As filed with the Securities and Exchange Commission on July 13, 1998
Registration No. 333-
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
POSSIS MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Minnesota 41-0783184
(State or other jurisdiction (I.R.S Employer
of incorporation) Identification No.)
9055 Evergreen Boulevard N.W.
Minneapolis, Minnesota 55433
(612) 780-4555
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
Robert G. Dutcher Copy to:
President and Chief Executive Officer Amy E. Ayotte, Esq.
Possis Medical, Inc. Dorsey & Whitney LLP
9055 Evergreen Boulevard N.W. Pillsbury Center South
Minneapolis, Minnesota 55433 220 South Sixth Street
(612) 780-4555 Minneapolis, Minnesota 55402-1498
(Name, address, including zip code, and telephone number, including area
code, of agent for service)
Approximate date of commencement of proposed sale to the public: From time
to time after the effective date of this Registration Statement.
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, other than securities offered only in connection with dividend or interest
reinvestment plans, 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
Proposed Proposed
Title of Each Amount Maximum Maximum Amount of
Class of Securities to be Offering Price Aggregate Registration
to be Registered Registered* Per Share* Offering Price* Fee
Common Stock
($.40 par value) 18,750 $12.00 $225,000 $67
* Registration fee calculated pursuant to Rule 457 based on maximum
aggregate offering price of $225,000. Proposed Maximum Offering Price Per Share
represents the final sale price for the Common Stock on July 8, 1998 as reported
on the Nasdaq National Market.
The Registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the Registrant shall
file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
Subject to Completion, dated July 13, 1998
PROSPECTUS
POSSIS MEDICAL, INC.
____________________
18,750 Shares
of
Common Stock
($.40 par value)
____________________
This Prospectus relates to an aggregate of 18,750 shares (the "Shares") of
Common Stock, par value $.40 per share (the "Common Stock"), of Possis Medical,
Inc., a Minnesota corporation ("Possis" or the "Company"), that may be sold from
time to time by LAmed Vertriebs GmbH ("LAmed" or the "Selling Shareholder"). See
"Selling Shareholder." The Company will not receive any proceeds from the sale
of the Shares. The Company has agreed to pay the expenses of registration of the
Shares, including certain legal and accounting fees.
Any or all of the Shares may be offered from time to time in transactions
on the Nasdaq National Market, in brokerage transactions at prevailing market
prices or in transactions at negotiated prices. See"Plan of Distribution."
The Shares offered hereby have not been registered under the blue sky or
securities laws of any jurisdiction, and any broker or dealer should assure the
existence of an exemption from registration or effectuate such registration in
connection with the offer and sale of the Shares.
The Common Stock is traded on the Nasdaq National Market under the symbol
"POSS." On July 8, 1998, the last reported sale price of the Common Stock as
reported on the Nasdaq National Market was $12.00 per share.
____________________
For information concerning certain risks related to this offering,
see "Risk Factors" beginning on page 3 of this Prospectus.
____________________
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 person has been authorized to give any information or to make any
representations other than those contained in this Prospectus in connection with
the offer contained herein, and, if given or made, such information or
representations must not be relied upon as having been authorized by the
Company. This Prospectus does not constitute an offer to sell, or a solicitation
of an offer to buy, any securities offered hereby in any jurisdiction in which
it is not lawful or to any person to whom it is not lawful to make any such
offer or solicitation. Neither the delivery of this Prospectus nor any sale made
hereunder shall, under any circumstances, create any implication that
information herein is correct as of any time subsequent to the date hereof.
The date of this Prospectus is _____________ 1998.
[Information contained herein is subject to completion or amendment. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may not be sold nor may
offers to buy be accepted prior to the time the registration statement becomes
effective. This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of these securities
in any State in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securites laws of any such State.]
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files reports, proxy statements and other information with the
Securities and Exchange Commission (the "Commission"). Such reports, proxy
statements and other information filed by the Company can be inspected and
copied at the public reference facilities of the Commission at 450 Fifth Street,
N.W., Washington, D.C. 20549, and at the Commission's regional offices at 7
World Trade Center, Suite 1300, New York, New York 10048 and CitiCorp Center,
500 West Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such
materials can be obtained from the Public Reference Section of the Commission at
450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed rates. The
Commission maintains a Web site that contains reports, proxy and information
statements and other information regarding registrants that file electronically
with the Commission at (http://www.sec.gov). In addition, the Common Stock of
the Company is listed on the Nasdaq National Market, and reports, proxy
statements and other information concerning the Company can also be inspected at
the offices of the National Association of Securities Dealers, 1735 K. Street,
N.W., Washington, D.C. 20006. This Prospectus does not contain all the
information set forth in the Registration Statement and exhibits thereto which
the Company has filed with the Commission under the Securities Act of 1933, as
amended (the"Securities Act"), and to which reference is hereby made.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents of the Company, which have been filed with the
Commission, are hereby incorporated by reference in this Prospectus:
(a) the Company's Annual Report on Form 10-K for the fiscal year ended July
31, 1997;
(b) the Company's Quarterly Reports on Form 10-Q for the quarters ended
October 31, 1997, January 31, 1998 and April 30, 1998; and
(c) the descriptions of the Company's Common Stock and the Company's
Preferred Share Purchase Rights contained in any Registration Statement of the
Company filed under the Exchange Act, and any amendment or report filed for the
purpose of updating such descriptions.
