April 11, 2001 — MINNEAPOLIS — MedAmicus, Inc has filed a 510K application with the Food and Drug Administration to gain clearance to market its center-line retractable Guidewire Introducer Safety Needle, a product licensed from and co-developed with Med-Design Corporation.

“This product retracts into a protective sheath while still in the patient eliminating the possibility of a needle stick after coming in contact with a patient’s blood,” said Mark Kraus, vice president and general manager of the Company’s Percutaneous Delivery Solutions division (PDS). “It is an elegant design and one that we can manufacture and bring to market at an attractive cost. It also meets the guidelines of the Needlestick Safety and Prevention Act, which Congress passed and the President signed in November 2000, mandating the use of effective, safer needles.

“Our FDA application for marketing clearance, which traditionally have been approved in ninety days or less, keeps us on schedule for a third quarter projected launch,” Kraus added. “In addition to the FDA work, we have made significant capital investments in tooling and fixtures as well as a planned expansion of our cleanroom space. We intend to initially distribute the product through our relationships with our OEM customers, and will continue to explore with Med-Design other market opportunities.”

MedAmicus, Inc., based in Plymouth, Minn., is a medical products company engaged in the design, development, manufacture and marketing of medical products for the cardiology, gynecology and urology markets. Its products include venous vessel introducers and safety products for use in the implantation of pacemakers, defibrillators, catheters and infusion ports sold through OEM relationships with other medical device companies as well as Lumax fiber optic monitors and catheters for the diagnosis of incontinence.