FOXBOROUGH, Mass.--(BUSINESS WIRE)--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN;
"Cyberkinetics"; "Company"), a medical device company focused on
developing novel implantable products to treat neurological diseases
and injuries of the
Central Nervous System, announced that the
Company's Andara(TM) OFS(TM) Therapy for acute spinal cord injury has
been selected for inclusion in the 2007 Advanced Medical Technology
Association's ("AdvaMed") "Progress You Can See" events on Capitol
Hill. Cyberkinetics is one of several companies that will be
represented at the event by a physician and patient pair.
On Wednesday, June 20, 2007, Beverly C. Walters, M.D., a
neurosurgeon and consultant to Cyberkinetics; Brandon Ingram, one of
the first patients treated in the clinical trial of Cyberkinetics'
Andara(TM) OFS(TM) Therapy following his spinal cord injury; and other
representatives of Cyberkinetics will speak with members of Congress
concerning the critical importance of making available innovative
treatments, such as the Andara(TM) OFS(TM) Therapy, which is designed
to restore function and improve long-term medical outcomes in people
with spinal cord injuries.
"Immediately after my injury, my doctors told me I'd never have
any movement or sensation below my waist again," commented Brandon
Ingram, founder of Positive Images, a foundation to provide
inspirational programs to youth and adults. "The Andara(TM) OFS(TM)
Therapy has helped me regain some ability to move my legs and toes and
to have some return of sensation. I'm now happily married and have a
job. We need to make sure that new treatments like the Andara(TM)
OFS(TM) Therapy are available to people who can benefit from them."
Mr. Ingram was injured in a car accident in 2002 in which he suffered
a spinal cord injury that left him paralyzed from the waist down.
"Cyberkinetics is emblematic of the type of entrepreneurial,
highly-innovative company that develops novel technologies, such as
the Andara(TM) OFS(TM) Therapy, we want to highlight to Congress,"
added Stephen J. Ubl, President and Chief Executive Officer of
AdvaMed. "I believe that the Andara(TM) OFS(TM) Therapy is positioned
to become a viable treatment for patients with spinal cord injuries."
"We are very pleased that AdvaMed has selected the Andara(TM)
OFS(TM) Therapy as an example of the value of medical device
technology," stated Timothy R. Surgenor, Cyberkinetics' President and
Chief Executive Officer. "The potential benefit for our Andara(TM)
OFS(TM) System to restore some sensation and Motor function in people
with spinal cord injuries represents an important advance."
The Andara(TM) OFS(TM) 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 HDE approval process, similar to the Orphan Drug
designation, is an expedited approval process designed by the FDA to
encourage companies to develop products that address significant
medical needs in patient populations of less than 4,000 patients
annually.
About the Andara(TM) OFS(TM) System
Cyberkinetics' Andara(TM) Oscillating Field Stimulator ("OFS(TM)")
System is designed to be implanted in patients within 18 days
following a spinal cord injury. The Andara(TM) OFS(TM) System applies
an oscillating field of low-voltage, direct electrical current to the
area surrounding the spinal cord to stimulate the regrowth of nerve
tissue across the area of injury to restore sensory and motor
function. Published data from randomized, controlled preclinical
studies indicate that the Andara(TM) OFS(TM) System aided in the
restoration of sensation and some motor function in naturally injured
dogs. Results of the first ten-patients enrolled in a clinical study
of the Andara(TM) OFS(TM) System were published in the Journal of
Neurosurgery: Spine in January of 2005. Subsequently, four additional
patients enrolled in the clinical study.
Results from all 14 patients, including 13 for whom extended
follow-up data were available, that participated in the clinical trial
were reported at the 29th Annual Meeting of the Bioelectromagnetics
Society in Kanazawa, Japan, on Tuesday, June 12, 2007. Based on
reported results, 12 of 13 patients had improvement in sensory or
motor function that met a "response to therapy" definition related to
improvement several levels below the level of injury where historical
data indicate that spontaneous recovery rarely occurs. In addition,
none of the 13 patients reported moderate or severe pain at one year,
despite the common occurrence of Neuropathic Pain in spinal
cord-injured patients, with average pain scores on the Visual Analog
Scale less than 1 on scale of 0 to 10.
About Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Neurotechnology Systems, Inc., a leader in the
neurotechnology industry, is developing neural stimulation, sensing
and processing technology designed 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(TM) OFS(TM) Therapy
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. 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.
