Cool-Cap hits the market
This article was originally published in The Gray Sheet
Executive Summary
Natus Medical subsidiary Olympic Medical receives FDA approval Feb. 11 to begin U.S. shipments of its Cool-Cap device to treat hypoxic ischemic encephalopathy in newborns, and expects to fulfill most of its backlog orders by the end of the first quarter. Cool-Cap, which lowers body temperature to reduce brain swelling, was FDA-approved in December 2006, but required PMA-supplements for component updates before it could be sold commercially. Separately, Natus launched a restructuring plan to be phased in during the first nine months of 2008 to improve operating efficiency after recent acquisitions, including the November 2007 purchase of Xltek (1"The Gray Sheet" Oct. 15, 2007, In Brief). Natus will cut its North American field sales and service force, and continue to outsource assemblies to contract manufacturers, the firm said Feb. 11. The plan is expected to save $2.4 million in 2009