As filed with the Securities and Exchange Commission on June 9, 1999
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)
Irving R. Colacci Vice President, Legal Affairs Copy to: Amy E. Ayotte,
Esq. & Human Resources, General Counsel Dorsey & Whitney LLP and Secretary
Pillsbury Center South Possis Medical, Inc. 220 South Sixth Street 9055
Evergreen Boulevard N.W. Minneapolis, Minnesota 55402-1498 Minneapolis,
Minnesota 55433 (612) 340-6323 (612) 780-4555 (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.[_]
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
Title of
securities Proposed maximum Proposed maximum Amount of
to be Amount to be offering price aggregate offering registration
registered registered(1) per share(2) price(2) fee
Common Stock
$.40 par value 952,030 $10.50 $9,996,315 $2,779
(1) Pursuant to Rule 416 under the Securities Act of 1933, as amended, this
registration statement also covers such indeterminate number of shares of common
stock as may be required to prevent dilution resulting from stock splits, stock
dividends or similar events, or changes in the exercise price of the warrants.
(2) Estimated solely for purposes of computing the registration fee and
based upon the average of the high and low sale prices for the common stock on
June 2, 1999, 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 June 9, 1999
PROSPECTUS
POSSIS MEDICAL, INC.
952,030 Shares
Common Stock
This prospectus covers the sale of shares of the common stock, par value
$.40 per share, of Possis Medical, Inc. The shares covered by this prospectus
consist of 827,852 shares of common stock, 124,178 shares of common stock
issuable upon the exercise of warrants and, in accordance with Rule 416 under
the Securities Act of 1933, as amended, an indeterminate number of additional
shares as may be required to prevent dilution resulting from stock splits, stock
dividends or similar events, or changes in the exercise price of warrants. The
shares will be sold from time to time by the selling shareholders named in this
prospectus. Possis Medical will not receive any of the proceeds from the sale of
the shares.
The common stock is traded on the Nasdaq National Market under the symbol
"POSS." On June 8, 1999, the last reported sale price of the common stock as
reported on the Nasdaq National Market was $11-1/4 per share.
_______________
See the section titled "Risk Factors" beginning on page 3 to read about
certain factors you should consider before buying shares of our common stock.
Neither the securities and exchange commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
_______________
The information in this prospectus is not complete and may be changed.
These securities may not be sold until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
POSSIS MEDICAL, INC.
9055 Evergreen Boulevard N.W.
Minneapolis, Minnesota 55433
(612) 780-4555
The date of this prospectus is __________, 1999.
<PAGE>
TABLE OF CONTENTS
Risk Factors............................................... 4
Where You Can Find More Information........................ 9
About Possis Medical, Inc.................................. 10
Selling Shareholders....................................... 12
Plan of Distribution....................................... 13
Experts.................................................... 13
Legal Matters.............................................. 13
<PAGE>
RISK FACTORS
An investment in our common stock involves a number of risks. You should
consider carefully the following risk factors, together with the other
information in this prospectus, before buying any shares. You also should be
aware that this prospectus contains forward-looking statements that are not
related to historical results. These forward-looking statements, such as
statements concerning our strategies, plans, objectives, expectations and
intentions, involve risks and uncertainties. Our actual results could differ
materially from those anticipated in these forward-looking statements. Factors
that could cause or contribute to such differences include, but are not limited
to, the following risk factors.
We have a history of operating losses and a lack of profitable operations.
We incurred losses for fiscal years 1996, 1997 and 1998. As of April 30,
1999, we had accumulated a deficit of $47.7 million. We incurred a net operating
loss of $9.9 million for the year ended July 31, 1996, a net operating loss of
$9.6 million for the year ended July 31, 1997, and a net operating loss of $12.5
million for the year ended July 31, 1998.
We do not expect to become profitable unless we achieve significant sales
in the United States. We must convince health care professionals, third-party
payors and the general public of the medical and economic benefits of the
AngioJet(R) Rheolytic(tm) Thrombectomy System. We cannot assure you that we will
succeed in marketing is product and achieve significant sales. Even if we
accomplish this goal, we cannot assure you that we will operate profitably on a
consistent basis.
There has been limited regulatory approval for our products, and our
products are subject to extensive governmental regulation.
Our products and manufacturing activities are subject to extensive and
rigorous federal and state regulation in the United States and various
regulatory requirements in other countries, including Japan. Current United
States Food and Drug Administration enforcement policy strictly prohibits the
marketing of approved medical devices for unapproved uses. Therefore, even if
our products receive regulatory approval, regulators may significantly limit the
uses for which our products may be marketed. In addition, the process of
obtaining and maintaining required regulatory approvals can be lengthy and
expensive, and the outcome of the process can be uncertain. Moreover, regulatory
approvals may be withdrawn if we fail to comply with regulatory standards or if
unforeseen problems arise following the initial marketing of a product.
