posam
As filed with the Securities and Exchange Commission on January 28, 2008
Registration No. 333-138265
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
POST-EFFECTIVE AMENDMENT NO. 1 TO FORM SB-2
ON
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
UROPLASTY, INC.
(Exact Name of Registrant as specified in its charter)
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Minnesota
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3841
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41-1719250 |
(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number)
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(I.R.S. Employer
Identification No.) |
5420 Feltl Road
Minnetonka, Minnesota 55343
Telephone: (952) 426-6140
(Address, including zip code and telephone number, including
area code, of Registrants principal executive offices)
David B. Kaysen
President and Chief Executive Officer
5420 Feltl Road
Minnetonka, Minnesota 55343
Telephone: (952) 426-6140
(Name, address, including zip code and telephone
number, including area code, of agent for service)
Copies to:
Jeffrey C. Robbins, Esq.
Messerli & Kramer P.A.
150 South Fifth Street, Suite 1800
Minneapolis, Minnesota 55402
Telephone: (612) 672-3600
Facsimile: (612) 672-3777
Approximate date of commencement of proposed sale to the public:
From time to time after this registration statement becomes effective.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box: o
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box: o
If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I. D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
The registrant hereby amends this registration statement on such date or dates as may be
necessary to delay its effective date until the registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement
shall become effective on such date as the Securities and Exchange Commission, acting pursuant to
said Section 8(a), may determine.
EXPLANATORY NOTE
This Post-Effective Amendment No. 1 on Form S-3 contains an updated prospectus relating to the
offering and sale of shares of common stock issuable upon the exercise of warrants that were
previously issued to the selling agent in connection with the registrants public offering. These
securities were initially registered on the Registration Statement on Form SB-2 (File No.
333-138265) that was declared effective by the SEC on December 12, 2006. This Post-Effective
Amendment No. 1 is being filed in compliance with Section 10(a)(3) of the Securities Act and to
convert such Registration Statement on Form SB-2 into a Registration Statement on Form S-3 in
reliance upon Rule 401 under the Securities Act. All filing fees payable in connection with the
registration of these securities were previously paid in connection with the filing of the
Registration Statement on Form SB-2.
The information in this prospectus is not complete and may be changed. These securities may not be
sold until the registration statement filed with the Securities and Exchange Commission is
effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy
these securities in any jurisdiction where an offer or sale is not permitted.
Subject to Completion Dated January 28, 2008
PROSPECTUS
121,500 Shares of Common Stock
Issuable Upon Exercise of Warrants
This prospectus relates to 121,500 shares of our common stock issuable upon the exercise of
warrants, which were originally issued to the selling agent in connection with our public offering
completed in December 2006. We will not receive proceeds from the sale of the underlying common
stock.
Our common stock is traded on the American Stock Exchange under the symbol UPI. On January 25,
2008, the closing price of our common stock on the American Stock
Exchange was $4.00 per share.
Our public float, calculated pursuant to General Instruction I.B.6 of Form S-3, was $49.8 million
as of January 16, 2008. The amount of securities offered pursuant to General Instruction I.B.6 of
Form S-3 during the previous 12 months, including the proposed sale, is $483,570.
This investment is speculative and involves a high degree of risk. See Risk Factors on page 3 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 dated , 2008
TABLE OF CONTENTS
You should rely only on the information contained or incorporated by reference in this prospectus.
We have not authorized anyone to provide you with different information. This prospectus may be
used only where it is legal to sell these securities. The information in this prospectus and
documents incorporated by reference in this prospectus is accurate only as of the date on those
respective documents.
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PROSPECTUS SUMMARY
This summary highlights the key information contained in this prospectus. Because it is a summary,
it does not contain all the information you should consider before investing in our common stock.
You should read carefully this entire prospectus, including the section entitled Risk Factors and
the financial statements incorporated by reference in this prospectus.
Overview
We are a medical device company that develops, manufactures and markets innovative, proprietary
products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of
our Urgent PC® system, which we believe is the only FDA-approved non-surgical neurostimulation
therapy for the treatment of overactive bladder symptoms. We also offer Macroplastique® Implants,
a bulking agent for the treatment of urinary incontinence. We believe that physicians prefer our
products because they offer an effective therapy for the patient, can be administered in
office-based settings and, with reimbursement in place, provide the physicians a new profitable
recurring revenue stream. We believe that patients prefer our products because they are
non-surgical treatment alternatives that do not have the side-effects associated with
pharmaceutical treatment options.
Market
The field of neurostimulation, a form of therapy in which a low-voltage electrical current is used
to treat medical conditions affecting parts of the nervous system, has grown dramatically in recent
years. According to Medtech Insight, the U.S. market for neurostimulation devices is expected to
grow from approximately $628 million in 2006 to approximately $2 billion in 2012, representing a
compound annual growth rate in excess of 20%. FDA-approved neurostimulation devices are currently
utilized to treat a range of indications, including voiding dysfunctions, chronic pain, epilepsy,
essential tremor, Parkinsons disease, hearing loss and depression. These devices are implanted in
the body or used in a non-invasive manner to stimulate different parts of the nervous system,
including the spinal cord, sacral nerves and vagus nerve, among other areas. We believe the
neurostimulation market represents a significant opportunity for us in the treatment of overactive
bladder symptoms.
Voiding dysfunctions affect urinary control and can result in uncontrolled bladder sensations
(overactive bladder) or unwanted leakage (urinary incontinence). Overactive bladder (OAB) is a
prevalent and challenging urologic problem affecting an estimated 34 million Americans. The Agency
for Health Care Policy and Research (AHCPR), a division of the Public Health Service, U.S.
Department of Health and Human Services, estimates that urinary incontinence affects about 13
million people in the United States, of which 85% (11 million) are women. AHCPR estimates the
total cost of treating incontinence (management and curative approaches) of all types in the United
States is $16 billion. Historically, only a small percentage of the patients suffering from these
disorders have sought treatment. In recent years, however, the number of people seeking treatment
has grown as a result of the publicity associated with new minimally invasive treatment
alternatives.
When patients seek treatment, physicians generally assess the severity of the symptoms as mild,
moderate or severe. Regardless of the degree of severity, however, patients will often consider
drug therapy and minimally invasive treatment first. We believe that our company is uniquely
positioned because we offer officebased, minimally invasive solutions.
