Bio-Plexus Comments On 510K Approval of Catheter Introducer.

Business Editors/Health and Medical Writers

VERNON, Conn.--(BW HealthWire)--May 30, 2000

510K approval was recently granted to Teleflex, Inc. by the Food and Drug Administration to market a new peripherally inserted central catheter (PICC) introducer. The PICC introducer was developed in a partnership with Bio-Plexus and Teleflex (NYSE:TFX) of Jaffrey New Hampshire. It will be manufactured by Teleflex on production equipment designed and built by Bio-Plexus, and marketed exclusively by Bard Access Systems (NYSE:BCR) of Salt Lake City, Utah.

Bard is the dominant force in the PICC market segment, and unveiled the new product, the Safety Excalibur(R) Introducer at the Intravenous Nurses Society Annual Meeting and Industrial Exhibition in Minneapolis earlier this month. "We are excited to deliver the Safety Excalibur to the marketplace. The Safety Excalibur, featuring Punctur- Guard internal blunting technology, has created quite a positive reaction among healthcare workers who have seen the device," said Amy Paul, Division President, Bard Access Systems. "We expect it to make PICC insertion procedures significantly safer for healthcare workers," she added.

Bard will include a reference to Bio-Plexus and Punctur-Guard internal blunting technology on its packaging and labeling for the Safety Excalibur Introducer.

In addition, Bio-Plexus recently received a patent on the catheter's distinctive shape which offers the user enhanced visual confirmation of flashback, superior ergonomics and ease-of-use. Examples of this design can be seen in the Bard Safety Excalibur(R) Introducer and in Johnson and Johnson's (NYSE:JNJ) Protectiv(R) Acuvance(R) safety I.V. catheter which is expected to be commercially available shortly.

Tom Sutton, Bio-Plexus Executive Vice President commented: "This most recent 510K approval and Bard's launch of the PICC introducer demonstrates our success in continuing to commercialize Punctur-Guard internal blunting technology in a variety of medical needle device market segments. It is very significant to note that the market leader in PICCs (Bard) and I.V. catheters (JJMI), have both chosen Bio-Plexus Punctur-Guard internal blunting technology as the safety platform for their next generation of safer needle products," Sutton continued.

"Punctur-Guard is the only safety technology available that is made safe during use. This means the clinician should never be exposed to a sharp, blood-contaminated needle after removal from the patient. Shielding technologies, offered by many of our competitors, are activated after use -- exposing the clinician to a contaminated sharp until the shield is activated. As Punctur-Guard products get into the hands of healthcare workers, the risk of an accidental needlestick is significantly reduced, and the clinician can more fully concentrate on patient care. This partnership with Teleflex, and theirs' with Bard is one more way that we are penetrating the market with our leading-edge internal blunting technology," Sutton concluded.

Bio-Plexus, Inc. (NASDAQ:BPLX), designs, develops, manufactures and holds U.S. and international patents on safety medical needles and other products under the PUNCTUR-GUARD(R), DROP-IT(R), and PUNCTUR-GUARD REVOLUTION(TM) brand names. In studies by the Centers for Disease Control (MMWR, January 1997) and ECRI (Health Devices, June 1998 and October 1999) PUNCTUR-GUARD(R) needles ranked highest of all devices studied. Accidental needlesticks number about one million per year in the United States and can result in the transmission of deadly diseases including HIV and Hepatitis B and C.

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