15.11.02

15.11.2002: Meldung: Spire Receives FDA Clearance to Market Dual Wire Insertion Kit for Hemodialysis Catheters SafeTrac

Bedford, Mass. 14.1.2002. Spire Corporation (Nasdaq: SPIR) announced today that Spire Biomedical, Inc., its wholly owned subsidiary, has received 510(k) clearance from the Food and Drug Administration to market its SafeTrac(TM) dual wire insertion kit. The kit provides an innovative insertion method for Spire Biomedical"s Pourchez XpressO(TM) and Pourchez RetrO(TM) catheters, which are used for long-term vascular access in patients suffering from chronic kidney disease. Spire Biomedical introduced SafeTrac(TM) and displayed its other hemodialysis catheter products at a meeting of the American Society of Nephrology in Philadelphia last week.

Mr. Mark Little, CEO of Spire Biomedical, Inc., stated, "The majority of tunneled hemodialysis catheters are inserted by using a sheath/dilator to help guide the catheter into the vascular system. We believe that the SafeTrac(TM) system, which uses an over-the-wire insertion method, will appeal to many physicians because it eliminates some potential complications associated with sheath/dilator insertion. Initial clinical feedback has been very encouraging; for certain procedures we see this product as the preferred method of insertion. Introduction of the SafeTrac(TM) kit demonstrates our commitment to provide physicians with a broad range of superior products and the tools necessary to meet the needs of their patients."

About Spire Biomedical, Inc.

Spire Biomedical, Inc., a wholly owned subsidiary of Spire Corporation, provides premium medical products and biotechnology surface engineering services for improving the performance of implantable medical devices. For more information, visit Spire Biomedical, Inc."s web site at www.spirebiomedical.com.

About Spire Corporation

Spire Corporation provides solar electric systems for distributed power generation and is a leading supplier of photovoltaic module manufacturing equipment and turnkey solar energy businesses. For more information, visit Spire Corporation"s web site at www.spirecorp.com.
Certain matters discussed 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 -
Corporate Headquarters
One Patriots Park
Bedford, MA 01730-2396/USA
FAX +1 781-275-7470
EMAIL email@spirecorp.com
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