Bio-Plexus Receives 510-k- Approval From the FDA to Market Punctur-Guard Winged Set for Blood Collection Safety Needles.

Business Editors & Health/Medical Writers

BIOWIRE2K

VERNON, Conn.--(BW HealthWire)--Jan. 10, 2001

Bio-Plexus, Inc. (NASDAQ: BPLX), a leader in the design, manufacture and marketing of safety medical needles and other products, today announced that it has been granted 510(k) approval from the U.S. Food and Drug Administration ("FDA") to market a new version of its PUNCTUR-GUARD(R) Winged Set for Blood Collection safety needle. This new product will be manufactured and marketed exclusively by Bio-Plexus.

Winged sets are steel hollow bore needles with tubing attached used for blood collection. The National Surveillance System for Health (NaSH) reports that Winged Sets account for 67% of the accidental needlesticks associated with Blood Collection. The PUNCTUR-GUARD(R) Winged Set incorporates the same internal blunt technology used in the PUNCTUR-GUARD(R) multi-sample blood collection needle. An inner hollow blunt needle extends beyond the sharp point of the outer needle prior to removal of the device from the patient, thereby eliminating exposure to possibly contaminated sharp needles. Current devices require removal of the contaminated sharp from the patient before the outer sheath can be moved into place over the sharp.

John S. Metz, President and Chief Executive Officer of Bio-Plexus, stated, "We are pleased to have obtained this 510(k) approval as it is an essential step in bringing our new PUNCTUR-GUARD(R) Winged Set to the marketplace. We believe this safety device is technologically superior to existing safety winged sets. NaSh reports indicate that 53% of all injuries using safety devices occur using winged steel needle devices. Therefore, we believe there is a need for better products. Significantly, the PUNCTUR-GUARD(R) Winged Set becomes yet another important part of our product portfolio to help reduce the incidence of accidental needlesticks suffered by our nation's healthcare workers."

Mr. Metz continued, "From a business standpoint, we are optimistic that this leading-edge medical safety device will become a significant revenue producer for us. We believe the potential available market for safety blood collection products is in the hundreds of million dollars in the US alone. Market conversion to safety is well below 50 percent but growing rapidly, due to the recently enacted state and federal legislation aimed at ensuring that health care workers have unprecedented access to safety needles."

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. For independent evaluations of the PUNCTUR-GUARD(R) blood collection needle, refer to the Centers for Disease Control (MMWR, January 1997) and ECRI (Health Devices, June 1998 and October 1999) studies. 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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