Imi Medical Innovations (AMEX:IME)
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IMI provides operational update and previews fiscal 2004 results
- Significantly advanced commercialization of PREVU(x) Skin Sterol Test -
Expanded scientific validation of products - Poised to generate revenue
TORONTO, March 8 /PRNewswire-FirstCall/ -- Predictive medicine company IMI
International Medical Innovations Inc. (TSX: IMI; Amex: IME) today provided
investors with a year-end operating update and previewed financial results for
the fourth quarter and fiscal year ended December 31, 2004.
"Fiscal 2004 was an eventful year, with the completion of a significant
worldwide marketing agreement with McNeil Consumer Healthcare, Canada, for our
cardiovascular products, continuing advances in our clinical program and new
publications and presentations," said Dr. Brent Norton, President and Chief
Executive Officer. "These accomplishments speak strongly to the scientific
credibility and growth opportunities for our products."
Dr. Norton continued, "Looking ahead, fiscal 2005 will be a pivotal year for
IMI. We are poised to generate revenue from PREVU(x) Point of Care Skin Sterol
Test, which is currently being commercialized in Canada, the U.S. and select
markets in Europe, where it is available as a point-of-care test. We are also
aiming to advance two additional formats of our skin sterol technology. Another
key focus will be on accelerating development of our cancer products with new
clinical studies.
Additionally, to date this year three papers about our skin sterol technology
have already been accepted for future publication in leading medical journals,
including the American Heart Journal. Earlier this week, exciting new data on
PREVU(x) presented at the American College of Cardiology annual conference
attracted positive international media coverage, and we expect to present at
similar forums later this year. These are all important accomplishments that
will add significant value to our business."
Operational Review
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Advancing commercialization of PREVU(x) Skin Sterol Test
During 2004, IMI worked with McNeil to brand the company's skin sterol
technology as PREVU(x) Skin Sterol Test, a complex process that ranged from
software enhancements to extended dating on the test kits. IMI shipped product
to McNeil in the second and fourth quarters of 2004 and received license
revenue in the second, third and fourth quarters for total annual revenue of
approximately $485,000.
McNeil is establishing a high profile in the professional market with the
active promotion of PREVU(x) POC to the medical community through a number of
marketing vehicles. McNeil has demonstrated the test to cardiovascular
specialists at major medical conferences in Canada, the U.S., and, most
recently, the United Kingdom. These include the Canadian Cardiovascular
Congress, the American Heart Association annual conference, and the American
College of Cardiology annual meeting earlier this week, among others.
Presentation of new clinical data for cardiovascular and cancer products
During the year IMI continued to strengthen the credibility of its products and
raise the company's profile with the international medical community:
- In May, new data on LungAlert(TM) was presented at the 100th Annual
American Thoracic Society (ATS) international annual conference in
Orlando, Florida, confirming that LungAlert's reactivity in sputum
samples may be useful as an initial screening test to identify
high-risk subjects who would benefit from other tests, such as spiral
computed tomography.
- In July, clinical trial results for the company's breast cancer test
were published in the prestigious American Cancer Society journal
Cancer. The data showed that IMI's test demonstrated a statistically
significant difference between early-stage breast cancer and non-
cancerous samples, which demonstrates the test's effectiveness in
identifying early-stage disease.
- PREVU(x) Point of Care Skin Sterol Test was the subject of a
presentation at the Canadian Cardiovascular Congress in October.
These findings confirmed that skin sterol provides new information
about heart disease risk in patients on statin drug therapy
independent of traditional risk factors. This trial also provided
important new data about skin sterol levels, which were higher in
patients with a history of stroke, angina and diabetes. Conversely,
blood markers did not positively correlate with prior stroke, angina
or diabetes.
Initiated important new clinical study
In December, IMI started a new multi-center skin sterol study, led by the
prestigious Montreal Heart Institute. The study will determine whether skin
sterol values measured by PREVU(x) Point of Care Skin Sterol Test are
substantially equivalent to skin sterol values as measured by IMI's new
lab-processed format of the test, PREVU(x) Skin Sterol Test LT. Successful
completion of this trial will pave the way for additional product approvals in
key markets as well as milestone payments.
Increased market presence
IMI continued to broaden its relationships with the professional investment
community in Canada as well as the United States, where the company engaged The
Investor Relations Group (IRG). IMI is also working to increase public
awareness of its unique products, with recent coverage in The Wall Street
Journal, Chicago Tribune, National Post, Calgary Herald and Toronto Star, among
others, and in numerous trade publications.
Enhanced breadth and depth of Board of Directors
In June, Ron Henriksen was appointed to IMI's Board of Directors, bringing a
wealth of international knowledge and international perspective. Mr. Henriksen
has more than 30 years of experience in the healthcare field, working in the
pharmaceutical, biotechnology, consulting and venture capital industries.
Financial Highlights (unaudited)
--------------------
IMI recorded revenue of approximately $485,000, consisting of product sales to
McNeil as well as license revenue.
IMI's cash burn for the fourth quarter was within management's expectations.
Expenses increased about 25 percent from fiscal 2003, reflecting higher
research and development costs related to clinical trials, product development
and increased general and administrative expenses.
