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VOLUME 07 : ISSUE 54
MIVT:
The End of the Beginning
As
hard as some of us might try to make investing a complicated matter, sometimes
I really think the wise investment move is just to take things at face
value. That's what I thought of when I read last night's news from MIV
Therapeutics (OTCBB: MIVT)
anyway....the news is what it is. No angles, no fine print - just
a milestone I'm sure many of you have been waiting for. And yes, I think
this may be the catalyst the stock needs, now that an idea has become reality.
Normally
I'd throw out a little teaser here and hope to build some suspense, but
I'm not feeling like Michael Creighton today - this is too important. As
of yesterday, one of MIV's next-generation heart stents has been implanted
into a human patient in Brazil. Thus, the clinical trial phase of
the coated stent's evolution has begun. If the trials proceed as well
as the pre-clinical research suggests they will, I personally believe the
win for the medical community could be the only victory bigger than the
win for the company's stock.
I'm
guessing for some of you who've been following the MIV story, I could wrap
things up right there - the research and work so far has now basically
gotten past the 'end of the beginning' stage. I'd consider clinical
trials more like the beginning of the middle.
If
instead you're not familiar with what the big deal is about MIV's
heart stents, then I strongly recommend you keep reading. The biotechnology
is as impressive as the growth opportunity for the company's stock.
Putting
The 'Tech' Back Into Biotechnology
I'm
not a doctor....I don't even play one on TV. That's a good thing
for all of us though, since it forces me to understand this stuff in plain
English, which in turn allows me to explain it in plain English.
A
stent is just a mesh wire tube that acts as a scaffold for a blocked artery.
When they were introduced in 1993, they were hailed as a breakthrough.
The tune has changed for the worse a couple of times since then. Why? As
it turns out, the stents may be doing more harm than good.
Early
metal stents as an experiment were fine, but as a standard treatment for
actual patients, putting raw metal into a bloodstream is not ideal. There's
the possibility a stent could break, and leave metal fragments in the bloodstream
(near the heart, no less), or there was the high possibility of an infection
where the metal was pressed up against artery walls...and those were just
the obvious potential complications.
To
avoid those kinds of problems, medical manufacturers began making stents
with specialized medical coatings. From some perspectives, they worked
- no longer would a heart patient have to worry about the dangers of foreign
metal objects in their body. The downside is, they created a whole new
set of problems. These coatings have now been linked to blood clotting,
and scarring (thrombosis) near the affected area. In some cases, the coated
stents are even blamed for fatal heart attacks...the very thing they
were designed to prevent.
So
it's a trade-off only affecting the medical community? Not quite - this
has had repercussions for a huge number of investors as well.
As
evidence of just how big the problem is......Johnson & Johnson (NYSE:
JNJ) recently announced they were discontinuing the pre-clinical development
of a coating, not to mention they were discontinuing sales of the underlying
stent. And, you may recall late last year that Boston Scientific's (NYSE:
BSX) coated 'Taxus' stent as well as JNJ's coated 'Cypher' stent have
led to enormous class action lawsuits, ultimately costing the shareholder's
of those companies.
Enter
MIV Therapeutics. They've been working on a coated stent that (1) works,
and (2) doesn't cause even more harm. Their own internal testing shows
they've done exactly that, but the viability of their stent has also been
validated by other parties performing longevity tests.
How'd
they do it? In a nutshell, the coating they use is the same stuff teeth
and bones are made of. Simple yet brilliant. Fortunately they own the patent
on the coating, which allows them to protect their shareholder's profits
on the technology for many years.
And
now, they just took a giant step towards the commercialization of the stent.
It all starts with one patient; I doubt the next one is too far off. Pretty
soon, I suspect the company will have a full-blown clinical trial on their
hands, which I firmly believe will get a buzz started within the investment
community.
Some
Bang For Your Biotech Buck
I have
to be blunt here (as if I'm usually not).....I'm stunned you can still
own this stock at 60 cents. My only guess is the rest of the market doesn't
fully understand the kind of potential numbers we're seeing here. I don't
particularly have a problem with the story not being viral yet,
as in my experience, great investment stories eventually get told. My concern
is in how it gets told. If a fund manager wakes up one day and likes
the idea, they could easily take on a huge piece of the 80 million or so
outstanding shares and send the stock rocketing higher at the drop of the
hat, leaving any procrastinators behind the eight ball.
Or
- and I have no specific reason to expect it - I have to wonder
if MIV is a potential acquisition target. It's just chatter, but considering
the company's entire market cap is only $48 million, it wouldn't take much
for a JNJ or a Boston Scientific to buy their way back into the thick of
the $7 billion stent market by using a successful and proven stent coating.
Just a thought.
In
the meantime, here's the rough math we did a couple of months ago - let's
say a successfully-approved MIV heart stent can capture just 5% of that
potential $7 billion market (conservative, in our opinion). That would
mean annual sales of about $350 million to be spread out over just 80 million
I&O shares, or per-share revenue of about $4.37. Yet, the current
trading level is only 60 cents per share?!?! With most price/sales
ratios somewhere around 3.0, based on our hypothetical market penetration
you
could actually justify a valuation of at least $10.00, if not more.
