July 10, 2001 — MINNEAPOLIS, MN — MedAmicus, Inc. has received 510K clearance from the Food and Drug Administration to market its center-line retractable Guidewire Introducer Safety Needle, a product licensed from and co-developed with Med-Design Corporation. The company is also finishing an expansion of its cleanroom.

“This product can be activated while still in the patient further reducing the possibility of an accidental needle stick after coming in contact with a patient’s blood,” said Mark Kraus, vice president and general manager. “The unique design characteristics of the center-line retraction technology allowed the needle to be designed such that it should have minimal impact on the technique for use.”

The needle also meets the guidelines of the Needlestick Safety and Prevention Act, which went into effect in April which mandates the use of safer needles

“Our FDA marketing clearance keeps us on schedule for a projected third quarter launch,” Kraus added. “In addition to the FDA work, we made significant capital investments in tooling and fixtures to support the projected demand, and we are completing an expansion of our cleanroom manufacturing space.”

MedAmicus, Inc., based in Plymouth, Minn., is a medical products company engaged in the design, development, manufacture and marketing of percutaneous delivery systems. Its products include venous vessel introducers, safety needles and other disposable delivery products for use in the implantation of pacemakers, defibrillators, catheters and infusion ports sold through OEM relationships with other medical device companies.

Med-Design Corporation, based in Ventura, California designs and develops safety needle devices covering applications within the important risk areas of blood collection, infusion therapy, insertion and injection.