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Spire Corporation (SPIR) Receives FDA Clearance For Decathlon Separated-Tip Catheter


10/19/2005 5:10:21 PM

BEDFORD, Mass.--(BUSINESS WIRE)--March 9, 2004--Spire Corporation (Nasdaq: SPIR - News) announced today that Spire Biomedical, its wholly owned subsidiary, has received FDA 510(k) clearance for its Decathlon(TM) catheter. The Company has released Decathlon for sale through its national network of specialty distributors. Made for the chronic hemodialysis vascular access market, Decathlon incorporates clinical innovations such as advanced CarbothaneĀ® material plus superior kink resistance and distal tip configurations, all of which will enhance dialysis function and durability. Currently, Spire markets the Pourchez XpressO(TM) and Pourchez RetrO(TM) hemodialysis catheters and related dialysis access accessory products. Both of these products, along with Decathlon, may be inserted using either a sheath/dilator or over a guidewire. Mark Little, CEO of Spire Biomedical, commented on the FDA clearance, "The Decathlon complements the other products in Spire's growing hemodialysis catheter line. With the addition of Decathlon we can now offer physicians a broad range of hemodialysis access catheters with different insertion options. We believe that this will improve our ability to obtain full hospital conversions. In line with our strategy of offering high performance products, the Decathlon targets the premium end of the separated-tip catheter market."

CarbothaneĀ® is a registered trademark of Thermedics Polymer Products. Pourchez XpressO(TM), Pourchez RetrO(TM) and Decathalon(TM) are trademarks of Spire Corporation.

Spire Corporation provides products and services to the biomedical and solar industries worldwide, all based upon a common technology platform.

Certain matters described in this news release may be forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the risk of dependence on market growth, competition and dependence on government agencies and other third parties for funding contract research and services, as well as other factors described in the Company's Form 10-KSB filed with the Securities and Exchange Commission.

Contact:

Spire Corporation Mark C. Little, CEO, Spire Biomedical, 781-275-6000

Source: Spire Corporation


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