As filed with the Securities and Exchange Commission on May 24, 1996.
File No. 333-03843
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
--------------------------------
AMENDMENT NO. 1
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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UROMED CORPORATION
(Exact name of Registrant as specified in its charter)
MASSACHUSETTS 04-3104185
(State or other jurisdiction (I.R.S. Employer
of organization) Identification No.)
64 A Street, Needham, Massachusetts 02194 (617) 433-0033
(Address and telephone number of registrant's principal executive offices)
--------------------------------
JOHN G. SIMON
Chairman of the Board of Directors,
President and Chief Executive Officer
UroMed Corporation
64 A Street
Needham, Massachusetts 02194
(617) 433-0033
(Name, address and telephone number of agent for service)
with copies to:
DONALD-BRUCE ABRAMS, ESQ.
Bingham, Dana & Gould LLP
150 Federal Street
Boston, Massachusetts 02110
(617) 951-8000
Approximate date of commencement of proposed sale to the public:
As soon as practicable after this Registration Statement becomes effective
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If the only securities being registered on this form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [ ]
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, check the following box. |X|
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. [ ]
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. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
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Proposed Proposed
Title of Securities Amount to Maximum Maximum Amount of
to be Registered be Registered Offering Price Aggregate Registration
Per Share* Offering Fee
Price*
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<S> <C> <C> <C> <C>
Common Stock
No Par Value 2,335,026 $9.25 $21,598,991 $7,448.00
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</TABLE>
*The registration fee, which was previously paid, was estimated solely for the
purpose of determining the registration fee. Calculated in accordance with Rule
457(c) based on the average of the high and low prices reported in the
consolidated trading system on May 8, 1996.
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 Commission, acting pursuant to Section 8(a), may
determine.
<PAGE>
P R O S P E C T U S
UROMED CORPORATION
2,335,026 Shares of
Common Stock, No Par Value
May 24, 1996
-----------
This Prospectus ("Prospectus") of UroMed Corporation, a Massachusetts
corporation (the "Company"), relates to up to 2,335,026 shares (the "Shares") of
the Company's common stock, no par value per share (the "Common Stock") being
sold by certain stockholders of the Company (the "Selling Stockholders"), for
their respective accounts. See "Selling Stockholders." The Company will not
receive any proceeds from the sale of Shares by the Selling Stockholders. The
Common Stock is traded on The Nasdaq Stock Market under the symbol "URMD." On
May 23, 1996, the last reported sale price of the Common Stock on The Nasdaq
Stock Market was $13.13 per share.
The Company will pay all of the expenses incident to the registration,
offering and sale of the Shares to the public hereunder (other than commissions,
fees and discounts of underwriters, brokers, dealers and agents), estimated to
be $50,948. The Company has agreed to indemnify the Selling Stockholders and any
underwriters against certain liabilities, including liabilities under the
Securities Act of 1933 (the "Securities Act").
Subject to the conditions of a Registration Rights Agreement, dated as of
May 9, 1996, by and among the Company, the ASI Liquidating Trust (the "Trust")
the trustees of the Trust (the "Trustees") and certain beneficiaries of the
Trust (The Selling Stockholders) (the "Registration Rights Agreement"), all or a
portion of the Shares may be disposed of by the Selling Stockholders hereunder
from time to time in one or a combination of the following transactions: (a)
transactions (which may involve block transactions) on the National Market
System of the Nasdaq Stock Market, or otherwise, at market prices prevailing at
the time of sale or at prices related to such prevailing market prices; or (b)
privately negotiated transactions at negotiated prices, including underwritten
offerings. Pursuant to the Registration Rights Agreement, the Trust, the
Trustees and the Selling Stockholders have each agreed, subject to certain
conditions, that they will not, and they will cause any permitted transferee of
their rights under the Registration Rights Agreement not to, sell any Shares
other than through any of PaineWebber Incorporated, Vector Securities
International, Inc. or Volpe, Welty & Company (together the "Permitted
Brokers"). The Selling Shareholders may effect such transactions by selling the
Shares directly to purchasers or by selling the shares to or through the
Permitted Brokers or, in certain cases, through other underwriters, brokers or
dealers, and the Permitted Brokers or such other underwriters, brokers or
dealers may receive compensation in the form of discounts, concessions or
commissions from the Selling Shareholders or the purchasers of the Shares for
whom the Permitted Brokers or such other underwriters, brokers or dealers may
act as agent, or to whom they sell as principal, or both (which compensation to
a particular underwriter, broker or dealer might be in excess of customary
commissions or be changed from time to time). The Selling Shareholders and the
Permitted Brokers or any other underwriters, brokers, dealers or agents who
participate in a sale of the Shares may be deemed "underwriters" within the
meaning of Section 2(11) of the Securities Act and the commissions paid or
discounts allowed to any of the Permitted Brokers or any such other
underwriters, brokers, dealers or agents in addition to any profits received on
resale of the Shares if any of the Permitted Brokers or any such any
underwriters, brokers, dealers or agents should purchase any Shares as a
principal may be deemed to be underwriting discounts or commissions under the
Securities Act. See "Plan of Distribution."
Certain of the Permitted Brokers or the other underwriters, dealers,
brokers or agents may have other business relationships with the Company and/or
its affiliates in the ordinary course.
-----------
THESE SECURITIES INVOLVE A HIGH DEGREE OF RISK. SEE "RISK FACTORS AND
CAUTIONARY STATEMENT" ON PAGE 3.
<PAGE>
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THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED
UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
-----------
No dealer, salesperson or other person has been authorized to give any
information or to make any representations not contained in this Prospectus or
any Prospectus Supplement, and, if given or made, such information or
representations must not be relied upon as having been authorized by the
Company. Neither this Prospectus nor any Prospectus Supplement constitutes an
offer to sell or a solicitation of an offer to buy any of the securities offered
hereby in any jurisdiction to any person to whom it is unlawful to make such an
offer in such jurisdiction. Neither the delivery of this Prospectus or any
Prospectus Supplement nor any sale made thereunder shall, under any
circumstances, create any implication that there has been no change in the
affairs of the Company since the date hereof or thereof.
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Underwriting Proceeds to Selling
Price to Public Discounts Stockholders
and Commissions
- -------------------------------------------------------------------------------
Per Share (l) (1)(2) (1)(2)
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Total (1) (1)(2) (1)(2)
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(1) Under the securities laws of certain states, the Shares may be sold in such
states only through registered or licensed brokers or dealers. In addition,
in certain states the Shares may not be sold unless the Shares have been
registered or qualified for sale in such state or an exemption from
registration or qualification is available and is complied with.
See "Plan of Distribution" and "Selling Stockholders."
(2) The Company has agreed to prepare and file this Prospectus and the related
Registration Statement and supplements and amendments thereto required by
the Securities Act with the Securities and Exchange Commission, to register
and qualify the Common Stock if required under applicable Blue Sky laws,
and to deliver copies of the Prospectus to the Selling Stockholders. The
expenses incurred in connection with the same, estimated at $50,948, will
be borne by the Company. The Company will not be responsible for any
discounts, concessions, commissions or other compensation due to any broker
or dealer in connection with the sale of any of the shares offered hereby,
which expenses will be borne by the applicable Selling Stockholder.
