoenix,
Arizona on October 8, 2004 and the Society for Neuroscience in New
Orleans on October 24, 2004.
About the BrainGate System
The BrainGate Neural Interface System is a proprietary, investigational
brain-computer interface that consists of an internal sensor to detect
brain cell activity and external processors that convert these brain
signals into a computer-mediated output under the person's own control.
The sensor is a tiny silicone chip about the size of a baby aspirin
with one hundred electrodes, each thinner than a hair, that detect
the electrical activity of neurons. The sensor is implanted on the
surface of the area of the brain responsible for movement, the primary
motor cortex. A small wire connects the sensor to a pedestal which
is mounted on the skull, extending through the scalp. An external
cable connects the pedestal to a cart containing computers, signal
processors and monitors which enable the study operators to determine
how well a study participant can control his neural output. 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.
About the Spaulding Rehabilitation Hospital
The Spaulding Rehabilitation Hospital, home to Harvard Medical
School’s Department of Physical Medicine and Rehabilitation,
has built a national reputation for excellent clinical care, advanced
research, and innovative programs in rehabilitation. Spaulding is
the only rehabilitation hospital in New England ranked among the nation’s
best in U.S. News & World Report. The Spinal Cord Injury Rehabilitation
Program at Spaulding is part of the New England Regional Spinal Cord
Injury Model Systems Program. A member of Partners HealthCare, the
Spaulding Network includes its main campus, a 296-bed facility located
in Boston, Mass., and eight outpatient sites throughout the Greater
Boston area.
About Cyberkinetics Neurotechnology Systems,
Inc.
Cyberkinetics, a leader in neurotechnology, an emerging field
driven by advances in neuroscience, computer science, and engineering,
is focused on treating diseases and disorders of the nervous system.
Cyberkinetics’ first product, BrainGate™ Neural Interface
System, is designed to give severely paralyzed individuals a long-term,
direct brain-computer interface for the purpose of communication and
control of a computer and other devices. Patients are currently being
enrolled into a pilot clinical trial to test its safety and effectiveness.
Cyberkinetics’ intellectual property features key technologies
licensed from Brown University, the Massachusetts Institute of Technology,
Emory University, and the University of Utah. Cyberkinetics 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™ clinical trial
please send an email to braingateinfo@cktrial.com
Forward Looking Safe Harbor Statement:
This news release contains “Forward Looking Statements.”
These statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ materially
from the statements made. Forward-looking statements include, but
are not limited to, statements concerning our future expectations,
plans, prospects and future operating results as well as projections
of cash and marketable securities and sufficiency of funding for capital
expenditures. Actual results may differ materially from those indicated
by these forward-looking statements as a result of various factors
including risks related to: our access to additional capital; our
ability to obtain additional funding to support our business activities;
our dependence on third parties for development, manufacture, marketing,
sales and distribution of our products; our development of products;
our ability to obtain and maintain patent protection for our discoveries
and products; and our limited operating history; as well as those
risks more fully discussed in the "Risk Factors" section
of the Form 8-K filed with the Securities and Exchange Commission
on October 8, 2004. Any forward-looking statements represent our views
only as of today and should not be relied upon as representing our
views as of any subsequent date.
Pilot Study Information:
If you are a patient interested in receiving information about the
BrainGate pilot study please contact:
Leigh R. Hochberg, M.D., Ph.D., Spaulding Rehabilitation Hospital
(617) 726-4218
Media Contacts: Note: Multimedia available
(B-roll and illustrations of the BrainGate System)
|