All documents filed by the Company pursuant to Section 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 into this Prospectus and to be a part hereof from the
respective dates of filing of such documents. Any statement contained herein or
in a document all or part 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
subsequently filed document 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.
The Company will provide without charge to any person, including any
beneficial owner, to whom this Prospectus is delivered, upon the written or oral
request of such person, a copy of any or all of the foregoing documents
incorporated herein by reference (other than certain exhibits to such
documents). Requests for such copies should be directed to Irving R. Colacci,
Possis Medical, Inc., 9055 Evergreen Boulevard N.W., Minneapolis, Minnesota
55433, telephone number (612) 780-4555.
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<PAGE>
RISK FACTORS
This Prospectus, including the information incorporated herein by
reference, contains forward-looking statements as defined under the Private
Securities Litigation Reform Act of 1995, which are intended to qualify for the
"safe harbor" provision thereunder. Forward-looking statements represent the
Company's expectations or beliefs concerning future events. Possis cautions that
these statements are further qualified by important factors that could cause
actual results to differ materially from those projected in the forward-looking
statements as a result, in part, of the risk factors set forth below. In
connection with the forward-looking statements that appear in this Prospectus,
including the information incorporated herein by reference, prospective
purchasers of the Common Stock offered hereby should carefully review the
factors set forth below.
History of Operating Losses; No Assurance of Future Profitability
The Company has incurred losses for fiscal years 1995, 1996 and 1997, and
as of July 31, 1997, had a retained deficit of $26.2 million. For the year ended
July 31, 1995, the Company had a net operating loss of $5.6 million. For the
year ended July 31, 1996, the Company incurred a net operating loss of $9.9
million. The Company incurred a net operating loss of $9.6 million for the year
ended July 31, 1997, and a net operating loss for the nine months ended April
30, 1998 of $8.6 million. No assurance can be given that the Company will
operate profitably on a quarterly or annual basis in the future.
The Company does not expect to become profitable unless it achieves
significant sales in the United States and its products receive additional
United States Food and Drug Administration ("FDA") marketing approvals. There
can be no assurance that significant sales or additional marketing approvals
will occur. In addition, the Company must also convince health care
professionals, third party payors and the general public of the medical and
economic benefits of its AngioJet Rheolytic Thrombectomy System, Perma-Flow
Coronary Bypass Graft and Perma-Seal Dialysis Access Graft. However, no
assurance can be given that the Company will be successful in marketing the
AngioJet, Perma-Flow or Perma-Seal products, or that the Company will be able to
operate profitably on a consistent basis, even following FDA approval.
Limited Regulatory Approval for Company's Products; Government Regulation
The Company's products and its manufacturing activities are subject to
extensive and rigorous federal and state regulation in the United States and to
various regulatory requirements in other countries, including Japan. Regulatory
approvals, if granted, may include significant limitations on the indicated uses
for which a product may be marketed. In addition, the process of obtaining and
maintaining required regulatory approvals can be lengthy, expensive and
uncertain.
Current FDA enforcement policy strictly prohibits the marketing of approved
medical devices for unapproved uses. In addition, product approvals could be
withdrawn for failure to comply with regulatory standards or the occurrence of
unforeseen problems following initial marketing. The Company will be required to
adhere to applicable regulations setting forth Quality System Regulations
"QSR"), which include design, development, manufacturing, servicing, testing and
documentation requirements. Failure to comply with applicable QSR or other
regulatory requirements can result in, among other sanctions, fines, delays or
suspensions of approvals, injunctions against further distribution, seizures or
recalls of products, adverse publicity, operating restrictions and criminal
prosecutions. Furthermore, changes in existing regulations or adoption of new
regulations could prevent the Company from obtaining, or affect the timing of,
future regulatory approvals and could adversely affect the continued marketing
of the Company's existing products. No assurance can be given that the Company
will be able to obtain necessary regulatory approvals on a timely basis or at
all, and delays in receipt of or failure to receive such approvals, the loss of
previously received approvals, or failure to comply with regulatory requirements
would have a material adverse effect on the Company's business, financial
condition and results of operations.
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<PAGE>
Uncertainty of Clinical and Marketing Acceptance; Technology Uncertainty
Use of the AngioJet System for vascular, cardiovascular and intercranial
clots is new and only now becoming widely known. Similarly, use of the
Perma-Flow Graft in lieu of saphenous veins to perform coronary artery bypass
graft ("CABG") procedures is new and not yet widely known. Market acceptance of
the Company's AngioJet, Perma-Flow and Perma-Seal products will depend in large
part on the Company's ability to demonstrate to the medical community in
general, and to cardiac surgeons and cardiologists in particular, the efficacy,
relative safety and cost effectiveness of treating cardiovascular disease using
the Company's products and to train cardiac surgeons and cardiologists to
perform necessary procedures using the Company's products. There can be no
assurance that the Company's products will provide benefits considered adequate
by providers of cardiovascular and vascular treatments or that a sufficient
number of such providers will use the Company's products for commercial success
to be achieved. To date, the Company has trained only a limited number of
physicians and will need to expand its marketing and training capabilities.
