VANCOUVER, British Columbia--(BUSINESS WIRE)--Nov. 15, 2005--MIV Therapeutics, Inc. (OTCBB:
MIVT -
News; FWB:MIV), a leading
developer of new generation biocompatible coatings and advanced drug
delivery systems, announced today that a pivotal long-term animal
study of its novel stent coating technology has been concluded, with
results that were unequivocally successful in demonstrating the
coating's excellent biocompatibility and safety.
The 6-month study, performed by Center for Research in
Cardiovascular Interventions of the Methodist Hospital Research
Institute, an independent research organization, indicated that MIVT's
Hydroxyapatite-based coatings were excellent candidates for advanced
drug-eluting stent coatings.
Dr. Greg L. Kaluza, MD, scientific director of the CRCI at the
Methodist Hospital Research Institute, was the lead investigator for
the study. Dr. Fred J. Clubb, Jr. of Texas Heart Institute served as a
study pathologist.
"The study's results are particularly encouraging for several
reasons," said Dr. Kaluza. "The polymeric stent coatings that are now
widely used are increasingly criticized as a suboptimal solution,
because many of them may elicit prolonged foreign body response and
foster platelet deposition which may in turn trigger in-stent
thrombosis," he said. "In contrast, the Hydroxyapatite coating we
studied is built entirely of a mineral native to the human body and as
such may have a long-term biocompatibility advantage."
The results of this recently completed study indicate this coating
may be safely used as a drug-eluting platform since it may be expected
from the present study that the Hydroxyapatite (HAp) coating will
remain inert in the arterial wall even long after the drug is
completely eluted. The well-known long-term neutral effects and
natural absorption of HAp coatings from orthopedic and dental implants
strongly reinforce this belief. The HAp coating with microporous
structure is expected to enable effective drug elution without ever
involving any polymer, a design concept that is currently viewed as
superior and the most attractive for drug-eluting stents."
"We now have a comprehensive set of data demonstrating that the
ultra-thin Hydroxyapatite coating with a potential for use in
non-polymeric and composite drug-eluting systems selected for this
study has excellent biocompatibility at all three studied time points,
up to as long as six months of observation," said Dr. Kaluza. "The
safety profile of the studied coating is exemplary and appears at
least on par with stainless steel stent surface, which remains a
benchmark whose biocompatibility has not been surpassed by any coating
to date."
Stents are devices implanted in the arteries to prop open the
blood vessels and maintain healthy blood flow to the heart and
throughout the body. MIVT has developed a next-generation line of
coatings based on a substance called Hydroxyapatite (HAp), to create
both passive and drug-eluting coatings designed to eliminate many of
the serious problems that are associated with current generations of
stent coatings.
"The study provided critical long-term data that reinforced our
preliminary research that has indicated the exceptional safety and
biocompatibility of our proprietary coating technologies," said Alan
Lindsay, CEO of MIVT. "The uncompromised biocompatibility stands
behind the potential of MIVT's HAp coating technologies and their
expected therapeutic advantages over the existing coatings and stent
technologies currently available to the biomedical industry."
The successful results of the animal study will enable MIVT to
plan future clinical trials to continue to advance its research and
product development programs for the multi-billion-dollar global stent
marketplace.
The study was conducted in a standard model of porcine coronary
arteries and utilized angiography, intravascular ultrasound and
histology to evaluate tissue response to HAp-coated stents in
comparison to identical stainless steel stents. The study was
performed in compliance with GLP (Good Laboratory Practice)
guidelines, CE-Mark and FDA requirements.
MIV Therapeutics is developing a diverse suite of HAp coating
formulas to enable the surface of stents and other implanted devices
to virtually mimic the natural state of structurally-sound 100%
biocompatible and bio-active tissue. Hydroxyapatite, unlike polymer
coatings, is naturally derived and found in such hard tissues and
bioceramic materials as human bone and teeth. Research has indicated
that MIVT's HAp coatings do not trigger the various adverse and
inflammatory reactions that are often associated with implantation of
polymer-coated stents and other foreign substances. HAp coatings are
also expected to reduce the risk of thrombogenic (blood clotting)
events attributable in some instances to polymer-coated stents. Some
of the most recent information presented at the TCT 2005 conference
estimated that thrombogenicity was identified in 20,000 cases of
implanted drug-eluting stents to-date, resulting in approximately
8,000 premature deaths.
About The Methodist Hospital Research Institute
The Methodist Hospital Research Institute in Houston, TX, 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
http://www.methodisthealth.com/.
About MIV Therapeutics, Inc.
MIV Therapeutics, Inc. is developing a next-generation line of
advanced biocompatible coatings for passive and drug-eluting
application on cardiovascular stents and for application on broad
range of other implantable medical devices. The Company's ultra-thin
coating formulation is designed primarily to protect surrounding
tissue from the chemical interaction with metal stents. The Company's
unique ultra-thin coating has been derived from a 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 technologies based on Hydroxyapatite provide an
attractive alternative solution to polymer-based drug-eluting coatings
currently in the stent market. The Company's drug-eluting coating is
designed to suit a broad range of implantable medical devices which
may benefit from a highly customizable drug release profile. 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. For more information, please visit
http://www.trilogy-capital.com/tcp/mivt/website.html. To read or
download MIV Therapeutics' Investor Fact Sheet, visit
http://www.trilogy-capital.com/tcp/mivt/factsheet.html. To obtain
daily and historical Company stock quote data, and recent Company news
releases, visit http://www.trilogy-capital.com/tcp/html/mivt.htm. MIVT
is traded on the Frankfurt, Germany, stock exchange under the symbol
MIV.
Forward-Looking Statements
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.
