e424b3
|
|
|
|
|
|
PROSPECTUS SUPPLEMENT NO. 15
|
|
Filed pursuant to Rule 424(b)(3) |
(To Prospectus dated May 1, 2006)
|
|
Registration No. 333-133072 |
UROPLASTY, INC.
1,918,809 Shares of Common Stock
and
1,180,928 Shares of Common Stock
Issuable Upon Exercise of Warrants
This prospectus supplement relates to shares of our common stock that may be sold at various times
by certain selling shareholders. You should read this prospectus supplement no. 15, the prior
prospectus supplements and the prospectus dated May 1, 2006, which are to be delivered with this
prospectus supplement. Our May 1, 2006 prospectus is a combined prospectus under Rule 429(a) of
the Securities Act of 1933, as amended, with our prior prospectus dated July 29, 2005 and
supplements thereto (See Registration No. 333-126737 filed with the Securities and Exchange
Commission on July 20, 2005 and declared effective on July 29, 2005).
This prospectus supplement contains our Current report on Form 8-K relating to the pre-market
approval we received from the U.S. Food and Drug Administration for our Macroplastique Implants.
This report was filed with the Securities and Exchange Commission on October 31, 2006. The
attached information supplements and supersedes, in part, the information contained in the
prospectus.
Our common stock is traded on the American Stock Exchange under the symbol UPI. On October 30,
2006, the closing price of our common stock on the American Stock Exchange was $2.90 per share.
This investment is speculative and involves a high degree of risk. See Risk Factors on page 6 of
the prospectus to read about factors you should consider before buying shares of the common stock.
Neither the SEC nor any state securities commission has approved or disapproved these securities or
passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
Prospectus Supplement dated October 31, 2006
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: October 31, 2006
UROPLASTY, INC.
(Exact name of registrant as specified in charter)
|
|
|
000-20989
|
|
41-1719250 |
(Commission File No.)
|
|
(IRS Employer Identification No.) |
Minnesota
(State or other jurisdiction of incorporation or organization)
5420 Feltl Road
Minnetonka, Minnesota 55343
(Address of principal executive offices)
952-426-6140
(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 |
|
|
|
|
|
|
|
|
|
Item 9.01 Financial Statements and Exhibits. |
|
|
|
|
|
|
|
|
|
Signatures |
|
|
|
|
|
|
|
|
|
Press Release |
|
|
|
|
Item 8.01 Other Events
On October 31, 2006 we issued a press release announcing that we received from the U.S. Food and
Drug administration (FDA) pre-market approval (PMA) for our Macroplastique Implants for the
treatment of female stress urinary incontinence.
Item 9.01 Financial Statements and Exhibits.
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
|
|
99.1 |
|
|
Press Release dated October 31, 2006 (filed herewith). |
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: October 31, 2006
|
|
|
|
|
|
UROPLASTY, INC.
|
|
|
By: |
/s/ Mahedi A. Jiwani
|
|
|
|
Mahedi A. Jiwani |
|
|
|
Vice President, Chief Financial Officer and Treasurer |
|
|
Exhibit 99.1
NEWS RELEASE
UROPLASTY RECEIVES FDA APPROVAL LETTER
FOR
MACROPLASTIQUE
MINNEAPOLIS, MN, OCTOBER 31, 2006 Uroplasty, Inc. (AMEX:UPI) announced today that it
received from the U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for its
Macroplastique® Implants. With this approval, Uroplasty can begin marketing Macroplastique in the
United States for the treatment of female stress urinary incontinence primarily due to intrinsic
sphincter deficiency. Following market introduction, the Company will conduct customary,
FDA-required post approval studies to obtain market feedback on safety and effectiveness of the
product.
Uroplasty President and CEO, David B. Kaysen, commented, We have been selling Macroplastique in
Europe since 1991 and this approval allows us to commercialize the product in the United States.
We expect to begin marketing this product in the United States in early 2007.
The addition of Macroplastique to the U.S. product line provides Uroplasty with the unique
opportunity to treat multiple indications of voiding dysfunctions with a platform of safe and
effective products, continued Mr. Kaysen.
Uroplastys other products include:
· I-Stop, a minimally invasive biocompatible, polypropylene, tension-free sling for the
treatment of female urinary incontinence. The I-Stop sling can correct stress urinary incontinence
by providing tension-free hammock-type support for the urethra to prevent its downward movement and
the associated leakage of urine.
· The Urgent® PC neuromodulation system, a minimally invasive device designed for
office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and
urinary frequency. This product uses percutaneous tibial nerve stimulation to deliver an
electrical pulse that travels to the sacral nerve plexus, a control center for bladder function.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for certain
forward-looking statements. This press release contains forward-looking statements, which reflect
our views regarding future events and financial performance. These forward-looking statements are
subject to certain risks and uncertainties, including those identified below, which could cause
actual results to differ materially from historical results or those anticipated. The words aim,
believe, expect, anticipate, intend, estimate and other expressions, which indicate
future events and trends, identify forward-looking statements. Actual future results and trends
may differ materially from historical results or those anticipated depending upon a variety of
factors,
including, but not limited to: the effect of government regulation, including when and if we
receive approval for marketing products in the United States; the impact of international currency
fluctuations on our cash flows and operating results; the impact of technological innovation and
competition; acceptance of our products by physicians and patients, our historical reliance on a
single product for most of our current sales; our ability to commercialize our recently licensed
product lines; our intellectual property and the ability to prevent competitors from infringing our
rights; the ability to receive third party reimbursement for our products; the results of clinical
trials; our continued losses and the possible need to raise additional capital in the future; our
ability to manage our international operations; our ability to hire and retain key technical and
sales personnel; our dependence on key suppliers; future changes in applicable accounting rules;
and volatility in our stock price. We cannot assure that we can market Macroplastique profitably
in the United States.
FOR FURTHER INFORMATION: visit
Uroplastys web page at www.uroplasty.com or contact Mr. Kaysen.
UROPLASTY, INC.
David B. Kaysen, President / CEO
5420 Feltl Road
Minnetonka, Minnesota 55343
Tel: 952.426.6140
Fax: 952.426.6199
E-mail: dave.kaysen@uroplasty.com