PROSPECTUS
POSSIS MEDICAL, INC.
____________________
3,332,278 Shares
of
Common Stock
($.40 par value)
____________________
This Prospectus relates to the offer and sale from time to time by certain
persons listed under the caption "Selling Shareholders" (collectively, the
"Selling Shareholders") of (i)up to an aggregate of 3,332,278 shares
(collectively, the "Share") of common stock, par value $.40 per share (the
"Common Stock"), of Possis Medical, Inc., a Minnesota corporation ("Possis" or
the "Company"), and (ii)in accordance with Rule 416 under the Securities Act of
1933, as amended (the "Securities Act"), such indeterminate number of additional
shares as may be required to effect conversion of the Company's SeriesA 5%
Convertible Debentures Due July 15, 2004 (the "Debentures") and the payment of
interest thereon or the exercise of the warrants (the "Warrants") issued in
connection with the Debentures, in each case to prevent dilution resulting from
stock splits, stock dividends or similar events, or by reason of changes in the
conversion price of the Debentures or the exercise price of the Warrants. See
"Selling Shareholders" and "Plan of Distribution." 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.
Certain of the Selling Shareholders currently hold the Debentures and the
Warrants, which are convertible into or exercisable for the Shares offered
hereby. See "Incorporation of Certain Documents by Reference" and "Selling
Shareholders." Neither the Debentures nor the Warrants themselves have been
registered under the Securities Act of 1933, as amended, and this Prospectus
does not relate to the offer or sale of either the Debentures or the Warrants.
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 August11, 1998, the last reported sale price of the Common Stock as
reported on the Nasdaq National Market was $ 9.4375 per share.
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For information concerning certain risks related to this offering, see
"Risk Factors" beginning on page 3 of this Prospectus.
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<PAGE>
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 August 21, 1998.
<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 7World
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
October31, 1997, January 31, 1998 and April 30, 1998;
(c) the Company's Current Report on Form 8-K filed on July24, 1998; and
(d) 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.
<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 July31, 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.
<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 Compan'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.
<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 Company'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.
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.
<PAGE>
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 Company'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.
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 anticipates that cash on hand, interest expected to be earned
thereon and anticipated revenues will be sufficient to finance the Company's
operations for at least the next six to twelve months, although there can be no
assurance that additional capital will not be required sooner. 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 securities 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.
<PAGE>
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 Compan'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.
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 AngioJet System is marketed in the United States for
treatment of dialysis access graft thrombosis.
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 August 1998, 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 of
the Company's Vegas 2 Coronary AngioJet U.S. clinical trial results. These
important clinical results, involving approximately 350 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 Premarket Approval ("PMA") application with the FDA in August
1998 seeking U.S. marketing approval for artery and coronary bypass graft blood
clot removal.
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.
Patient enrollment in the study is expected to begin in August 1998. The Company
believes that the treatment of stroke is a significant marketing opportunity for
the AngioJet System.
<PAGE>
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.
The Perma-Seal Dialysis Access 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 provides 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 mid-August, 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.
<PAGE>
<TABLE>
SELLING SHAREHOLDERS
The following table sets forth the names of the Selling Shareholders, the
principal amount of the Debentures issued, the number of shares of Common Stock
owned prior to the offering, the number of Shares that may be offered for sale
pursuant to this Prospectus and the number of Warrants or other warrants held as
of July 31, 1998.
The Company has agreed to register initially 3,332,278 shares for resale by
the Selling Shareholders holding the Debentures and the Warrants as well as
other warrants. The number of Shares shown as being offered by the Selling
Shareholders that hold the Debentures and Warrants does not include such
indeterminate number of shares as may be required to effect conversion of the
Debentures and the payment of interest thereon or exercise of the Warrants, in
each case to prevent dilution resulting from stock splits, stock dividends or
similar events, or by reason of changes in the conversion price of the
Debentures or the exercise price of the Warrants, but which shares are, in
accordance with Rule 416 under the Securities Act, included in the Registration
Statement of which this Prospectus forms a part.
