Healthcare Industry News:  Polysomnography 

Devices FDA Neurology

 News Release - February 12, 2008

Natus Medical to Resume Domestic Shipments of Olympic Cool-Cap

Company Receives FDA Clearance of Upgrades

SAN CARLOS, Calif.--(HSMN NewsFeed)--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.


Source: Natus Medical

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