Additionally, we are required to adhere to Quality System Regulations
relating to product design, development, manufacturing, servicing, testing and
documentation. Failure to comply with applicable Quality System Regulations or
other regulatory requirements may result in fines, delays or suspensions of
approvals, injunctions against further distribution of our products, seizures or
recalls of products, operating restrictions, criminal prosecutions or other
sanctions, in addition to adverse publicity. The adoption of new regulations or
changes in existing regulations could prevent us from obtaining, or affect the
timing of, future regulatory approvals and could adversely affect the marketing
of our existing products. We cannot assure you that we will be able to obtain
necessary regulatory approvals on a timely basis or at all. Delays in our
receipt of or failure to receive regulatory approvals, the loss of previously
received approvals or our failure to comply with regulatory requirements would
have a material adverse effect on our business, financial condition and results
of operations.
<PAGE>
Clinical and marketing acceptance of our products is uncertain.
Because our products are new to the market, they are still unfamiliar to
many members of the medical community. The AngioJet System has only recently
begun to be used for the removal of vascular, cardiovascular and intercranial
blood clots, known to the medical community as "thrombus." Similarly, the
medical community has only recently begun to use our Perma-Flow(R) Coronary
Bypass Graft to perform coronary artery bypass graft procedures and our
Perma-Seal(tm) Dialysis Access Graft to provide A-V access for kidney dialysis
patients. Market acceptance of our AngioJet, Perma-Flow and Perma-Seal products
will depend largely on our ability to demonstrate to the medical community in
general, and to cardiologists and cardiac surgeons in particular, the efficacy,
relative safety and cost-effectiveness of treating cardiovascular disease using
our products, as well as on our ability to train cardiologists and cardiac
surgeons to perform necessary procedures using our products. We cannot assure
you that our products will provide benefits considered adequate by providers of
cardiovascular and vascular treatments, or that enough providers will use our
products to ensure their commercial success. Moreover, even if our products
become generally accepted by the medical community, physicians trained to use
our products may not use them or may recommend a competitor's products. We
cannot assure you that cardiologists, cardiac surgeons or other physicians will
determine that our AngioJet, Perma-Flow or Perma-Seal products are appropriate
courses of treatment for their patients or acceptable alternatives to other
therapies. Even if they are accepted by the medical community, our ability to
successfully market our products before they receive FDA approval may be limited
by FDA regulations, guidelines or policies. Lack of clinical and market
acceptance and significant restrictions on our marketing program would have a
material adverse effect on our business, financial condition and results of
operations.
The Company is dependent on its AngioJet Products.
We have focused our resources on the continued development and refinement
of our AngioJet System. If we fail to obtain necessary regulatory approvals, or
the medical community rejects the use of the AngioJet System for multiple
purposes, our business, financial condition and results of operations would be
materially and adversely affected.
The industry in which the Company competes is characterized by rapid
technological change and intense competition.
The medical products market is characterized by rapidly evolving technology
and intense competition. Our future success depends on our ability to keep pace
with advancing technology and competitive innovations. 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
accomplish desired therapeutic effects through entirely different methods than
the products we are developing.
We believe our AngioJet System will face intense competition from a variety
of treatments for the removal of blood clots, including clot-dissolving
(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. We know of a small number of synthetic grafts
being developed that could compete with our Perma-Flow Graft. However, we
believe we are 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. Our Perma-Seal Graft competes
with expanded polytetrafluoroethylene synthetic grafts (also known as "ePTFE"
grafts) and other synthetic grafts with needle sealing properties.
Many of the companies developing competing devices have substantially
greater capital and substantially greater resources for and experience in
research and development, regulatory matters, manufacturing and marketing than
we have. These companies will be serious competitors for us and may succeed in
developing products that are more effective and/or less costly than the AngioJet
System or the Perma-Flow and Perma-Seal Grafts. Furthermore, these companies may
be more successful than we are in manufacturing and marketing their products.
Our competitors or others may develop technologies, products or procedures that
are more effective or less invasive than any we are developing or that may
render our technology and products obsolete or noncompetitive. The advent of new
devices, procedures or new pharmaceutical agents could hinder our ability to
compete effectively and could have a material adverse effect on our business,
financial condition and results of operations.
<PAGE>
The Company's success will depend on its ability to maintain patents and other
proprietary rights.
Our success depends and will continue to depend in part on our ability to
maintain patent protection for our products and processes, to preserve our trade
secrets and to operate without infringing the proprietary rights of third
parties. We attempt to protect our technology by filing patent applications for
technology that we consider important to the development of our business, among
other measures. We currently hold five United States patents and eighteen
foreign patents related to the Perma-Flow Graft, and we have two additional
patent applications pending in the United States and one patent application
pending in foreign jurisdictions relating to the Perma-Flow Graft. We currently
hold three United States patents relating to the AngioJet System, and we have
twelve United States and numerous foreign patent applications pending relating
to the AngioJet System. The European Patent Office has accepted three of our
AngioJet System patent applications. In connection with the Perma-Seal Graft, we
hold two United States patents, with three pending foreign patent applications.