<CAPTION>
Principal Number of Number of
Amount of Shares Number of Shares
Debentures Owned Shares Owned
Held Prior to Prior to the Ofered After the
Name the Offering(1) Offering Warrants Hereby(7) Offering(8)
<S> <C> <C> <C> <C> <C>
Brown Simpson Strategic
Growth Fund, L.P.......... $ 700,000(2) 47,330(1)(3) 4,354(4)(6) 185,283(6) 0
Brown Simpson Strategic
Growth Fund, Ltd.......... 1,300,000(2) 87,898(1)(3) 8,086(4)(6) 344,097(6) 0
Westover Investments, L.P.... 1,200,000 81,136(1)(3) 11,064(4) 321,228 0
Montrose Investments, Ltd.... 2,800,000 189,318(1)(3) 25,816(4) 749,532
Lehman Brothers, Inc......... 3,000,000(2) 202,840(1)(3) 33,660(4)(6) 809,069(6) 0
Bay Harbor Investments, Inc.. 3,000,000 202,840(1)(3) 27,660(4) 803,069 0
John G. Kinnard & Co......... N/A 1,615 120,000(5) 120,000 1,615
Total..................... $12,000,000 812,977 230,640 3,332,278 1,615
</TABLE>
_______________
(1) The Debentures, in the aggregate principal amount of $12,000,000, were
issued to certain of the Selling Shareholders pursuant to a Convertible
Debenture Purchase Agreement, dated as of July14, 1998, and are convertible into
shares of Common Stock. The price at which the Debentures may be converted and
the maximum number of shares available for conversion may vary depending on the
date of the conversion and the trading price of the Common Stock prior to
conversion. Between July15, 1998 and for a period of 180 days thereafter, the
Debentures are convertible, at the option of the holder thereof, at a price of
$14.79 per share. Between the 181st day and 365th day following July 15, 1998
(the "Second Period"), the Debentures are convertible, at the option of the
holder thereof, at the lesser of $14.79 or the average of the closing bid prices
for any 10 consecutive trading days selected by the holder during a look-back
period consisting of 30 consecutive trading days prior to the date of conversion
(such lesser amount, the "Conversion Price"), subject to a maximum number of
shares of Common Stock available for such conversion equal to the amount
obtained by dividing (x) the total principal amount of Debentures held by such
purchaser on the first day of the Second Period by (y) 50% of the average
closing bid price for the 10 trading days immediately preceding the commencement
of the Second Period (the "Initial Maximum Share Number"). From and after the
366th day following July 15, 1998 (the "Third Period"), the Debentures are
convertible, at the option of the holder thereof, at the Conversion Price,
subject to a maximum number of shares of Common Stock available for such
conversion (minus any shares of Common Stock received by the purchaser upon
conversion of Debentures during the Second Period) equal to the greater of (i)
the amount obtained by dividing (x) the total principal amount of Debentures
held by such purchaser on the first day of the Second Period by (y) 50% of the
average closing bid price of the Common Stock for the 5 trading days immediately
preceding the commencement of the Third Period, and (ii) the Initial Maximum
Share Number. The Debentures are subject to certain conversion restrictions; for
example, holders of the Debentures may not convert to the extent that such
conversion would result in the holder beneficially owning in excess of 4.999% of
the Common Stock of the Company. In addition, the Debentures are convertible at
the option of the Company, subject to certain conditions. The Debentures are due
on or prior to July15, 2004, and bear an interest rate of 5% per annum. The
foregoing information is only a summary and is qualified in its entirety by the
information contained in the documents filed as exhibits to the Company's
Current Report on Form 8-K filed on July24, 1998. See "Incorporation of Certain
Documents by Reference."
<PAGE>
(2) The Debentures listed for Brown Simpson Strategic Growth Fund, L.P. and
Brown Simpson Strategic Growth Fund, Ltd. are held of record by Lehman Brothers,
Inc. as nominee for Brown Simpson Strategic Growth Fund, L.P. and Brown Simpson
Strategic Growth Fund, Ltd., respectively. Beneficial ownership, however,
remains in Brown Simpson Strategic Growth Fund, L.P. and Brown Simpson Strategic
Growth Fund, Ltd., respectively.
(3) The number of shares owned prior to the offering was calculated by
dividing (I) the principal amount of the Debentures held prior to the offering
by (II) the initial conversion price of $14.79. None of the Selling Shareholders
own Company Common Stock other than the shares issuable upon conversion of the
Debentures or exercise of the Warrants or other warrants.
(4) The Warrants have an exercise price of $15.578 and are exercisable from
July 15, 1998 until July 15, 2002, subject to certain restrictions. For detailed
information concerning the Warrants, see the documents filed as exhibits to the
Company's Current Report on Form 8-K filed on July 24, 1998, which is
incorporated herein under "Incorporation of Certain Documents by Reference."
(5) John G. Kinnard & Co. ("Kinnard") holds warrants to purchase 120,000
shares of Common Stock. The warrants were issued to Kinnard in connection with
its role in the public offering of 1,522,500 shares of Common Stock of the
Company in September 1994.