Our Strategy
Our goal is to become the leading provider of non-surgical neurostimulation solutions for patients
who suffer from OAB symptoms. We also plan to market other innovative products to physicians
focused on office-based procedures for the treatment of urinary incontinence. We believe that,
with our Urgent PC and Macroplastique products, we will increasingly garner the attention of key
physicians, our independent sales representatives and distributors to grow revenue. The key
elements of our strategy are to:
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Educate physicians about the benefits of our Urgent PC neurostimulation system. |
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Build patient awareness of office-based solutions |
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Focus on office-based solutions for physicians |
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Increase market coverage in the United States sales and internationally. |
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Develop, acquire or license new products. |
Our Products
The Urgent PC neurostimulation system is a minimally invasive device designed for office-based
treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary
frequency. The Urgent PC system uses percutaneous tibial nerve stimulation to deliver an
electrical pulse that travels to the sacral nerve plexus, a control center for bladder function.
We have received regulatory approvals for sale of the Urgent PC system in the United States, Canada
and Europe. We launched sales of our second generation Urgent PC system in late 2006.
Macroplastique is a minimally invasive, implantable soft tissue bulking product for the treatment
of 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 has been sold for urological
indications in over 40 countries outside the United States since 1991. In October 2006, we
received from the FDA pre-market approval for the use of Macroplastique to treat female stress
incontinence. We began marketing this product in the United States in early 2007.
Sales and Marketing
We are focusing our sales and marketing efforts primarily on office-based and outpatient
surgery-based urologists, urogynecologists and gynecologists with significant patient volume. We
believe the United States is a significant opportunity for future sales of our products. In order
to grow our United States business, we have expanded our sales organization, consisting of direct
field sales personnel and independent sales representatives, marketing organization and
reimbursement department to market our products directly to our customers. By expanding our United
Sates presence, we intend to develop long-standing relationships with leading physicians treating
overactive bladder symptoms and incontinence.
Corporate Information
Our company was incorporated in Minnesota in 1992. Our headquarters are located at 5420 Feltl
Road, Minnetonka, Minnesota, 55343. Our telephone number is (952) 426-6140. We maintain a web
site at www.uroplasty.com. Information contained on our web site is not part of, and is not
incorporated by reference into, this prospectus.
Urgent® PC, Macroplastique®, Bioplastique®, PTQ®, VOX® and I-Stop are trademarks we own or
license. This prospectus also refers to trademarks and tradenames of other organizations.
The Offering
This prospectus covers 121,500 shares of our common stock issuable upon the exercise of warrants at
an exercise price of $2.40 per share. We originally sold the warrants to Craig-Hallum Capital
Group LLC, as selling agent in connection with our public offering, pursuant to a prospectus dated
December 21, 2006. We will not receive any proceeds from the sale of the underlying common stock.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the
risk factors set forth below and all other information contained or incorporated by reference in
this prospectus before purchasing our common stock. If the following risks actually occur, our
business, financial condition and results of operations could be seriously harmed, the price of our
common stock could decline and you could lose part or all of your investment.
Risks Relating to Our Company and Industry
We continue to incur losses and may never reach profitability.
We have incurred net losses in each of the last five fiscal years. As of September 30, 2007, we
had an accumulated deficit of approximately $18.2 million primarily as a result of costs relating
to the development, including seeking regulatory approvals, and commercialization of our products.
We expect our operating expenses relating to sales and marketing activities, product development
and clinical trials, including for FDA-mandated post-market clinical study for our Macroplastique
product, will continue to increase during the foreseeable future. To achieve profitability, we must
generate substantially more revenue than we have this year or in prior years. Our ability to
achieve significant revenue growth will depend, in large part, on our ability to achieve widespread
market acceptance for our products and successfully expand our business in the U.S., which we
cannot guarantee will happen. We may never realize sufficient revenue from the sale of our
products to be profitable.
If we are not able to attract, retain and motivate our sales force and expand our distribution
channels, our sales and revenues will suffer.
In the U.S., we have a sales organization consisting of direct sales personnel and a network of
independent sales representatives. In the United Kingdom, we have direct sales personnel. Our
marketing organization supports our U.S. and U.K. sales and international distributor
organizations. We anticipate continuing to expand our sales and marketing organization, as needed
to support our growth. We have and will continue to incur significant additional expenses to
support this organization. We may not be able to recruit, train, motivate or retain qualified
sales and marketing personnel or independent sales representatives. Our ability to increase
product sales in the U.S. will largely depend upon our ability to develop and maintain the sales
organization. Outside of the U.S. and the U.K., we sell our products primarily through a network of
independent distributors. Our ability to increase product sales in foreign markets will largely
depend on our ability to develop and maintain relationships with our existing and additional
distributors. We may not be able to retain distributors who are willing to commit the necessary
resources to market and sell our products to the level of our expectations. Failure to expand our
distribution channels or to recruit, retain and motivate qualified personnel could have a material
adverse effect on our product sales and revenues.
We are unable to predict how quickly or how broadly the market will accept our products. If demand
for our products fails to develop as we expect, our revenues may decline or we may be unable to
increase our revenues and be profitable.
Our failure to achieve sufficient market acceptance of our products in the U.S., particularly for
the Urgent PC system, will limit our ability to generate revenue and be profitable. Market
acceptance of our products will depend on our ability to demonstrate the safety, clinical efficacy,
perceived benefits, cost-effectiveness and third party reimburseability of our products compared to
products or treatment options of our competitors, and to train physicians in the proper application
of our products. We cannot assure you that we will be successful in educating the marketplace
about the benefits of using our products. Even if customers accept our products, this acceptance
may not translate into sales if our competitors have developed similar products that our customers
prefer. Furthermore, if our products do not achieve increasing market acceptance in the U.S. and
internationally, our revenues may decline or we may be unable to increase our revenues and be
profitable.
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We are primarily dependent on sales of two product lines and our business may suffer if sales of
these product lines decline.
Currently, we are primarily dependent on sales of our Urgent PC system and Macroplastique product.