Moreover, even if the Company's products become generally accepted by the
medical community, physicians trained in the use of the Company's products may
elect not to use or to recommend a competitor's products instead of the
Company's products. The ability of the Company to conduct such marketing
programs prior to FDA approval of the Company's products may be limited or
restricted by FDA regulations, guidelines or policies. No assurance can be given
that the Company's products will be accepted as an alternative to other existing
or new therapies, or that cardiologists, cardiac surgeons or other physicians
will accept AngioJet, Perma-Flow or Perma-Seal products as appropriate courses
of treatment for their patients. Lack of clinical and market acceptance would
have a material adverse effect on the Company's business, financial condition
and results of operations.
Dependence on AngioJet Products
The Company is focusing its resources on the continued development and
refinement of its AngioJet System. If the Company is unable to obtain requisite
regulatory approvals or to achieve commercial acceptance of the AngioJet System
for multiple purposes, the Company's business, financial condition and results
of operations will be materially and adversely affected.
Rapid Technological Change and Intense Competition
The medical products market is characterized by rapidly evolving technology
and intense competition. The future success of the Company will depend on its
ability to keep pace with advancing technology and competitive innovations. Many
potential competitors have significantly greater research and development
capabilities, experience in obtaining regulatory approvals, established
marketing and financial and managerial resources than the Company. Additionally,
many potential competitors have developed or are in the process of developing
technologies that are, or in the future may be, the basis for competitive
products, some of which may employ an entirely different approach or means of
accomplishing the desired therapeutic effect than products being developed by
the Company.
The Company believes that its AngioJet System will face intense competition
from a variety of treatments for the ablation and removal of blood clots,
including thrombolytic drug therapies, surgical intervention, balloon
embolectomy, mechanical and laser thrombectomy devices, ultrasound ablators, and
other thrombectomy devices based on waterjet systems that are currently being
developed by other companies. The Company is aware of a small number of
synthetic grafts being developed that could compete with the Perma-Flow Graft.
However, the Company believes it is the first developer to obtain FDA approval
for U.S. clinical trials with a synthetic coronary bypass graft and the first to
obtain CE Mark approval for marketing such a product in Europe. The Company's
Perma-Seal Graft will compete with ePTFE grafts and other synthetic grafts with
needle sealing properties.
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<PAGE>
Many of the companies manufacturing these devices have substantially
greater capital, as well as greater research and development, regulatory,
manufacturing and marketing resources and experience than the Company and
represent significant competition for the Company. Such companies may succeed in
developing products that are more effective and/or less costly in treating
thrombosis than the AngioJet System and more effective and/or less costly than
the Perma-Flow and Perma-Seal grafts. Further, these companies may be more
successful than the Company in manufacturing and marketing their products. No
assurance can be given that the Company's competitors or others will not succeed
in developing technologies, products or procedures that are more effective or
less invasive than any being developed by the Company or that would render the
Company's technology and products obsolete or noncompetitive. The advent of new
devices, procedures or new pharmaceutical agents could hinder the Company's
ability to compete effectively and have a material adverse effect on its
business, financial condition and results of operations.
Reliance Upon Patents and Proprietary Rights
The Compan's success depends and will continue to depend in part on its
ability to maintain patent protection for products and processes, to preserve
its trade secrets and to operate without infringing the proprietary rights of
third parties. The Company's policy is to attempt to protect its technology by,
among other things, filing patent applications for technology that it considers
important to the development of its business. The Company currently holds five
United States patents and 18 foreign patents related to the Perma-Flow Graft and
has two patent applications pending in the United States and two patent
applications pending in foreign jurisdictions. The Company also holds two United
States patents relating to the AngioJet System. In addition, the Company has ten
United States and numerous foreign patent applications pending relating to the
AngioJet System. Two AngioJet System patent applications have been accepted by
the European Patent Office. In connection with the Perma-Seal Graft, two United
States patents are pending and four foreign patent applications are pending. The
validity and breadth of claims covered in medical technology patents involve
complex legal and factual questions and, therefore, may be highly uncertain. No
assurance can be given that the Company's pending applications will result in
patents being issued or, if issued, that such patents, or the Company's existing
patents, will provide a competitive advantage, or that competitors of the
Company will not design around any patents issued to the Company. In addition,
no assurance can be given that third parties will not receive patent protection
on their own waterjet devices.
The Company has acquired rights through licensing agreements to patents
relating to processes used in the manufacture of the Perma-Seal Graft. Under
these agreements, Possis is required to pay certain annual fees and royalties
based on net sales of products using the technology covered by these patents.
The Company requires all its employees to execute non-disclosure agreements
upon commencement of employment with the Company. These agreements generally
provide that all confidential information developed or made known to the
individual by the Company during the course of the individual's employment with
the Company is to be kept confidential and not disclosed to third parties. There
can be no assurance, however, that the Company's non-disclosure agreements and
other safeguards will protect its proprietary information and know-how or
provide adequate remedies for the Company in the event of unauthorized use or
disclosure of such information, or that others will not be able to independently
develop such information. In addition, others may hold or receive patents which
contain claims that may cover products developed by the Company.