Claims relating to medical technology patents involve complex legal and factual
questions. Therefore, their outcomes are highly uncertain. We cannot assure you
that our pending applications will result in patents being issued to us or that
either our new patents or our existing patents will give us a competitive
advantage. Moreover, our competitors may design around any patents issued to us,
third parties may receive patent protection on their own waterjet devices, and
others may hold or receive patents containing claims that may cover products
developed by us.
We require all our employees to execute non-disclosure agreements when they
join Possis Medical. These agreements generally provide that all confidential
information developed or made known to the employee by us during the course of
his or her employment with Possis Medical must be kept confidential and not
disclosed to third parties. We cannot assure you, however, that these
non-disclosure agreements and other safeguards will protect our proprietary
information and know-how, or that they will provide us adequate remedies in the
event of unauthorized use or disclosure of confidential information. We also
cannot assure you that others will be unable to develop such information
independently.
We also rely on unpatented proprietary technology and trade secrets that we
seek to protect in part through confidentiality agreements with employees and
other parties. We cannot assure you that the employees and other parties will
comply with these agreements, that we will have adequate remedies for any breach
or that we can meaningfully protect our rights to unpatented proprietary
technology in any other way. We also cannot assure you that others will be
unable independently to develop or otherwise acquire substantially equivalent
proprietary technology and trade secrets, or that they will keep the technology
secret. The disclosure of this type of information could have a material adverse
effect on our business, financial condition and results of operations.
The medical device industry has seen much litigation with respect to patent
and other intellectual property rights. Litigation may be necessary for us to
enforce our patents, to protect our trade secrets and know-how, to defend
against claimed infringement of others' rights or to determine the ownership,
scope or validity of the proprietary rights of Possis and others. However,
litigation also could be extremely costly to us and could divert our resources
and efforts away from our products and day-to-day business matters. If the
litigation had an adverse outcome, it could subject us to substantial
liabilities to third parties, require us to seek licenses from third parties and
prevent us from manufacturing, selling or using our products. Any of these
results could have a material adverse effect on our business, financial
condition and results of operations.
<PAGE>
Acceptance of our products and our profits may be limited by inadequate third-
party reimbursements.
Health care providers (such as hospitals and physicians) that purchase
medical devices like the AngioJet System or the Perma-Seal and Perma-Flow Grafts
for the treatment of patients generally rely on third-party payors like
Medicare, Medicaid and private insurance plans to reimburse all or part of the
costs associated with the health care services they provide. In certain foreign
markets, the pricing of and profits generated by health care products are
subject to government control. In some states, Medicare and Medicaid payors
reimburse hospitals for inpatient medical procedures at a pre-determined rate
based on diagnosis-related groups. If these rates do not include, and
third-party payors do not otherwise provide, adequate reimbursement to health
care providers for the cost of our products, our products will not gain wide
market acceptance and our financial results will suffer.
The Health Care Financing Administration is the federal agency responsible
for administering the Medicare system. HCFA has prohibited Medicare from paying
for procedures that are still under investigation or that are not deemed safe
and effective for the condition being treated. Therefore, even if a device has
FDA approval, Medicare payors may deny reimbursement if they conclude that the
device is experimental or that it will not improve the condition being treated.
The market for our products also could be adversely affected by future
legislation to reform the nation's health care system or by changes in industry
practices regarding reimbursement. We cannot assure you that the reimbursement
rates of third-party payors will allow us to price our products at levels
sufficient to realize an appropriate return on our investment in product
development.
The Company is dependent on key personnel.
We depend greatly on a limited number of key management and technical
personnel. Moreover, because of the highly technical nature of our business, our
ability to continue our technological developments and to market our products
- --and thereby develop a competitive edge in the marketplace -- depends in large
part on our ability to attract and retain qualified technical and key management
personnel. Competition for qualified personnel is intense, and we cannot assure
you that we will be able to attract and retain the individuals we need. The loss
of key personnel, or our inability to hire or retain qualified personnel, could
have a material adverse effect on our business, financial condition and results
of operations.
The Company may be subject to product liability claims, for which insurance
coverage may be insufficient.
The manufacture and sale of our products may subject us to product
liability claims. In a recent decision, the United States Supreme Court held
that, despite a company's compliance with FDA regulations, it may not be
shielded from common-law negligent-design claims or manufacturing and labeling
claims based on state laws. Product liability insurance is expensive and in the
future may not be available on acceptable terms, if at all. We cannot assure you
that the coverage limits of our product liability insurance policies will be
adequate if a product liability claim is brought against us. A successful claim
or series of claims against us that exceeds our insurance coverage could have a
material adverse effect on our business, financial condition and results of
operations. Moreover, whether or not successful, product liability litigation
would likely divert the attention of our key personnel and could adversely
affect our reputation and the marketability of our technology and products.
