MIV Therapeutics Reports on Successful Progress of Animal Studies of Hydroxyapatite in Preparation for Clinical Trials Thursday June 23, 3:30 am ET
HAp-Coated Cardiovascular Stents Demonstrate Excellent Safety and Feasibility at 3-Month Follow-up after Porcine Implantation
VANCOUVER, British Columbia--(BUSINESS WIRE)--June 23, 2005--MIV
Therapeutics, Inc. (OTCBB:MIVT - News), a developer of next-generation
biocompatible stent coatings and drug delivery technologies, has
announced that its proprietary Hydroxyapatite (HAp) stent coating has
demonstrated excellent performance and biocompatibility in key areas
assessed at the three-month follow-up stage of an ongoing study in
which HAp-coated stents were implanted in pig cardiovascular arteries.
The results of the study, conducted at The Methodist Hospital Research
Institute in cooperation with Texas Heart Institute, pave the way for
upcoming human clinical trials of HAp coatings for stents.
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"We are greatly encouraged with the interim results of this
porcine study, which confirm our earlier observations about the superb
biocompatibility and safety of our proprietary coating technologies
based on Hydroxyapatite," said Alan Lindsay, CEO and Chairman of MIVT.
"Successful completion of this critical arm of the animal study marks
another decisive step toward the technology's readiness for human
trials, and ultimately the realization of its full business potential
in several multi-billion-dollar biomedical segments. Our HAp-based
coating technology's unique, long-term biocompatibility and safety is
among its major advantages over conventional but outdated
polymer-based coatings currently available on the market."
"MIVT's D4080 Hydroxyapatite coating had no impact whatsoever on
the acute operational characteristics of the stent In-vivo, including
pushability, trackability, flexibility, retention on the balloon in
transit and ease of deployment and removal of the delivery system,"
said Dr. Greg L. Kaluza, Scientific Director of the Center for
Research in Cardiovascular Interventions at the Methodist Hospital
Research Institute in Houston, TX, who coordinates the porcine study.
"These were all on par with leading stents on the market. No elevated
inflammatory response was seen in any stents coated with
Hydroxyapatite in comparison to bare metal stents, suggesting
excellent biocompatibility. The favorable qualitative impression on
biocompatibility was complemented by low neointimal thickness and
percent area stenosis," he added.
The porcine study focuses on non-drug-eluting, or "passive," HAp
coating technologies. MIVT, however, also plans to apply its coating
technology to other medical device products in development, as well as
to other kinds of coatings, including "active" drug-eluting coatings.
"The study offers for the first time important insights into the
mid-to-long-term porcine performance of MIVT's non-drug eluting, or
"passive," Hydroxyapatite coating technologies applied to the
cardiovascular stents and studied in an in-vivo environment," said Dr.
Arc Rajtar, Vice President of Operations and coordinator of MIVT's
research program. "The latest results reinforce our strategy of using
this highly innovative HAp coating technology as both a drug-eluting
and non-drug eluting option, and moreover, not only for cardiovascular
stents, but for a variety of additional medical devices, to meet the
demands for safety and long-term performance of implantable medical
devices. We have a number of solutions at advanced stages of
development that will combine highly controllable drug-eluting profile
of novel composites with exemplary long-term biocompatibility,
excellent safety and unique properties of HAp. We expect this
combination of highly desirable properties to meet demands of
implantable medical devices that may act also as effective drug
delivery systems with minimized or completely eliminated risks and
weaknesses attributable to the similar devices available at the
present time."
About the Methodist Hospital Research Institute, Houston
The Methodist Hospital Research Institute is a cornerstone of The
Methodist Hospital's strategic vision for its future as a top-ranked
academic medical center. The Research Institute is committed to moving
the latest discoveries in the laboratory to the bedside in order to
provide a new standard of care for our patients in Houston and in
other parts of the country. For more information on The Methodist
Hospital and the Methodist Hospital Research Institute, see
www.methodisthealth.com.
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. The
Company's ultra-thin coating formulation is designed primarily to
protect surrounding tissue from the chemical interaction of metal
stents. The Company's ultra-thin coating has been derived from a
unique biocompatible material called hydroxyapatite (HAp) that during
in-vivo animal trials demonstrated excellent safety and superior
healing properties pursued by the science in the field of advanced
implantable drug delivery systems. Hydroxyapatite is a bioactive
porous material that makes up the bone mineral and matrix of teeth. It
is widely used as a bone substitute material and for coating
implantable fixation devices in orthopedic, dental and other
applications. The Company's novel drug eluting technology provides an
alternative solution to polymer-based drug eluting coatings currently
in the stent market. A broader spectrum of synthetic parameters allows
The Company's drug eluting coating easily and widely applicable to
various implantable devices with a pre-designed drug release profile
to meet desirable clinical performance. MIVT reached a Collaborative
Research Agreement (CRA) with the University of British Columbia and
supported a research and development grant from the Natural Sciences
and Engineering Research Council of Canada (NSERC) in 2002 for the
development of hydroxyapatite as a drug eluting coating. In December
2004 MIVT received a Government grant for the research program titled
"Development of Novel Drug Eluting Composite Coatings for
Cardiovascular Stents" under the National Research Council -
Industrial Research Assistance Program (NRC-IRAP). Under this
sponsorship the Company will progress to the development stage, which
is expected to finalize the drug-eluting research and development
program.
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.
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