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<PAGE>
The Company also relies upon unpatented proprietary technology and trade
secrets that it seeks to protect, in part, through confidentiality agreements
with employees and other parties. No assurance can be given that these
agreements will not be breached, that the Company will have adequate remedies
for any breach, that others will not independently develop or otherwise acquire
substantially equivalent proprietary technology and trade secrets or disclose
such technology or that the Company can meaningfully protect its rights in such
unpatented technology. Any disclosure of such information could have a material
adverse effect on the Company's business, financial condition and results of
operations.
There has been substantial litigation regarding patent and other
intellectual property rights in the medical device industry. Litigation, which
could result in substantial cost to and diversion of effort by the Company, may
be necessary to enforce patents issued to the Company, to protect trade secrets
or know-how owned by the Company, to defend the Company against claimed
infringement of the rights of others to determine the ownership, scope or
validity of the proprietary rights of the Company and others. An adverse
determination in any such litigation could subject the Company to significant
liabilities to third parties, could require the Company to seek licenses from
third parties and could prevent the Company from manufacturing, selling or using
its products, any of which could have a material adverse effect on the Company's
business, financial condition and results of operations.
Potential Limitations on Third-Party Reimbursement
Health care providers, such as hospitals and physicians, that purchase
medical devices such as the AngioJet System or the Perma-Seal and Perma-Flow
Grafts for use on their patients generally rely upon third party payors, such as
Medicare, Medicaid and private insurance plans, to reimburse all or part of the
costs and fees associated with the health care services provided to their
patients. Medicare and Medicaid payors (in some states) determine whether to
provide coverage for a particular procedure and reimburse hospitals for
inpatient medical procedures at a prospectively determined rate according to
diagnosis related groups ("DRGs"). The Health Care Financing Administration (the
"HCFA"), the agency responsible for administering the Medicare system, has
prohibited Medicare coverage for procedures that are not deemed safe and
effective for the condition being treated, or which are still investigational.
Even if a device has FDA approval, Medicare payors may deny reimbursement if
they conclude that the device is experimental or used for an unimproved
indication. In certain foreign markets, pricing or profitability of health care
products is subject to government control. Reimbursement levels with respect to
a medical products such as those of the Company are critical for the market
acceptance of the product and the financial results of its manufacturer. The
market for the Compan's products could also be adversely affected by future
legislation to reform the nation's health care system or by changes in industry
practices regarding reimbursement policy and procedures. There can be no
assurance that adequate third party coverage will be available for the Company
to maintain price levels for its products sufficient to realize an appropriate
return on its investment in product development.
Dependence Upon Key Personnel
The Company is highly dependent on a limited number of key management and
technical personnel. In addition, the highly technical nature of the Company's
business, its ability to continue its technological developments and to market
its products and thereby develop a competitive edge in the marketplace depends,
in large part, on its ability to attract and maintain qualified technical and
key management personnel. Competition for such personnel is intense, and no
assurance can be given that the Company will be able to attract and retain such
personnel. The loss of key personnel, or inability to hire or retain qualified
personnel, could have a material adverse effect on the Company's business,
financial condition and results of operations.
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<PAGE>
Product Liability and Possible Insufficiency of Insurance
The manufacture and sale of the Company's products entail the risk of
product liability claims. A recent United States Supreme Court decision held
that despite a company's compliance with FDA regulations, it still may not be
shielded from common-law negligent design claims or manufacturing and labeling
claims based on state rules. No assurance can be given that the coverage limits
of the Company's product liability insurance policies will be adequate. Such
insurance is expensive and in the future may not be available on acceptable
terms, if at all. A successful claim or series of claims brought against the
Company in excess of its insurance coverage, and the effect any product
liability litigation may have upon the reputation and marketability of the
Company's technology and products, together with diversion of the attention of
the Company's key personnel, could have a material adverse effect on the
Company's business, financial condition and results of operations.
Future Capital Needs; Uncertainty of Additional Funding
The Company is currently evaluating its options for raising capital and
will seek to raise additional capital in fiscal 1998. In the future, the Company
may be required to raise additional funds. No assurance can be given that
additional capital will be available to the Company or that capital, if any,
will be available upon satisfactory terms. Any additional equity financings may
be dilutive to purchasers in this offering, and any debt financing may involve
restrictive covenants. Failure to secure additional financing if and when needed
could adversely affect the Company and its operations.
Volatile Securities Market Factors and Possible Wide Fluctuations in Stock Price
The market price of the Company's stock has in the past been subject to
significant fluctuations. Moreover, the markets for equity security in general,
and for those of medical device manufacturers in particular, have been volatile,
and the price of the Company's common stock in the future could be subject to
wide fluctuations in response to quarterly variations in operating results, news
and product announcements, trading volume, general market trends and other
factors. No assurance can be given that the Company's common stock will trade in
the future at market prices in excess of its current market price.
Anti-Takeover Provisions
Of the 100 million shares of capital stock authorized under the Company's
Amended and Restated Articles of Incorporation, the Company has 79 million
undesignated shares, which shares the Board of Directors may issue on such
terms, and with such rights, preferences and designations, as the Board of
Directors may determine, without further shareholder action. In addition, the
Company has adopted a shareholder rights plan, which provides for the exercise
of preferred share purchase rights when a person has become, subject to certain
exceptions, the beneficial owner of 15% or more of the outstanding Common Stock.
