Greatbatch Inc. (GB) recently received the U.S. Food and Drug Administration (FDA) 510 (k) approval to market its next generation valved peelable introducer, OptiSeal, in the United States. The OptiSeal valved peelable introducer is used in the delivery of leads and catheters into the venous system. The product has earlier received marketing clearance in Canada and Europe.
Greatbatch Medical develops OptiSeal in collaboration with its various original equipment manufacturer (OEM) customers. The company is in the process of setting up a distribution agreement with OEMs.
Per the agreement, Greatbatch Medical will manufacture OptiSeal which will be distributed globally by the company’s OEM customers. Greatbatch expects to finalize the distribution agreement by the second half of 2010.
Greatbatch reported disappointing fourth quarter and fiscal 2009 results. Total revenue in the quarter declined 14% year over year to $125.8 million. Greatbatch Medical revenue declined 14% year over year to $108.8 million. The decline was broad-based across all the sub-segments. Electrochem sales declined 14% year over year to $17.1 million.
Earnings per share of 40 cents in the fourth quarter were also lower than the year-ago figure of 50 cents. However, earnings were higher than the Zacks Consensus Estimate of 34 cents.
Total revenues in fiscal 2009 declined 5% year over year to $521.8 million. Greatbatch Medical revenue declined 3% year over year to $455.1 million. Electrochem sales declined 15% year over year to $66.8 million.
Greatbatch, Inc., headquartered in Clarence, NY, is a leading producer and supplier of batteries, capacitors and components used in implantable medical devices. The company also produces batteries for commercial and industrial applications such as oil and gas exploration, oceanographic equipment, seismic surveying equipment and others. The National Aeronautics and Space Administration (NASA) uses Greatbatch’s batteries in its aerospace programs.
Presently, we are ‘Underperform’ on Greatbatch.
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