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BIODYNAMICS INTERNATIONAL ANNOUNCES FDA ACCEPTANCE OF 510 (k) NOTICE RELATED TO AUTOTRANSFUSION SYSTEM

 BIODYNAMICS INTERNATIONAL ANNOUNCES FDA ACCEPTANCE
 OF 510 (k) NOTICE RELATED TO AUTOTRANSFUSION SYSTEM
 TAMPA, Fla., June 9 /PRNewswire/ -- Biodynamics International, Inc. (NASDAQ: BDYN) today announced that the 510 (k) notification of intent to market the PlateletPlus Autotransfusion System submitted by Advanced Haemotechnologies ("AHT") has been accepted by the U.S. Food and Drug Administration. The AHT system reduces the risk of donor blood transfusions through recycling the patient's own blood lost during surgery.
 AHT, a Houston area based partnership engaged in the manufacturing, marketing, and distribution of this advanced blood processing system, is a 50/50 joint venture of Biodynamics International, Inc. and the TMP subsidiary of Surgimedics, Inc.
 John V. Hargiss, president of Biodynamics said, "We are extremely pleased with the FDA decision as related to AHT's 510 (k) application. This significant event paves the way to enter this growing market." The company estimates the current market for autotransfusion blood processing systems is approximately $140 million, and is growing at approximately 15 percent per year. Some industry experts believe that autotransfusion has penetrated only 20 percent of its worldwide potential.
 A company spokesman noted that the PlateletPlus Autotransfusion System offers surgeons a technologically advanced product which preserves a significant percentage of the patient's platelets, while eliminating potential exposure to possible donor blood contaminants such as AIDS and hepatitis. The easy to use, light weight (52 lbs.) system reduces set-up time and is one of the most automated blood recovery systems available today. Its competitive cost, as well as the system's simplicity of operation, should make autotransfusion available to more smaller and medium size hospitals. Advanced Haemotechnologies plans to initiate marketing efforts in the U.S. and Europe later this fiscal year. Finally, the company emphasized that while FDA acceptance permits the device to proceed to market, such acceptance does not imply approval of the device.
 Biodynamics International, Inc. provides specialty surgical products to the neurosurgical, orthopedic, cardiovascular, plastic and reconstructive surgical specialties. The company is a Florida corporation with its executive offices in Tampa, Fla.
 -0- 6/9/92
 /CONTACT: John V. Hargiss, president and CEO, or Marti Bruce, controller of Biodynamics International, Inc., 813-979-0016/
 (BDYN) CO: Biodynamics International, Inc. ST: Florida IN: HEA SU:


JB-AW -- FL004 -- 8303 06/09/92 10:53 EDT
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Publication:PR Newswire
Date:Jun 9, 1992
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