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Biotech / Medical : IMI:TSE International Medical Innovations Inc. -- Ignore unavailable to you. Want to Upgrade?


To: gg cox who wrote (46)6/16/2004 1:16:36 PM
From: gg cox  Respond to of 66
 
"""Overview June 2004:
Cash on hand $8 Million, 35.6 months at current burn of $900,000 per quarter

13 new clinical trials commenced in 2003
20-30 trials are in the field at any one time of which we pay 28%

Currently 4 or 5 diagnostics are in the pipeline.
Each diagnostic may have 2 or 3 spinoffs such as Lab Test, Point of Care, Home Test
They should hit the market at the rate of 1 or 2 pipes per year in this order:
PreVu
ColorectAlert
LungAlert
BreastAlert
'CervixAlert' a new unnamed cervical cancer test was alluded too in late 2003

PreVu
Our lead diagnostic will be available in 3 products: Point of Care, Tape Test, Home Wallet Test
There are 7 identified markets:
Lab Testing, Home Testing, Insurance/ Occupational Health, Pharmacies, Co- Promotion, Physicians Offices.

Completed Milestones by timeline:

CH123: Pivotal trials commence November 1997
ColorectAlert: May 1998 IMI licences a cholorectal cancer sugar marker
ColorectAlert: January 1999 IMI files patent application for colorectal cancer detection
LungAlert: January 1999, IMI files patent application for lung cancer detection test based on a sugar moiety in sputum

ColorectAlert: May 2000, Clinically more accurate than FOBT

CH123: January 29, 2001, Canadian marketing clearance
LungAlert: May 2001 American Thoracic Society report, 1st and only early stage test Lung Cancer Test
CH123: June 11, 2001 FDA submission
CH123: July 10, 2001 DCL agrees to make CH123
CH123: October 29, 2001 resubmission to FDA, shares tank to $3.00

CH123: February 25, 2002 Multi-Ethnic Study of Atherosclerosis (MESA 6500 souls)
CH123: April 8, 2002 Sprecher breakthrough at American Heart Association
ColorectAlert: April 15, 2002 ColorectAlert beats FOBT financially
CH123: May 10, 2002 McNeil CDN partnership announced
CH123: June 2002 American Journal of Cardiology paper, Mancini
CH123: June 24, 2002 FDA approval
CH123: Sept. 2002 European approval
CH123 @ home: Oct Q4 2002 Unveiling of 2 new modified home tests
CH123: Oct. 28th 2002 McNeil demos 123 at the Canadian Cardiovascular Congress, Edmonton
CH123: December 2002 signs agreement with McNeil to expand US marketing to the insurance industry, no FDA required

CH123: Feb 27th 2003 Revenue commences with Milestone Payment $100,000
D-TECT: Feb 27th 2003 new Coronary Heart Disease Predictor announced
SEC: March 12th 2003, Stock market approval clears IMI for a US listing
SARS: Toronto meeting cancelled due to SARS Apr. 2, 2003
ColorectAlert: Apr. 5, 2003,Trial results detected 54% early stage, 85% accurate clearing non cancer patients
LungAlert: Apr.5 Japanese trial with major Japanese Partner commences
LungAlert: Apr. 5, 2003 Trial results: detected 65% of all cancers, 57% early stage lung cancer with only 10% false positives
BreastAlert: Apr 12 preliminary trial results encouraging
CH123: June 2003 Australian Approval
CH123: June 2003 Found to be reliable and harmless in testing Pediatric cholesterol
CH123: August 21 2003 John Hopkins presented at the American Heart Association, Skin cholesterol is more strongly associated with Arteriosclerosis than blood tests CH123: August 28, 2003 AtheroGenics initiates a $40-million Phase III trial to test 4,000 heart patients using CH123 as a diagnostic
AMEX: Sept 19 2003: IMI begins trading on the American Stock Exchange symbol IME
IMI: October 24, 2003 ISO certification, the certificate states that IMI complies with ISO 13488:1996 standards
LungAlert: Nov. 2003 Joins National Cancer Institute I-ELCAP study, to report in 1 year
December 17, 2003, publication of its pivotal skin-cholesterol in the journal Atherosclerosis, 649 subjects

LungAlert: May 24, 2004 New Clinical Data Presented at the 100th American Thoracic Society
PreVu: May 28, 2004 McNeil becomes world wide licencee, IMI to receive up to $21M in royalties starting at 8-9% +/- escalating to 12% +/- down the road
in addition to a percentage of gross sales and a supply mark up on the product itself

Milestones yet to come

PreVu: McNeil to launch in 2004, Labelling and Packaging to be revealed, Revenue stream commences
PreVu: Accreditation by OHIP
CH123: Japanese Approval Process completing
PreVu: Home Wallet Tests completes FDA trials in 2005
ColorectAlert: Canadian Approval then FDA trials commence 2005
LungAlert: Canadian Approval then FDA trials commence 2005
BreastAlert: expanded trials to report 2004

Major Research Partners:
CH123: AtheroGenics Phase III ARISE Trial due Q4 2004-5
CH123: National Heart, Lung, and Blood Institute MESA study
CH123: Pfizer Parke-Davis Avasimibe trial Phase III trial
CH123: The Cleveland Clinic, Dennis Sprecher
Lungalert: National Cancer Institute I-ELCAP International Early Lung Cancer Action Program
Lungalert: St. Joseph's Healthcare, Dr. Gerard Cox and Dr. John Miller
ColorectAlert: St. Michael's Hospital testing since 1998 Dr. Norman Marcon
Genomic Research: McMaster University. IMI sponsors research using genomics to detect cancer and receives first right of refusal

Marketing foot notes:

Cardiovascular disease cost $329 Billion US.
Cancer cost $180 Billion US
All healthcare $1.4 Trillion US
65,000 deaths from Colorectal Cancer in 2004 in North America
179,000 deaths from Lung Cancer in 2004 in North America
45,000 deaths from Breast Cancer in 2004 in North America
1 in 3 women will be diagnosed with cancer
1 in 2 men will be diagnosed with cancer

Home testing market is said to reach $2.8 Billion in 2005
61.8 Million Americans have Cardiovascular Disease.
102 Million have elevated Cholesterol.
25 Million people worldwide are on cholesterol reducing medications
11% of the body's cholesterol is in the skin
It is estimated that between 500~780 million cholesterol tests are performed annually worldwide.

Lungalert, there are 800 million smokers world wide, 100 million in the US and Canada
If the test sells at $25 the revenue potential from only 24 Million smokers is $600,000,000.00 US per year.

Breast cancer kills 400,000 women each year worldwide.
There were 700,000 mammograms in 2002."""

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Above post from HarryKane on stockhouse