Researchers report that people with spinal cord injuries treated with
Cyberkinetics’ Andara™
OFS™ System showed significantly greater
neurological improvement than those in a separate study who received no
therapy for their spinal cord injuries.
FOXBOROUGH, Mass.--(BUSINESS WIRE)--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN;
"Cyberkinetics") today announced that the Company’s
Andara™ Oscillating Field Stimulator (OFS™)
System was the subject of two presentations at the 24th
Annual Meeting of the AANS/CNS (American Association of Neurological
Surgeons/Congress of Neurological Surgeons) Section on Disorders of the
Spine and Peripheral Nerves in Orlando, Florida. The Andara™
OFS™ System, which uses electrical
stimulation to promote the growth of nerve fibers, 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.
“Results from each of these studies continue
to support the probable benefit of the Andara™
OFS™ System for people with acute spinal cord
injuries,” said Timothy R. Surgenor,
President and Chief Executive Officer at Cyberkinetics. “We
now have data that show two or three times the level of sensory
improvement compared to results from people that did not receive therapy
following their injuries in a prior study.”
Surgenor continued, “Reported results also
indicate that 90 percent of patients treated with the Andara™
OFS™ System were responders to the therapy.
Those patients also believe the treatment they received greatly improved
their quality of life.”
In a presentation Thursday, February 28, 2008, entitled, “Neurological
Recovery and Patient Satisfaction Following Early Treatment of Spinal
Cord Injury with Oscillating Field Stimulation,”
Richard B. Rodgers, M.D., reported findings for 13 people with
spinal cord injuries who participated in clinical trials of the Andara™
OFS Device. One patient in the study was lost to follow-up at one year.
Dr Rodgers reported that the findings indicate that the Andara™
OFS™ System can produce improvements in
neurological function and diminish pain. Based on the data, improvements
in the Functional recovery of the patients were statistically
significantly improved more than two spinal levels below “the
zone of partial Preservation,” the maximum
level at which spontaneous recovery of Motor and sensory function is
generally preserved. These results are consistent with results from the
first ten patients in the trial that were published in the January 2005
issue of the Journal of Neurosurgery: Spine.
Dr. Rodgers also reported that the majority of the trial
participants regarded their treatment with the Andara OFS System
beneficial and would elect to undergo the treatment again.
Authors of the study include: Scott Shapiro, M.D., Principal
Investigator for the clinical trials of the Andara™
OFS™ System and the Robert L. Campbell
Professor of Neurosurgery at the Indiana University School of Medicine;
Richard B. Rodgers, M.D., Assistant Professor, Department of
Neurological Surgery and Director, Neurotrauma and Neurocritical Care,
Indiana University School of Medicine; Robert Pascuzzi, M.D., Vice
Chairman and Professor, Department of Neurology, Indiana University
School of Medicine; Philip Yoder Smucker, M.D., Department of
Neurological Surgery, Indiana University School of Medicine; and Richard
B. Borgens, Ph.D., founder and Director of Purdue’s
Center for Paralysis Research, where initial research for the Andara™
OFS™ technology was performed under Dr.
Borgens’ direction, and the Mari Hulman
George Professor of Applied Neurology in the School of Veterinary
Medicine at Purdue University.
In a presentation on Saturday, March 1, 2008, entitled, “Comparison
of Outcomes of Oscillating Field Stimulation in AIS A Patients to
Spontaneous Recovery Alone,” Beverly C.
Walters, M.D., reported findings that compared neurological improvements
for the 13 people with spinal cord injuries that participated in the
clinical trials of the Andara™ OFS™
System for whom one-year data were available to the placebo group from a
previous large multicenter trial. Patients were matched with respect to
the level of injury, baseline sensory and motor scores, age and gender.
The purpose of the comparison was to determine if improvements reported
by participants in clinical trials of the Andara™
OFS™ System were greater than would be
expected by spontaneous recovery alone. According to the study analysis,
people treated with the Andara™ OFS™
System demonstrated statistically significantly more neurological
improvement than those in the placebo group in the previous study.
People that responded to Andara™ OFS™
Treatment were reported to have double or triple the level of
improvement compared to those that had no treatment.
Authors of the study include: Beverly C. Walters, M.D., Consulting
Medical Director, Cyberkinetics; William P. Coleman, Ph.D., Consulting
Statistician, Cyberkinetics; Scott Shapiro, M.D.; Richard Borgens,
Ph.D.; and Fred H. Geisler, M.D., Ph.D., founder of the Illinois
Neuro-Spine Center and founding member of the Institute for Spine Care
at the Chicago Institute of Neurosurgery and Neuroresearch.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, Inc., a leader in the
neurotechnology industry, is developing products to restore function for
people with spinal cord and other nerve injuries, as well as disorders
and conditions of the nervous system. Cyberkinetics' product development
pipeline includes: the Andara™ Oscillating
Field Stimulator (OFS™) System 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.
PNIR (Peripheral Nerve Injury Repair), LLC, a joint venture of
Cyberkinetics and NeuroMetrix, Inc., is working to develop a product to
treat peripheral nerve injury based on Cyberkinetics’
Andara™ OFS™
Therapy platform. Additional information is available at Cyberkinetics'
website at www.cyberkinetics.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. Such statements may be considered "forward-looking"
within the meaning of the United States Private Securities Litigation
Reform Act of 1995. You can identify these statements by the use of
words like "may," "will," "could," "should," "project," "believe,"
"anticipate," "expect," "plan," "estimate," "forecast," "potential,"
"intend," "continue" and variations of these words or comparable words.
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 ability to secure
regulatory approval for our products; 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 Company's Annual Report on Form 10-KSB filed
with the SEC on April 2, 2007, and our other public documents filed with
the SEC. In addition, 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.
Contacts
Cyberkinetics Neurotechnology Systems, Inc.
Elizabeth A.
Razee, 508-549-9981, Ext. 109
Manager, Corporate Communications
erazee@cyberkinetics.com