The date of this Prospectus is May 24, 1996.
2
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the reporting requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files periodic reports and other information with the Securities and
Exchange Commission (the "Commission"). Such reports, proxy statements and other
information concerning the Company may be inspected and copies may be obtained
(at prescribed rates) at public reference facilities maintained by the
Commission at Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549
and at the regional offices of the Commission located at Seven World Trade
Center, 13th Floor, New York, New York 10048 and at Northwest Atrium Center, 500
W. Madison Street, Suite 1400, Chicago, Illinois 60661-2511. Copies of such
material can also be obtained from the Public Reference Section, Securities and
Exchange Commission, 450 Fifth Street, N.W., Washington, D.C. 20549, upon
payment of prescribed rates. The Company's Common Stock is listed on The Nasdaq
Stock Market, and reports, proxy statements and other information concerning the
company can also be inspected the offices of the National Association of
Securities Dealers, Inc. at 1735 K Street, Washington, D.C. 20006.
The Company has filed a Registration Statement on Form S-3 (the
"Registration Statement") under the Securities Act with the Commission with
respect to the Common Stock being offered pursuant to this Prospectus. As
permitted by the rules and regulations of the Commission, this Prospectus omits
certain of the information contained in the Registration Statement. For further
information with respect to the Company and the Common Stock being offered
pursuant to this Prospectus, reference is hereby made to such Registration
Statement, including the exhibits filed as part thereof. Statements contained in
this Prospectus concerning the provisions of certain documents filed with, or
incorporated by reference in, the Registration Statement are not necessarily
complete, each such statement being qualified in all respects by such reference.
Copies of all or any part of the Registration Statement, including the documents
incorporated by reference therein or exhibits thereto, may be obtained upon
payment of the prescribed rates at the offices of the Commission set forth
above.
Upon request, the Company will provide without charge to each person to
whom a copy of this Prospectus has been delivered a copy of any information that
was incorporated by reference in the Prospectus (other than exhibits to
documents, unless such exhibits are specifically incorporated by reference into
the information incorporated by reference in the Prospectus). The Company will
also provide upon specific request, without charge to each person to whom a copy
of this Prospectus has been delivered, a copy of all documents filed from time
to time by the Company with the Commission pursuant to the Exchange Act.
Requests for such copies should be directed to Karen Galfetti, Investor
Relations Specialist, 64 A Street, Needham, Massachusetts 02194. Telephone
requests may be directed to Ms. Galfetti at (617) 433-0033.
3
<PAGE>
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
There is incorporated herein by reference the Annual Report on Form 10-K
of the Company for the fiscal year ended December 31, 1995 and the Quarterly
Reports on Form 10-Q of the Company for the fiscal quarters ended March 31,
1995, June 30, 1995, September 30, 1995 and March 31, 1996 filed with the
Commission pursuant to Section 13(a) of the Exchange Act, the Current Reports on
Form 8-K of the Company filed on March 26, and May 15, 1996 with the Commission
pursuant to Section 13(a) of the Exchange Act and the description of the Common
Stock contained in the Company's Registration Statement on Form 8-A filed with
the Commission pursuant to Section 12(g) of the Exchange Act.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act subsequent to the date of this Prospectus and prior
to the termination of the offering of the Common Stock shall be deemed to be
incorporated by reference in this Prospectus and to be a part hereof from the
date of filing such documents. Any statement contained herein or in a document,
all or a portion of which is incorporated or deemed to be incorporated by
reference herein, shall be deemed to be modified or superseded for purposes of
this Prospectus to the extent that a statement contained herein or in any other
subsequently filed document or portion thereof which also is or is deemed to be
incorporated by reference herein modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Prospectus.
RISK FACTORS AND CAUTIONARY STATEMENT
An investment in the Shares being offered herein involves a high degree of
risk. Prospective investors should consider carefully the risk factors contained
in the Annual Report on Form 10-K of the Company for the fiscal year ended
December 31, 1995 which are incorporated herein by reference, in addition to the
following risk factors and the other information contained in this Prospectus
and the other information contained in the Registration Statement of which this
Prospectus is a part, including all information incorporated hereby by
reference, before purchasing the Shares offered hereby. From time to time, the
Company issues statements in public filings or press releases, or officers of
the Company may make public oral statements with respect to the Company, that
may be considered forward-looking. In connection with the "safe harbor"
provisions of the Private Securities Reform Act of 1995, the Company believes
that the following important factors which , among others, could cause the
Company's actual results for its 1996 fiscal year and beyond to differ
materially from those expressed in any forward-looking statements made by, on
behalf of, or with respect to, the Company, should be considered by investors
when reviewing such statements:
(bullet) The uncertainty of Federal regulatory approval for the Reliance Insert.
(bullet) The uncertainty that the Reliance Insert and the Miniguard Patch(TM)
will gain market acceptance either among physicians or UI sufferers
in the United States or in Europe.
(bullet) The dependence by the Company on the success of two products, the
Reliance Insert and the Miniguard Patch(TM).
(bullet) The uncertainty that the Company will be able to develop the ability to
produce commercial quantities of its products and produce such
quantities at an acceptable cost.
(bullet) The uncertainty that the Company will be able to develop an effective
sales force and implement a successful marketing plan for the Reliance
Insert and the Miniguard Patch(TM) in the United States.
(bullet) The Company's dependence on others for raw materials, including certain
materials available only from single sources.
(bullet) The effect of competing products and surgical and non-surgical
alternative treatments for incontinence.
(bullet) The uncertainty that the Company will be able to develop an effective
distribution network and implement a successful distribution strategy
for the Reliance Insert and the Miniguard Patch(TM) in Europe and
elsewhere.
(bullet) The uncertain protection afforded the Company by its patents and other
intellectual property relating to the Reliance Insert and the Miniguard
Patch.
(bullet) The uncertainty whether the Company will be able to achieve medical
reimbursement for the Reliance Insert or the Miniguard Patch in the
United States or in all European Markets.
(bullet) The uncertainty whether the Company will be able to manufacture, market
and sell its products at prices that permit it to achieve satisfactory
margins in the production and marketing of its products.
4
<PAGE>
RISK FACTORS
Product Development Risks; Uncertainty of Regulatory Approval for the Reliance
Insert
The Company's Reliance Insert and Miniguard Patch are new and,
accordingly, their safety and efficacy have not yet been fully established. In
addition, clinical testing of the Reliance Insert has not been completed. The
production and marketing of the Company's proposed products, and the Company's
ongoing research and development activities, are subject to regulation by
numerous government authorities in the United States and other countries. The
manufacture and sale of the Reliance Insert are subject to review and approval
of the United States Food and Drug Administration ("FDA"), and the exact nature
of the FDA regulatory process that will be required for the Reliance Insert is
uncertain. Generally, the process of obtaining FDA and other regulatory
approvals is lengthy, expensive and uncertain and there can be no assurance that
the Reliance Insert will be approved for marketing on a timely basis, if at all.