During the nine-month period ended December 31, 2007, sales of our Urgent PC system and
Macroplastique product accounted for approximately 45% and 37% of our total sales. Our Macroplastique
product line accounted for 51% and 67%, respectively, of total net sales during fiscal 2007 and
2006. If demand for our two product lines decline, our revenues and business prospects may suffer.
We may require additional financing in the future which may not be available to us when required,
or may be available only on unfavorable terms.
Our future liquidity and capital requirements will depend on numerous factors including: the timing
and cost involved in manufacturing scale-up and in expanding our sales, marketing and distribution
capabilities in the United States markets; the cost and effectiveness of our marketing and sales
efforts with respect to our existing products in international markets; the effect of competing
technologies and market and regulatory developments; and the cost involved in protecting our
proprietary rights. Because we have yet to achieve profitability and generate positive cash flows,
we may need to raise additional financing to support our operations and planned growth activities
in the future. Any equity financing could substantially dilute your equity interests in our
company and any debt financing could impose significant financial and operational restrictions on
us. There can be no guarantee that we will be successful, as we currently have no committed
sources of, or other arrangements with respect to, additional equity or debt financing. We cannot
assure you that we will obtain additional financing on acceptable terms, or at all.
The size and resources of our competitors may allow them to compete more effectively than we can,
which could adversely affect our potential profitability.
Our products compete against similar medical devices and other treatment methods, including drugs,
for treating voiding dysfunctions. Many of our competitors have significantly greater financial,
research and development, manufacturing and marketing resources than we have. Our competitors
could use these resources to develop or acquire products that are safer, more effective, less
invasive, less expensive or more readily accepted than our products. Their products could make our
technology and products obsolete or noncompetitive. Our competitors could also devote greater
resources to the marketing and sale of their products and adopt more aggressive pricing policies
than we can. If we are not able to compete effectively, then we may not be profitable.
Our products and facilities are subject to extensive regulation, with which compliance is costly
and which exposes us to penalties for non-compliance.
The production and marketing of our products and our ongoing research and development, preclinical
testing and clinical trial activities are subject to extensive regulation and review by numerous
governmental authorities both in the United States and abroad. U.S. and foreign regulations
applicable to medical devices are wide-ranging and govern, among other things, the testing,
marketing and pre-market review of new medical devices, in addition to regulating manufacturing
practices, reporting, advertising, exporting, labeling and record keeping procedures. We are
required to obtain regulatory approval or clearance before we can market our products in the United
States and certain foreign countries. The regulatory process requires significant time, effort and
expenditures to bring our products to market. We cannot assure you that we will obtain approval
for any future products or that we will maintain approval to sell any of our existing products.
Any failure to obtain or retain regulatory approvals or clearances could prevent us from
successfully marketing our products, which could adversely affect our business and results of
operations. Our failure to comply with applicable regulatory requirements could result in
governmental agencies:
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imposing fines and penalties on us; |
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preventing us from manufacturing or selling our products; |
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bringing civil or criminal charges against us; |
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delaying the introduction of our new products into the market; |
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enforcing operating restrictions; |
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recalling or seizing our products; or |
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withdrawing or denying approvals or clearances for our products. |
If any or all of the foregoing were to occur, we may not be able to meet the demands of our
customers and our customers may cancel orders or purchase products from our competitors, which
could adversely affect our business and results of operations.
Even if we receive regulatory approval or clearance of a product, the approval or clearance could
limit the uses for which we may label and promote the product, which may limit the market for our
products. Further, for a marketed product, its manufacturer and manufacturing facilities are
subject to periodic reviews and inspections by FDA and foreign regulatory authorities. Subsequent
discovery of problems with a product, manufacturer or facility may result in restrictions on the
product, manufacturer or facility, including withdrawal of the product from the market or other
enforcement actions. In addition, regulatory agencies may not agree with the extent or speed of
corrective actions relating to product or manufacturing problems.
If additional regulatory requirements are implemented in the foreign countries in which we sell our
products, the cost of developing or selling our products may increase. In addition, we may rely on
our distributors outside the United States in seeking regulatory approval to market our devices in
particular countries. To the extent we do so, we are dependent on persons outside of our direct
control to make regulatory submissions and secure approvals, and we do or will not have direct
access to health care agencies in those markets to ensure timely regulatory approvals or prompt
resolution of regulatory or compliance matters. If our distributors fail to obtain the required
approvals or do not do so in a timely manner, our revenues from our international operations and
our results of operations may be adversely affected.
In addition, our business and properties are subject to federal, state and local laws and
regulations relating to the protection of the environment, natural resources and worker health and
safety and the use, management, storage, and disposal of hazardous substances, wastes, and other
regulated materials. The costs of complying with these various environmental requirements, as they
now exist or may be altered in the future, could adversely affect our financial condition and
results of operations.
The marketing of our products requires a significant amount of time and expense and we may not have
the resources to successfully market our products, which would adversely affect our business and
results of operations.
The marketing of our products requires a significant amount of time and expense in order to
identify the physicians who may use our products, invest in training and education and employ a
sales force that is large enough to interact with the targeted physicians. We may not have
adequate resources to market our products successfully against larger competitors who have more
resources than we do. If we cannot market our products successfully, our business and results of
operations would be adversely affected.
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If third parties claim that we infringe upon their intellectual property rights, we may incur
liabilities and costs and may have to redesign or discontinue selling the affected product.
The medical device industry is litigious with respect to patents and other intellectual property
rights. Companies operating in our industry routinely seek patent protection for their product
designs, and many of our principal competitors have large patent portfolios. Companies in the
medical device industry have used intellectual property litigation to gain a competitive advantage.
Whether a product infringes a patent involves complex legal and factual issues, the determination
of which is often uncertain. We face the risk of claims that we have infringed on third parties
intellectual property rights. Our efforts to identify and avoid infringing on third parties
intellectual property rights may not always be successful. Any claims of patent or other
intellectual property infringement, even those without merit, could:
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be expensive and time consuming to defend; |
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result in us being required to pay significant damages to third parties; |
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cause us to cease making or selling products that incorporate the challenged intellectual property; |
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require us to redesign, reengineer or rebrand our products, if feasible; |
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require us to enter into royalty or licensing agreements in order to obtain the right to use a
third partys intellectual property, which agreements may not be available on terms acceptable to
us or at all; |
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divert the attention of our management; or |
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result in our customers or potential customers deferring or limiting their purchases or use of the
affected products until resolution of the litigation. |
In addition, new patents obtained by our competitors could threaten a products continued life in
the market even after it has already been introduced.