Consequently, any product liability litigation could have a material adverse
effect on our business, financial condition and results of operations.
It is uncertain whether the Company will be able to obtain funding sufficient to
meet its future capital needs.
We anticipate that cash on hand, the interest expected to be earned on such
cash and expected revenues will be sufficient to finance our operations for at
least the next six to twelve months. However, we cannot assure you that
additional capital will not be needed sooner. We anticipate that we may need to
raise additional funds in the future. We cannot assure you that additional
capital will be available to us or that it will be available on satisfactory
terms. Raising additional capital through equity financing may dilute the equity
interests of the shareholders of the company, and debt financing may involve
restrictive covenants. Failure to secure additional financing if and when needed
could have a material adverse effect on our business, financial condition and
results of operations.
The securities market is volatile, and the Company's stock price may fluctuate
widely.
The market price of our 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 in the
past, and the price of our 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.
We cannot assure you that our common stock will trade in the future at market
prices in excess of its current market price.
The Company has in place certain protections against takeover attempts.
Of the 100 million shares of capital stock authorized by our amended and
restated articles of incorporation, 79 million shares are undesignated. Our
board of directors may issue the undesignated shares on terms and with the
rights, preferences and designations determined by the board without shareholder
action. In addition, we have adopted a shareholder rights plan that provides for
the exercise of preferred share purchase rights when a person becomes the
beneficial owner of 15% or more of our outstanding common stock (subject to
certain exceptions). We also are subject to provisions of the Minnesota Business
Corporation Act that limit the voting rights of shares acquired in specified
types of acquisitions and that restrict specified types of business
combinations. The existence or issuance of "blank check" stock, the existence of
our shareholder rights plan and the effect of anti-takeover provisions under
Minnesota law, individually or in the aggregate, may discourage potential
takeover attempts and delay, defer or prevent a change in control. They also may
make the removal of management more difficult, which could deprive our
shareholders of opportunities to sell their shares at prices higher than
prevailing market prices.
The Company is dependent on single source suppliers.
We depend on single source suppliers for some of the raw materials used in
the manufacture of our products. If we cannot obtain key raw materials from our
suppliers, we cannot assure you that the materials will be available from other
suppliers, that other suppliers will agree to supply the materials to us, or
that our use of the other suppliers would be approved by the FDA. Although we
believe our supply of raw materials currently is adequate for the needs of our
business, we cannot assure you that new sources of supply will be available when
needed. Any interruption in our supply of raw materials could have a material
adverse effect on our ability to manufacture our products until a new source of
supply is located and, therefore, could have a material adverse effect on our
business, financial condition and results of operations.
No dividends have been paid.
We have never paid cash dividends on our common stock. We currently intend
to retain all future earnings, if any, for use in our business and do not
anticipate paying cash dividends in the near future.
There may be risks associated with the Year 2000.
In May 1998 we established a team to assess and address our possible
exposure related to the Year 2000 computer software issue. The team investigated
areas including product issues and our business computer systems, production
equipment, vendor readiness and contingency plans. Products currently sold by us
are Y2K compliant. We do not use internally developed computer software and
therefore do not anticipate major reprogramming efforts. Our primary financial
and operational system has been assessed and is certified Y2K compliant. The
equipment we use for production and quality control does not use dates to
control operations. However, several of our personal productivity applications
are not Y2K compliant. We are working to make them compliant and expect them to
be compliant by mid-calendar year 1999. Also, a number of our personal computers
are not Y2K compliant. We plan to replace these computers as part of our
technology update strategy. However, to the extent the applications and
computers are not made Y2K compliant during 1999, problems arising as a result
of noncompliance could have a material adverse effect on our business, financial
condition and results of operations.
<PAGE>
Moreover, if our significant vendors are not Y2K compliant, their inability
to provide services to us in a timely and efficient manner could adversely
affect our business and, consequently, our financial conditions and results of
operations. Although at this time we do not expect the Y2K issue to have a
significant impact on our business, financial condition or results of
operations, our internal preparations and the preparations of our vendors are
not yet complete. Therefore, we cannot assure you that our systems will be
converted on a timely basis or that our operations will be unaffected by the Y2K
issue.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. You may read and copy any document we file at the
SEC's public reference room at 450 Fifth Street N.W., Washington, D.C. 20549, or
at the SEC's public reference rooms in New York, N.Y. and Chicago, Illinois.
Please call the SEC at 1-800-SEC-0330 for further information on the public
reference rooms. Our SEC filings also are available to the public from the SEC's
website at http://www.sec.gov. You also may inspect reports, proxy statements
and other information concerning Possis Medical at the offices of the National
Association of Securities Dealers, 1735 K. Street N.W., Washington, D.C. 20006.