The Company submitted a Section 510(k) Notification to the FDA in December 1994
to seek regulatory clearance to market the Reliance Insert in the United States.
In September 1995, the FDA advised the Company that it was granting "expedited
review" status to an updated 510(k) Notification filed by the Company on August
18, 1995, because the Reliance Insert appeared to satisfy the criterion of
potentially offering a specific public health benefit. However, in March 1996,
the Company met with the FDA as part of its ongoing dialogue in connection with
its 510(k) application for market clearance of its Reliance Insert. Based on
some of the comments made at the meeting, the Company believes that market
clearance is not likely to be imminent because there remain a range of matters
that are being actively discussed. It remains uncertain whether the FDA will
ultimately accept the 510(k) application, whether the FDA will require more
information, or whether the FDA will require the more lengthy PMA process for
the Reliance Insert. Failure to obtain the necessary FDA approvals for the
Reliance Insert, or to obtain such approvals on a timely basis, would have a
material adverse effect on the Company's business, financial condition and
results of operations.
Uncertainty of Market Acceptance of the Reliance Insert and Miniguard Patch
Each of the Reliance Insert and the Miniguard Patch represents a new
approach to managing certain types of UI, and there can be no assurance that
either product will gain any significant degree of market acceptance (in the
case of the Reliance Insert, if and when necessary regulatory approvals are
obtained). The Company believes that recommendations by physicians will be
essential for market acceptance of both the Reliance Insert and the Miniguard
Patch, and there can be no assurance that any such recommendations will be
obtained. In addition, there can be no assurance that the Reliance Insert or the
Miniguard Patch will be accepted by UI sufferers in the United States or abroad.
The Reliance Insert must be inserted into the urethra. Accordingly, some UI
sufferers may not be willing to use the device. Furthermore, certain transitory
adverse effects such as hematuria (incidence of blood in the urine), urinary
tract infection, device migration and anatomical findings such as irritation of
the mucosa, have been evident in varying degrees in the Company's clinical
trials. The observation of such adverse effects in patients, or the perception
that the product could cause any such adverse effects, could have the effect of
discouraging some potential users of the Reliance Insert. The Reliance Insert
and the Miniguard Patch are each patient-managed therapies and as such patients
may at any time decide to discontinue their use. During the course of the
Company's clinical trials with the Reliance Insert, significant numbers of
patients have chosen to discontinue use of the Reliance Insert for a variety of
reasons, including the demands of compliance with study protocols (including
follow-up doctor visits, invasive medical testing, laboratory testing and
requirements that patients comply with record-keeping requirements), discomfort
experienced while using the Reliance Insert and, in a comparatively small number
of cases, urinary tract infections experienced while using the device.
Furthermore, the Reliance Insert and the Miniguard Patch also may not be
appropriate for use by UI patients who lack sufficient dexterity or who suffer
from other physical or mental conditions which could have an impact on the safe
and efficacious use of the device.
5
<PAGE>
Finally, the pricing of the Reliance Insert and the Miniguard Patch in the
United States and in many foreign markets has not yet been determined, and the
pricing policies of the Company and its European distributors could adversely
impact market acceptance of these products as compared to competing products and
treatments. Any of the foregoing factors, or other factors, could limit or
detract from market acceptance of the Company's products in the United States
and abroad. Insufficient market acceptance of the Reliance Insert or the
Miniguard Patch would have a material adverse effect on the Company's business,
financial condition and results of operations. Although the safety and
efficacy of the Miniguard Patch was sufficient for FDA clearance, there can be
no assurance that the Miniguard Patch will continue to prove to be safe and
effective over the long-term and after wider use.
Dependence on Two Products
The Company expects to derive a substantial majority of its future
revenues from sales of the Reliance Insert and the Miniguard Patch. The
Company's failure to commercialize both of these products successfully would
have a material adverse effect on the Company's business, financial condition
and results of operations.
Limited Operating History; History of Losses; Profitability Uncertain
Since inception in October 1990, the Company has been primarily engaged
in research and development of the Reliance Insert. The Company acquired assets
relating to the Miniguard Patch in May 1996. The Company has experienced
significant operating losses since inception and, as of March 31, 1996, had an
accumulated deficit of $26.7 million. In addition, the development and
commercialization by the Company of the Reliance Insert, the Miniguard Patch and
other new products, if any, will require substantial product development
expenditures for the foreseeable future. The Company expects its operating
losses to increase over the foreseeable future and there can be no assurance
that the Company will be profitable in the future or that the Company's existing
capital resources and any funds provided by future operations will be sufficient
to fund the Company's needs, or that other sources of funding will be available.
Limited Manufacturing Capability and Experience; Dependence on Others for Raw
Materials
The Company has limited experience in manufacturing commercial
quantities of its Reliance Insert and has not manufactured significant
quantities of any other products, including the Miniguard Patch. In addition,
the Company is currently unable to manufacture Reliance Inserts at a cost below
the price at which such products are currently being sold to its Company's
European distributors. In order to successfully commercialize the Reliance
Insert in the United States and abroad, the Company will have to reduce per-unit
manufacturing costs while maintaining the extremely high quality standards
required. In addition, the Company's current manufacturing capability for the
Reliance Insert may not be sufficient to produce the quantities which may be
required to support sales by its European distributors or, upon the receipt of
regulatory approval, by its direct customers in the United States. Moreover, the
Company may not be able to develop additional manufacturing capability to
produce quantities of the Reliance Insert sufficient to supply such
requirements. The Company has not yet developed any capacity to manufacture the
Miniguard Patch, and has not yet been able to demonstrate that it will be able
to manufacture the Miniguard Patch or to develop such capacity on a
cost-effective basis. Even if the Company does develop such capacity, it may not
be able to develop sufficient capacity to produce the quantities of the
Miniguard Patch that may be required to support its sales. In order to develop
sufficient additional manufacturing capacity, the Company will have to make
substantial capital expenditures on additional units of the Company's automated
assembly equipment for the Reliance Insert and new equipment to manufacture the
Miniguard Patch, and expand the Company's existing manufacturing facility, and
may have to acquire additional manufacturing space at other locations. In the
event that the Company is unable to manufacture sufficient quantities of the
Reliance Insert or Miniguard Patch to support its obligations under its
collaborative arrangements and ultimately to support sales, the Company may be
required to enter into arrangements with third parties to manufacture these
products. These other manufacturers may not be able to manufacture the Reliance
Insert or Miniguard Patch on commercially acceptable terms or in quantities
sufficient to permit the successful commercialization of such products.
6
<PAGE>
In addition, certain of the raw materials for the manufacture of the
Reliance Insert and the Miniguard Patch are available only from single sources.