If we are unable to adequately protect our intellectual property rights, we may not be able to
compete effectively and we may not be profitable.
Our success depends in part on our ability to protect our proprietary rights to the technologies
used in our products. We rely on patent protection, as well as a combination of trademark laws and
confidentiality, noncompetition and other contractual arrangements to protect our proprietary
technology. However, these legal means afford only limited protection and may not adequately
protect our rights or permit us to gain or keep any competitive advantage. Our patents and patent
applications, if issued, may not be broad enough to prevent competitors from introducing similar
products into the market. Our patents, if challenged or if we attempt to enforce them, may not
necessarily be upheld by the courts of any jurisdiction. In addition, patent protection in foreign
countries may be different from patent protection under U.S. laws and may not be favorable to us.
As a result, we may not be able to compete effectively.
We also rely on unpatented proprietary technology. We cannot assure you that we can meaningfully
protect all of our rights in our unpatented proprietary technology or that others will not
independently develop substantially equivalent products or processes or otherwise gain access to
our unpatented proprietary technology. We attempt to protect our trade secrets and other
unpatented proprietary technology through the use of confidentiality and noncompetition agreements
with our current key employees and with other parties to whom we have divulged trade secrets.
However, these agreements may not be enforceable or may not provide meaningful protection for our
proprietary information in the event of unauthorized use or disclosure or other breaches of the
agreements or in the event competitors discover or independently develop similar proprietary
information.
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Product liability claims could adversely affect our business and results of operations.
The manufacture and sale of medical devices exposes us to significant risk of product liability
claims, some of which may have a negative impact on our business. Our existing products were
developed relatively recently and defects or risks that we have not yet identified may give rise to
product liability claims. Our existing $2 million of worldwide product liability insurance
coverage would likely be inadequate to protect us from any liabilities we may incur or we may not
be able to maintain adequate product liability insurance at acceptable rates. If a product
liability claim or series of claims is brought against us for uninsured liabilities or in excess of
our insurance coverage and it is ultimately determined that we are liable, our business could
suffer. Additionally, we could experience a material design or manufacturing failure in our
products, a quality system failure, other safety issues or heightened regulatory scrutiny that
would warrant a recall of some of our products. A recall of any of our products likely would be
costly, would be uninsured and could also result in increased product liability claims. Further,
while we train our physician customers on the proper usage of our products, we cannot ensure that
they will implement our instructions accurately. If our products are used incorrectly by our
customers, injury may result and this could give rise to product liability claims against us. Any
losses that we may suffer from any liability claims, and the effect that any product liability
litigation may have upon the reputation and marketability of our products, may divert managements
attention from other matters and may have a negative impact on our business and our results of
operations.
If we are not able to successfully scale-up production of our products, our sales and revenues will
suffer.
In order to commercialize our products in the United States and international markets, we need to
be able to produce, or subcontract the production of, our products in a cost-effective way on a
large scale to meet demand, while maintaining high standards for quality and reliability, if and
when, such increased demand occurs. If we fail to successfully commercialize our products, we will
not be profitable.
We may experience manufacturing and control problems as we continue to scale-up our manufacturing
operations, and we may not be able to scale-up manufacturing in a timely manner or at a reasonable
cost to enable production in sufficient quantities. If we experience any of these problems, we may
not be able to have our products manufactured and delivered in a timely manner.
The loss or interruption of products or materials from any of our key suppliers could slow down the
manufacture and distribution of our products, which would limit our ability to generate sales and
revenues.
We currently purchase several products, and key materials used in our products, from single source
suppliers. Our reliance on a limited number of suppliers subjects us to several risks, including
an inability to obtain an adequate supply of required products and materials, price increases,
untimely delivery and difficulties in qualifying alternative suppliers. We cannot be sure that
acceptable alternative arrangements could be made on a timely basis. Additionally, the
qualification of materials and processes as a result of a supplier change could be deemed as
unacceptable to regulatory authorities and cause delays and increased costs due to additional test
requirements. A significant interruption in the supply of products or materials, for any reason,
could delay the manufacture and sale of our products, which would limit our ability to generate
revenues.
If we are not able to maintain sufficient quality controls, regulatory approvals of our products by
the FDA, European Union or other relevant authorities could be delayed or denied and our sales and
revenues will suffer.
Approval of our products could be delayed by the FDA, European Union or other related authorities
if our manufacturing facilities do not comply with applicable manufacturing requirements. The
FDAs Quality System Regulations impose extensive testing, control, documentation and other quality
assurance requirements. Canada and the European Union also impose requirements on quality systems
of manufacturers, which are inspected and certified on a periodic basis and may be subject to
additional
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unannounced inspections. Further, our suppliers are also subject to these regulatory requirements.
Failure by any of our suppliers or us to comply with these requirements could prevent us from
obtaining or retaining approval for and marketing of our products. We cannot assure you that our
suppliers or our manufacturing facilities will comply with applicable regulatory requirements on a
timely basis or at all.
Even with approval to market our products in the United States, European Union and other countries,
we must continue to comply with relevant manufacturing and distribution requirements. If
violations of applicable requirements are noted during periodic inspections of our manufacturing
facilities, we may not be able to continue to market our products and our revenues could be
materially adversely affected.
If we are unable to continue to develop and market new products and technologies, we may experience
a decrease in demand for our products or our products could become obsolete, and our business would
suffer.
We expect new products to represent a significant component of our future business. We may not be
able to compete effectively with our competitors unless we can keep up with existing or new
products and technologies in the urinary and fecal incontinence market. If we do not continue to
introduce new products and technologies, or if those products and technologies are not accepted, we
may not be successful and our business would suffer. Moreover, our clinical trials have durations
of several years and it is possible that competing therapies, such as drug therapies, may be
introduced while our products are still undergoing clinical trials. This could reduce the
potential demand for our products and negatively impact our business prospects. Additionally, our
competitors new products and technologies may beat our products to market, may be more effective
or less expensive than our products or render our products obsolete.
We are dependent on the availability of third-party reimbursement for our revenues.