The Company is also subject to certain provisions of the Minnesota Business
Corporation Act that limit the voting rights of shares acquired in certain
acquisitions and restrict certain business combinations. The existence or
issuance of "blank check" stock, the existence of the shareholder rights plan
and the effect of anti-takeover provisions under Minnesota law, individually or
in the aggregate, may have the effect of discouraging potential takeover
attempts and of delaying, deferring, or preventing a change in control of the
Company or making removal of management more difficult, which could deprive the
Company's shareholders of opportunities to sell their shares of Common Stock at
prices higher than prevailing market prices.
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Dependence on Single Source Suppliers
The Company depends on single source suppliers for certain of the raw
materials used in the manufacture of its graft products. In the event the
Company must obtain alternative sources for key raw materials, there can be no
assurance that such materials will be available for purchase from alternative
suppliers, that alternative suppliers will agree to supply the Company, or that
the Company's use of such suppliers would be approved by the FDA. Although the
Company currently has an adequate supply of raw materials and believes it will
be adequate for the needs of its graft business, there can be no assurance that
new sources of supply will be available when necessary. Any interruption in
supply of raw materials could have a material adverse effect on the Company's
ability to manufacture its products until a new source of supply is located and,
therefore, could have a material adverse effect on its business, financial
condition and results of operations.
Non-Payment of Dividends
The Company has never paid cash dividends on its common stock. The Company
currently intends to retain all future earnings, if any, for use in its business
and does not anticipate that cash dividends will be paid in the foreseeable
future.
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<PAGE>
POSSIS MEDICAL, INC.
General
Possis Medical, Inc. develops, manufactures and markets innovative medical
products that assist surgeons and interventionalists in treating cardiovascular
or vascular diseases or conditions requiring vascular intervention. Currently,
the Company's products -- the AngioJet Rheolytic Thrombectomy System, Perma-Flow
Coronary Bypass Graft and Perma-Seal Dialysis Access Graft -- are in clinical
trials in the United States and in early stages of commercialization in Europe,
Japan and Canada.
The Company's AngioJet Rheolytic Thrombectomy System utilizes a disposable
catheter that delivers pressurized saline jets to remove blood clots in a rapid
and minimally invasive manner. The development of blood clots in various
segments of the vascular system is common and is one of the leading causes of
morbidity and death. Possis believes that its AngioJet System represents a novel
approach to the removal of blood clots from arteries, veins and grafts and
offers certain potential advantages over the current primary methods of
treatment -- thrombolytic drugs and mechanical devices. In early stages of
commercialization and in U.S. clinical trials, the AngioJet System has
demonstrated the ability to remove blood clots within seconds to minutes without
surgical intervention and without the risk of uncontrolled bleeding. A Phase I
clinical trial involving the use of the AngioJet System for removing blood clots
from peripheral arteries and vascular grafts was completed in March 1994. On
December 6, 1996 the Company received United States Food and Drug Administration
("FDA") clearance to commence U.S. marketing of the AngioJet System with
labeling claims for removal of blood clots from grafts used by patients on
kidney dialysis. In July 1997, the Company plans to submit a 510(k) application
to the FDA seeking clearance to expand label claims for its AngioJet System to
include use in peripheral arteries and bypass grafts in the U.S. The Company
expects an FDA decision on the application in 1998.
In March 1996, Possis received FDA approval to initiate Phase 2 clinical
testing of its AngioJet System for use in removing blood clots from coronary
arteries and bypass grafts. In May 1998, the FDA agreed to permit unblinding the
Compan's Vegas 2 Coronary AngioJet U.S. clinical trial results. These important
clinical results, involving over 300 patients, showed the AngioJet System to be
much faster than urokinase, removing blood clots in minutes versus the hours
required by urokinase. In addition, the AngioJet System typically achieved more
complete thrombus removal than urokinase, caused fewer adverse events and
resulted in lower treatment costs. The Company plans to file an AngioJet System
510(k) application with the FDA in late July seeking U.S. marketing clearance
for artery and bypass graft blood clot removal. The Company believes that the
coronary application of the AngioJet System will be subject to a premarket
approval ("PMA") process and anticipates filing a PMA application with the FDA
in the second half of 1998.
In December 1997, the Company received approval to commence a clinical
study of the AngioJet System for use in the treatment of stroke caused by
blockage of the carotid arteries, the main vessels supplying blood to the brain.
The Company believes that the treatment of stroke is a significant marketing
opportunity for the AngioJet System.