As at December 31, 2004, the company had cash, cash equivalents and short-term
investments totaling approximately CDN$5.2 million. Management believes that,
based on historic cash expenditures and the current expectation of further
revenues from partnering activities and product sales, IMI's existing cash
resources together with investment tax credits receivable will be sufficient to
meet current operating and capital requirements through at least 2005.
IMI will file complete audited financial results on March 31, 2005.
Subsequent to Year End
----------------------
In January, new skin sterol data from a study conducted independently at the
University of Vienna was published in the January edition of the Journal of
Clinical Chemistry. This initial data showed that skin sterol might be a useful
monitoring tool for patients taking statins.
Also in January, IMI initiated a new clinical trial at the University of
British Columbia to evaluate the relationship between skin sterol values and a
variety of new and established coronary artery disease (CAD) markers, including
ankle/brachial blood pressure index (ABI) and vascular compliance, in high-risk
patients.
In late February, IMI announced that amendments approved by the U.S. Food and
Drug Administration (FDA) to accelerate AtheroGenics, Inc.'s ARISE (Aggressive
Reduction of Inflammation Stops Events) clinical trial will increase patient
enrollment and provide IMI with valuable new data on skin sterol and its
relationship to primary events such as heart attacks and stroke sooner than
expected. The ARISE study is expected to be completed in the first quarter of
2006.
In early March, IMI filed a new patent application with the United States
Patent and Trademark Office (PTO) related to a new format of PREVU(x) Skin
Sterol Test. This patent, titled Method and Apparatus for Non-Invasive
Measurement of Skin Tissue Cholesterol, further establishes IMI's leadership in
non-invasive cardiovascular disease risk assessment and broadens the company's
intellectual property position around PREVU(x) Skin Sterol Test in major world
markets.
Earlier this week, new data was presented at the 54th Annual Scientific Session
of the American College of Cardiology, in Orlando, Florida, showing a strong
correlation between skin sterol and increased carotid intima-media thickness
(CIMT), a well-established marker of atherosclerosis, in patients with no
symptoms of vascular disease. CIMT is an independent predictor of myocardial
infarction and stroke. The findings of the study, titled Skin Cholesterol
Content Identifies Subclinical Atherosclerosis in Asymptomatic Adults, by Wendy
S. Tzou, Maureen E. Mays, Claudia E. Korcarz, Susan E. Aeschlimann and James H.
Stein, will be published in the American Heart Journal later this year.
Outlook
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"While we cannot provide any guidance on the volume or timing of sales of
PREVU(x), we are encouraged by the response of the medical community to date,"
continued Dr. Norton. "We do expect to record revenue in 2005, but how and when
that happens will be determined by McNeil. Our focus is on driving our clinical
program to support additional new regulatory claims for PREVU(x) and to advance
the lab-processed and home-use formats of the test to strengthen the overall
value and potential of our skin sterol technology."
"We also intend to move forward aggressively with our cancer portfolio in 2005,
with new as well as expanded studies," added Dr. Norton. "We are entering a
growth phase that we believe will generate significant long-term value for our
shareholders."
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Conference Call and Webcast
IMI will hold a conference call and webcast tomorrow, March 9, 2005, at
10 a.m. ET. To access the conference call, please dial (416) 640-4127 in
Toronto, or 1 (800) 814-4862 elsewhere in North America. A live audio
webcast will be available at http://www.imimedical.com/, and will be
subsequently
archived for three months. To access the replay via telephone, which will
be available until March 16, 2005, please dial (416) 640-1917 or
(877) 289-8525 and enter the passcode 21116488 followed by the number
sign.
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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. IMI's
cardiovascular products, which are branded as PREVU(x) Skin Sterol Test, are
being marketed and distributed worldwide by McNeil Consumer Healthcare, Canada.
The company's cancer tests include ColorectAlert(TM), LungAlert(TM) and a
breast cancer test. IMI'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 http://www.imimedical.com/.
This press release contains forward-looking statements. These statements
involve known and unknown risks and uncertainties, which could cause the
Company's actual results to differ materially from those in the forward-
looking statements. Such risks and uncertainties include, among others, the
lack of operating profit and availability of funds and resources to pursue R&D
projects, the successful and timely completion of clinical studies, the
successful development or marketing of the Company's products, reliance on
third-party manufacturers, the competitiveness of the Company's products if
successfully commercialized, the ability of the Company to take advantage of
business opportunities, uncertainties related to the regulatory process, and
general changes in economic conditions. In addition, while the Company
routinely obtains patents for its products and technology, the protection
offered by the Company's patents and patent applications may be challenged,
invalidated or circumvented by our competitors and there can be no guarantee of
our ability to obtain or maintain patent protection for our products or product
candidates.
Investors should consult the Company's quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information on risks
and uncertainties relating to the forward-looking statements. Investors are
cautioned not to rely on these forward-looking statements. IMI is providing
this information as of the date of this press release and does not undertake
any obligation to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
DATASOURCE: IMI International Medical Innovations Inc.
CONTACT: Company Contact, Sarah Borg-Olivier, Director, Communications,
T: (416) 222-3449, ; U.S. Investor Contact, Andrea
Faville, The Investor Relations Group, T: (212) 825-3210,