STEWARTVILLE, Minn., Sept. 30 /PRNewswire/ -- Rochester Medical
Corporation (Nasdaq: ROCM) announced that the FemSoft(R) Insert was approved
for sale by the U.S. Food and Drug Administration (FDA) for the treatment of
stress urinary incontinence or the involuntary loss of urine.  This condition,
affecting approximately 6.6 million women in the U.S., is caused by pressure
on the bladder from everyday activities as common as laughing, sneezing,
coughing, lifting a bag of groceries, rising from a sitting position, or
exercising.

    The FemSoft Insert: A Soft, Easy-to-Use Solution
    The FemSoft Insert is a small, single-use, liquid and silicone device that
a woman can easily insert into her urethra.  The latex-free insert consists of
a narrow, silicone tube, completely encapsulated by a soft, conformable,
fluid-filled sleeve.
    As a woman inserts the thin device, the sleeve slides into and conforms to
the urethra, creating an effective seal at the neck of the bladder to prevent
unintended urine leakage.  It is removed during routine bathroom visits,
discarded and replaced by a fresh insert.  The FemSoft Insert will be sold by
prescription, with toll-free phone orders discreetly shipped to a woman's
home.  Each insert is expected to cost less than $2.

    The FemSoft Insert Wins Physician and Patient Support
    "The clinical trial results indicate the FemSoft Insert is a highly
effective treatment that can help women suffering from stress urinary
incontinence return to their normal active lives," said Dr. Larry Sirls,
Urologist, William Beaumont Hospital, Royal Oak, Mich.  "In fact, our research
found that 90 percent of the study participants were satisfied with dryness
when using the FemSoft Insert.  Participants also reported a high level of
satisfaction and an overall improved quality of life.  Nearly 80 percent of
women indicated a desire to continue using the product and over 95 percent
said they would recommend the FemSoft Insert to a friend."
    Clinical trials were conducted at eight medical institutions throughout
the United States including:  Mayo Clinic, Rochester, Minn.; Northeast Indiana
Urology, P.C., Ft. Wayne, Ind.; San Diego Uro-Research, San Diego, Calif.;
Shepherd Center Urology, Atlanta, Ga.; University of Iowa, Iowa City, Iowa;
University of Washington, Seattle, Wash.; UroFitness, Aurora, Colo.; and
William Beaumont Hospital, Royal Oak, Mich.
    "When I had problems with leaking, it made me feel very self-conscious and
uncomfortable -- especially in social situations," said Jane, participant in
the FemSoft Insert clinical trials.  "When I found out the FemSoft Insert
could alleviate my symptoms, it was a great relief.  Now I'm able to do all of
the activities I used to do before, with great confidence."
    The FemSoft Insert's Pre Market Approval application was submitted to the
FDA in January 1999.  Today's FDA notification of the PMA approval allows
Rochester Medical to move forward with its plans for a phased introduction of
the FemSoft Insert throughout the coming year.
    "We are extremely pleased to add the FemSoft Insert to our product
portfolio and anticipate that it will secure a solid presence in the
continence care marketplace," said Anthony J. Conway, president and chief
executive officer of Rochester Medical Corporation.  "The FemSoft Insert is
the soft and gentle solution women are looking for to effectively manage
stress incontinence and to ultimately improve their overall quality of life."
    Rochester Medical Corporation develops, manufactures and markets
latex-free disposable catheters and devices for urological and continence care
applications.  The Company markets its products under its own Rochester
Medical(R) brand and under existing private label arrangements.
    The immediately preceding document contains forward looking statements
that involve risks and uncertainties.  The commercial success of the FemSoft
Insert is subject to the uncertainty of market acceptance of the device.
Other risks and uncertainties include the results of product evaluations, the
timing of purchases by customers, manufacturing capacities for both current
and future products, the results of clinical tests, the timing of clinical
preference testing and product introductions, as well as other risk factors
listed from time to time in the Company's SEC reports including, without
limitation, the section entitled "Risk Factors" in the Company's Annual Report
on Form 10K (Part II, Item 6) for the fiscal year ended September 30, 1998.

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