Our success depends on the availability of reimbursement for the cost of our products from
third-party payors, such as government health authorities, private health insurance plans and
managed care organizations. There is no uniform policy for reimbursement in the United States and
foreign countries. As a relatively new therapy, PTNS using the Urgent PC system has not been
assigned a reimbursement code unique to the technology. A number of practitioners are using an
existing reimbursement code that closely describes the procedure. In addition, Aetna and Blue
Cross Blue Shield of Minnesota, Delaware, Northern Virginia, District of Columbia and Maryland have
published policies providing coverage for PTNS under an existing reimbursement code. However, we
cannot assure you that adequate coverage and reimbursement will be provided for the Urgent PC
system in the future by third party payors. Accordingly, changes in the extent or type of coverage
or a reduction in reimbursement rates under any or all third-party reimbursement programs may cause
a decline in purchases of our products, which would materially adversely affect the market for our
products. Alternatively, we might respond to reduced reimbursement rates by reducing the prices of
our products, which could also reduce our revenues.
If physicians do not recommend and endorse our products, our sales may decline or we may be unable
to increase our sales and profits.
In order for us to sell our products, physicians must recommend and endorse them. We may not
obtain the necessary recommendations or endorsements from physicians. Acceptance of our products
depends on educating the medical community as to the distinctive characteristics, perceived
benefits, safety, clinical efficacy, cost-effectiveness and third party reimburseability of our
products compared to products of our competitors, and on training physicians in the proper
application of our products. If we are not successful in obtaining the recommendations or
endorsements of physicians for our products, our sales may decline or we may be unable to increase
our sales and profits.
8
Our business strategy relies on assumptions about the market for our products, which, if incorrect,
would adversely affect our business prospects and profitability.
We are focused on the market for minimally invasive therapies used to treat voiding dysfunctions.
We believe that the aging of the general population will continue and that these trends will
increase the need for our products. However, the projected demand for our products could
materially differ from actual demand if our assumptions regarding these trends and acceptance of
our products by the medical community prove to be incorrect or do not materialize. Actual demand
for our products could also be affected if drug therapies gain more widespread acceptance as a
viable alternative treatment, which in each case would adversely affect our business prospects and
profitability.
Negative publicity regarding the use of silicone material in medical devices could harm our
business and result in a material decrease in revenues.
Macroplastique is comprised of medical grade, heat-vulcanized polydimethylsiloxane, which results
in a solid, flexible silicone elastomer. In the early 1990s, the United States breast implant
industry became the subject of significant controversies surrounding the possible effects upon the
human body of the use of semi-liquid silicone gel in breast implants, resulting in product
liability litigation and leading to the bankruptcy of several companies, including our former
parent, Bioplasty, Inc. We use only medical grade solid silicone material in our tissue bulking
products and not semi-liquid silicone gel, as was used in breast implants. Negative publicity
regarding the use of silicone materials in our products or in other medical devices could have a
significant adverse affect on the overall acceptance of our products. We cannot assure you that
the use of solid silicone in medical devices implanted in the human body by us and others will not
result in negative publicity.
The risks inherent in operating internationally and the risks of selling and shipping our products
and of purchasing our components and products internationally may adversely impact our net sales,
results of operations and financial condition.
We still derive a substantial portion of our revenues from customers and operations in
international markets. We expect non-United States sales to continue to represent a significant
portion of our revenues until we achieve sufficient market acceptance from United States customers
of the already FDA-approved products, and in particular the Urgent PC system. The sale and
shipping of our products and services across international borders, as well as the purchase of
components and products from international sources, subject us to extensive U.S. and foreign
governmental trade regulations. Compliance with such regulations is costly and exposes us to
penalties for non-compliance. Any failure to comply with applicable legal and regulatory
obligations could impact us in a variety of ways that include, but are not limited to, significant
criminal, civil and administrative penalties, including imprisonment of individuals, fines and
penalties, denial of export privileges, seizure of shipments, restrictions on certain business
activities, and exclusion or debarment from government contracting. Also, the failure to comply
with applicable legal and regulatory obligations could result in the disruption of our shipping and
sales activities.
In addition, many of the countries in which we sell our products are, to some degree, subject to
political, economic and/or social instability. Our international sales operations expose us and
our representatives, agents and distributors to risks inherent in operating in foreign
jurisdictions. These risks include:
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the imposition of additional U.S. and foreign governmental controls or regulations; |
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the imposition of costly and lengthy new export licensing requirements; |
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the imposition of U.S. and/or international sanctions against a country, company, person or entity
with whom the company does business that would restrict or prohibit continued business with the
sanctioned country, company, person or entity; |
9
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political and economic instability; |
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fluctuations in the value of the U.S. dollar relative to foreign currencies; |
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a shortage of high-quality sales people and distributors; |
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loss of any key personnel that possess proprietary knowledge, or who are otherwise important to our
success in certain international markets; |
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changes in third-party reimbursement policies that may require some of the patients who receive our
products to directly absorb medical costs or that may necessitate the reduction of the selling prices
of our products; |
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changes in duties and tariffs, license obligations and other non-tariff barriers to trade; |
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the imposition of new trade restrictions; |
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the imposition of restrictions on the activities of foreign agents, representatives and distributors; |
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scrutiny of foreign tax authorities which could result in significant fines, penalties and additional
taxes being imposed on us; |
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pricing pressure that we may experience internationally; |
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laws and business practices favoring local companies; |
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longer payment cycles; |
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difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; |
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difficulties in enforcing or defending intellectual property rights; and |
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exposure to different legal and political standards due to our conducting business in approximately
40 countries. |
We cannot assure you that one or more of these factors will not harm our business. Any material
decrease in our international sales would adversely impact our net sales, results of operations and
financial condition. Our international sales are predominately in Europe. In Europe, health care
regulation and reimbursement for medical devices vary significantly from country to country. This
changing environment could adversely affect our ability to sell our products in some European
countries.
Fluctuations in foreign exchange rates could negatively impact our results of operations.
Because our international sales are denominated primarily in euros, currency fluctuations in
countries where we do business may render our products less price competitive than those of
competing companies whose sales are denominated in weaker currencies. We report our financial
results in U.S. dollars, and fluctuations in the value of either the dollar or the currencies in
which we transact business can have a negative impact on our results of operations and financial
condition. Consequently, we have exposure to foreign currency exchange risks. We do not hedge any
of our foreign currency risk.
