Healthcare Industry News:  vascular access 

Devices

 News Release - November 9, 2006

Spire Introduces New Clot-Resistant Dialysis Catheter at ASN Renal Week 2006 Conference; Spire Biomedical Offers FDA-Approved Decathlon Gold(TM) Coated Catheter

SAN DIEGO--(HSMN NewsFeed)--Nephrologists from throughout the world will gather at the San Diego Convention Center the week of November 14-19 for the American Society of Nephrology's (ASN) 39th Annual "Renal Week 2006" Meeting. Among the nearly 200 exhibitors featured at this year's conference is Spire Biomedical, Inc., a Bedford, Massachusetts-based manufacturer of medical devices and provider of advanced surface modification services. With special expertise in catheter technology for use by the Nephrology community, Spire will introduce an innovative new product at the ASN conference: the Decathlon Gold End-Point(TM) Bonded heparin coated catheter, which received clearance earlier this year from the U.S. Food and Drug Administration (FDA) for use in long-term hemodialysis treatment.

The first of its kind, the Decathlon Gold long-term hemodialysis catheter features a heparin coating that has been used successfully and proven effective on a wide range of other medical devices, including vascular grafts, coronary stents, ventricular assist devices and blood oxygenators. The coating is firmly bonded to both the internal and external catheter surfaces, and has been shown to maintain 100% of its bioactive properties for a minimum of 90 days.(1) When compared to uncoated catheters in in-vitro and animal studies, this new catheter also demonstrated a significant reduction in potentially harmful catheter-related complications and dysfunction -- such as clotting -- that commonly afflict long-term dialysis patients. With a 96% (in-vitro study) and 94% (animal study) reduction in thrombus and fibrin sheath formation,(1) the Decathlon Gold catheter has the potential for reducing the frequency of thrombosis-related catheter obstructions (occlusions), which account for 58% of all occlusive events.(2)

In the U.S. alone, total Medicare expenditures for End-Stage Renal Disease (ESRD) were $12.7 billion in 1999 and are expected to rise to more than $28 billion by 2010. Although ESRD patients comprise less than 1% of the Medicare population, these costs are more than 5% of total Medicare spending. Accounting for a significant portion of that annual price tag, access-related dysfunction and complication rates (higher for dialysis catheters versus other access methods) are among the leading causes of hospitalization for hemodialysis patients, costing an estimated $8,000 per patient per year at risk. In fact, average catheter survival at 12 months has been reported at only between 30% and 65%, with the average time period to first intervention only about 73-84 days.(3)

Should the benefits observed in the in-vitro and animal studies translate to the clinic, Decathlon Gold is expected provide longer-term use, and reduced dysfunction and complications, resulting in both extensive clinical benefits (such as increased patient comfort, decreased access-related complications, morbidity and mortality rates) and associated savings on direct costs (such as hospital stays/visits, catheter renewals/reinsertions, devices/supplies and medical staff work hours).

The medical community is already taking note of the product release. Dr. Tom Vesely, a noted Interventional Radiologist from St. Louis, Missouri, expressed his enthusiasm for the Decathlon Gold catheter: "The pre-clinical animal studies are encouraging. My expectations are that this antithrombotic surface coating will decrease catheter-related complications and improve catheter longevity."

Mark Little, CEO of Spire Biomedical, Inc., stated, "We are excited about the opportunity to showcase our new catheter to the Nephrology community at the ASN Meeting. Device-related complications are a significant problem in dialysis treatment. The Decathlon Gold catheter is a new approach to address these issues and strongly distinguishes Spire's product offerings in this market segment." Mr. Little continued, "For almost two decades, Spire has been providing advanced surface treatments for a variety of medical devices. By combining our dialysis catheter market presence with this proven expertise, we continue to make strides in our pursuit of reducing device-related complications and dysfunction."

ABOUT SPIRE BIOMEDICAL

Spire Biomedical, Inc., a subsidiary of Spire Corporation (NASDAQ: SPIR ), manufactures medical devices and provides advanced medical device surface treatment processes. For nearly 20 years, Spire Biomedical has been the market leader in surface engineering services for improving the performance of orthopedic cardiovascular and other medical devices. Spire manufactures a comprehensive family of hemodialysis catheters and continues to enhance medical devices to create better performing, highly differentiated products for the healthcare community. For more information, visit www.spirebiomedical.com.

(1)In-vitro and animal data on file; Sheep study duration: 25-30 days

(2)Nurse's guide to understanding and treating thrombotic occlusion of central venous access devices. (Clinical Practice), MedSurg Nursing, Dec., 2004.

(3)Statistics obtained from "Clinical and Economic Issues in vascular access for Hemodialysis,"Vol. 1, No. 1, 2002. Ahrens Balvit & Associates, Inc.

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.


Source: Spire Biomedical

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