FT. LAUDERDALE, Florida, Sept. 14 /PRNewswire/ -- Bioheart Inc. synopsis
of company presentation at Emerging Medical Technologies East Conference:
Bioheart, Inc. is a cardiovascular disease management organization with
products that prevent heart attacks and assist those individuals that have
suffered from a heart attack return to a full quality of life. Bioheart's
products consist of (i) tissue engineered products for heart muscle
regeneration and (ii) customized therapies based on genotyping to prevent
cardiovascular disease and heart attacks.
Product And Technology -- Bioheart Inc. Microimplant -- Myogenesis Program
1. Derive autologous cells from the patient
2. Culture autologous cells, including separation and expansion
techniques.
3. Autologous cells are delivered to the damaged portion of the heart
utilizing Bioheart's proprietary delivery systems, including surgical
and percutaneous, endovascular procedures.
Bioheart's autologous cell source consists of myoblasts (skeletal muscle
cells), easily attainable from a 2 gram muscle biopsy have proven as an
effective cell source for heart muscle regeneration because they are committed
to become muscle, are resistant to ischemia, do not over proliferate and are
able to withstand cardiac workload. Dr. Doris Taylor, Vice President of
Research and Assistant Professor at Duke University, recognized as the leading
scientist in the field of heart muscle tissue regeneration has shown that
immature myoblasts are key to the success of the procedure. Dr. Taylor,
published in the August 1998 issue of Nature Medicine documenting improved
cardiac performance in animals. Bioheart's method for regenerating heart
muscle tissue is being replicated around the world.
Product And Technology -- Bioheart Inc. Genotyping
Knowledge of a patients unique cardiovascular genetic profile can be
useful for matching the appropriate drug at the right dose for the patient, or
for identifying predisposition to risk factors early so that preventative
measures can be taken before the symptoms of disease manifest. Bioheart is
positioning itself to become the primary resource to cardiologists for genetic
tests that identify cardiovascular risk factors for which there is a
therapeutic solution. Bioheart is currently launching it's proprietary PLA2
test for the identification of thrombosis susceptibility and predisposition to
early heart attack. Bioheart has introduced four additional panels of genetic
cardiovascular risk factors. Bioheart holds an exclusive proprietary position
for PLA2in both the U.S. and Europe.
Bioheart has established, and is continuing to develop, what we believe
will be the premier portfolio of intellectual property and proprietary
technologies in the field of heart muscle regeneration. Our patents and
patents pending (both licensed and owned by us) support the approaches for
regenerating damaged heart muscle. When taken as a whole we believe we have
assembled the strongest portfolio of intellectual property in the field of
myocardial regeneration and device delivery technology.
Bioheart Inc. Milestones
Event Anticipated Date
Human cases Accomplished
Initiate European clinical trial October 2000
Initiate US clinical trial January 2000
Foreign sales First quarter 2001
FDA Approval Fourth quarter 2003
Management Team
Mr. Leonhardt, the founder of World Medical Manufacturing, that developed
the Talent AAA stent graft and was acquired by AVE/Medtronic for approximately
$70 million. Mr. Lashinski was the co-founder of AVE, a leading coronary stent
and balloon catheter manufacturer that was sold to Medtronic for approximately
$4 billion. Mr. Lashinski's role at Bioheart consists of leading the
development of our delivery systems as Chief Consultant of Product
Development. Bioheart has also established an impressive array of strategic
partners including, Dr. Taylor, Duke University, Dr. Chiu, McGill University,
Dr. Race Kao, East Tennessee State, Dr. Phillippe Menasche, Dr. Charles
Murray, a leading cardiovascular pathologist, IntroGene, The Cleveland Clinic
Foundation, Columbia University and Lenox Hill.
Financial Forecast
With the collection of researchers, proven management and strong
intellectual property portfolio we believe that Bioheart will be the leader in
heart muscle regeneration, a segment positioned for significant growth over
the next five years. Additionally, we believe that autologous cell
transplantation will represent one of the first true therapies for treating
the cause of disease states such as congestive heart failure. Bioheart is
planning to close on a $20 - $25 Million Series B round of financing in Q4 to
support clinical trials and operations into mid-2002. During this period
Bioheart intends to advance its clinical progress, promote foreign sales and
market genotyping products.
SOURCE Bioheart, Inc.
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Related links:
http://www.bioheartinc.com
CONTACT:
Howard Leonhardt of Bioheart, 954-217-7259,
or Hleonhardt@aol.com
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