19.02.2008 13:29:00
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NeuroMetrix and Cyberkinetics Form Joint Venture to Develop Andara(TM) OFS(TM) Therapy for Peripheral Nerve Injury
Cyberkinetics Neurotechnology Systems, Inc. (OTCBB:CYKN; Cyberkinetics),
a medical device company focused on developing novel implantable
products to treat injuries and conditions of the nervous system, and
NeuroMetrix, Inc. (Nasdaq: NURO; NeuroMetrix), a medical device company
developing and marketing innovative products that aid physicians in the
diagnosis and treatment of neuropathies and neurovascular disorders and
provide regional anesthesia and pain control, today announced that they
have formed PNIR, LLC (Peripheral Nerve Injury Repair), a joint venture
to develop and commercialize a therapeutic product for peripheral nerve
injury based on Cyberkinetics’ Andara™
Oscillating Field Stimulator (OFS™)
neurostimulation technology platform. Each company will have equal
ownership in PNIR.
Under the terms of the joint venture agreement, NeuroMetrix will fund
the first $2 million of the development costs at PNIR during the next
two years and will provide PNIR with biomedical engineering and
neurophysiology expertise. Cyberkinetics will contribute intellectual
property related to its Andara™ OFS™
Therapy platform and provide technical and scientific expertise to the
joint venture. After the initial $2 million investment by NeuroMetrix,
the two companies will each contribute equally to future development
costs. As part of the agreement, NeuroMetrix will distribute and
Cyberkinetics will manufacture any products developed by the joint
venture.
"With our soldiers returning from combat,
there has been a dramatic increase in the number of multiple, severe
injuries to the arms, legs, head and neck,”
commented James M. Ecklund, M.D., Chairman of Neurosciences at Inova
Fairfax Hospital in Falls Church, Virginia. "These
injuries, which often involve severe nerve damage, highlight the
profound clinical need to develop therapies to repair and restore
sensory and motor function.” Dr. Ecklund is
the prior Chairman of the National Capital Consortium Neurosurgery
Program and retired Colonel, United States Army. He also previously
served as Professor and Chief of the Division of Neurosurgery at the
Uniformed Services University in Bethesda, Maryland.
"We are very excited to initiate the joint
venture with NeuroMetrix, which represents an important step forward in
our nerve repair strategy,” said Timothy R.
Surgenor, President and Chief Executive Officer of Cyberkinetics. "We
look forward to working with NeuroMetrix to achieve our goal of
extending the clinical application of the Andara OFS Therapy platform
from treatment of spinal cord injuries to the treatment of peripheral
nerve injuries.”
Shai N. Gozani, M.D., Ph.D., NeuroMetrix' President and Chief Executive
Officer, added, "Our collaboration with
Cyberkinetics leverages NeuroMetrix’
strengths to broaden our business into the development of novel medical
device therapies. We expect that our jointly developed peripheral nerve
therapy products, if successfully commercialized, will build on our
Company’s strong franchise in the diagnosis
of peripheral nerve injuries. Bringing valuable therapeutic products to
these patients, many of whom have been assessed using NeuroMetrix’
diagnostic products, could represent a tremendous benefit to thousands
who face permanent loss of function and productivity.”
According to industry estimates, each year approximately 800,000 people
in the United States alone sustain peripheral nerve injuries that
require surgical intervention and that can result in disabilities that
permanently impair sensory and motor function. Of these, Cyberkinetics
and NeuroMetrix estimate that as many as 100,000 people with laceration,
stretch and compression injuries could benefit from nerve fiber growth
repair treatment using Andara™ OFS™
Therapy.
About Andara™ Oscillating Field Stimulator
(OFS™) Therapy
Cyberkinetics’ Andara™
OFS™ System 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. The Andara™ OFS™
technology is designed to restore sensory and motor function through the
use of low voltage, direct current, electrical stimulation that promotes
and directs the nerve fibers to grow across the area of injury. Results
from a Phase Ia, 10-patient clinical trial of the Andara™
OFS™ Therapy in patients with recent spinal
cord injuries were published in the January 2005 issue of the Journal
of Neurosurgery: Spine, and indicated statistically significant
improvements in sensory and motor function at 12 months after treatment.
Four additional patients were subsequently enrolled in a Phase Ib the
trial.
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, 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.cyberkineticsinc.com.
About NeuroMetrix, Inc.
NeuroMetrix is a medical device company advancing patient care through
the development and marketing of innovative medical device products that
aid physicians in the diagnosis and treatment of diseases of the nervous
system and neurovascular disorders, and to provide regional anesthesia
and pain control. To date, our focus has been on the diagnosis of
neuropathies and neurovascular disorders. Neuropathies are diseases of
the peripheral nerves and parts of the spine that frequently are caused
by or associated with diabetes, low back pain and carpal tunnel
syndrome, as well as other clinical disorders. The NC-stat System, the
Company's neuropathy diagnostic system, has been on the market since May
1999 and is used in over 5,500 physician's offices and clinics in the
United States. Diabetic retinopathy is a common neurovascular
complication of diabetes and the leading cause of blindness among
working age adults. Through the Company’s
acquisition of EyeTel Imaging, NeuroMetrix markets the DigiScope, which
is a retinal imaging system designed for use at the point-of-care in
physician offices and vision clinics.
Forward-Looking Statements
This announcement contains forward-looking statements, including
statements about 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 Cyberkinetics’
Annual Report on Form 10-KSB filed with the SEC on April 2, 2007, the
NeuroMetrix Annual Report on Form 10-K for the year ended December 31,
2006, and each of 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.
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