UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: August 10, 2005
UROPLASTY, INC.
(Exact name of registrant as specified in charter)
|
|
|
000-20989
(Commission File No.)
|
|
41-1719250
(IRS Employer Identification No.) |
Minnesota
(State or other jurisdiction of incorporation or organization)
2718 Summer Street NE
Minneapolis, Minnesota 55413-2820
(Address of principal executive offices)
612-378-1180
(Registrants telephone number, including area code)
Not Applicable
(Former Name and Address)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
|
|
|
o |
|
Written communications pursuant to Rule 425 of the Securities Act (17 CFR 230.425) |
|
|
|
o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
|
o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
|
o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 8.01 Other Events
The following forward-looking statements are subject to risks and uncertainties. We may not meet
our expectations set out below for business and financial reasons. In addition to the specific
risks described below, we recommend that you carefully consider the risk factors described in our
other SEC filings in evaluating us.
Regulatory Matters. Uroplasty has submitted requests to the U.S. Food and Drug
Administration for 510(k) clearance to market two new products. The first submission requested
clearance to market the Urgent®PC Neuromodulation System for treatment of overactive bladder
symptoms. A second 510(k) submission requested FDA clearance to market the I-STOP Mid-Urethral
Sling System for treatment of female stress urinary incontinence.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release, dated August 10, 2005
SIGNATURES
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, thereunto duly authorized.
Dated: August 10, 2005
|
|
|
|
|
|
UROPLASTY, INC.
|
|
|
By: |
/s/ SAM B. HUMPHRIES
|
|
|
|
Sam B. Humphries |
|
|
|
President and Chief Executive Officer |
|
|
2