10
Proposals to modify the health care system in the U.S. or other countries could affect the pricing
of our products. If we cannot sell our products at the prices we plan to, our margins and
profitability could be adversely affected.
Proposals to modify the current health care system in the United States to improve access to health
care and control its costs are continually being considered by the federal and state governments.
We anticipate that the U.S. Congress and state legislatures will continue to review and assess
alternative health care reform proposals. We cannot predict whether these reform proposals will be
adopted, when they may be adopted or what impact they may have on us if they are adopted. Any
spending decreases or other significant changes in government programs such as Medicare could
adversely affect the pricing of our products.
Like the United States, foreign countries have considered health care reform proposals and could
materially alter their government-sponsored health care programs by reducing reimbursement rates.
Any reduction in reimbursement rates under United States or foreign health care programs could
negatively affect the pricing of our products. If we are not able to charge a sufficient amount
for our products, our margins and our profitability will be adversely affected.
If our information systems fail or if we experience an interruption in their operation, our
business and results of operations could be adversely affected.
The efficient operation of our business is dependent on our management information systems. We
rely on our management information systems to effectively manage accounting and financial
functions, order entry, order fulfillment and inventory replenishment processes, and to maintain
our research and development and clinical data. The failure of our management information systems
to perform as we anticipate could disrupt our business and product development and could result in
decreased sales, increased overhead costs, excess inventory and product shortages, causing our
business and results of operations to suffer. In addition, our management information systems are
vulnerable to damage or interruption from:
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earthquake, fire, flood and other natural disasters; |
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terrorist attacks and attacks by computer viruses or hackers; and |
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power loss or computer systems, Internet, telecommunications or data network failure. |
Any such interruption could adversely affect our business and results of operations.
If we lose the services of our chief executive officer or other key personnel, we may not be able
to manage our operations and meet our strategic objectives.
Our future success depends, in large part, on the continued service of our senior management. We
have no key person insurance with respect to any of our senior managers, and any loss or
interruption of their services could significantly reduce our ability to effectively manage our
operations and implement our strategy. Also, we depend on the continued service of key managerial,
scientific and technical personnel. Further, we depend on our ability to continue to attract and
retain additional highly qualified medical device sales personnel. Any loss or interruption of the
services of our other key personnel could also significantly reduce our ability to effectively
manage our operations and meet our strategic objectives because we cannot assure you that we would
be able to find an appropriate replacement should the need arise.
11
If we are not able to acquire or license other products, our business and future growth prospects
could suffer.
As part of our growth strategy, we intend to acquire or license additional products and product
candidates for development and commercialization. The success of this strategy depends upon our
ability to identify, select and acquire the right products.
Any product candidate we license or acquire may require additional development efforts prior to
sale, including clinical testing and approval by the FDA and other regulatory bodies. Product
candidates may fail to receive or experience a significant delay in receiving the necessary
approvals. In addition, we cannot assure you that any approved products that we acquire or license
will be manufactured economically, successfully commercialized or widely accepted in the
marketplace. Other companies, including those with greater financial, marketing and sales
resources, may compete with us for the acquisition or license of product candidates or approved
products. We may not be able to acquire or license the right to other products on terms that we
find acceptable, or at all.
To finance any acquisitions, we may choose to issue shares of our common stock as consideration,
which would dilute your interest in us. If the price of our common stock is low or volatile, we
may not be able to acquire other products or companies for stock. Alternatively, it may be
necessary for us to raise additional funds for acquisitions through public or private financings.
Additional funds may not be available on terms that are favorable to us, or at all.
Even if we complete future acquisitions, our business, financial condition and the results of
operations could be negatively affected because:
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we may be unable to integrate the acquired business successfully and
realize anticipated economic, operational and other benefits in a
timely manner; and/or |
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the acquisition may disrupt our ongoing business, distract our
management and divert our resources. |
Risks Relating to Our Common Stock and This Offer
You may be unable to sell the common stock you purchase in this offering.
There is only a limited trading market for our common stock, which is quoted on the AMEX.
Transactions in our common stock may lack the volume, liquidity and orderliness necessary to
maintain a liquid and active trading market. Accordingly, an investor should consider the potential
lack of liquidity before investing in our common stock.
Our stock price may fluctuate and be volatile.
The market price of our common stock may be subject to significant fluctuation due to the following
factors, among others:
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variations in our quarterly financial results; |
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developments regarding regulatory clearances or approvals of our products; |
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market acceptance of our products; |
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the success of our efforts to acquire or license additional products; |
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announcements of new products or technologies by us or our competitors; |
12
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developments regarding our patents and proprietary rights or those of our competitors; |
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developments in U.S. or international reimbursement systems; |
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changes in accounting standards, policies, guidance or interpretations; |
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sales of substantial amounts of our stock by existing shareholders; and |
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general economic or market conditions. |
The stock market in recent years has experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of affected companies. These
broad market fluctuations may cause the price of our common stock to fall abruptly or remain
significantly depressed.
Future sales of our common stock in the public market could lower our share price.
The market price of our common stock could decline due to sales by our existing shareholders of a
large number of shares of our common stock or the perception that these sales could occur. These
sales could also make it more difficult for us to raise capital through the sale of common stock at
a time and price we deem appropriate.
We have a significant number of equity instruments outstanding subject to conversion to our common
stock. As of December 31, 2007, we had 2,030,600 shares of our common stock subject to outstanding
options (of which 1,571,596 are exercisable) and 2,116,928 shares of our common stock subject to
outstanding warrants. Further, in April 2007, we issued 1,417,144 shares of our common stock to
purchase from CystoMedix, Inc. certain intellectual property assets related to the Urgent PC
system. The shares issued to CystoMedix will become eligible for public resale beginning in April
2008.
We will be exposed to risks relating to evaluations of controls required by Section 404 of the
Sarbanes-Oxley Act.