The SEC allows us to "incorporate by reference" the information that we
file with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be part of this prospectus, and later information that we file
with the SEC automatically will update and supersede this prospectus. We
incorporate by reference the following documents listed below and any future
filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, until the selling shareholders sell
all of the shares:
- our annual report on Form 10-K for the fiscal year ended July 31, 1998;
- our quarterly reports on Form 10-Q for the quarters ended October 31, 1998
and January 31, 1999;
- our current reports on Form 8-K filed on December 16, 1998 and May 13, 1999;
and
- the description of our common stock contained in any of our registration
statements filed under the Exchange Act, and any amendment or report filed
for the purpose of updating the description.
Upon written or oral request, we will provide a copy of these filings, at
no cost, to each person to whom a copy of this prospectus is delivered. You may
request a copy of these filings by writing or telephoning us at the following
address:
Irving R. Colacci
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, Minnesota 55433
(612) 780-4555
You should rely only on the information incorporated by reference or
provided in this prospectus or any supplement. We have not authorized anyone
else to provide you with different information. The selling shareholders should
not make an offer of the shares in any state where the offer is not permitted.
You should not assume that the information in this prospectus or any supplement
to this prospectus is accurate as of any date other than the date on the cover
page of this prospectus or any supplement.
<PAGE>
ABOUT POSSIS MEDICAL, INC.
We develop, manufacture and market innovative medical products that assist
interventionalists and surgeons in treating cardiovascular or vascular diseases
or conditions requiring vascular intervention. Our primary product, the
AngioJet(R) Rheolytic(tm) Thrombectomy System, is marketed in the United States
for blood clot removal from dialysis access grafts and coronary arteries and
coronary bypass grafts. Our three FDA-approved products -- the AngioJe(R)
System, the Perma-Flow(R) Coronary Bypass Graft and the Perma-Seal(R) Dialysis
Access Graft -- are in early stages of commercialization in the United States,
Europe, Japan and Canada.
Our objective is to become a leading supplier of innovative medical
products for the treatment of cardiovascular or vascular diseases or conditions.
We will pursue our strategy by seeking to demonstrate the safety and efficacy of
our products, developing relationships with leading clinicians, establishing
world-class manufacturing processes and commercializing our products rapidly. We
also intend to expand our product portfolio by applying our 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.
Our principal executive offices are located at 9055 Evergreen Boulevard
N.W., Minneapolis, Minnesota 55433, telephone number (612) 780-4555. For further
information concerning Possis Medical, see the section titled "Where You Can
Find More Information."
The AngioJet(R) Rheolytic(tm) Thrombectomy System
The development of blood clots in various parts of the vascular system is
common and is a leading cause of death. Our AngioJet System is designed to
remove blood clots from large-diameter and small-diameter blood vessels
throughout the body in a rapid, minimally invasive and cost-effective manner.
The AngioJet System delivers jets of pressurized saline solution through small
openings in the tip of a disposable catheter positioned near the blood clot,
breaking the clot into tiny particles that are propelled back through the
catheter out of the patient's body and into a disposable collection bag. We
believe our AngioJet System is a novel approach to the removal of blood clots
from arteries, veins and grafts and offers advantages over thrombolytic
(clot-dissolving) drugs and other mechanical devices, the current primary
methods of treatment. 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 two Phase clinical trial involving the use of the AngioJet System to
remove blood clots from peripheral arteries and vascular grafts was completed in
March 1994. On December 6, 1996, we received FDA clearance to begin marketing
the AngioJet System in the United States with label claims for use in removing
blood clots from vascular access grafts used by patients on kidney dialysis.
Until March 1999, this was the only use for which the AngioJet System was
approved.
In March 1996 we received FDA approval to initiate Phase 2 clinical testing
of our AngioJet System for use in removing blood clots from coronary arteries
and bypass grafts supplying blood to the heart muscle. In May 1998 the FDA
agreed to permit the disclosure of results of our major coronary clinical trial
in the United States, the VeGAS 2 Coronary Clinical Trial. These important
clinical results, involving approximately 350 patients, were presented in
October and November 1998 and showed the AngioJet System to be much faster than
urokinase, a clot-dissolving drug, removing blood clots in minutes rather than
the hours required by urokinase. Additionally, in most cases, the AngioJet
System also achieved more complete thrombus removal than urokinase, caused fewer
adverse events and resulted in lower treatment costs. Results of a 12-month
study presented in March 1999 also showed the AngioJet System to be more
cost-effective than urokinase.
<PAGE>
In August 1998 we submitted additional information in support of our
existing 510(k) application to the FDA seeking clearance to expand label claims
to include use in peripheral arteries and bypass grafts in the United States.
