Vital Signs receives FDA clearance on flush device

Business Wire, Dec 22, 1995

TOTOWA, N.J.--(HealthWire)--Dec. 22, 1995--Vital Signs Inc. (NASDAQ:VITL) announced the receipt of 510K notification by the FDA to market its Vascular Access Flush Device ("Viringe") for both saline and heparin applications.

As previously announced the flush device utilized in both the hospital and home care markets is expected to be commercially introduced to the market in March, 1996.

The Viringe, a pre-filled needleless flush device, has been developed as an improvement over pre-filled syringes used to periodically flush IV catheter lines to prevent clotting at the top of the catheter.

The Viringe provides the user with both a safe and more cost effective method to flush IV lines over existing devices. The company believes that the U.S. market potential for IV flush devices is approximately $150 million annually.

Terence Wall, chief executive officer commented "We are extremely pleased to receive FDA approval on our flush device, removing the U.S. regulatory hurdle as an obstacle to the commercial introduction of this new product. We expect to sell to the U.S. home care market through an exclusive relationship with a national alliance of home care dealers.

"Given the company's recent CE Mark certification, sales introduction to the European market should occur later in 1996 as well as the introduction to the U.S. hospital market through the VSI direct sales force."

The company also announced that Anthony P. Martino has joined Vital Signs effective Jan. 15, 1996 as the vice president of research and development. He brings with him over 25 years of medical device industry experience. He has held various technical positions with Becton Dickinson and Co., most recently as the director of technology advancement for the Beaver Surgical Division.

In addition, Stephen Onody has joined Vital Signs as the vice president of marketing following 20 years of experience in the medical device industry with SpaceLabs Medical Inc. and Boston Scientific Corp.

Terry Wall commented: "The addition of these two senior executives will contribute value to the product development process with the goal to accelerate the timeframe from concept to commercial introduction of our future products."

The company was recently recognized in the November issue of Forbes Magazine as one of "The 200 Best Small Companies in America" signifying the company's continual commitment to design, manufacture and market only the highest quality single-patient use products for anesthesia and critical care.

CONTACT: Vital Signs Inc., Totowa

Terence D. Wall or Tony Dimun, 201/790-1330

or

Torrance Group, New York

Judy Santiago, 212/508-3460