Changing laws, regulations and standards relating to corporate governance and public disclosure,
including the Sarbanes-Oxley Act and related regulations implemented by the SEC, are creating
uncertainty for public companies, increasing legal and financial compliance costs and making some
activities more time consuming. We are evaluating our internal controls systems to allow
management to report on, and our independent auditors to attest to, our internal controls. We will
be performing the system and process evaluation and testing (and any necessary remediation)
required to comply with the management certification and auditor attestation requirements of
Section 404 of the Sarbanes-Oxley Act. While we anticipate being able to fully implement
management attestation requirements relating to internal controls and all other aspects of Section
404 by our March 31, 2008 deadline and auditor attestation requirements by March 31, 2009, we
cannot be certain as to the timing of completion of our evaluation, testing and remediation actions
or the impact of the same on our operations. If we are not able to implement the requirements of
Section 404 in a timely manner or with adequate compliance, we may be subject to sanctions or
investigation by regulatory authorities, including the SEC. This type of action could adversely
affect our financial results or investors confidence in our company and our ability to access
capital markets and could cause our stock price to decline. In addition, the controls and
procedures that we will implement may not comply with all of the relevant rules and regulations of
the SEC. If we fail to develop and maintain effective controls and procedures, we may be unable to
provide the required financial information in a timely and reliable manner. Further, if we acquire
any company in the future, we may incur substantial additional costs to bring the acquired
companys systems into compliance with Section 404.
13
Our corporate documents and Minnesota law contain provisions that could discourage, delay or
prevent a change in control of our company.
Provisions in our articles of incorporation may discourage, delay or prevent a merger or
acquisition involving us that our stockholders may consider favorable. For example, our articles
of incorporation provide for a staggered board of directors, whereby directors serve for three-year
terms, with approximately one third of the directors coming up for reelection each year. Having a
staggered board will make it more difficult for a third party to obtain control of our board of
directors through a proxy contest, which may be a necessary step in an acquisition of us that is
not favored by our board of directors.
We are also subject to the anti-takeover provisions of Section 302A.673 of the Minnesota Business
Corporation Act. Under these provisions, if anyone becomes an interested shareholder, we may not
enter into a business combination with that person for four years without special approval, which
could discourage a third party from making a takeover offer and could delay or prevent a change of
control. For purposes of Section 302A.673, interested shareholder means, generally, someone
owning 10% or more of our outstanding voting stock or an affiliate of ours that owned 10% or more
of our outstanding voting stock during the past four years, subject to certain exceptions.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes or incorporates forward-looking statements. All statements other than
statements of historical facts are forward-looking statements, including statements regarding our
future financial position, business strategy, and plans and objectives for future operations and
products. The words may, will, believe, expect, estimate, continue, anticipate,
intend and similar expressions are intended to identify forward-looking statements. We have
based these forward-looking statements largely on our current expectations and projections about
future events and trends that we believe may affect our financial condition, results of operations,
business strategy, business operations and financial needs. These forward-looking statements are
subject to a number of risks, uncertainties and assumptions, including, among other things:
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the highly competitive nature of the markets in which we sell our products; |
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regulatory hurdles that may prevent, delay or make more expensive our introduction
of products; |
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the failure to continue developing innovative products; |
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the loss of our customers; |
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increases in prices for raw materials or the loss of key supplier contracts; |
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employee slowdowns, strikes or similar actions; |
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product liability claims exposure; |
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risks in connection with our operations outside the United States; |
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conditions and changes in the medical device industry generally; |
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the failure in protecting our intellectual property; |
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exposure to competitors assertions of intellectual property claims; |
14
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the failure to retain senior management or replace lost senior management; |
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changes in U.S. generally accepted accounting principles or the rules and
regulations of the Securities and Exchange Commission; |
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changes in general economic and business conditions; |
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changes in currency exchange rates and interest rates; |
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introduction of competing products; |
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lack of acceptance of new products; |
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competitive pressures on the transactional sales and margins, and competition from
new market participants for our sales; |
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adverse changes in applicable laws or regulations; |
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the incurrence of additional debt, contingent liabilities and expenses in connection
with future acquisitions; |
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the failure to integrate effectively newly acquired operations; and |
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the absence of expected returns from the amount of intangible assets we have
recorded. |
We believe that the above factors are important, but not necessarily all of the important factors
that could cause actual results to differ materially from those expressed in any forward-looking
statement. Unpredictable or unknown factors could also have material adverse effects on us. Since
our actual results, performance or achievements could differ materially from those expressed in, or
implied by, the forward-looking statements, we cannot give any assurance that any of the events
anticipated by the forward-looking statements will occur or, if any of them do, what impact they
will have on our results of operations and financial condition. All forward-looking statements
included or incorporated in this prospectus are expressly qualified in their entirety by the
foregoing cautionary statements. You should not place undue reliance on these forward-looking
statements. We do not undertake any obligation to update any of the forward-looking statements,
except as may be required under federal securities laws.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares. The proceeds, if any, we receive from
the exercise of the warrants will be used for general corporate purposes.
VALIDITY OF COMMON STOCK
The validity of the shares of common stock offered by this prospectus has been passed upon by
Messerli & Kramer P.A.
EXPERTS
Our consolidated financial statements as of and for the years ended March 31, 2007 and 2006,
incorporated by reference in this prospectus, have been so included in reliance upon the report of
McGladrey & Pullen, LLP, independent registered public accounting firm, given on the authority of
said firm as experts in accounting and auditing.
15
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is a part of a registration statement on Form S-3. Parts of the registration
statement have been omitted in accordance with the rules and regulations of the SEC. For further
information about us and our common stock, we refer you to the registration statement.
We file annual, quarterly and current reports, proxy statements, and other information with the
SEC. You can read and copy any document we file with the SEC at the SECs public reference room at
100 F Street, N.E., Washington, D.C. 20549. You may obtain information on the operation of the
public reference room by calling the SEC at 1-800-SEC-0330. Our SEC filings are also available to
the public at the SECs website at http://www.sec.gov.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference certain of our publicly-filed documents into this
prospectus, which means that we can disclose important information to you by referring you to
another document filed separately with the SEC. The information incorporated by reference is
considered part of this prospectus. This prospectus incorporates by reference the documents listed
below and any future filings we make with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of
the Securities Exchange Act of 1934 before the termination of this offering:
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Our Annual Report on Form 10-KSB for the fiscal year ended March 31, 2007; |
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Our Quarterly Reports on Form 10-QSB for the fiscal quarters ended June 30, 2007 and
September 30, 2007; |
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Our Current Reports on Form 8-K filed June 7, 2007, November 1, 2007, November 7, 2007
and December 7, 2007; and |
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The description of our common stock contained in our Registration Statement on SB-2 filed
with the SEC (No. 333-133072). |
Any statement contained in the documents incorporated by reference in this prospectus will be
deemed to be modified or superceded for purposes of this prospectus to the extent that a statement
contained in this prospectus modifies or supercedes the statement. Information that we file later
with the SEC before the termination of this offering will automatically modify and supercede the
information previously incorporated by reference and the information in this prospectus. Any
statement so modified or superceded will not be deemed, except as so modified or superceded, to
constitute a part of this prospectus.
