SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE
SECURITIES EXCHANGE ACT OF 1934
Dated March 9, 2004
IMI International Medical Innovations Inc.
Commission File Number 1-31360
300-4211 Yonge Street
Toronto, Ontario M2P 2A9
CANADA
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F
Form 20-F X Form 40-F
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Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(1):
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Note: Regulation S-TRule 101(b)(1) only permits the submission in paper of
a Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(7):
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Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a
Form 6-K if submitted to furnish a report or other document that the
registrant foreign private issuer must furnish and make public under the laws of
the jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrant's "home country"), or under the rules of the home
country exchange on which the registrant's securities are traded, as long as the
report or other document is not a press release, is not required to be and has
not been distributed to the registrant's security holders, and, if discussing a
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material event, has already been the subject of a Form 6-K submission or other
Commission filing on EDGAR.
Indicate by check mark whether by furnishing the
information contained in this Form, the registrant is also thereby furnishing
the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes No X
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If "Yes" is marked, indicate
below the file number assigned to the registrant in connection with Rule
12g3-2(b): 82-
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IMI International Medical Innovations Inc.
Form 6-K
On March 9, 2004, the Registrant publicly disseminated a press release to
provide investors with a year-end operating update and a preview of financial
results for its fourth quarter and fiscal year ended December 31, 2003. The
information contained in the press release is incorporated herein by reference
and filed as Exhibit 99 hereto.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned, thereunto duly authorized.
IMI International Medical Innovations Inc.
By: /s/ Ronald G. Hosking
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Ronald G. Hosking
Vice President and Chief Financial Officer
Date: March 9, 2004
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EXHIBIT INDEX
Exhibit
Number Description
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99 The Registrant's Press Release
Dated March 9, 2004
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Exhibit 99
Press release
IMI PROVIDES FISCAL 2003 COMMERCIAL UPDATE AND PREVIEWS YEAR-END RESULTS
-- Expanded clinical program through new research partnerships
-- Well positioned to move forward on product development plans
-- Solid financial foundation at year end
Toronto, Ontario (March 9, 2004) - IMI International Medical Innovations Inc.
(TSX:IMI; Amex: IME), a world leader in predictive medicine, today provided
investors with a year-end operating update and previewed financial results for
its fourth quarter and fiscal year ended December 31, 2003.
"Fiscal 2003 was a significant year of growth for IMI, during which we
demonstrated steady progress towards our strategic goals, for both our products
and the company as a whole. We continued to gain global exposure for IMI's
cardiovascular and cancer franchises while building awareness and acceptance of
new approaches to predicting disease," said Dr. Brent Norton, President and CEO
of IMI.
"In addition, our partner, McNeil Consumer Healthcare, took significant steps in
marketing PreVu* Coronary Heart Disease Predictor, IMI's skin sterol test for
heart disease. We are pleased with the progress to date and have every
confidence that McNeil will make PreVu* a success in heart disease risk
assessment. In addition, we are actively negotiating licensing partnerships for
the U.S. and European markets with several companies."
Dr. Norton continued, "Our achievements in fiscal 2003 represent a strong
platform for long-term, sustainable value creation. With a solid financial
position and prudent management, IMI is poised to advance its strategic plan ---
the commercialization of multiple products united by the single vision of
predictive medicine."
Fiscal 2003 Operating Highlights
--------------------------------
New research partnerships
-- Established two major collaborative research partnerships, with
AtheroGenics, Inc., a pharmaceutical company focused on the discovery,
development and commercialization of novel anti-inflammatory drugs,
including one for the treatment of atherosclerosis, and the
International Early Lung Cancer Action Program (I-ELCAP), a large,
international study sponsored by the National Cancer Institute.
Presentation of new clinical data for cardiovascular and cancer products
-- IMI's skin test was the subject of a presentation at the American
Heart Association (AHA) in November as researchers from Johns Hopkins
University presented data from the Multi-Ethnic Study on
Atheroscerlosis (MESA). This data showed that IMI's skin test can help
to identify subclinical, or hidden, heart disease.