This application is still pending with the FDA. We also filed a premarket
approval application with the FDA in September 1998 seeking U.S. marketing
approval of the AngioJet System for coronary artery and bypass graft blood clot
removal. We asked the FDA for broad labeling claims including AngioJet System
use in native coronary arteries and saphenous vein bypass grafts, in patients
experiencing angina (chest pain) and heart attack, and in patients
contraindicated for drug lysis therapy. On March 12, 1999, the FDA gave us
approval to market the AngioJet System for use in coronary arteries and coronary
bypass grafts, granting us all the usage indications we requested.
In April 1999, results of our Japanese Coronary AngioJet System clinical
trials were published in the American Journal of Cardiology. The trial results
demonstrated full restoration of blood flow in all 29 patients who received
AngioJet treatment for severe acute heart attacks in native coronary blood
vessels. Our Japanese distributor intends to submit these results, together with
similar results obtained from treating 32 patients at Toho University in Japan,
to the Japanese Ministry of Health and Welfare during the summer of 1999 to
support our request for approval to market the AngioJet System in Japan for
coronary use.
In December 1997 we received approval to begin a clinical trial of the
AngioJet System for use in the treatment of stroke caused by blocked carotid
arteries, the main vessels supplying blood to the brain. Patient enrollment in
the trial began in August 1998, and the first patient was treated in January
1999. Phase I of the trial calls for ten patients to be treated. Three patients
have been enrolled to date. A larger U.S. clinical trial is planned for
investigating the use of the AngioJet System for use in strokes that occur in
cerebrovascular circulation, which are more common. Enrollment in this trial is
expected to begin by the end of 1999. We believe that the treatment of stroke is
a significant marketing opportunity for the AngioJet System.
The Perma-Flow(R) Coronary Bypass Graft
The Perma-Flow Coronary Bypass Graft is a synthetic graft designed for use
in coronary artery bypass surgery. Bypass surgery is performed to treat impaired
blood flow to portions of the heart. In bypass surgery, physicians generally use
patients' own vessels to complete the bypasses. However, sometimes patients' own
vessels are insufficient or inadequate for use in bypass surgery. Our Perma-Flow
Coronary Bypass Graft is intended to serve as a substitute for native blood
vessels in patients whose own vessels cannot be used in bypass surgery. We
believe the Perma-Flow Graft ultimately may be used as a substitute for native
saphenous veins, thus avoiding the trauma and expense associated with the
surgical harvesting of native veins. On May 4, 1998, we received a Humanitarian
Device Exemption from the FDA for U.S. marketing of the Perma-Flow Graft. We
have stopped enrollment in Phase 2 of a FDA clinical trial of the Perma-Flow
Graft and are currently seeking a strategic alliance with or sale to a third
party in order to maximize the value of our entire vascular graft portfolio to
our shareholders.
The Perma-Seal(R) Dialysis Access Graft
The Perma-Seal Dialysis Access Graft is a self-sealing synthetic graft used
as a point of vascular access in kidney dialysis patients. We believe the
Perma-Seal Graft offers advantages over currently used synthetic grafts because
of its needle-hole sealing capability. We believe this characteristic is
effective in sealing puncture sites in the grafts with minimal compression time
and bleeding when compared with other currently available graft products,
resulting in shortened dialysis sessions and reduced administrative time and
costs per patient. 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. We 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 asked for data on 124 study patients followed for 12
months. In May 1997 we completed our enrollment for the Perma-Seal Graft trials
in the United States. In August 1997 we resubmitted our 510(k) application. At
our 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 and, after consulting with us, converted the 510(k)
filing to a premarket approval application. In September 1998, the FDA gave us
approval to market the Perma-Seal Graft in the United States. In December 1998
we entered into an exclusive worldwide supply and distribution agreement for the
Perma-Seal Graft with Horizon Medical Products, Inc., a Georgia specialty
medical device company focused on marketing vascular products.
<PAGE>
<TABLE>
Other Developments
In December 1998, we submitted a 510(k) application to the FDA requesting
marketing clearance for three expanded ePTFE synthetic vascular grafts of
varying diameters and wall thicknesses. The ePTFE grafts are the most commonly
used synthetic grafts in peripheral vessel bypass procedures, including dialysis
access grafts. In February 1999, we received clearance from the FDA to market
the three expanded ePTFE grafts.
SELLING SHAREHOLDERS
We have agreed to register initially 952,030 shares for resale by the
selling shareholders. This number includes 827,852 shares of common stock owned
by the selling shareholders and 124,178 shares of common stock that may be
issued upon the exercise of warrants owned by the selling shareholders. This
number does not include an indeterminate number of additional shares that may be
registered and issued in accordance with Rule 416 under the Securities Act of
1933, as amended, to prevent dilution of the common stock resulting from stock
splits, stock dividends or other events, or changes in the exercise price of
warrants.
