VANCOUVER, British Columbia--(BUSINESS WIRE)--July 13, 2005--In
BW5738 issued July 13, 2005: This replaces the release of earlier
today, providing greater clarity on the applications of the technology
discussed.
The corrected release reads:
MIV THERAPEUTICS SUCCESSFULLY COMPLETES ANIMAL FEASIBILITY STUDIES
OF STROKE-PREVENTION DEVICES
POSITIVE EXPERIMENTAL RESULTS SPEED MIVT'S SAGAX SUBSIDIARY TOWARD
HUMAN TRIALS OF NOVEL AORTIC EMBOLIC PROTECTION DEVICE
MIV Therapeutics, Inc. (OTCBB:MIVT - News), a developer of
next-generation biocompatible stent coatings and drug delivery
technologies, has successfully completed Phase I animal feasibility
studies in sheep of two models of a novel implantable arterial
filtration technology device designed to prevent strokes by diverting
embolic particles flowing through the bloodstream. These two models of
MIVT's unique Aortic Embolic Protection Device (AEPD) are being
designed to prevent both major types of embolic strokes -- those
triggered by heart surgery and catheterization, and those that occur
naturally, not in connection with such procedures.
This successful first phase of the animal studies pave the way for
further animal studies, and then for human clinical trials - the last
major testing milestones as the Company prepares the stroke-preventing
technology for FDA approval and potential commercialization. The AEPD
filtration devices are being developed by wholly-owned MIVT subsidiary
SagaX Medical Technologies Inc.
Both SagaX AEPD filter prototypes employ proprietary stent-based
filter-deflector technology. The AEPD I prototype model is designed to
be implanted temporarily in the aorta, the body's main artery, during
heart surgery and heart catheterization to divert particles that might
otherwise reach the brain, where they could trigger embolic strokes.
The AEPD II prototype is designed to be implanted permanently to
prevent the embolic strokes that occur from natural causes, such as
aging.
"We fully expect that this new technology, once ready for the
market, will have the capacity to save countless cardiac patients from
the devastating effects of embolic stroke," said Dr. Dov Shimon,
founder and CEO of SagaX, and Chief Medical Officer and Director of
MIVT. "We look forward to proceeding to the next phases of animal
studies, which are the next milestones in readying this technology for
human trials."
Embolic particles that reach the brain are among the chief causes
of strokes, which are the third-leading cause of death and the leading
cause of disability in the world. AEPD is one of the latest
innovations in the field of filter-based embolic protection devices
and is the only filter being developed for use in the aorta.
MIVT estimates that the global market for AEPD devices could
exceed $1.5 billion by 2009. The Company believes AEPD-1 will be
particularly useful during invasive heart procedures such as
electrophysiology, valve dilatations and valve repair through
angioplasty, as well as heart operations. The permanently implanted
AEPD-II is designed to find broad preventive applications.
MIV Therapeutics' CEO Alan Lindsay said he was greatly encouraged
with the results. "The feasibility studies confirm earlier
observations in the laboratory showing excellent efficacy and function
of AEPD," he said. "This continued progress in our development of both
prototypes of the AEPD is essential in our realization of the devices'
full business potential in multi-billion-dollar neurovascular
marketplace segments."
AEPD is one of the latest innovations in the field of filter-based
embolic protection devices, and is the only filter developed for use
in the aorta. Preliminary evaluation of prototype devices confirmed
effectiveness of AEPD in an in-vitro model.
The AEPD I version is a self-expanding stent-based filter in the
aorta, and designed for temporary application. The AEPD II prototype
is a braided self-expanding stent deployed in the innominate artery,
extending downwards into the aorta. This version can be implanted
permanently to prevent cardioembolic stroke. Both AEPD I and AEPD II
were inserted through a small catheter in the sheep's femoral artery
and were passed retrogradely under fluoroscopy to the aortic arch.
"The study demonstrated excellent hemodynamics, ample X-ray
visibility and easy drivability through 6 French (2.3mm)-diameter
catheter," said Dr. Shimon. "Direct echocardiography demonstrated
ample location and no significant flow disturbances. In addition, AEPD
I is deployed, recaptured, relocated and removed using a proprietary
delivery system designed to make it an ideal solution for embolic
protection for heart surgery and invasive trans-catheter procedures in
the heart."
The studies are being conducted at the world-renowned Hadassah
University Hospital Cardiology Research Institute in Jerusalem,
Israel, under the stewardship of cardiac specialists, Dr. Chaim
Danenberg and Dr. Ronen Beeri.
Cardioembolism occurs spontaneously without procedures in 30% of
all stroke victims. The risk factors for cardioembolic stroke include
previous strokes; rhythm irregularities such as atrial fibrillation
(present in 1-2% of the adult population and 7-10% of the people above
70); congenital malformations of the heart, such as patent foramen
ovale (PFO); heart valve disease, and previous heart valve surgery.
About SagaX Medical Technologies, Inc.
SagaX develops a range of proprietary solutions, primarily
endovascular interventional products, which decrease the likelihood of
strokes and other serious complications that may result from cardiac
procedures, as well as from naturally occurring Cardioembolic strokes.
The Company's R&D center is located in Herzlya Israel, directed by Dr.
Dov V. Shimon, M.D., a heart surgeon, the founder and CEO of SagaX
Inc., and MIV Therapeutics director and Chief medical Officer. In
March 2005, MIVT completed its acquisition of SagaX. One of the
flagship technologies from SagaX is its Aortic Embolic Protection
Device (AEPD), which employs proprietary stent based filter-deflector
technology that can be used during Trans-Catheter Cardiology
procedures, as well as during heart surgery, to minimize the risk of
stroke.
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 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 technology provides an
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.
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.
Copyright © 2005 MIV Therapeutics Inc. All rights reserved.
Contact:
MIV Therapeutics Inc.
Investors:
800-221-5108
Fax: 604-301-9546
inverstor@mivtherapeutics.com
or
SagaX Inc. Product Inquiries:
Dov Shimon, M.D., 011-972-9-950-8089
dov@sagaxmed.com
or
Trilogy Capital Partners (Investor Relations)
Paul Karon, 800-342-1467
paul@trilogy-capital.com
