MedAmicus Files for FDA Clearance on Safety Needle; Filing Keeps Development Schedule on Track

Apr 10, 2001, 01:00 ET from MedAmicus, Inc.

    MINNEAPOLIS, April 10 /PRNewswire/ -- MedAmicus, Inc. (Nasdaq: MEDM)
 announced that it 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 (Nasdaq: MEDC).
     "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 clean room 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 sold
 through its own direct sales force.  MedAmicus is traded on the Nasdaq Stock
 Market under the symbol MEDM.
     Med-Design Corporation, based in Ventura, Calif., is a leader in the
 design and development of user-friendly and cost effective safety needle
 devices covering applications within the important risk areas of blood
 collection, infusion therapy, insertion and injection.  Med-Design is traded
 on the Nasdaq National Stock Market under the symbol MEDC.
     This news release contains forward-looking statements as defined by the
 Private Securities Litigation Reform Act of 1995.  Certain important factors
 could cause results to differ materially from those anticipated by some
 statements made herein.  You are cautioned that all forward-looking statements
 involve risks and uncertainties.  Among the factors that could cause results
 to differ materially are the following: attracting and retaining key
 personnel; lack of market acceptance of the Company's products, especially the
 safety needle; introduction of competitive products; patent and government
 regulatory matters; successful implementation of the Company's safety needle
 production ramp-up schedule; economic conditions; and the ability to raise
 capital.  All such forward-looking statements, whether written or oral, and
 whether made by or on behalf of the Company are expressly qualified by these
 cautionary statements.  In addition, the Company disclaims any obligation to
 update forward-looking statements to reflect events or circumstances after the
 date hereof.
 
 

SOURCE MedAmicus, Inc.
    MINNEAPOLIS, April 10 /PRNewswire/ -- MedAmicus, Inc. (Nasdaq: MEDM)
 announced that it 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 (Nasdaq: MEDC).
     "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 clean room 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 sold
 through its own direct sales force.  MedAmicus is traded on the Nasdaq Stock
 Market under the symbol MEDM.
     Med-Design Corporation, based in Ventura, Calif., is a leader in the
 design and development of user-friendly and cost effective safety needle
 devices covering applications within the important risk areas of blood
 collection, infusion therapy, insertion and injection.  Med-Design is traded
 on the Nasdaq National Stock Market under the symbol MEDC.
     This news release contains forward-looking statements as defined by the
 Private Securities Litigation Reform Act of 1995.  Certain important factors
 could cause results to differ materially from those anticipated by some
 statements made herein.  You are cautioned that all forward-looking statements
 involve risks and uncertainties.  Among the factors that could cause results
 to differ materially are the following: attracting and retaining key
 personnel; lack of market acceptance of the Company's products, especially the
 safety needle; introduction of competitive products; patent and government
 regulatory matters; successful implementation of the Company's safety needle
 production ramp-up schedule; economic conditions; and the ability to raise
 capital.  All such forward-looking statements, whether written or oral, and
 whether made by or on behalf of the Company are expressly qualified by these
 cautionary statements.  In addition, the Company disclaims any obligation to
 update forward-looking statements to reflect events or circumstances after the
 date hereof.
 
 SOURCE  MedAmicus, Inc.