The Perma-Flow Coronary Bypass Graft is a synthetic graft that acts as a
substitute for native blood vessels used in coronary artery bypass surgery,
which is performed to treat the impairment of blood flow to portions of the
heart. The Perma-Flow Graft is intended initially to provide an alternative to
patients with insufficient or inadequate native vessels for use in bypass
surgery. The Company believes that the Perma-Flow Graft may ultimately be used
as a substitute for native saphenous veins, thus avoiding the trauma and expense
associated with the surgical harvesting of native veins. The Perma-Flow Graft is
currently in Phase 2 clinical trials in the United States, and an interim
analysis of the results continues to show use of the Perma-Flow Graft to be safe
in patients who require bypass surgery but who have inadequate native vessels to
complete all of the bypasses needed. Other clinical indicators, such as
reduction in angina and improved heart function classifications, also continue
to demonstrate that patients experience clinical benefits from Graft use. On May
4, 1998, the Company received a Humanitarian Device Exemption (HDE) from the FDA
for U.S. marketing of the Perma-Flow Graft. This exemption will allow the
Company to market the product in the U.S. for patients who require coronary
bypass surgery but who have inadequate blood vessels of their own for use in the
surgery while the Company completes the U.S. clinical study and PMA registration
designed to provide broad marketing approval. The Company currently anticipates
filing a PMA application for marketing authorization for the Perma-Flow Graft in
the U.S. in 2000.
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<PAGE>
The Perma-Seal Graft is a self-sealing synthetic graft used as a point of
vascular access in kidney dialysis patients. The Company believes that its
Perma-Seal Graft may offer advantages over currently used synthetic grafts
because of its needle hole sealing capability. The Company believes that this
characteristic will be effective in sealing puncture sites in the grafts with
minimal compression time and bleeding as compared with other currently available
graft products and, as a result, will reduce dialysis procedure and
administrative time per patient and the costs associated therewith. In addition,
because of its ability to seal a needle puncture without depending on tissue
ingrowth, the Perma-Seal Graft may provide an option for patients who require
dialysis immediately after implant. In May 1997, the Company completed its
enrollment for the Perma-Flow Graft clinical trials in the U.S. The Company
filed a 510(k) application for marketing authorization with the FDA in August
1994 and responded to a request for additional information from the FDA in
August 1995. In November 1995, the FDA responded to the 510(k) with additional
questions and in February 1996, the FDA told the Company it wanted to see data
on 124 study patients followed for 12 months. In August 1997, the Company
resubmitted its 510(k) application, and at its April 23, 1998 meeting to review
the 510(k) application, an FDA Circulatory Systems Advisory Panel made
recommendations on appropriate labeling for market release of the product. The
Company anticipates a final FDA decision by the end of fiscal 1998.
The Company's objective is to become a leading supplier of innovative
medical products for the treatment of cardiovascular or vascular diseases or
conditions. The Company will pursue its strategy by seeking to demonstrate the
safety and efficacy of its products, developing relationships with leading
clinicians, establishing world-class manufacturing processes and rapidly
commercializing its products. In addition, Possis intends to expand its product
portfolio by applying its existing product technology to additional
cardiovascular or vascular treatment needs, by developing new product technology
and, in some cases, by using existing product technology in non-vascular
applications. In January 1998 the Company engaged Salomon Smith Barney to assist
in the development and implementation of a strategic plan designed to maximize
the value of the Company's vascular graft business.
The Company's executive offices are located at 9055 Evergreen Boulevard
N.W., Minneapolis, Minnesota 55433. Its telephone number is (612) 780-4555.
SELLING SHAREHOLDER
The Selling Shareholder and the Company entered into a distribution
agreement pursuant to which the Selling Shareholder was granted distribution
rights in Germany for all Company products. The distribution rights for
Perma-Flow and Perma-Seal graft products were subsequently terminated, and LAmed
was granted an option to purchase 25,000 shares of Common Stock. In February
1997, the Company terminated the distribution agreement entirely. LAmed
commenced litigation against the Company alleging that such termination violated
the terms of the distribution agreement. In June 1998, the Company settled the
dispute with LAmed by agreeing to issue to LAmed such number of shares of Common
Stock as determined by dividing $225,000 by the last sale price of the Common
Stock (as reported by the Nasdaq National Market) on the last trading day prior
to the date of this Prospectus.
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<PAGE>
The following table sets forth the number of shares of Common Stock
beneficially owned by the Selling Shareholder as of the date of this Prospectus
and the maximum number of Shares that may be sold by the Selling Shareholder
pursuant to this Prospectus. Because the Selling Shareholder may offer all, some
or none of its Common Stock, no definitive estimate as to the number of shares
that will be held by the Selling Shareholder after such offering can be
provided, and the following table has been prepared on the assumption that all
shares of Common Stock covered by this Prospectus will be sold. The Selling
Shareholder has sole voting and sole investment power with respect to all shares
beneficially owned.
Number of
Shares Owned Number of Number of
Prior to the Shares Offered Shares Owned
Name Offering Hereby After the Offering
LAmed Vertriebs GmbH 43,750 18,750 25,000
The Selling Shareholder acquired the 18,750 shares of Common Stock owned by
it and offered hereby in connection with the settlement reached with the Company
in July 1998. The additional shares of Common Stock represent shares issuable
upon the exercise of the currently exercisable option granted to the Selling
Shareholder in connection with the distribution agreement described above.
PLAN OF DISTRIBUTION
The Shares will be offered and sold by the Selling Shareholder for its own
account. The Company will not receive any proceeds from the sale of the Shares
pursuant to this Prospectus. The Company has agreed to pay the expenses of
registration of the Shares, including a certain amount of legal and accounting
fees.
