HK Medical Technologies Announces FDA Approval to Initiate PMA Study for Its Autocath(R) 100 Bladder Control Device

December 31, 1997

SAN ANTONIO, Dec. 30 /PRNewswire/ via Individual Inc. -- HK Medical Technologies, Inc. announced today that it had received FDA approval to initiate its long-term pivotal study for the Company's self-contained Autocath(R) 100 bladder control device to treat stress urinary incontinence. The study will be pursuant to a simpler protocol than the Company's feasibility study and will provide for a 6-month term per device with two terms per patient expected. Initially, 60 patients will be enrolled.

Frank Van Court, President and CEO of HK, stated that the Company was pleased to receive the approval and that the study would begin in January, primarily at sites affiliated with Affiliated Research Centers, a physician- owned clinical research organization. Van Court stated that "we are particularly excited about the 6-month term per device, as this is complementary to our effort in Europe where we have received approval to market our device for 6-month terms. We believe that providing a longer term intraurethral treatment for urinary incontinence before a patient must return to her physician for insertion of a new device will give us a significant competitive advantage and allow us to be more price sensitive. We look forward to eventually bringing to American women an alternative for treatment of their incontinence that we have brought to European women suffering from the same problem. Now that we know the FDA's requirements, we can accomplish this in an expeditious manner."

SOURCE HK Medical Technologies, Inc.

CONTACT: Frank Van Court, President and CEO of HK Medical Technologies, Inc., 210-590-1144