The following table lists the selling shareholders and the number of shares
they beneficially own and may sell pursuant to this prospectus.
<CAPTION>
Number of Shares
of Common Stock
Number of Shares Subject to Number of Shares
of Common Stock Warrants Maximum Number of of Common Stock
Beneficially Beneficially Shares to Be Sold Beneficially
Owned Prior to Owned Prior to Pursuant to this Owned After the
Name of Selling the Offering the Offering Prospectus(1)(2) Offering(1)
Shareholder
<S> <C> <C> <C> <C>
- --------------------------- ------------------- ------------------- -------------------- ------------------
The Anglo Irish Global 60,000 9,000 69,000 0
Equity Fund
The Bank of England 50,500 7,575 58,075 0
Pension Fund
The Tail Wind Fund 414,201 62,130 476,331 0
Jersey Phoenix Trust 45,000 3,750 28,750 20,000
Limited
North American Growth 18,000 1,575 12,075 7,500
Investments Ltd.
Special Situations Cayman 29,448 4,417 33,865 0
Fund, L.P.
Special Situations Fund 88,345 13,252 101,597 0
III, L.P.
Mr. Geoffrey Galley 149,858 22,479 172,337 0
- --------------------------- ------------------- ------------------- -------------------- ------------------
Total 855,352 124,178 952,030 27,500
</TABLE>
(1) Assumes the sale of all of the shares offered by this prospectus.
(2) Includes warrants to purchase a total of 124,178 shares of common stock.
<PAGE>
PLAN OF DISTRIBUTION
We are registering the shares on behalf of the selling shareholders. As
used in this prospectus, "selling shareholders" includes donees, pledgees and
transferees selling shares received from a named selling shareholder after the
date of this prospectus. The selling shareholders may offer and sell from time
to time all or a portion of their shares of common stock in one or more types of
transactions (which may include block transactions) on the Nasdaq National
Market, in privately negotiated transactions, through put or call options
transactions, through short sales, or through a combination of these methods of
sale, at market prices prevailing at the time of sale or 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
shareholders or the purchasers of the shares. As of the date of this prospectus,
we are not aware of any agreement, arrangement or understanding between any
broker or dealer and any of the selling shareholders. The selling shareholders
also may resell all or a portion of their shares in open market transactions in
reliance upon Rule 144 of the Securities Act, provided they meet the criteria
and conform to the requirements of Rule 144. There is no assurance that the
selling shareholders will sell any or all of the shares they offer for sale.
The selling shareholders and any brokers or dealers who participate in the
sale of the shares may be deemed to be "underwriters" within the meaning of the
Securities Act. In that event, any commissions received by the brokers or
dealers and any profits realized by them on the resale of shares purchased by
them may be deemed to be underwriting commissions or discounts under the
Securities Act. Because the selling shareholders may be deemed to be
"underwriters" within the meaning of the Securities Act, the selling
shareholders will be subject to the prospectus delivery requirements of the
Securities Act. We have informed the selling shareholders that their sales in
the market must comply with the requirements of the rules and regulations of the
Exchange Act.
We will pay all expenses associated with the registration of the shares,
and the selling shareholders will pay all their expenses other than specified
legal and due diligence expenses that will be reimbursed by us. Brokerage
commissions and similar selling expenses, if any, attributable to the sale of
the shares will be paid by the selling shareholders. We have agreed to indemnify
the selling shareholders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
EXPERTS
The financial statements and schedules of Possis Medical for the year ended
July 31, 1998, have been audited by Deloitte & Touche LLP, independent auditors,
as stated in their report. These financial statements and schedules of Possis
Medical and the report of Deloitte & Touche LLP are incorporated in this
prospectus by reference to our Annual Report on Form 10-K for the year ended
July 31, 1998, in reliance on Deloitte & Touche LLP's report given upon its
authority as experts in accounting and auditing.
LEGAL MATTERS
The validity of the shares offered in this prospectus has been passed upon
for us by Dorsey & Whitney LLP, 220 South Sixth Street, Minneapolis, Minnesota
55402.
<PAGE>
PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
SEC Registration Fee...................................... $ 2,779
Accounting Fees and Expenses.............................. 2,500
Legal Fees and Expenses................................... 8,000
Miscellaneous ............................................ 1,721
Total............................................ $ 15,000
All fees and expenses other than the SEC registration fee are estimated.
The expenses listed will be paid by Possis Medical.
Item 15. Indemnification of Officers and Directors
Section 302A.521 of the Minnesota Business Corporation Act requires
corporations to indemnify any person who is made or threatened to be made a
party to any proceeding, by reason of the person's former or present official
capacity, against judgments, penalties, fines, settlements and reasonable
expenses, including attorneys' fees and disbursements, incurred by the person in
connection with the proceeding if certain statutory standards are met.