The Selling Shareholder may offer and sell the Shares from time to time in
transactions on the Nasdaq National Market, in brokerage transactions at
prevailing market prices or in transactions at negotiated prices. Sales may be
made to or through brokers or dealers who may receive compensation in the form
of discounts, concessions or commissions from the Selling Shareholder or the
purchasers of Shares for whom such brokers or dealers may act as agent or to
whom they may sell as principal, or both.
The Selling Shareholder and any brokers or dealers acting in connection
with the sale of the Shares hereunder may be deemed to be "underwriters" within
the meaning of Section 2(11) of the Securities Act, and any commissions received
by them and any profit realized by them on the resale of Shares as principals
may be deemed underwriting compensation under the Securities Act.
EXPERTS
The financial statements and the related financial statement schedule
incorporated in this Prospectus by reference from the Company's annual report on
Form 10-K for the year ended July 31, 1997 have been audited by Deloitte &
Touche, independent auditors, as stated in their report which is incorporated
herein by reference and have been so incorporated in reliance upon the report of
such firm given upon their authority as experts in accounting and auditing.
LEGAL MATTERS
The validity of the Shares offered hereby has been passed upon for the
Company by Dorsey & Whitney LLP, 220 South Sixth Street, Minneapolis, Minnesota
55402.
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<PAGE>
No dealer, salesperson or any other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus, and, if given or made, such information or representations must not
be relied upon as having been authorized by the Company, the Selling Shareholder
or any other person. This Prospectus does not constitute an offer to sell or a
solicitation of an offer to buy to any person in any jurisdiction in which such
offer or solicitation would be unlawful or to any person to whom it is unlawful.
Neither the delivery of this Prospectus nor any offer or sale made hereunder
shall, under any circumstances, create any implication that there has been no
change in the affairs of the Company or that the information contained herein is
correct as of any time subsequent to the date hereof.
__________
TABLE OF CONTENTS
Page
Available Information.......................... 2
Incorporation of Certain Documents
By Reference.............................. 2
Risk Factors................................... 3
Possis Medical, Inc............................ 9
Selling Shareholder............................ 10
Plan of Distribution........................... 11
Experts........................................ 11
Legal Matters.................................. 11
18,750 Shares
POSSIS MEDICAL, INC.
Common Stock
____________
PROSPECTUS
____________
, 1998
<PAGE>
PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth estimated expenses payable by the Company in
connection with the offering and sale of the Common Stock being registered
hereunder.
Commission Registration Fee.......................$ 67
Accounting Fees and Expenses...................... 2,000
Legal Fees and Expenses........................... 5,000
Miscellaneous .................................... 933
Total....................................$ 8,000
All fees and expenses other than the Commission registration fee are
estimated. All expenses listed above will be paid by the Company.
Item 15. Indemnification of Officers and Directors
Unless prohibited in a corporation's articles or bylaws, Minnesota Statutes
302A.521 requires indemnification of officers, directors, employees and agents,
under certain circumstances, against judgments, penalties, fees, settlements and
reasonable expenses (including attorney's fees and disbursements) incurred by
such person in connection with a threatened or pending proceeding with respect
to the acts or omissions of such person in his or her official capacity. The
general effect of Minnesota Statutes 302A.521 is to reimburse (or pay on behalf
of) directors and officers of the Company any personal liability that may be
imposed for certain acts performed in their capacity as directors and officers
of the Company, except where such persons have not acted in good faith. The
Bylaws of the Company provide for such indemnification to the maximum extent
permitted by Minnesota Statutes.
In addition, the officers and directors of the Company have entered into
indemnification agreements with the Company, and the Company maintains an
insurance policy to assist in funding indemnification of directors and officers
for certain liabilities.
Item 16. List of Exhibits
4.1 Rights Agreement, dated as of December 12, 1996, between the Company
and Norwest Bank Minnesota, National Association, including the Form of Right
Certificate attached as Exhibit B thereto (incorporated by reference to Exhibit
1 to the Company's Registration Statement on Form 8-A filed December 12, 1996)
5.1 Opinion of Dorsey & Whitney LLP
23.1 Consent of Deloitte & Touche LLP
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit5.1 to this
Registration Statement)
24.1 Power of Attorney
II-1
<PAGE>
Item 17. Undertakings
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 the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change to such information in the registration statement.
Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) under the Securities Act if,
in the aggregate, the changes in volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective 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 in the information set forth in the registration statement;
Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if
the registration statement is on Form S-3 or Form S-8, and the information
required to be included in a post-effective amendment by those paragraphs is
contained in periodic reports filed 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.
(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.
The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's 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
plan's 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.
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
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-2
<PAGE>
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 Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Minneapolis, State of Minnesota, on July 13, 1998.
POSSIS MEDICAL, INC.
By /s/ Robert G. Dutcher
Robert G. Dutcher
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the date indicated.
Name Title Date
/s/ Robert G. Dutcher President, Chief Executive Officer July 13, 1998
Robert G. Dutcher and Director
(Principal Executive Officer)
/s/ Russel E. Carlson Vice President, Finance and Chief July 13, 1998
Russel E. Carlson Financial Officer
(Principal Financial and Accounting Officer)
* Chairman of the Board
Donald C. Wegmiller
* Director
Dean Belbas
* Director
Seymour J. Mansfield
* Director
Demetre Nicoloff, MD
* Director
Ann M. Possis
*By: /s/ Robert G. Dutcher July 13, 1998 Robert G. Dutcher
Attorney-in-fact**
__________
** Executed on behalf of the indicated persons by
Robert G. Dutcher pursuant to the Powers of Attorney included as Exhibit 24.1 to
this registration statement.
