e424b3
 

PROSPECTUS SUPPLEMENT NO. 4
(To Prospectus dated July 29, 2005)
  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)
     
000-20989   41-1719250
     
(Commission File No.)   (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
(Registrant’s 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))
 
 

 


 

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
         
  UROPLASTY, INC.
 
 
  By:   /s/ SAM B. HUMPHRIES    
    Sam B. Humphries   
    President and Chief Executive Officer   
 

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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 Uroplasty’s 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