"Proceeding" means a threatened, pending or completed civil, criminal,
administrative, arbitration or investigative proceeding, including one by or in
the right of the corporation. The general effect of Minnesota Statutes Section
302A.521 is to reimburse (or pay on behalf of) the directors and officers of
Possis Medical with respect to any personal liability that may be imposed for
certain acts performed in their capacity as our directors and officers, except
where they have not acted in good faith. Section 302A.521 contains detailed
terms regarding this right of indemnification, and reference is made to Section
302A.521 for a complete statement of indemnification rights.
Our bylaws provide for indemnification to the maximum extent permitted by
Minnesota Statutes. In addition, the Company generally enters into
indemnification agreements with our officers and directors, and we maintain 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 Possis
Medical, Inc. and Norwest Bank Minnesota, National Association, including the
Form of Right Certificate attached as Exhibit B thereto (incorporated by
reference to Exhibit 1 to Possis Medical, Inc'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 Exhibit 5.1 to this
Registration Statement).
24.1 Power of Attorney.
<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;
(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 SEC 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 to such information in the registration statement;
Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) of this section
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 with or furnished to the SEC
by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act
that are incorporated by reference in the registration statement.
(2) That, for the purpose of determining any liability under the Securities
Act, 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, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Exchange
Act (and, where applicable, each filing of an employee benefit plan's annual
report pursuant to Section 15(d) of the Exchange Act) that is incorporated by
reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers, and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the SEC 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.
<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 June 9, 1999.
POSSIS MEDICAL, INC.
/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, June 9, 1999
Robert G. Dutcher Chief Executive Officer
and Director
(Principal Executive Officer)
/s/ Russel E. Carlson Vice President of Finance and June 9, 1999
Russel E. Carlson Chief Financial Officer
(Principal Financial and
Accounting Officer)
* Chairman of the Board June 9, 1999
Donald C. Wegmiller
Director June __, 1999
Dean Belbas
* Director June 9, 1999
Seymour J. Mansfield
* Director June 9, 1999
William C. Mattison
* Director June 9, 1999
Whitney A. McFarlin
* Director June 9, 1999
Rodney Young
*By: /s/ Robert G. Dutcher June 9, 1999
Robert G. Dutcher
Attorney-in-fact**
_______________
** Executed on behalf of the indicated persons by Robert G. Dutcher
pursuant to the Power of Attorney included as Exhibit 24.1 to this registration
statement.
<PAGE>
EXHIBIT INDEX
Exhibit
Number Description
4.1 Rights Agreement, dated as of December 12, 1996, between Possis
Medical, Inc. and Norwest Bank Minnesota, National Association,
including the Form of Right Certificate attached as Exhibit B
thereto (incorporated by reference to Exhibit 1 to Possis Medical,
Inc.'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 Exhibit 5.1 to this
Registration Statement).
24.1 Power of Attorney.
<PAGE>
Exhibit 5.1
[Letterhead of Dorsey & Whitney LLP]
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 827,852 shares (the "Shares") of common stock of the Company, par value
$.40 per share (the "Common Stock"), and 124,178 shares of Common Stock
initially issuable upon the exercise of warrants (the "Warrant Shares"). The
Shares and the Warrant Shares will be sold from time to time by the Selling
Shareholders named in the Registration Statement.
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 also have 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 and the
Warrant Shares to be sold by the Selling Shareholders pursuant to the
Registration Statement have been duly authorized by all requisite corporate
action, that the Shares are validly issued, fully paid and nonassessable, and
that the Warrant Shares, upon issuance, delivery and payment therefor in
accordance with the terms of the warrants, will be 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: June 9, 1999
Very truly yours,
/s/ Dorsey & Whitney LLP
<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 952,030 shares of
common stock of our report, dated August 28, 1998, appearing in the Annual
Report on Form 10-K of Possis Medical, Inc. for the year ended July 31, 1998,
and to the reference to us under the heading "Experts" in the Prospectus, which
is a part of this Registration Statement.
/s/ Deloitte & Touche LLP
Minneapolis, Minnesota
June 7, 1999
<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 undersigned'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 952,030 shares of Common Stock of Possis by the
Selling Shareholders named therein, 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 June 8, 1999
Donald C. Wegmiller
Director June _, 1999
Dean Belbas
/s/ Seymour J. Mansfield Director June 8, 1999
Seymour J. Mansfield
/s/ William C. Mattison Director June 9, 1999
William C. Mattison
/s/ Whitney A. McFarlin Director June 5, 1999
Whitney A. McFarlin
/s/ Rodney Young Director June 4, 1999
Rodney Young
/s/ Robert G. Dutcher President, June 4, 1999
Robert G. Dutcher Chief Executive Officer
and Director
/s/ Russel E. Carlson Vice President of Finance and June 8, 1999
Russel E. Carlson Chief Financial Officer