In the event that the Company replaces its current raw materials used in the
Reliance Insert with alternative materials, additional testing may be required
in order for the Reliance Insert to receive regulatory approval. In the event
the Company replaces its current raw materials for the Miniguard Patch with
alternative materials, the Miniguard Patch, as modified, may require new FDA and
other regulatory approvals, and additional clinical and other testing may be
required in order to obtain such approvals. In addition to interruptions in
supplies of raw materials which may occur as a result of business risks
particular to such suppliers or the failure of the Company and any such supplier
to maintain satisfactory terms, such sources may decide for reasons beyond the
control of the Company, such as concerns about potential medical product
liability risk in general, to cease supplying such materials for use in medical
devices generally. Any interruption in the supply of raw materials currently
used by the Company or the usage of any alternative raw materials could have a
material adverse effect on the Company's business, financial condition and
results of operations.
Lack of Marketing and Sales Experience; Dependence on European Collaborative
Arrangements
The Company has not sold any products in the United States. The Company
currently employs few in-house marketing and sales professionals, although it is
in the process of developing a direct marketing and sales group in the United
States for its products and is beginning to commercialize the Reliance Insert
internationally through collaborative arrangements. There can be no assurance
that the Company can build an effective sales force, attract and retain its own
qualified marketing and sales group in the United States, or otherwise design
and implement an effective marketing and sales strategy for the Reliance Insert,
the Miniguard Patch or any future product developed by the Company.
The Company believes that a significant portion of its future product
revenue will derive from certain European markets including Germany, France, The
Netherlands, the United Kingdom, Sweden, Norway, Denmark and Finland. The
Company has entered into collaborative arrangements with several European
companies providing for the marketing and sale of the Reliance Insert in these
countries. In general, pursuant to these agreements, the Company is required to
provide sufficient quantities of Reliance Inserts for sale by its European
distributors, and the Company's European distributors are required to market and
sell the Reliance Insert in such countries. There can be no assurance that the
Company's European distributors will be able to successfully market and sell the
Reliance Insert in their respective countries, that they will devote sufficient
resources to support the market launch of the Reliance Insert in those
countries, or that they will market the Reliance Insert at prices which will
permit the Reliance Insert to gain market acceptance in their respective
territories. In addition, the collaborative agreements impose certain
obligations upon the Company relating to delivery of commercial quantities of
the Reliance Insert, the maintenance of product liability insurance and the
clinical performance of the Reliance Insert. Failure or inability of the Company
to comply with any of these obligations under these agreements could permit the
Company's distributors to terminate their respective agreements. In addition,
there can be no assurance that each of these distributors will perform its
obligations under its respective agreement with the Company. Any such
termination or non-performance by one of the Company's European distributors
could have a material adverse impact on the ability of the Company to market and
sell the Reliance Insert in the relevant territories. Furthermore, failure by
the Company's European distributors to effectively market the Reliance Insert in
their respective territories could have a material adverse impact on the
Company's ability to market and sell the Reliance Insert in the United States
once the necessary regulatory approvals are received. The Company has not
entered into any distribution arrangements with respect to the Miniguard Patch
for the European market or elsewhere, and does not currently have a marketing
strategy that would enable it to undertake commercialization of the Miniguard
Patch in Europe on a unilateral basis. In the event that the Company is
successful in developing satisfactory collaborative distribution arrangements in
one or more European markets for the Miniguard Patch, such distribution
arrangements will be subject to risks and uncertainties similar to those of the
Company's existing relationships with respect to the Reliance Insert.
Competition and Technological Advances
7
<PAGE>
The Company's ability to compete in the UI management field will depend
primarily upon physician and consumer acceptance of the Reliance Insert and the
Miniguard Patch, consistency of product quality and delivery, price, technical
capability and the training of health care professionals and consumers. Other
factors within and outside the Company's control will also affect its ability to
compete, including its product development and innovation capabilities, its
ability to obtain required regulatory clearances, its ability to protect the
proprietary technology included in its products, its manufacturing and marketing
capabilities and its ability to attract and retain skilled employees. Certain of
the Company's competitors have significantly greater financial, technical,
research, marketing, sales, distribution and other resources than the Company.
The Company's products are intended to be management options for the treatment
of certain types of female UI, but are not permanent cures. The development of a
permanent cure for female UI by any of the Company's competitors could have a
material adverse effect on the Company's business, financial condition and
results of operations. There can be no assurance that the Company's present or
future competitors will not succeed in developing or marketing technologies and
products that are more effective than any that are being developed by the
Company or that would render the Company's technology and products obsolete or
non-competitive.
Risk of Inadequate Funding; Future Capital Funding
The Company plans to continue to expend substantial funds on research
and product development, pursuit of regulatory approvals, expansion of its
manufacturing facilities and marketing and distribution of its products. The
Company also intends to invest in additional equipment in order to establish
sufficient manufacturing capabilities to supply commercial volumes of its
Reliance Insert and Miniguard Patch in the United States and abroad. Changes in
technology or sales growth beyond currently contemplated manufacturing
capabilities will require further capital investment. There can be no assurance
that the Company's existing capital resources and any funds generated from
future operations will be sufficient to finance any required investment or that
other sources of funding will be available. In addition, future sales of
substantial amounts of the Company's securities in the public market could
adversely affect prevailing market prices and could impair the Company's future
ability to raise capital through the sale of its securities.
Continuing Risks of Regulatory Oversight
A medical device and its manufacturer are subject to continual review
after approval, and later discovery of previously unknown problems with a
product or the manufacturing process may result in restrictions on such product
or the manufacturer, including withdrawal of the product or products from the
market. The Company's manufacturing facilities are also subject to registration
requirements with and ongoing inspections by the FDA. Failure to comply with
applicable regulatory requirements may, among other things, result in fines,
suspensions of regulatory approvals, product recalls, operating restrictions and
criminal prosecution. The Company is also subject to regulation under federal,
state and local regulations regarding work place safety, environmental
protection and hazardous and controlled substance controls, among others. In
addition, the Company cannot predict the extent of government regulations or
impact of new government regulations which might have an adverse effect on the
production and marketing of the Company's products.
Uncertainty Regarding Patents and Protection of Proprietary Technology
The Company's ability to compete effectively will depend, in part, on
its ability to develop and maintain proprietary aspects of its technology. There
can be no assurance as to the validity of the United States patents held by the
Company with respect to the technology underlying the Reliance Insert or as to
the validity of the United States patents underlying the Miniguard Patch, or as
to the degree of protection offered by these patents. There can be no assurance
that the Company's patents will not be challenged, invalidated or circumvented
in the future. In addition, there can be no assurance that competitors, many of
which have substantial resources and have made substantial investments in
competing technologies, will not seek to apply for and obtain patents that will
prevent,
8
<PAGE>
limit or interfere with the Company's ability to make, use and sell its
products either inside or outside the United States. The defense and prosecution
of patent litigation or other legal or administrative proceedings related to
patents is both costly and time-consuming, even if the outcome is favorable to
the Company. An adverse outcome could subject the Company to significant
liabilities to third parties, require disputed rights to be licensed from others
or require the Company to cease making, using or selling any products. There can
be no assurance that any licenses required under any patents or proprietary
rights would be made available on terms acceptable to the Company, if at all.
