SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: June 7, 1996
UROMED CORPORATION
(Exact name of registrant as specified in its charter)
Massachusetts 000-23266 04-3104185
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(State or Other (Commission File (I.R.S. Employer
Jurisdiction of Number) Identification No.)
Incorporation)
64 A Street, Needham, Massachusetts 02194
Address of principal executive offices
Registrant's telephone number, including area code: (617) 433-0033
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Item 5. Other Events
On June 7, 1996, the Registrant issued a press release announcing that it
had met with the Staff of the United States Food and Drug Administration ("FDA")
as part of its ongoing dialogue in connection with its 510(k) application for
market clearance of its Reliance(R) Urinary Control Insert. Attatched as
Exhibit 99.1 hereto is a copy of the press release.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
Exhibit Number Description
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99.1 Press Release issued June 7, 1996 announcing an update of
the regulatory status of the Reliance Insert.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
UROMED CORPORATION
Dated: June 7, 1996 By: /s/ Paul J. Murphy
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Paul J. Murphy, Treasurer and
Chief Financial Officer
Exhibit 99.1
[UroMed Logo]
64 A Street
Needham, MA 02194
(617) 433-0033 FAX: (617) 4330032
FOR IMMEDIATE RELEASE
Contact:
Kristen Galfetti or Sally J. Curley
Investor Relations Specialist Account Executive
UroMed Corporation Sharon Merrill Associates, Inc.
617/433-0033 617/262-1800
UROMED CORPORATION ANNOUNCES REGULATORY UPDATE
Company's Reliance (R) Insert to be Reviewed by the FDA Panel in Late July
NEEDHAM, MA, June 7, 1996 -- UroMed Corporation (NASDAQ: URMD) today
announced that the United States Food and Drug Administration (FDA) informed
it at a meeting yesterday afternoon of an internal ruling that the agency had
erred in asking that the Reliance (R) Urinary Control Insert be submitted as a
510(k) application and that a Pre-Market Approval (PMA) application is the
appropriate regulatory path. This decision was reached because Reliance is a
first-of-a-kind intraurethral device intended for managing female stress urinary
incontinence.
FDA's decision incorporates three important commitments to UroMed
Corporation: (1) the current Reliance Insert expedited review application has
been converted from the 510(k) to the PMA track; (2) the PMA application has
been filed since there are no major scientific deficiencies that may preclude
making a determination assuring safety and effectiveness; and (3) the PMA
application will be reviewed by a FDA panel called specifically for this
purpose, currently planned for late July. FDA has said that it regrets that,
after 17 months of interaction, it has converted the Reliance application to a
PMA track, because the agency believes a PMA application is the most appropriate
regulatory path for this product category. The unusual step of conversion was
taken because the FDA incorrectly advised the company to submit a 510(k). The
FDA has said that it will review the application as expeditiously as possible
and that the quality of the application and the completeness of its data has
allowed it to be immediately filed. In addition, the FDA has said it has
scheduled a panel meeting to review the just converted application in under
eight weeks, which is very unusual.
(more)
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UroMed/2
"Based on these facts, all of our conversations with the FDA to date, and
contingent upon a panel recommendation and final agency action, we could expect
final approval for marketing no later than the third quarter of this year,"
remarked John G. Simon, UroMed's chairman of the board and chief executive
officer.
Simon further said, "We are certainly surprised by FDA's policy change,
especially since the FDA originally requested and continually reinforced the
510(k) pathway to achieve clearance. The Director of the Office of Device
Evaluation has explained to us that the agency's confirmation that there was a
suitable predicate was an error on the agency's part. However, we can now
proceed with greater clarity regarding the timing of the next steps in the
process. FDA has made significant public commitments to assure us that the
application will continue to move rapidly through the process. Designating our
PMA application as immediately 'filed' indicates to us that the FDA believes
that existing data is sufficient to move to panel review and final agency
action."
Simon concluded, "This is an important milestone for the company. We are
looking forward to this clearer process during the next few months and, given
the vast amount of available data and all of our conversations with the FDA to
date, we are expecting a successful outcome similar to that of our
newly-acquired, FDA-cleared product, the Miniguard (TM) Patch."
The Company recognizes that the previous paragraphs contain
forward-looking statements and as such, the outcomes described are subject to
certain risks. Such risks chiefly include the risk that the FDA, at its sole
discretion, could shift its position at a later date. There can be no assurance
that such a shift would not have a material adverse effect on the company. Other
relevant risks are described in the company's 1995 Annual Report on Form 10-K
under the heading "Risk Factors and Cautionary Statement for Purposes of the
'Safe Harbor' Provisions of the Private Securities Litigation Reform Act of
1995, which is incorporated herein by reference.
(more)
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UroMed/3
UroMed Corporation was founded to develop, manufacture and market products
for the management of urological and gynecological disorders. The company's
first two products, the Reliance Urinary Control Insert and the Miniguard Patch,
are intended for the management of certain types of female urinary incontinence.
According to company estimates, urinary incontinence (UI), the loss of bladder
control resulting in the involuntary leakage of urine, afflicts approximately 26
million women in the United States, Japan and selected countries in Europe.
UroMed's Reliance Insert and Miniguard Patch are designed for an estimated
target market in excess of six million of these women worldwide who suffer from
certain types of UI and seek to maintain their active lifestyles. UroMed has
designed the Reliance Insert in order to provide the appropriate UI patient, who
now typically wears diapers or pads, with similar lifestyle benefits to those
conferred by a tampon in the case of menstruation. UroMed's Miniguard Patch is
designed for a broader group of mild to moderate UI patients.
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Reliance(R) Insert is a registered trademark of UroMed Corporation.
MiniGuard(TM) Patch is a trademark of UroMed Corporation.
