Natus Medical : Natus Medical Receives FDA Approval for the Olympic Cool-Cap
12/21/2006| 06:00am US/Eastern

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Natus Medical Incorporated (Nasdaq:BABY) today announced that it
has received premarket approval (?PMA?)
from the Food & Drug Administration (?FDA?)
to market its Olympic Cool-Cap, a Class III medical device. The Cool-Cap
system, which is the only FDA-approved device for the treatment of
hypoxic ischemic encephalopathy (?HIE?)
in term newborns, provides selective head cooling to prevent or reduce
the severity of neurologic injury associated with HIE.
Approximately three in 1,000 newborns are at risk of brain injury due to
an interruption of blood flow and oxygen supply during labor and
delivery. In 1999, Olympic Medical initiated a four-year international
multi center study of the Cool-Cap system. Results of the study
confirmed that when head cooling therapy was administered to patients
within the first six hours of life, thereby lowering the body
temperature three to four degrees Centigrade, the severity of brain
injury was significantly decreased compared to the untreated control
group. The study enrolled babies at high risk for moderate to severe
brain injury as diagnosed by using the Company's
Olympic CFM 6000 Cerebral Function Monitor, which aids in identifying
neurological abnormalities such as HIE.
"Until now, there has been no FDA approved way to improve life for these
babies,? stated John D. E. Barks M.D.,
Associate Professor of Pediatrics and Director of the Neonatal-Perinatal
Research Programs at The University of Michigan. ?Now
cooling the brain lets us offer hope to parents. Most parents quickly
grasp the concept underlying cooling and are ready to accept the therapy
for their child. I use the analogy of icing an injured joint. As a
cooling referral center, we have three Cool-Caps, because on more than
one occasion we have had to simultaneously treat two babies and also
needed a back-up."
Natus plans to market the Cool-Cap system to Level III neonatal
intensive care departments (?NICU's?)
worldwide, with each center utilizing two Cool-Cap devices. Based on
these metrics, Natus anticipates a market potential of over 4,000
devices worldwide. Natus expects that NICU's
in regional centers of excellence will become the first adopters of the
treatment and that head cooling therapy will quickly become a standard
of care for the treatment of newborn HIE.
Olympic Medical, which was acquired by Natus in October 2006, developed
the CFM 6000 Cerebral Function Monitor and received FDA 510(k) clearance
to market the product in 2003. The CFM 6000 is used in the Neonatal
Intensive Care Unit and other acute care departments to perform
continuous, long-term monitoring of a newborn's
brain activity. The CFM 6000 monitor enables clinical staff to assess
the function of the brain as an aid to both diagnosis and treatment of a
variety of neurological conditions such as seizures, HIE, and the
effects of medication. The Olympic CFM 6000 utilizes an FDA-cleared
single-channel amplitude-integrated EEG algorithm for cerebral function
monitoring that is the basis for most clinical studies published on the
subject since 1975. The FDA treatment protocol for the Cool-Cap system
requires an assessment made with the Olympic CFM 6000 to select patients
for treatment.
?Natus once again is leading the market by
providing customers with products that deliver significant benefits,?
stated Jim Hawkins, President and Chief Executive Officer of Natus. ?We
clearly were the leader in developing newborn hearing screening into a
standard of care, and we expect to leverage that experience as we now
look to make routine brain monitoring and head-cooling of newborns a new
standard of care.?
About Natus Medical
Natus is a leading provider of healthcare products used for the
screening, detection, treatment, monitoring and tracking of common
medical ailments such as hearing impairment, neurological dysfunction,
epilepsy, sleep disorders, newborn jaundice, and newborn metabolic
testing.
Additional information about Natus Medical can be found at www.natus.com.
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, particularly
statements regarding the expectations, beliefs, plans, intentions and
strategies of Natus. These forward-looking statements include, but are
not limited to, statements regarding the market potential for the
Cool-Cap(R) and CFM 6000 Cerebral Function Monitor(R) products as well
as acceptance of the therapy as a standard of care for the treatment of
HIE. These statements relate to future events or Natus' future financial
performance or results, and involve known and unknown risks,
uncertainties and other factors that may cause actual results, levels of
activity, performance, or achievements to differ materially from those
expressed or implied by the forward-looking statements. Forward-looking
statements are only predictions and the actual events or results may
differ materially. Natus cannot provide any assurance that its future
results or the results implied by the forward-looking statements will
meet expectations. Our future results could differ materially due to a
number of factors, including the effects of competition, the demand for
our products and services, our ability to expand our sales in
international markets, our ability to maintain current sales levels in a
mature domestic market, our ability to control costs, and risks
associated with bringing new products to market and integrating acquired
businesses. Natus disclaims any obligation to update information
contained in any forward-looking statement.
More information about potential risk factors that could affect the
business and financial results of Natus is included in Natus' annual
report on Form 10-K for the year ended December 31, 2005, and its
quarterly reports on Form 10-Q, and in other reports filed from time to
time by Natus with the U.S. Securities and Exchange Commission.
© Business Wire 2006
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