The Company also relies on unpatented proprietary technology and there
can be no assurance that others may not independently develop the same or
similar technology or otherwise obtain access to the Company's unpatented
proprietary technology. In addition, the Company cannot be certain that others
will not independently develop substantially equivalent or superseding
proprietary technology, or that an equivalent product will not be marketed in
competition with the Company's products, thereby substantially reducing the
value of the Company's proprietary rights. There can be no assurance that any
confidentiality agreements between the Company and its employees will provide
meaningful protection for the Company's trade secrets, know-how or other
proprietary information in the event of any unauthorized use or disclosure of
such trade secrets, know-how or other proprietary information. Finally, there
can be no assurance that the Company's Reliance(TM) trademark or any trademarks
chosen and registered for the Miniguard Patch will provide meaningful
protection.
Product Liability Risk; Limited Insurance Coverage
The manufacture and sale of medical products and the conduct of
clinical trials using new technology entail the risk of product liability
claims. There can be no assurance that the Company's existing insurance coverage
limits are adequate to protect the Company from any liabilities which it might
incur in connection with the clinical trials of the Company's Reliance Insert,
the initial commercialization of the Reliance Insert in Europe or the sale and
use of the Miniguard Patch. The Company will require increased product liability
insurance coverage in connection with the commercial distribution of its
products in the United States and abroad. Such insurance is expensive and in the
future may not be available on acceptable terms, if at all. A successful product
liability claim or series of product liability claims brought against the
Company in excess of its insurance coverage could have a material adverse effect
on the Company's business, financial condition and results of operations. In
addition, any claims, even if not ultimately successful, could adversely affect
the market acceptance of the Company's products.
Dependence on Key Personnel
The Company is dependent upon a number of key scientific and management
personnel. The loss of the services of one or more key individuals would have a
material adverse effect on the Company's business, financial condition and
results of operations. The Company's success will also depend on its ability to
attract and retain other highly qualified scientific and management personnel.
The Company faces competition for such personnel and there can be no assurance
that the Company will be able to attract or retain such personnel.
Uncertainty Relating to Third-Party Reimbursement
In the United States and many foreign countries, third-party
reimbursement is currently generally available for surgical procedures for
incontinence, but generally unavailable for patient-managed products such as
diapers and pads. As part of its near-term marketing plan in the United States,
the Company does not intend to seek third-party reimbursement for its Reliance
Insert or Miniguard Patch and the Company believes that the prospect of
government or private insurance reimbursement in the United States is unlikely.
In Europe, the Company and its European distributors have agreed to adopt a
strategy of pursuing reimbursement for the use of the Reliance Insert in each of
their respective territories where it is appropriate. The availability of
third-party reimbursement for the Reliance Insert in Europe varies from country
to country. While the Company has received notice that full reimbursement for
the use of the Reliance Insert would be provided by the relevant German, Swedish
and
9
<PAGE>
Norwegian governmental authorities and by certain authorities covering much
of Denmark, and Finland, it is unclear whether reimbursement will be available
for the Reliance Insert in the remainder of Denmark or Finland, or whether
reimbursement will be available for the Reliance Insert in France, The
Netherlands or the United Kingdom. It is also unclear whether or not such
reimbursement approvals as the Company has received may at some point in the
future be reversed. The Company has not yet established a strategy with respect
to seeking reimbursement for the Miniguard Patch outside of the United States.
If third-party reimbursement is unavailable in the relevant European country or
in the United States, consumers will have to pay for the Reliance Insert or
Miniguard Patch themselves, resulting in greater relative out-of-pocket cost of
such therapies as compared to surgical procedures and other management options
for which third-party reimbursement is available. Changes in the availability of
third-party reimbursement for the Reliance Insert or Miniguard Patch, for
products of the Company's competitors or for surgical procedures may affect the
pricing of the Company's products or the relative cost to the consumer. The
Company is not able to predict the effect that the availability or
unavailability of third-party reimbursement for the Reliance Insert or Miniguard
Patch may have on the commercialization of the such products abroad or in the
United States.
International Sales and Operations Risks
The Company, in conjunction with its European distributors, is
currently marketing the Reliance Insert in Germany, Sweden, Denmark, Norway
and Finland and intends to sell the Reliance Insert, the Miniguard Patch and any
future products to customers (including its European distributors) outside of
the United States. International sales and operations may be limited or
disrupted by the imposition of government controls, export license requirements,
political instability, trade restrictions, changes in tariffs or difficulties in
staffing and managing international operations. Foreign regulatory agencies
often establish product standards different from those in the United States and
any inability to obtain foreign regulatory approvals on a timely basis could
have an adverse effect on the Company's international business and its financial
condition and results of operations. Additionally, the Company's business,
financial condition and results of operations may be adversely affected by
fluctuations in currency exchange rates as well as increases in duty rates and
difficulties in obtaining export licenses. There can be no assurance that the
Company will be able to successfully commercialize the Reliance Insert, the
Miniguard Patch or any future product in any foreign market.
Volatility of Stock Price
The market price of the Common Stock may be highly volatile. Factors
such as quarter-to-quarter variations in the Company's operations or financial
performance and announcements of technological innovations or new products,
results of clinical trials or other regulatory or reimbursement events by the
Company or its competitors or any of its or their regulators could cause the
market price of the Common Stock to fluctuate significantly. In addition, in
recent years the stock markets in general, and the market prices for medical
technology companies in particular, have experienced significant volatility,
which often may have been unrelated to the operating performance of the affected
companies.
Such volatility may adversely affect the market price of the Common Stock.
Certain Charter and By-Law Provisions May Affect Stock Price
The Company's Articles of Organization and the Company's Amended and
Restated By-Laws contain provisions that may have the effect of making it more
difficult for a third party to acquire control of, or of discouraging
acquisition bids for, the Company. This could limit the price that certain
investors might be willing to pay in the future for shares of Common Stock.
10
<PAGE>
Certain Massachusetts Laws May Affect Stock Price
Certain Massachusetts laws contain provisions that may have the effect
of making it more difficult for a third party to acquire control of, or of
discouraging acquisition bids for, the Company. These laws include Chapter 110F
of the Massachusetts General Laws, which prohibits certain "business
combinations" with "interested stockholders," and Chapter 110D, entitled
"Regulation of Control Share Acquisitions." These provisions could limit the
price that certain investors might be willing to pay in the future for shares of
Common Stock.
Effect of Issuance of Preferred Stock
Shares of preferred stock may be issued in the future without further
stockholder approval and upon such terms and conditions, and having such rights,
privileges and preferences, as the Board of Directors may determine. The rights
of the holders of Common Stock will be subject to, and may be adversely affected
by, the rights of the holders of any preferred stock that may be issued in the
future. In addition, the issuance of preferred stock could have the effect of
making it more difficult for a third party to acquire control of, or of
discouraging acquisition bids for, the Company. This could limit the price that
certain investors might be willing to pay in the future for shares of Common
Stock.
Concentration of Ownership
As of May 25, 1996, Directors and officers of the Company and their
affiliates owned approximately 26% of the Common Stock. As a result, such
persons have the ability to control the Company and direct its affairs and
business.
