Message #42 From:
NewsBot Date: December 6, 2006 07:26:00 AM
CYKN News Cyberkinetics Receives Notification of Key Patent Allowance for Treatment of Spinal Cord Injury Using the Andara(TM) OFS(TM) PLUS Device
FOXBOROUGH, Mass.--(BUSINESS WIRE)--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN;
Cyberkinetics), a neurotechnology company focused on neurostimulation
and neural sensing to restore function, announced that a notification of
allowance has been received from the U.S. Patent and Trademark Office
for publication number US20040214790A1, entitled “Method
of Treatment for Spinal Cord Injury”. The
patent relates to the Company’s Andara™
Oscillating Field Stimulator (OFS™) neural
stimulation technology platform.
“In early 2007, we expect to file an
application for a Humanitarian Device Exemption on the Andara™
OFS™ Device which is intended for the
treatment of acute spinal cord injuries. The fundamental science that
underlies the claims in this patent is directed toward enabling us to
treat spinal cord and other nervous system injuries that occurred months –
even years – ago,”
stated Timothy R. Surgenor, Cyberkinetics’
President and Chief Executive Officer. “This
technology may one day allow us to provide sensation and motor function
to the large numbers of people living with spinal cord injuries today.
The allowance of this patent significantly extends coverage of our Andara™
OFS™ technology platform and strengthens our
position in the rapidly expanding neurostimulation marketplace.”
Cyberkinetics gained rights to the patent through the acquisition of
Andara™ Life Science, Inc. The patent
application is based on technology licensed from Purdue Research
Foundation and Indiana University Research and Technology Corporation.
The initial research was performed at Purdue University’s
Center for Paralysis Research under the direction of:
Richard Borgens, Ph.D., inventor of Cyberkinetics’
Andara™ OFS™
Device technology, founder and Director of Purdue’s
Center for Paralysis Research, and the Mari Hulman George Professor of
Applied Neurology in the School of Veterinary Medicine at Purdue
University; and
Scott Shapiro, M.D., the Principal Investigator for the clinical trial
of the Andara™ OFS™
Device and the Robert L. Campbell Professor of Neurosurgery at the
Indiana University School of Medicine.
About the Andara™ OFS™
Technology Platform
Cyberkinetics’ Andara™
OFS™ Device 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 regeneration. The Andara™
OFS™ Device 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.
In April 2006, Scott Shapiro, M.D., Principal Investigator in the Andara™
OFS™ Device clinical trial, presented basic
research results that demonstrated - for the first time –
that Cyberkinetics’ Andara™
OFS™PLUS System induced nerve regeneration
and functional recovery in a model of chronic, or long-term, spinal cord
injury. These results supplement the findings of a Phase Ia clinical
trial of ten participants who received the Andara™
OFS™ Device within 18 days of their injuries
that demonstrated that the Andara™ OFS™
Device, used alone, is capable of restoring sensation and motor function.
In September 2006, Cyberkinetics received notification from the Food and
Drug Administration (FDA) that the Company’s
Andara™ OFS™
Device was designated as a Humanitarian Use Device (HUD) for use
immediately after (within 18 days) certain types of spinal cord
injuries. This special FDA designation enables Cyberkinetics to file an
HDE application with the FDA to use Cyberkinetics’
Andara™ OFS™
Device to treat patients with acute, or recent, spinal cord injuries.
Cyberkinetics expects to file the HDE application in early 2007.
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 Andara™
Oscillating Field Stimulator (OFS™) Device,
an investigative device designed to stimulate regeneration of the neural
tissue surrounding the spinal cord; the BrainGate System, an
investigative device designed to provide communication and control of a
computer, assistive devices, and, ultimately, limb movement; and the FDA
cleared-to-market NeuroPort™ System, a neural
monitor designed for acute inpatient applications and labeled for
temporary (less than 30 days) recording and monitoring of brain
electrical activity. 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.