Upon written or oral request, free of charge, we will provide any person, including beneficial
owners, to whom a copy of this prospectus is delivered a copy of any document incorporated by
reference, excluding all exhibits unless we specifically incorporated by reference an exhibit in
this prospectus. Any such requests should be addressed to:
Uroplasty, Inc.
5420 Feltl Road
Minnetonka, Minnesota 55343
Attn: Chief Financial Officer
(952) 426-6140
16
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses payable by us in connection with the
registration of the common stock hereunder. All amounts are estimated, except for the SEC
registration fee.
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SEC registration fee |
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$ |
1,348 |
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Accountants fees and expenses |
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27,000 |
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Legal fees and expenses |
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55,000 |
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Printing expenses |
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30,000 |
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NASD and AMEX fees |
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45,000 |
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Blue sky fees and expenses |
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3,000 |
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Transfer Agent and Registrar fees and expenses |
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1,000 |
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Miscellaneous |
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7,652 |
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Total |
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170,000 |
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ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Minnesota Statutes Section 302A.521 provides that a corporation shall indemnify any person made or
threatened to be made a party to a proceeding by reason of the former or present official capacity
of such person against judgments, penalties, fines (including, without limitation, excise taxes
assessed against such person with respect to any employee benefit plan), settlements and reasonable
expenses, including attorneys fees and disbursements, incurred by such person in connection with
the proceeding, if, with respect to the acts or omissions of such person complained of in the
proceeding, such person (1) has not been indemnified therefor by another organization or employee
benefit plan; (2) acted in good faith; (3) received no improper personal benefit and Section
302A.255 (with respect to director conflicts of interest), if applicable, has been satisfied; (4)
in the case of a criminal proceeding, had no reasonable cause to believe the conduct was unlawful;
and (5) reasonably believed that the conduct was in the best interests of the corporation in the
case of acts or omissions in such persons official capacity for the corporation or reasonably
believed that the conduct was not opposed to the best interests of the corporation in the case of
acts or omissions in such persons official capacity for other affiliated organizations. Our
Bylaws provide that we shall indemnify officers and directors to the extent permitted by Section
302A.521.
II-1
ITEM 16. EXHIBITS
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4.1 |
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Form of Stock Certificate representing shares of our Common Stock
(Incorporated by reference to Exhibit 3.1 to Registrants Registration
Statement on Form 10SB) |
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4.3* |
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Form of Selling Agents Warrant |
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5* |
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Legal Opinion of Messerli & Kramer P.A. |
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23.1# |
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Consent of McGladrey & Pullen, LLP |
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23.2* |
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Consent of Messerli & Kramer P.A. (included in Exhibit 5) |
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24.1 |
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Power of Attorney (included on signature page of Form SB-2 as initially filed) |
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* |
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Previously filed |
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Filed herewith |
ITEM 17. UNDERTAKINGS.
(a) |
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The undersigned registrant hereby undertakes: |
(1) To file, during any period in which offers or sales are being made, a post-effective amendment
to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of
this registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in
this registration statement; and
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement;
provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the
information required to be included in a post-effective amendment by those paragraphs is contained
in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or
section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the
registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that
is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such
post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being
registered which remain unsold at the termination of the offering.
II-2
(4) That, for the purpose of determining liability of the registrant under the Securities Act of
1933 to any purchaser in the initial distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the
offering required to be filed pursuant to Rule 424 (§230.424 of this chapter);
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided by or on behalf of
the undersigned registrant; and
(iv) Any other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the registrants annual report pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has
duly caused this Post-Effective Amendment No. 1 to the Registration Statement (333-138265) to be
signed on its behalf by the undersigned, thereunto duly authorized, in the City of Minnetonka,
State of Minnesota, on January 28, 2008.
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UROPLASTY, INC.
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By: |
/s/ David B. Kaysen |
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David B. Kaysen |
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President and Chief Executive Officer |
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Pursuant to the requirements of the Securities Act of 1933, this Post-Effective Amendment No. 1 to
the Registration Statement (333-138265) has been signed by the following persons in the capacities
and on the dates indicated.
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Signature |
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Title/Capacity |
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Date |
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/s/ David B. Kaysen
David B. Kaysen
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President, Chief Executive
Officer and Director (Principal
Executive Officer)
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January 28, 2008 |
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/s/ Mahedi A. Jiwani
Mahedi A. Jiwani
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Vice President, Chief Financial
Officer and Treasurer (Principal
Financial Officer and Principal
Accounting Officer)
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January 28, 2008 |
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*
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Chairman of the Board of Directors
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January 28, 2008 |
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R. Patrick Maxwell |
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*
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Director
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January 28, 2008 |
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Thomas E. Jamison |
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*
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Director
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January 28, 2008 |
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Lee A. Jones |
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*
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Director
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January 28, 2008 |
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James P. Stauner |
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*
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Director
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January 28, 2008 |
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Sven A. Wehrwein |
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*By: |
/s/ David B. Kaysen |
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David B. Kaysen, Attorney-in Fact |
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EXHIBIT INDEX
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Number |
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Description |
4.1
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Form of Stock Certificate representing shares of our Common Stock
(Incorporated by reference to Exhibit 3.1 to Registrants Registration
Statement on Form 10SB) |
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4.3*
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Form of Selling Agents Warrant |
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5*
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Legal Opinion of Messerli & Kramer P.A. |
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23.1#
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Consent of McGladrey & Pullen, LLP |
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23.2*
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Consent of Messerli & Kramer P.A. (included in Exhibit 5) |
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24.1
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Power of Attorney (included on signature page of Form SB-2 as initially filed) |
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* |
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Previously filed |
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# |
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Filed herewith |