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PROSPECTUS SUPPLEMENT NO. 4
(To Prospectus dated July 29, 2005)
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Filed pursuant to Rule 424(b)(3)
Registration No. 333-126737 |
UROPLASTY, INC.
2,147,142 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. 4 together
with the prior prospectus supplements and prospectus dated July 29, 2005, which are to be delivered
with this prospectus supplement.
This prospectus supplement contains our Current Report on Form 8-K relating to the 510(k) premarket
clearance of the Urgent® PC Neuromodulation System. This report was filed with the Securities and
Exchange Commission on October 19, 2005. 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 18,
2005, the closing price of our common stock on the American Stock Exchange was $3.20 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 19, 2005
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 19, 2005
UROPLASTY, INC.
(Exact name of registrant as specified in charter)
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000-20989
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41-1719250 |
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(Commission File No.)
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(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:
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o Written communications pursuant to Rule 425 of the Securities Act (17 CFR 230.425) |
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o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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.
Uroplasty announces the U.S. Food and Drug Administration 510(k) premarket clearance of the Urgent®
PC Neuromodulation System, the only minimally invasive nerve stimulation device designed for
office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and
urinary frequency. Uroplasty will execute Urgent PC launch plans and introduce an updated version
of this novel, non-surgical neuromodulation device to the U.S. market.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release, dated October 19, 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: October 19, 2005
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UROPLASTY, INC.
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By: |
/s/ SAM B. HUMPHRIES
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Sam B. Humphries |
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President and Chief Executive Officer |
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2
Exhibit 99.1
UROPLASTY, INC. ANNOUNCES
FDA MARKETING CLEARANCE FOR
UROLOGICAL NEUROSTIMULATION DEVICE
MINNEAPOLIS, MN, October 19, 2005 Uroplasty, Inc. (AMEX: UPI), a medical device company
that develops, manufactures and markets innovative, proprietary products for the treatment of
voiding dysfunctions, today announced the company received clearance from the U.S. Food and Drug
Administration (FDA) to market the Urgent® PC Neuromodulation System for treatment of urinary
urgency, urinary frequency, and urge incontinence.
Sam B. Humphries, President and Chief Executive Officer, stated, We are excited we can execute our
Urgent PC launch plans and introduce an updated version of this novel, non-surgical neuromodulation
device to the U.S. market. Neuromodulation therapies are recognized to be the next frontier for
medical devices and to offer significant growth opportunities. Our two recent FDA market
clearances (Urgent® PC and I-STOP Mid-Urethral Sling) expand our platform of minimally invasive
treatments for voiding dysfunctions. Most importantly, these products offer new solutions for
individuals with overactive bladder symptoms and for women with stress urinary incontinence. Many
women suffer from both.
The Urgent® PC Neuromodulation System is the only minimally invasive nerve stimulation device
designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary
urgency and urinary frequency. Using percutaneous tibial nerve stimulation, Urgent PC delivers an
electrical pulse that travels to the sacral nerve plexus, a control center for bladder function.
Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that
lead to the symptoms of overactive bladder.
About Uroplasty, Inc.
In addition to the Urgent PC, Uroplasty offers other minimally invasive products for the treatment
of voiding dysfunctions, including a mid-urethral sling and proprietary soft tissue bulking
products.
The I-STOP Mid-Urethral Sling is a biocompatible tension-free sling for the treatment of stress
urinary incontinence. Stress urinary incontinence may result from urethral hypermobility, a
condition in which the urethra is not properly supported by surrounding tissues and/or may result
from intrinsic sphincter deficiency, a condition resulting from weakened muscles surrounding the
urethra and bladder neck. The I-STOP sling provides a hammock-like support for the urethra to
prevent urine leakage associated with activities such as coughing, laughing, lifting or jumping.
Macroplastique® Implants is a proprietary, implantable soft tissue bulking material sold outside
the U.S. since 1991 for the treatment of both male and female urinary incontinence. When
Macroplastique is injected into tissue around the urethra, it stabilizes and bulks tissues close
to the urethra, thereby providing the surrounding muscles with increased capability to control the
release of urine. Macroplastique is also used to treat vesicoureteral reflux, a predominately
pediatric condition, in which the urine flows backward from the bladder to the kidney. Other
proprietary, implantable soft tissue bulking agents sold by Uroplasty outside the U.S. include PTQ
Implants for fecal incontinence, VOX® Implants for vocal cord rehabilitation and Bioplastique®
Implants for dermal augmentation.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for certain
forward-looking statements. This press release contains forward-looking statements relating to
regulatory activities, which reflect and affect 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 of our 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.
FOR FURTHER INFORMATION: visit Uroplastys web page at www.uroplasty.com or contact Mr. Humphries.
UROPLASTY, INC.
Sam B. Humphries, President / CEO
2718 Summer Street N.E., Minneapolis, MN 55413-2820
Tel: 612-378-1180
Fax: 612-378-2027
E-mail: samh@uroplasty.com