Absence of Dividends
The Company has not paid cash dividends and does not anticipate doing
so for the foreseeable future.
Shares Available for Future Sale
The future sale of shares of the Company's Common Stock could have an
adverse effect on the market price of the Common Stock. Such sales could be made
by existing stockholders and by holders of outstanding options and warrants to
purchase shares of Common Stock pursuant to Rule 144 or Rule 701 under the
Securities Act of 1933, as amended (the "Securities Act"), by stockholders
purchasing shares of Common Stock in the offering contemplated by this
prospectus or in the public market after completion of the offering, by
stockholders, optionholders or warrantholders exercising outstanding
registration rights or pursuant to one or more registration statements covering
the issuance of stock options and Common Stock to employees of the Company. The
Company currently has an effective registration statement on file with the
Securities and Exchange Commission covering the sale of up to 6,184,522 shares
of Common Stock. This registration statement was filed pursuant to the exercise
of registration rights previously provided to certain shareholders of the
Company. Including the shares covered by such registration statement, the
2,500,000 shares sold by the Company in a public offering completed in November
1995, the 5,000,000 shares sold in the Company's initial public offering in
March 1994, and the 2,335,016 shares covered by the registration statement of
which this prospectus is a part, the Company estimates that approximately
25,000,000 shares of Common Stock (including shares of Common Stock issuable
upon exercise of outstanding options that were exercisable at March 31, 1996)
are eligible for sale pursuant to Rule 144 or Rule 701 or an effective
registration statement under the Securities Act.
11
<PAGE>
THE COMPANY
The Company is focused on the development, manufacture and marketing of
products for the management of urological and gynecological disorders. The
Company's first two products, the Reliance Insert, a small balloon-tipped,
single-use plug, and the Miniguard(TM) Patch, a small, disposable, prescription
adhesive patch placed against the urethral opening, are intended for the
management of certain types of female urinary incontinence ("UI"). UI is the
loss of bladder control resulting in the involuntary leakage of urine in amounts
considered to be a social or personal problem. According to the U.S. Department
of Health and Human Services, there are approximately 10 million UI sufferers in
the United States, of which the Company estimates that approximately 85% are
women. Of these 8.5 million women, the Company has initially identified a target
market of 1.5 million UI sufferers as potential users of its Reliance Insert. A
broader group of mild to moderate UI sufferers will be targeted for use of the
Miniguard Patch, which has been approved for marketing by the U.S. Food and Drug
Administration. Sales of the Reliance Insert commenced in Germany in September
1995, and pre-commercialization activities have been initiated in certain
additional European countries. Clinical trials of the Reliance Insert are
continuing in the United States.
The address of the principal executive office of the Company is 64 A
Street, Needham, Massachusetts 02194. The telephone number of the Company is
(617) 433-0033.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the shares by
the Selling Stockholders.
SELLING STOCKHOLDERS
On May 9, 1996, the ASI Liquidating Trust (the "Trust") acquired 1,868,021
shares of the Common Stock from the Company in a transaction exempt from the
registration requirement of the Securities Act, in connection with an Asset
Purchase Agreement, dated as of May 9, 1996, pursuant to which the Company
purchased a majority of the assets of the Trust in exchange for $7,000,000 in
cash, 1,868,021 of the Shares and an obligation to issue 467,005 additional
shares of the Common Stock to the Trust, subject to adjustment under certain
circumstances, on the effective date of the registration statement of which this
prospectus is a part. Such additional shares of the Common Stock are currently
anticipated by the Company to be issued in a transaction or transactions exempt
from the registration requirement of the Securities Act.
The Trust has represented to the Company that the 1,868,021 shares of the
Common Stock issued to the Trust in the transaction described above and any
additional shares of the Common Stock issued pursuant to such transaction were,
or will be, acquired by the Selling Stockholders (who, the Company understands
from the Trust, are all beneficiaries of the Trust or limited partners of such
beneficiaries) from the Trust in transactions exempt from the registration
requirement of the Securities Act. Pursuant to the Registration Rights
Agreement, dated as of May 9, 1996, among the Company, the Trust, the trustees
of the Trust and certain of the Selling Stockholders, the Company agreed to file
with the Commission the Registration Statement, of which this Prospectus is a
part, with respect to the resale of the Shares. The Company has committed to
keep the Registration Statement effective until the earlier of (i) the second
anniversary of the latest date on which shares of the Common Stock covered by
such Registration Statement are issued by the Company to the Trust, (ii) such
time as all the Common Stock covered by such Registration Statement have been
sold, or (iii) such time that all shares of the Common Stock for which the
Company has an obligation to register pursuant to the terms of the Registration
Rights Agreement may be sold without limitation under the Securities Act.
However, the Company may in its discretion agree to extend the effectiveness of
the Registration Statement beyond such date. The Company has agreed to indemnify
the Selling Shareholders and their officers, directors and controlling persons
against certain liabilities, including certain liabilities under the Securities
Act.
12
<PAGE>
As of May 23, 1996, except as noted below, none of the Selling
Shareholders held of record more than 1% of the Company's outstanding Common
Stock. None of the Selling Stockholders has had any position, office or other
material relationship within the past three years with the Company or its
affiliates.
As of May 10, 1996, there were 25,989,033 shares of the Common Stock
issued and outstanding.
The following table sets forth certain information regarding the
beneficial ownership of the Common Stock as of May 15, 1996 and as adjusted to
reflect the sale of all of the Common Stock offered hereby by each of the
Selling Stockholders.
<TABLE>
<CAPTION>
Name of Selling Shares Beneficially Owned Shares to be Beneficially
Stockholder Prior to Offering (1) Shares Offered (2) Owned After Offering
- ---------------- ------------------------- ------------------ -------------------------
<S> <C> <C> <C>
Crosspoint Venture Partners II,
a California Limited Partnership 478,468 478,468 0
H & Q Life Science Ventures 218,795 218,795 0
Hamquist 4,518 4,518 0
H & Q Investors 1,556 1,556 0
H & Q Ventures International 41,998 41,998 0
H & Q Ventures IV 41,998 41,998 0
Hambrecht & Quist Group 26,562 26,562 0
H & Q TV Management N.V. 22 22 0
Hambrecht & Quist Venture
Partners 1,879 1,879 0
H&Q London Ventures 21,859 21,859 0
Hansa A.G. 23,345 23,345 0
Southern California Ventures II,
a California Limited Partnership 297,864 297,864 0
Robert Elliott 68,145 68,145 0
Bruce E. Fettel Separate Property
Trust Est. February 18, 1982 27,608 27,608 0
Walter S. Baer Revocable Trust
Dated August 19, 1987 7,137 7,137 0
Miriam Baer 3,784 3,784 0
Alan Baer 2,235 2,935 0
13
<PAGE>
Nick E. Yocca Profit Sharing
Trust 4,308 4,308 0
Louis Knobbe 2,154 2,154 0
Brentwood Associates IV, L.P. 296,496 296,496 0
Evergreen IV, L.P. 111,736 111,736 0
Medicus Venture Partners 1990 186,436 186,436 0
Medicus Venture Partners 1992 12,131 12,131 0
Medicus Venture Partners 1993 25,104 25,104 0
Robert F. Rosenbluth 251,584 251,584 0
Jay Lenker 59,453 59,453 0
Thomas J. Berryman 21,295 21,295 0
Brian Cox 6,436 6,436 0
Rodney Brenneman 3,748 3,748 0
Nick E. Yocca 1,780 1,780 0
James Swope 1,609 1,609 0
Kim Maya 192 192 0
John Schaffer 58 58 0
Sandra K. Fiori 1,897 1,897 0
Steve Trom 2,414 2,414 0
Sue Lyons 1,092 1,092 0
Michael Jackson 862 862 0
G. Robert Greene 20,697 20,697 0
Dana Luitjens 1,092 1,092 0
R. Perez-Marrero 344 344 0
Norma E. Bonis 517 517 0
William Moseley 2,587 2,587 0
Lynette Marksberry 1,092 1,092 0
Michael Brown 2,414 2,414 0
14
<PAGE>
Barry Calvarese 12,397 12,397 0
Rick Carlson 11,498 11,498 0
Barbara Campagna 931 931 0
Michael Shine 1,559 1,559 0
Pat Maley 9,578 9,578 0
William Amaden 11,038 11,038 0
The ASI Liquidating Trust 24 24 0
</TABLE>
(1) The Company believes, based on information provided by the Trust and
the Selling Stockholders, that each Selling Stockholder has sole voting and
investment power with respect to the shares beneficially owned.