(6) Brown Simpson Strategic Growth Fund, L.P. received Warrants to purchase
6,454 shares on July 15, 1998, and Brown Simpson Strategic Growth Fund, Ltd.
received Warrants to purchase 11,986 Shares on July 15, 1998. Subsequently,
these entities transferred Warrants to purchase 2,100 and 3,900 shares,
respectively, to Lehman Brothers, Inc. The number of Warrants being registered
for each entity and for Lehman Brothers, Inc. reflects such transfers.
(7) The number of shares offered hereby was determined by agreement between
the Company and the Selling Shareholders and was allocated pro rata among the
Selling Shareholders (other than Kinnard) based on their respective initial
holdings of Debentures. Because the number of shares that will ultimately be
issued upon conversion of the Debentures and payment of interest thereon is
dependent upon a number of factors, including the variable conversion price as
well as certain antidilution adjustments, and cannot be determined at this time,
the Company has agreed to include herein a number of shares in excess of the
number of shares the Selling Shareholders own prior to the offering
(8) The number of shares owned after the offering assumes the sale of all
the shares of Common Stock offered hereby.
PLAN OF DISTRIBUTION
The Selling Shareholders, their pledgees, donees, transferees or other
successors-in-interest, may, from time to time, sell all or a portion of the
shares of Common Stock being registered hereunder (the "Shares") in privately
negotiated transactions or otherwise, at fixed prices that may be changed, at
market prices prevailing at the time of sale, at prices related to such market
prices or at negotiated prices. The Shares may be sold by the Selling
Shareholders by one or more of the following methods, without limitation:
(a)block trades in which the broker or dealer so engaged will attempt to sell
the Shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction, (b)purchases by a broker or dealer as
principal and resale by such broker or dealer for its account pursuant to this
Prospectus, (c)an exchange distribution in accordance with the rules of the
applicable exchange, (d)ordinary brokerage transactions and transactions in
which the broker solicits purchasers, (e)privately negotiated transactions,
(f)short sales, (g)a combination of any such methods of sale and (h)any other
method permitted pursuant to applicable law.
From time to time the Selling Shareholders may engage in short sales, short
sales against the box, puts and calls and other transactions in securities of
the Company or derivatives thereof, and may sell and deliver the Shares in
connection therewith or in settlement of securities loans. If the Selling
Shareholders engage in such transactions, the applicable conversion price may be
affected. From time to time the Selling Shareholders may pledge their Shares
pursuant to the margin provisions of its customer agreements with its brokers.
Upon a default by the Selling Shareholders, the broker may offer and sell the
pledged Shares from time to time.
<PAGE>
In effecting sales, brokers and dealers engaged by the Selling Shareholders
may arrange for other brokers or dealers to participate in such sales. Brokers
or dealers may receive commissions or discounts from the Selling Shareholders
(or, if any such broker-dealer acts as agent for the purchaser of such shares,
from such purchaser) in amounts to be negotiated which are not expected to
exceed those customary in the types of transactions involved. Broker-dealers may
agree with the Selling Shareholders to sell a specified number of such Shares at
a stipulated price per share, and, to the extent such broker-dealer is unable to
do so acting as agent for a Selling Stockholder, to purchase as principal any
unsold Shares at the price required to fulfill the broker-dealer commitment to
the Selling Shareholders. Broker-dealers who acquire Shares as principal may
thereafter resell such Shares from time to time in transactions (which may
involve block transactions and sales to and through other broker-dealers,
including transactions of the nature described above) in the over-the-counter
market or otherwise at prices and on terms then prevailing at the time of sale,
at prices then related to the thencurrent market price or in negotiated
transactions and, in connection with such resales, may pay to or receive from
the purchasers of such Shares commissions as described above. The Selling
Shareholders may also sell the Shares in accordance with Rule 144 under the
Securities Act, rather than pursuant to this Prospectus.
The Selling Shareholders and any broker-dealers or agents that participate
with the Selling Shareholders in sales of the Shares may be deemed to be
"underwriters" within the meaning of the Securities Act in connection with such
sales. In such event, any commissions received by such broker-dealers or agents
and any profit on the resale of the Shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
The Company is required to pay all fees and expenses incident to the
registration of the Shares, including certain fees and disbursements of counsel
to the Selling Shareholders. The Company has agreed to indemnify the Selling
Shareholders against certain losses, claims, damages and liabilities, including
liabilities 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.
<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
Shareholders 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.......................... 4
Incorporation of Certain Documents
By Reference.............................. 4
Risk Factors................................... 5
Possis Medical, Inc............................ 10
Selling Shareholders........................... 12
Plan of Distribution........................... 13
Experts........................................ 14
Legal Matters.................................. 15
3,332,278 Shares
POSSIS MEDICAL, INC.
Common Stock
____________
PROSPECTUS
____________
August 21, 1998