MIVT News MIV Therapeutics Announces Company's Biocompatible Stents Matches or Outperforms World's Leading Drug-Eluting Stent in Key Categories
ATLANTA--(BUSINESS WIRE)--MIV Therapeutics Inc. (OTCBB:MIVT)
(FWB:MIV), a leading developer of next-generation biocompatible
polymer-free drug-eluting stents and advanced drug delivery systems,
announced today that a comparative animal study of two of its novel
polymer-free drug-eluting stent coating technologies has concluded with
positive results.
This study compared stents coated with MIVT’s
polymer-free drug-eluting technologies to the J&J CypherTM
stent, one of the world’s best selling
drug-eluting stents. The Study successfully demonstrated that both of
MIVT’s proprietary, polymer-free, Sirolimus
eluting coatings are at least as good as Johnson & Johnson’s
CypherTM Stent. The study also demonstrated MIVT’s
coatings’ potential and efficacy when compared
to CypherTM.
The independently conducted four-week porcine study, performed by the
Department of Cardiology, Thoraxcenter, Erasmus University Medical
Center in the Netherlands, indicated that three variations of MIV’s
polymer-free Drug-Eluting coatings were at least as effective as -- and
in some cases, better -- than Johnson & Johnson’s
Cypher, one of the world’s leading
drug-eluting cardiovascular stents.
Dr Willem J. van der Giessen, MD, PhD, Interventional Cardiologist and
Dr. Heleen M.M van Beusekom, PhD, Experimental Cardiology, from the
Thoraxcenter at the Erasmus University Medical Center were the study
directors. The objectives of the study were to evaluate the safety of
MIVT’s Hydroxyapatite coating and to assess
the efficacy of MIVT Sirolimus coated stents in a porcine coronary model.
The results from the first part of the study, conducted with no drug
added to the coatings, showed that HAp coated stents and bare metal
stents did best and performed equally well.
The results from the second part of the study, with drugs added to the
coatings, showed that all of the MIVT drug-eluting technologies
performed at least as well, and in some cases better than the industry’s
benchmark, the J&J Cypher™ stent.
The study concluded that MIV’s HAp coating,
with or without drugs, demonstrated highly promising performance. Based
on these results the company will begin preparations for human
implantation.
“The results of this study indicate that our
drug-eluting polymer-free technologies are at least on par with the best
in the world. We believe we have very strong candidates for a superior
product as we move into the next phase of our regulatory program,”
said Dr. Mark Landy, President of MIV Therapeutics.
The study was conducted in a standard model of porcine coronary arteries
and utilized angiography and histology to evaluate tissue response to
stents coated with MIVT’s proprietary
polymer-free coatings in comparison to identical bare metal stents and
also stents coated with MIVT’s proprietary
Sirolimus eluting technology to J&J’s
Cypher™ (Sirolimus) stent.
MIV Therapeutics is developing a diverse suite of Polymer-Free HAp
coating formulas to improve the biocompatibility of stents and other
implantable medical devices. Hydroxyapatite (HAp) occurs naturally in
human bones and teeth. It rapidly integrates into the human body and has
been shown to have excellent stability and biocompatibility. HAp is
non-toxic, non-thrombogenic, non-inflammatory and has been shown to
promote angiogenesis.
HAp coatings are also expected to reduce the increased risk of deadly
blood clots currently associated with today’s
polymeric drug-eluting stents. Recent information presented at leading
cardiology conferences estimated that blood clots have been identified
in at least 20,000 cases of implanted drug-eluting stents to-date,
resulting in approximately 8,000 premature deaths.
MIVT recently announced that it intends to begin the first human
implants of a HAp Nano Film Coated stent early in 2007. Human
implantation represents a significant milestone in MIVT's strategic plan
to develop a new class of polymer-free drug-eluting stents that could
provide patients with superior outcomes.
About MIV Therapeutics, Inc.
MIV Therapeutics is developing a next-generation line of advanced
biocompatible coatings for passive and drug-eluting applications on
cardiovascular stents and a broad range of other implantable medical
devices. The Company's ultra-thin coating formulation is designed to
protect surrounding tissue from potentially harmful interactions with
bare metallic stents. The Company's unique ultra-thin coating platform
is derived from an organic material called hydroxyapatite (HAp) which
has demonstrated excellent safety and biocompatibility in vivo animal
studies. Hydroxyapatite is a bioactive porous material that makes up the
bone mineral and matrix of teeth and is widely used today as a bone
substitute material and for coatings on implantable fixation devices in
orthopedic, dental and other applications. The Company's novel
polymer-free drug-eluting technologies based on Hydroxyapatite could
also provide an attractive alternative to current polymer-based
drug-eluting coatings on the stent market, which have been associated
with undesirable medical effects. The Company's drug-eluting coatings
are additionally designed to suit a broad range of implantable medical
devices that could benefit from highly customizable drug release
profiles. MIVT has a Collaborative Research Agreement (CRA) with the
University of British Columbia and has received Government grant for its
research program on the "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 is expected to complete its drug-eluting
research and development program and to reach product commercialization
stage. 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.
