Natus Medical to Resume Domestic Shipments of Olympic Cool-Cap
February 12 2008 - 7:00AM
Business Wire
Natus Medical Incorporated (Nasdaq:BABY) today announced that the
FDA has approved its supplement to the premarket approval
application for the Olympic Cool-Cap. Natus is now cleared to
resume shipping the device within the United States. The Cool-Cap
is the only FDA-approved device for the treatment of hypoxic
ischemic encephalopathy (�HIE�) in term newborns. The system
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,
the Company�s Olympic Medical division 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, 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. In December 2006, Natus
announced that it had received premarket approval (�PMA�) from the
FDA to market the Cool-Cap, a Class III medical device. In
transitioning production of the Cool-Cap from clinical units to
commercial units, the Company updated many of its components.
Because of its Class III device status, some of these component
updates required that the Company submit a PMA supplement to the
FDA, which the Company did in October 2007. The Company had
previously put a hold on domestic shipments of Cool-Cap units. The
Company received the supplement approval on February 11, 2008. Jim
Hawkins, President and Chief Executive Officer of the Company
commented, �We are pleased that the FDA has approved these upgrades
to the Olympic Cool-Cap. We can now resume shipments of the
Cool-Cap in the United States and we expect we will be able to
fulfill most, if not all, of our existing backlog of orders by the
end of the first quarter. �We also believe our customers will be
very happy that this issue has been satisfactorily resolved,� added
Hawkins. �Because the Cool-Cap is the only FDA approved medical
device for the treatment of HIE in term newborns, we want to get
the device into the marketplace as quickly as possible so
clinicians can begin using the device to treat these newborns.�
About Natus Medical Incorporated 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,
and newborn care. Product offerings include computerized
neurodiagnostic systems for audiology, neurology, polysomnography,
and neonatology, as well as newborn care products such as hearing
screening systems, phototherapy devices for the treatment of
newborn jaundice, head-cooling products for the treatment of brain
injury in newborns, and software systems for managing and tracking
disorders and diseases for public health laboratories. Additional
information about Natus Medical can be found at www.natus.com.
Cautionary Information Regarding 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 benefits of the
Olympic Cool-Cap System, including the CFM 6000 Cerebral Function
Monitor, and the ability of the Company to fulfill existing backlog
by the end of the first quarter 2008. 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. The future
results of Natus could differ materially due to a number of
factors, including the effects of competition, challenges incurred
in integrating acquired companies, the demand for products and
services, the ability to expand sales in international markets, the
ability to maintain current sales levels in a mature domestic
market, the ability to control costs, and risks associated with
bringing new products to market. 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, 2006,
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.
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