FDA advisory votes 5 to 3 against Base TEN's Prenval(TM) I approval; vote reflects conflict between FDA and panel members, but PMA remains under active FDA consideration.

TRENTON, N.J.--(BUSINESS WIRE)--April 3, 1995--BASE TEN SYSTEMS INC. (NASDAQ/NMS:BASEA) reported that an FDA Medical Devices Advisory Panel voted 3 in favor and 5 against approving PRENVAL(TM) I as a Class 3 medical device.

Several dissenters voted on the issue of device classification instead of the intended criteria of safety and effectiveness. In its presentation to the panel, the FDA endorsed PRENVAL(TM) I as safe and effective for the intended use and application. The FDA staff also indicated that the software product--the first ever to be presented as free standing software for the PMA process under new FDA guidelines--was thoroughly prepared and verified, a view repeated by members of the panel, including several dissenting members.

Mike Kranzler, chairman and CEO of Base Ten, said "We were advised by the Deputy Director of the FDA's Office of Device Evaluation that a panel recommendation for or against approval is not binding on the FDA. The Deputy Director further indicated that the pre-market approval application (PMA) for PRENVAL(TM) I is still very much under active consideration by the FDA, which will seek to conclude its review and make a decision as soon as possible."

FDA senior staff sought to focus the panel on its intended purpose of evaluating the program's safety and effectiveness, not its classification. Panel discussions on safety and effectiveness, however, were limited. One panel member strongly contested the FDA's classification of PRENVAL(TM) I as a Class 3 medical device, and other members then joined in the dissent. The Deputy Director clarified that PRENVAL(TM) I must carry a Class 3 requirement because it is used with Alpha-fetoprotein (AFP), and ancillary Class 3 medical device already approved by the FDA. In fact, the Class 3 designation was imposed by the FDA on Base Ten's product at the beginning of the approval process, more than three years ago. Another panel member objected on grounds that FDA approval of the program would give Base Ten an unfair monopoly. Some of the dissenting panel members recommended that the FDA allow Base Ten to immediately market and sell PRENVAL(TM) I without pre-market approval.

Because various panel members concentrated on classification rather than safety and effectiveness, a major conflict developed between those members and the FDA. The chairman of the panel understood the panel's responsibilities and voted to recommend approval of the PMA.

Mike Kranzler said "We believe the panel made an error that is reversible. Instead of voting on the safety and effectiveness of PRENVAL(TM) I as a Class 3 medical device, they focused on other considerations outside their authority. We are working with the FDA to resolve this matter favorably."

PRENVAL(TM) I is a software computer program to assist in the database management, calculations and reporting of results from quantitative measurements of AFP as an aid in the detection of fetal open neural tube defects.

Base Ten Systems Inc, is a diversified technology company concentrating on safety critical products for use in medical software, manufacturing execution systems and weapons control systems.

CONTACT: BASE 10 SYSTEMS, INC.

Edward J. Klinsport, 609/586-7010

or

Strategic Growth International, Inc.

Richard Cooper, 609/826-9622 REPEATS: New York 212-575-8822 or 800-221-2462; Boston 617-330-5311 or

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