I'd
be the first to say the risk compared to the potential reward seems hard
to believe. The risk is just that MIV's coating doesn't work out, and the
stock goes nowhere. The reward? MIV's coating does work out, and
this $48 million company could eventually be doing hundreds of millions
in stent sales each year. As an investor, I think the potential upside
dwarfs any downside, which is the name of the game for me - a positive
risk/reward scenario.
Like
I first said, sometimes the wise investment move is just taking things
at face value, and I think this is one of those times. Their first stent
is now in a human patient; more will follow. Other competitors in this
lucrative heart stent market are back-pedaling, or getting out altogether....the
liability is just too great for them with their current product line. MIV
Therapeutics, on the other hand, is picking up steam.
Bottom
line - I believe today's MIVT owners could be very well rewarded for
taking the time to understand just how big their potential upside is. Our
suggested target of $1.65 still stands.
MIV Therapeutics
Announces Start of Clinical Trial Marking First Ever Human Implantation
of a Hydroxyapatite Coated Stent
Trial to Study
Safety and Efficacy of One of the Company's Proprietary Polymer-Free Drug-Eluting
Stent Technologies
ATLANTA-- MIV
Therapeutics (OTCBB:MIVT)(FWB:MIV),
a leading developer of next-generation biocompatible coatings and advanced
drug delivery systems for cardiovascular stents and other implantable medical
devices, today announced the first ever human implantation of a hydroxyapatite
coated stent and the launch of the MIVT Pilot Trial.
The MIVT Pilot
Trial will evaluate the safety and efficacy of MIVT's polymer-free nanoscale
microporous hydroxyapatite drug-eluting stent for the treatment of single
de novo lesions in native coronary arteries.
The first procedure
was conducted by Dr. Alexandre Abizaid of Institute Dante Pazzanese of
Cardiology in Sao Paulo, Brazil. Dr. Abizaid and Institute Dante Pazzanese
of Cardiology are among the world's foremost experts in conducting clinical
trials researching both new and existing drug-eluting stents.
The beginning
of human implantation represents the culmination of extensive research
and development and a successful animal trial program. Human implantation
represents a crucial milestone in MIVT's strategic plan to develop a new
class of polymer-free drug-eluting stents that could provide patients with
superior outcomes.
"We are very pleased
to announce that our human trials are underway in-line with our previous
guidance," said Dr. Mark Landy, President of MIV Therapeutics. "We have
worked diligently to create a new, novel technology that we expect will
be an excellent alternative for millions of patients around the world suffering
from coronary artery disease.
MIV Therapeutics
is focused on commercializing the next generation of fully biocompatible
coatings for cardiovascular stents and drug delivery systems to treat coronary
artery disease, an estimated $6 billion worldwide market. The company's
technologies are expected to offer a safer alternative to current drug-eluting
stents and hope to solve the issues of late thrombosis.
MIVT's polymer-free
nanoscale microporous hydroxyapatite drug-eluting stent uses the Company's
GenX coronary stent system. The GenX stent is coated with one of MIVT's
proprietary hydroxyapatite polymer-free drug eluting systems that is 700
nanometers thin.
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 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. MIVT's intellectual property
portfolio includes patents held by the University of British Columbia (UBC).
MIVT has worldwide exclusive rights to the technologies licensed from UBC.
Key patent applications filed simultaneously in various countries around
the world, further protect the commercial exclusivity of MIVT's own inventions
in the global marketplace. For more information please visit www.MIVTherapeutics.com.
For investor 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 "proposed," "expected," "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 including, without
limitation, the potential for the unsuccessful closing by the Company of
its Vascore acquisition, together with the raising of funding sufficient
to continue with its operations and those contemplated by the Company as
a consequence thereof, and the ability of the Company to raise sufficient
funding and to continue to develop its various business interests as presently
contemplated. 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.
Contacts
MIV Therapeutics
Inc.
Investor Relations,
604-301-9545, x14
Toll-free: 800-221-5108
Fax: 604-301-9546
investor@mivtherapeutics.com
http://www.mivtherapeutics.com/
or
Trilogy Capital
Partners
Financial Communications
Ryon Harms, Toll-free:
800-592-6067
ryon@trilogy-capital.com
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From March of 2005 through July of
2006, TGR Group LLC was paid a fee of $40,000 by MIV Therapeutics for coverage
of the company. In addition, TGR Group LLC was also awarded 272,000 warrants
with an exercise price of $.26 by Trilogy Capital Partners for coverage
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and shares have been sold in the open market. On April 3rd of 2007, MIV
Therapeutics renewed coverage and paid TGR Group, LLC $30,000 in cash and
100,000 warrants, convertible into restricted shares at $.50. In addition,
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