About PlaCor
PlaCor, Inc. has developed a
simple, easy to use, proprietary test for platelet reactivity, a serious
risk factor for heart attack and stroke.
Most cardiologists are aware that up to 50% of patients taking
aspirin and/or Plavix®
still have high platelet reactivity, putting them
at an increased risk for experiencing a heart attack or stroke. The 128
million people with or at risk of cardiovascular disease (CVD) represent an
estimated $6.3 billion dollar potential market opportunity in the U.S.
alone.
Market Drivers
Cardiovascular
disease is the leading cause of death in the U.S.
_
80.7
million people in the U.S. have CVD (up from 79.4 million the previous
year).
_
47 million
additional people have risk factors for heart attack and stroke.
_
The aging
population is fueling this trend.
Antiplatelet
therapy has revolutionized the care of patients with CVD
_
Taking aspirin
can reduce the risk of a first heart attack by 32%. Physicians prefer to
prescribe aspirin rather than Plavix (about $4/day) if aspirin is
effective for their patients.
_
Plavix, a
strong anti-platelet drug, is critical to the success of drug eluting
stent placement. Patients that discontinue Plavix therapy have higher
rates of stent thrombosis (clotting).
_
Of the 128
million people with or at risk of developing CVD, only 48 million are on
antiplatelet therapy.
Up
to 50% of patients are not responding adequately to their antiplatelet
therapy
_
Studies
have demonstrated that nonresponders have a 3.5 times higher risk of
cardiovascular death.
_
As many as
50% of patients are either low or non-responders to Plavix/aspirin
therapy.
Even though cardiologists are
aware that up to 50% of patients may not be responding adequately to
their antiplatelet therapy, platelet reactivity testing has not been
widely used because a point-of-care test has not been available until
recently. However, the controversy surrounding the ever increasing use of
drug-eluting stents has brought the importance of platelet reactivity
testing to the forefront, increasing the adoption of testing.
Product and Technology
Antiplatelet agents inhibit
platelets from sticking together and initiating the clotting process.
Most testing methods determine how "sticky" (or reactive)
platelets are. PlaCor's PRTTM
(Platelet Reactivity Test) is
designed to be a point-of-care device that can be easily operated by
non-laboratory personnel
and mimics how platelets are
activated in the body. The methodology is quick, straightforward and can
be used not only with aspirin but with other antiplatelet drugs. No other
instrument can be used with such a wide range or combination of drugs. In
addition, PlaCor's PRT is the only instrument that can use blood from a
fingerprick sample, making it the fastest platelet reactivity test
available.
Market Potential and Strategy
The use of point-of-care
tests which ensure quick generation of results and better patient care is
growing rapidly. According to a recent InteLab Corporation industry
report, the world-wide point-of-care testing market is
outpacing the overall In
Vitro Diagnostics market and is expected to grow from $10.3 billion in
2005 to $18.7 billion by 2011. In
the U.S. alone, the market potential for testing the 128 million people
with or at risk of CVD is $6.3 billion. PlaCor’s market strategy is to
carefully stage the introduction of the PRT. The first target market in
the U.S. will be the 22,000 cardiologists seeing patients that have
recently had an event, those that have new symptoms of CVD and patients
that have CVD and are coming in for routine care.
European Market Introduction
PlaCor began a carefully
staged rollout of the PRT System in Europe at the end of the first
quarter of 2009. Specialized distributors are being selected and trained
and clinical reference centers are conducting testing and studies in key
markets. We have received introductory orders from several countries and
have commenced shipping.
Regulatory
The company filed a 510(k) application
with the FDA and anticipates receiving market clearance by the fourth
quarter of this year. The PRT
System is CE marked which enables PlaCor to market in Europe and several
other international markets.
PlaCor Management
The PlaCor founders worked
together previously at AVECOR Cardiovascular, Inc., from start-up to
acquisition by Medtronic. The founders have significant medical device
and business development experience.
Anthony
Badolato, Founder/Chairman, was the founder, President and CEO of
AVECOR. Under his guidance, AVECOR grew from a start-up to over $50
million in sales until its sale to Medtronic in March 1999. Previously, Mr. Badolato held senior
research and manufacturing positions at Biomedicus and Johnson &
Johnson.
John
Reinke, CEO, was most recently a Senior Vice President for
UnitedHealthGroup in Minnetonka, MN. Mr. Reinke has 30 years of
experience in health care, management consulting and financial services.
William
S. Haworth, Founder/CTO, was the Managing Director of AVECOR Ltd.
and VP of Engineering for AVECOR. Mr. Haworth also held senior R&D
positions at 3M.
Allan
R. Seck, Founder/VP Marketing and Sales, was also a founder and
VP of Marketing and Sales for AVECOR. Mr. Seck held senior marketing
positions at BioMedicus, Medtronic and Johnson & Johnson.
Joseph
D. Margarit, Chief Financial Officer, was the Chief Financial Officer
at Advanced Bio-Surfaces, Inc.
Dennis
E. Steger, VP of Regulatory Affairs and Reimbursement, was the VP
of Regulatory Affairs and Quality at Medical CV, Inc. and the Director of
Regulatory Affairs at AVECOR.
**
The PlaCor PRT is
for research use only and is not for sale in the U.S.
For more information about
PlaCor, please contact Joe Margarit, CFO at 763.398.6216 or
