(COMTEX) B: MIV Therapeutics' Biocompatible Stent Coating Successfully Completes Pyrogen Trial ( PRNewswire-FirstCall )
VANCOUVER, Jun 17, 2004 /PRNewswire-FirstCall via COMTEX/ -- MIV Therapeutics
Inc. (MIVT:OTCBB), announced today that its proprietary Hydroxyapatite (HAp)
ultra-thin "passive" stent coating has successfully passed the Rabbit Pyrogen
Test (Material Mediated) - ISO confirming that the coating is non-pyrogenic and
does not induce fever.
Biocompatibility is one of the key features that differentiate MIVT's
proprietary HAP coating technology. Dr. Tom Troczynski, MIVT's Vice President of
Coatings commented, "There is an extensive range of biocompatibility tests
performed on cardiovascular stents coated with our proprietary coating
technology that include a variety of short and long term assessments. In their
totality, this range of tests is expected to confirm total biocompatibility of
our proprietary HAp coating technologies. The Pyrogen test result proved that
HAp does not induce fever when injected into the blood system and once again
this result is in line with our long-standing expectations regarding total
biocompatibility of our HAp coating material which is at the heart of our
technologies."
The Rabbit Pyrogen (Material Mediated) - ISO Test was performed by Toxikon
Corporation in Bedford, Massachusetts, USA. Dr. Kathleen Krenzer, O.D., Ph.D.,
who supervised this test, summarized in the final report: "The extract of the
test article, Hydroxyapatite (HAp) coated stent, was evaluated for its potential
to produce a pyrogenic response (induce fever - MIVT comment) when tested in
rabbits. Based upon the criteria of the protocol, the test article meets the
requirements of the Pyrogen Test and is, therefore, considered non-pyrogenic."
The Pyrogen Test was designed to determine the presence of chemical pyrogens in
extracts of solid materials in order to limit risks of febrile reaction in a
patient. The test involved measuring the rise in temperature of New Zealand
White rabbits following the intravenous injection of a test article. New Zealand
White rabbits have been used for pyrogen evaluation studies in line with ISO
10993-11 guidelines. The test and control article was injected into the ear vein
of rabbits, and the body temperature of animals was monitored back-to-back with
control articles. The study conformed to all applicable laws and regulations,
including ISO 10993-11: 1993 standard for "Biological Evaluation of Medical
Devices - Part 11 "Tests for Systemic Toxicity", ISO 17025: 1999 "General
Requirements for the Competence of Testing and Calibration Laboratories" and ISO
10993-12: 1992 standard "Biological Evaluation of Medical Devices" - Part 12,
"Sample Preparation and Reference Materials", and met the requirements of the
Good Laboratory Practices (GLP) 21 CFR, Part 58 set by the U.S. Food and Drug
Administration, and complied with general CE Mark Application requirements.
Alan Lindsay, CEO of MIVT stated "As we progress through our R&D program, all
preliminary test results continue to support our firm belief that the Company's
proprietary HAp ultra-thin coating exhibits properties that provide our
technology with a clear competitive advantage. We persist in our drive towards
making our unique, biocompatible HAp ultra-thin coating the "coating of choice"
for cardiovascular stents and a broad range of future medical devices."
About Toxikon Corp.
"Toxikon Corp. (ISO/IEC 17025:1999 certified) has been known for the past 25
years for excellence in medical device testing, toxicology and bio- analytical
chemistry services. The Company provides comprehensive testing services to the
biomaterials/medical device market, the pharmaceutical and biotechnology
industry. Toxikon Corporation's testing services include biocompatibility
testing, toxicology, pharmacology, metabolism, bioanalysis, pharmaceutical
analysis, and biosafety testing. A leader in the industry, the company's
professional expertise along with a recognized stature in the industry provides
Toxikon Corporation a unique capability to assist clients in the successful
completion off their registration."
About MIV Therapeutics
MIV Therapeutics is developing a "next generation" line of advanced
biocompatible coatings for passive and drug-eluting application on
cardiovascular stents and other implantable medical devices. MIV's ultra-thin
coating has been designed to inhibit inflammatory response and restenosis.
The drug-eluting HAp technology is being developed in collaboration with UBC
under a Collaborative Research Agreement and is funded in part by a
Collaborative Research and Development Grant awarded by the Natural Sciences and
Engineering Council of Canada (NSERC).
MIVT's manufacturing facility meets the guidelines applicable to CE Mark, FDA
and GMP requirements. Please visit www.mivtherapeutics.com for more information.
Investor Inquiries:
Dan Savino Richard Cooper/Jennifer K. Zimmons, Ph.D.
Investor Relations, Strategic Growth International Inc.
MIV Therapeutics Inc. Ph: 212 838-1444
Ph: 1 800 221-5108 ex.16 Email: info@sgi-ir.com
Fax: 604 301-9546
Email: dsavino@mivi.ca
Product inquiries and business opportunities:
Arc Rajtar
arajtar@mivi.ca
(604) 301-9545 ext 22
Except for the historical information contained herein, the matters discussed in
this press release are forward-looking statements. Such statements are indicated
by words or phrases such as "believe", "will", "breakthrough", "significant",
"indicated", "feel", "revolutionary", "should", "ideal", "extremely" and
"excited". These statements are made under "Safe Harbor" provisions of the
Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those described in forward-looking statements and are subject to
risks and uncertainties. See the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's recent Form
10-K and Form 10-Qs, which identify specific factors that may cause actual
results or events to differ materially from those described in the
forward-looking statements.
SOURCE MIV Therapeutics Inc.
CONTACT: Investor Inquiries: Dan Savino, Investor Relations, MIV
Therapeutics Inc., Ph: 1 800 221-5108 ex.16, Fax: (604) 301-9
46, Email:
dsavino@mivi.ca; Richard Cooper/Jennifer K. Zimmons, Ph.D., S
rategic
Growth International Inc., Ph: (212) 838-1444, Email: info@sg
-ir.com;
Product inquiries and business opportunities: Arc Rajtar, ara
tar@mivi.ca,
(604) 301-9545 ext 22
(MIVT)
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KEYWORD: British Columbia
INDUSTRY KEYWORD: MTC
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