U.S. Food and Drug Administration Grants 510k Clearance For Specialized Health Products' Safety Huber Needle Infusion Set

U.S. Food and Drug Administration Grants 510k Clearance For Specialized Health Products' Safety Huber Needle Infusion Set

Business Wire - December 17, 2001

BOUNTIFUL, Utah--Specialized Health Products(R) International, Inc. (OTCBB: SHPI), a leader in the design and development of medical safety needles, today announced its wholly-owned subsidiary, Safety Syringe Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a new safety Huber needle infusion set. This new safety needle product will be distributed in the hospital market by Bard Access Systems, Inc., a subsidiary of C.R. Bard, Inc.

Clinicians will use this product to infuse IV fluids and drugs for oncology and other patients who are chronically ill and require a surgically implanted port. The SHPI LiftLoc(TM) Safety Infusion Set will compete in the $46 million domestic Huber needle market.

The SHPI LiftLoc(TM) Safety Infusion Set brings safety-engineered Huber needles to healthcare workers who treat patients having surgically implanted ports. The SHPI LiftLoc(TM) protective mechanism covers the needle tip with a protective sheath during removal from a patient to help protect the healthcare practitioner from an accidental needlestick. Additionally, the LiftLoc(TM) Safety Infusion Set incorporates a Patient Comfort Pad designed to bring added comfort to those patients requiring a Huber needle for infusion.

"Our LiftLoc(TM) safety Huber product is a significant contribution to the advancement of safety for clinicians who use Huber needle products," said Dr. Donald D. Solomon, Chief Operating Officer at SHPI. "This is our first family of OEM products. We are very excited about this expansion to our safety product offering. It not only brings easy to use safety-engineered products to a critical clinical application, it also provides an extra dimension of patient comfort."

About Specialized Health Products International, Inc.: SHPI designs, develops, manufactures, and licenses cost-effective, innovative safety healthcare products that minimize the risk of accidental needlesticks that are a leading cause of the spread of blood-borne diseases such as HIV/AIDS and hepatitis B and C. SHPI's allowed patents include twenty for safety medical needles, two for safety lancets, and seven for sharps containers. Trademarks include: ExtreSafe(R), Safety Cradle(R), LiftLoc(TM), AutoLoc(TM), TracLoc(TM), DentaLoc(TM), SecureLoc(TM), SlideLoc(TM), FlexLink(TM) and SharpsPaD(TM).

SHPI has 20 different and unique safety needle technologies. These technologies apply to almost all medical needles used today including: syringe, prefilled syringe, IV catheter, Seldinger, PICC introducer needles, winged needle sets, blood collection, epidural, spinal, plasma apheresis sets, dialysis sets, Huber, biopsy, laparoscopy, lancets and other specialty needles.

C.R. Bard, Inc. (www.crbard.com) headquartered in Murray Hill, New Jersey, is a leading multinational developer, manufacturer and marketer of health care products in the fields of vascular, urology, oncology and surgical specialty products.

This news release contains forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The Company may experience significant fluctuations in future operating results due to a number of economic conditions, risks in product and technology development, the effect of the Company's accounting policies and other risk factors detailed in the Company's SEC filings. These factors and others could cause operating results to vary significantly from those in prior periods and those projected in forward-looking statements. Additional information with respect to these and other factors, which could materially affect the Company and its operations, are included on certain forms the Company files with the Securities and Exchange Commission.

CONTACT: Specialized Health Products International, Inc. Keith L. Merrell, 801/298-3360 Fax: 801/298-1759 Kmerrell@shpi.com Website: www.shpi.com
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