(2) See "Plan of Distribution."
Certain of the Permitted Brokers or the other underwriters, dealers,
brokers or agents may have other business relationships with the Company and/or
its affiliates in the ordinary course.
Under the securities laws of certain states, the Shares may be sold in
such states only through registered or licensed brokers or dealers. In addition,
in certain states the Shares may not be sold unless the Shares have been
registered or qualified for sale in such state or an exemption for registration
or qualification is available and is complied with.
15
<PAGE>
The Company will pay all of the expenses incident to the registration,
offering and sale of the Shares to the public hereunder other than commissions,
fees and discounts of underwriters, brokers, dealers and agents. The Company has
agreed to indemnify the Selling Stockholders and any underwriters against
certain liabilities, including liabilities under the Securities Act. The Company
will not receive any of the proceeds from the sale of any of the Shares by the
Selling Stockholders. See "Plan of Distribution."
PLAN OF DISTRIBUTION
Subject to the conditions of the Registration Rights Agreement, all or a
portion of the Shares may be disposed of by the Selling Stockholders hereunder
from time to time in one or a combination of the following transactions (a)
transactions (which may involve crosses or block transactions) on the National
Market System of the Nasdaq Stock Market or otherwise, at market prices
prevailing at the time of sale, or at prices related to such prevailing market
prices; or (b) privately negotiated transactions at regulated prices, including
underwritten offerings. Pursuant to the Registration Rights Agreement, the
Trust, the Trustees and the Selling Stockholders have each agreed, subject to
certain conditions, that they will not, and they will cause any permitted
transferee of its rights under the Registration Rights Agreement not to, sell
any Shares other than through any of PaineWebber Incorporated, Vector Securities
International, Inc. or Volpe, Welty & Company (together the "Permitted
Brokers"). The Selling Shareholders may effect such transactions by selling the
Shares directly to purchasers or by selling the shares to or through the
Permitted Brokers or, in certain cases, through other underwriters, brokers or
dealers and the Permitted Brokers or such other underwriters, brokers or dealers
may receive compensation in the form of discounts, concessions or commissions
from the Selling Shareholders or the purchasers of the Shares for whom the
Permitted Brokers or such other underwriters, brokers or dealers may act as
agent, or to whom they sell as principal, or both (which compensation to a
particular underwriter, broker or dealer might be in excess of customary
commissions or be changed from time to time). The Selling Shareholders and the
Permitted Brokers or any other underwriters, brokers, dealers or agents who
participate in a sale of the Shares may be deemed "underwriters" within the
meaning of Section 2(11) of the Securities Act and the commissions paid or
discounts allowed to any of the Permitted Brokers or any such other
underwriters, brokers, dealers or agents in addition to any profits received on
resale of the Shares if any of the Permitted Brokers or any such any
underwriters, brokers, dealers or agents should purchase any Shares as a
principal may be deemed to be underwriting discounts or commissions under the
Securities Act.
Certain of the Permitted Brokers or the other underwriters, dealers,
brokers or agents may have other business relationships with the Company and/or
its affiliates in the ordinary course.
Under the securities laws of certain states, the Shares may be sold in
such states only through registered or licensed brokers or dealers. In addition,
in certain states the Shares may not be sold unless the Shares have been
registered or qualified for sale in such state or an exemption for registration
or qualification is available and is complied with.
The Company will pay all of the expenses incident to the registration,
offering and sale of the Shares to the public hereunder other than commissions,
fees and discounts of underwriters, brokers, dealers and agents. The Company has
agreed to indemnify the Selling Stockholders and any underwriters against
certain liabilities, including liabilities under the Securities Act. The Company
will not receive any of the proceeds from the sale of any of the Shares by the
Selling Stockholders.
If all or a portion of the Shares are offered through an underwritten
offering, the terms of such underwritten offering, including the initial public
offering price, the names of the underwriters and the compensation, if any, of
such underwriters, will be set forth in an accompanying Prospectus Supplement.
Under applicable rules and regulations of the Exchange Act, any person
engaged in a distribution of the Shares may not simultaneously engage in market
making activities with respect to the Common Stock for a period of
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<PAGE>
nine business days prior to the later of the commencement of offers or sales of
the Shares to be distributed and the time such person becomes a participant in
the distribution unless such person is a qualifying registered market maker on
the National Market System of The Nasdaq Stock Market, and such market-making
activities are conducted in accordance with Rule 10b-6A under the Exchange Act.
Pursuant to Rule 10b-6A, a qualified registered market maker is permitted to
engage in passive market making transactions during the two business days prior
to the commencement of offers or sales of the Shares which comply with
applicable volume and price limits and are identified as such. In general, a
passive market maker may display its bid at a price not in excess of the highest
independent bid for the security. If all independent bids are lowered below the
passive market maker's bid, however, such bid must then be lowered when certain
purchase limits are exceeded. Passive market making may stabilize the market
price of the Common Stock at a level above that which might otherwise prevail
and, if commenced, may be discontinued at any time. In addition to and without
limiting the generality of the foregoing, the Selling Shareholders and any other
person participating in such distribution will be subject to other applicable
provisions of the Exchange Act and rules and regulations thereunder, including
without limitation Rules 10b-6 and 10b-7, which provisions may further limit the
timing of purchases and sales of shares of Common Stock by the Selling
Shareholders and any other such person. All of the foregoing may limit the
marketability of the Shares and the ability of any underwriter, broker, dealer
or agent to engage in market making activities.
CERTAIN LEGAL MATTERS
The validity of the offered Common Stock will be passed upon for the
Company by Bingham, Dana & Gould LLP, 150 Federal Street, Boston, Massachusetts.