-- IMI's pivotal skin-cholesterol study, published in the December 2003
edition of Atherosclerosis, an international medical journal,
demonstrated that skin cholesterol is an independent risk factor for
coronary artery disease that provides new information about
cardiovascular disease risk.
-- In July, positive study results for all three of IMI's
cancer-detection tests were presented at the American Association for
Cancer Research (AACR) meeting in Washington, DC, with new data
showing continued strong performance of the test in detecting
early-stage colorectal, lung and breast cancers.
Advancing commercialization of first product
-- In November, IMI partner McNeil Consumer Healthcare announced the
brand name of IMI's skin sterol testing product in Canada as PreVu*
Coronary Heart Disease Predictor.
-- Advanced development of two new skin sterol test formats, one for lab
processing and the other for home use.
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-- In late 2003, McNeil Consumer Healthcare initiated an education and
awareness-building phase for its customers and expects to begin
supplying PreVu* in 2004.
Established quality management systems
-- Achieved ISO certification in October, which means that IMI meets the
highest international standards for quality control and customer
service. This certification is a regulatory requirement in Canada and
Europe for new product license submissions.
Increased U.S. market presence
-- Listed on American Stock Exchange in September, which positions IMI to
capitalize on U.S. investor interest in the field of predictive
medicine.
Subsequent to Year End
----------------------
In January 2004, the company announced that a scientific abstract featuring
LungAlert(TM) will be presented at the American Thoracic Society (ATS)
international annual conference on May 24, 2004 in Orlando, Florida. The ATS
annual conference attracts 14,000 delegates and is the premier international
forum for physicians and scientists who work in pulmonary and critical care
medicine.
The abstract accepted for presentation is Examination of the Association of
Galactose Oxidase Reactivity in Sputum with Lung Cancer. The findings further
support that GOS reactivity in sputum samples may be useful as an initial
screening test to identify high- risk subjects.
Financial Highlights (unaudited)
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IMI's cash burn for the fourth quarter was within management's expectations
while expenses were consistent with historical rates.
As at December 31, 2003, the company had cash, cash equivalents and short-term
investments totaling approximately CDN$6.7 million. Based on historic burn rates
and the expectation that revenues from partnering activities and product sales
will begin in 2004, management believes the company's cash resources, together
with investment tax credits receivable, are sufficient to meet its current
operating and capital requirements.
The company will report full financial results for the year upon completion of
its audit.
About IMI
IMI is a world leader in predictive medicine, dedicated to developing rapid,
non-invasive tests for the early detection of life-threatening diseases,
particularly cardiovascular disease and cancer. The company's head office is
located in Toronto, and its research and product development facility is at
McMaster University in Hamilton, Ontario. For further information, please visit
the company's website at www.imimedical.com.
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Conference Call and Webcast
IMI will hold a conference call and webcast today, March 9, 2004, at 10:30 a.m.
ET. To access the conference call, please dial (416) 640-4127 in Toronto, or 1
(800) 814-4857 elsewhere in North America. A live audio webcast will be
available at www.imimedical.com, and will be subsequently archived for three
months. To access the replay via telephone, which will be available until March
16, 2004, please dial (416) 640-1917 or (877) 289-8525 and enter the passcode
21041345#.
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This release contains forward-looking statements that reflect the company's
current expectation regarding future events. The forward-looking statements
involve risk and uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors including, but not limited
to, changing market conditions, successful and timely completion of clinical
studies, uncertainties related to the regulatory approval process, establishment
of corporate alliances and other risks detailed from time to time in the
company's quarterly, annual and other regulatory filings.
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For more information, please contact:
Sarah Borg-Olivier, Director, Communications
Ron Hosking, Vice President and CFO
(416) 222-3449
sbolivier@imimedical.com
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