II-4
<PAGE>
EXHIBIT INDEX
Exhibit
No. Description
5.1 Opinion of Dorsey & Whitney LLP
23.1 Consent of Deloitte & Touche LLP
23.2 Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)
24.1 Power of Attorney
II-5
<PAGE>
Exhibit 5.1
[Letterhead of Dorsey & Whitney LLP]
DORSEY & WHITNEY LLP
Pillsbury Center South
220 South Sixth Street
Minneapolis, Minnesota 55402-1498
Telephone: (612) 340-2600
Fax: (612) 340-2868
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, Minnesota 55433
Re: Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as counsel to Possis Medical, Inc., a Minnesota corporation
(the "Company"), in connection with a Registration Statement on Form S-3 (the
"Registration Statement") to be filed with the Securities and Exchange
Commission under the Securities Act of 1933, as amended, relating to the sale of
up to 18,750 shares of common stock of the Company, par value $.40 per share
("Common Stock"), all of which shares will be sold from time to time by the
Selling Shareholder named in the Registration Statement, on the Nasdaq National
Market or otherwise, directly or through underwriters, brokers or dealers.
We have examined such documents and have reviewed such questions of law as
we have considered necessary and appropriate for the purposes of our opinions
set forth below.
In rendering our opinions set forth below, we have assumed the authenticity
of all documents submitted to us as originals, the genuineness of all signatures
and the conformity to authentic originals of all documents submitted to us as
copies. We have also assumed the legal capacity for all purposes relevant hereto
of all natural persons and, with respect to all parties to agreements or
instruments relevant hereto other than the Company, that such parties had the
requisite power and authority (corporate or otherwise) to execute, deliver and
perform such agreements or instruments, that such agreements or instruments have
been duly authorized by all requisite action (corporate or otherwise), executed
and delivered by such parties and that such agreements or instruments are the
valid, binding and enforceable obligations of such parties. As to questions of
fact material to our opinions, we have relied upon certificates of officers of
the Company and of public officials.
Based on the foregoing, we are of the opinion that the shares of Common
Stock to be sold by the Selling Shareholder pursuant to the Registration
Statement have been duly authorized by all requisite corporate action, and are
validly issued, fully paid and nonassessable.
Our opinions expressed above are limited to the laws of the State of
Minnesota.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement, and to the reference to our firm under the heading
"Legal Matters" in the Prospectus constituting part of the Registration
Statement.
Date: July 13, 1998
Very truly yours,
/s/ Dorsey & Whitney LLP
AEA
<PAGE>
Exhibit 23.1
INDEPENDENT AUDITORS' CONSENT
We consent to the incorporation by reference in this Registration Statement
of Possis Medical, Inc. on Form S-3 relating to the sale of 18,750 shares of
common stock of our report, dated August 29, 1997 on the 1997 financial
statements and related financial statement schedule, appearing in the Annual
Report on Form 10-K of Possis Medical, Inc. for the year ended July 31, 1997 and
to the reference to us under the heading "Experts" in the Prospectus, which is
part of this Registration Statement.
Deloitte & Touche LLP
Minneapolis, Minnesota
July 10, 1998
<PAGE>
Exhibit 24.1
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints Robert G. Dutcher and Russel E.
Carlson, and each of them, the undersigne's true and lawful attorneys-in-fact
and agents, with full power of substitution and resubstitution, for the
undersigned and in his or her name, place and stead, in any and all capacities
(including the undersigned's capacity as a director and/or officer of Possis
Medical, Inc.), to sign a Registration Statement on Form S-3 of Possis Medical,
Inc. ("Possis") to be filed under the Securities Act of 1933 for the
registration of the resale of shares of Common Stock of Possis by LAmed
Vertriebs GmbH (the number of shares to be covered by such Registration
Statement to be determined by dividing $225,000 by the market price of the
Common Stock on the date prior to the effectiveness thereof), and any and all
amendments (including post-effective amendments) to such Registration Statement,
and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to
do and perform each and every act and thing requisite and necessary to be done
in about the premises, as fully to all intents and purposes as the undersigned
might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents or any of them, or their substitutes, may lawfully
do or cause to be done by virtue hereof.
Name Title Date
/s/ Donald C. Wegmiller Chairman of the Board July 13, 1998
Donald C. Wegmiller
/s/ Dean Belbas Director July 13, 1998
Dean Belbas
/s/Seymour J. Mansfield Director July 13, 1998
Seymour J. Mansfield
/s/ Demetre Nicoloff, MD Director July 13, 1998
Demetre Nicoloff, MD
/s/Ann M. Possis Director July 13, 1998
Ann M. Possis
/s/ Robert G. Dutcher President, Chief Executive July 13, 1998
Robert G. Dutcher Officer and Director
/s/ Russel E. Carlson Vice President of Finance and July 13, 1998
Russel E. Carlson Chief Financial Officer