EXPERTS
The financial statements of the Company as of December 31, 1995 and 1994
and for each of the three years in the period ended December 31, 1995,
incorporated by reference in this Prospectus, have been incorporated herein in
reliance on the report of Price Waterhouse, LLP, independent accountants, given
on the authority of that firm as experts in accounting and auditing.
17
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The estimated expenses in connection with the issuance and distribution of
the securities being registered, other than underwriting compensation,
are:
SEC Registration Fee.................. $ 7,448
Transfer Agent and Registrar Fees and Expenses 11,000
Legal Fees and Expenses............... 5,000
Blue Sky Fees and Expenses............ 5,000
Accounting Fees and Expenses.......... 5,000
Nasdaq Stock Market Fee............... 17,500
Miscellaneous......................... *
-------
Total................................. 50,948
=======
Item 15. Indemnification of Directors and Officers.
Section 67 of Chapter 156B of the Massachusetts General Laws provides a
statutory framework covering indemnification of directors, officers and
employees against liabilities and expenses arising out of legal
proceedings brought against them by reason of their status or service as
directors or officers. In addition, Article XXVIII of the Registrant's
Amended and Restated By-Laws provides for indemnification of directors,
officers and employees of the Registrant. Section 67 and the Registrant's
Amended and Restated By-Laws generally provide that a director, officer or
employee of the Registrant shall be indemnified by the Registrant for all
expenses and liabilities of legal proceedings brought against him/her by
reason of his/her status or service as a director, officer or employee
unless the director, officer or employee is adjudged not to have acted in
good faith in the reasonable belief that his/her action was in the best
interest of the Company or to the extent that such matter relates to
service with respect to an employee benefit plan, in the best interests of
the participants or beneficiaries of such plan. The Registrant's Articles
of Organization also incorporate certain provisions permitted under the
Massachusetts General Laws relating to the liability of directors. The
provisions eliminate a director's liability for monetary damages for a
breach of fiduciary duty, including gross negligence, except in
circumstances involving certain wrongful acts, such as the breach of a
director's duty of loyalty or acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law or
authorization of distributions in violation of the Articles of
Organization or of loans to officers or directors of the Registrant or any
transaction from which the director derived improper personal benefit.
These provisions do not eliminate a director's duty of care. Moreover, the
provisions do not apply to claims against a director for violations of
certain laws, including federal securities laws.
Item 16. Exhibits.
(4.1) Specimen Certificate for Shares of the Registrant's Common Stock,
no par value, incorporated by reference to Exhibit 4.1 to Amendment
No. 2 to the Company's Registration Statement on Form S-1 (Reg.
No. 33-74282).
(4.2) Amended and Restated By-Laws of the Registrant, incorporated by
reference to Exhibit 3.2 to the Company's Registration Statement on
Form S-1 (Reg. No. 33-74282).
II-1
<PAGE>
(4.3) Restated Articles of Organization of the Registrant, incorporated
by reference to Exhibit 3.3 to the Company's Annual Report on Form
10-K for the Company's 1994 fiscal year, filed with the Securities
and Exchange Commission on March 31, 1995.
*(4.4) Registration Rights Agreement, dated as of May 9, 1996, among the
Registrant and certain of its securityholders.
*(5) Opinion of Bingham, Dana & Gould LLP.
*(23.1) Consent of Bingham, Dana & Gould LLP (included in Exhibit 5).
(23.2) Consent of Price Waterhouse LLP.
*(24) Power of Attorney (included on signature page).
*Previously Filed.
Item 17. Undertakings.
(A) The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act each filing of the
registrant's annual report pursuant to section 13(a) or section 15(d)
of the Exchange Act (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to section 15(d) of
the Exchange Act) 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.
(B) The undersigned registrant hereby undertakes to deliver or cause to be
delivered with the prospectus, to each person to whom the prospectus
is sent or given, the latest annual report to security holders that
is incorporated by reference in the prospectus and furnished pursuant
to and meeting the requirements of Rule 14a-3 or Rule 14c-3 under the
Securities Exchange Act of 1934; and, where interim financial
information required to be presented by Article 3 of Regulation S-X
is not set forth in the prospectus, to deliver, or cause to be
delivered to each person to whom the prospectus is sent or given,
the latest quarterly report that is specifically incorporated by
reference in the prospectus to provide such interim financial
information.
(C) Insofar as indemnification for liabilities arising under the
Securities Act 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
Securities 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 Securities Act and will be governed by the final
adjudication of such issue.
(D) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities
Act of 1933, the information omitted from the form of
prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in a form of prospectus
filed by the registrant pursuant to
II-2
<PAGE>
Rule 424(b)(1) or (4) or 497(h) under the Securities Act
shall be deemed to be part of this registration statement as
of the time it was declared effective.
(2) For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus 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.
(E) 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.
(a) 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.
(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-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused Amendment No. 1 to this Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the Town of Needham
and the Commonwealth of Massachusetts as of May 24, 1996.
UROMED CORPORATION
By: /s/ John G. Simon
-------------------------------------
John G. Simon
Chairman of the Board, Chief Executive
Officer and President
Pursuant to the requirements of the Securities Act of 1933, Amendment No.
1 to this Registration Statement on Form S-3 has been signed below as of May 24,
1996 by the following persons on behalf of the Registrant and in the capacities
indicated.
/s/ John G. Simon Chairman of the Board, Chief Executive
- --------------------------- Officer and President (principal
John G. Simon officer)
/s/ Paul J. Murphy Chief Financial Officer and Treasurer
- --------------------------- (principal financial and accounting officer)
Paul J. Murphy
* Director
- ---------------------------
Elizabeth B. Connell
* Director
- ---------------------------
David P. Fialkow
Director
- ---------------------------
Steven J. Gilbert
Director
- ---------------------------
Richard A. Sandberg
* Director
- ---------------------------
Thomas E. Tierney
*By: /s/ John G. Simon
-----------------
John G. Simon
Attorney-in-Fact
II-4
<PAGE>
EXHIBIT INDEX
Exhibit Description
------- -----------
*(4.4) Registration Rights Agreement
*(5) Opinion of Bingham, Dana & Gould LLP
*(23.1) Consent of Bingham Dana & Gould LLP (included as exhibit 5)
(23.2) Consent of Price Waterhouse LLP.
*(24) Power of Attorney (included on signature page).
*Previously filed.
Consent of Independent Accountants
We hereby consent to the incorporation by reference in the Prospectus
constituting part of this Registration Statement on Form S-3 of our report dated
February 8, 1996, which appears on page 28 of the 1995 Annual Report to
Stockholders of UroMed Corporation, which is incorporated by reference to UroMed
Corporation's Annual Report on Form 10-K for the year ended December 31, 1995.
We also consent to the incorporation by reference of our report on the Financial
Statement Schedule, which appears on page 32 of such Annual Report on Form 10-K.
We also consent to the references to us under the heading "Experts" in such
prospectus.
Price Waterhouse LLP
/s/ Price Waterhouse LLP
Boston, Massachusetts
May 24, 1996
