BIOHEART INC.
February 2012
The Next Generation of
Regeneration
OTC: BHRT.OB
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Forward-Looking Statement
Except for historical matters contained herein, statements made in this presentation are
forward-looking and are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing,
words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”,
“could”, “would”, “estimate”, or “continue” or the negative other variations thereof or
comparable terminology are intended to identify forward-looking statements.
Investors and others are cautioned that a variety of factors, including certain risks, may
affect our business and cause actual results to differ materially from those set forth in the
forward-looking statements. These risk factors include, without limitation, (i) our ability to
obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our
ability to establish a distribution network for and commence distribution of certain
products for which we have acquired distribution rights; (iv) our ability to timely and
successfully complete our clinical trials; (v) the occurrence of any unacceptable side
effects during or after preclinical and clinical testing of our product candidates; (vi) the
timing of and our ability to obtain and maintain regulatory approvals for our product
candidates; (vii) our dependence on the success of our lead product candidate; (viii) our
inability to predict the extent of our future losses or if or when we will become profitable;
(ix) our ability to protect our intellectual property rights; and (x) intense competition. The
Company is also subject to the risks and uncertainties described in its filings with the
Securities and Exchange Commission, including the section entitled "Risk Factors" in its
Annual Report on Form 10-K for the year ended December 31, 2009, and its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2010.
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MyoCell® Cell Therapy Overview
 Muscle stem cell-based therapy designed to treat heart
damage by growing new muscle in damaged heart
tissue.
 Uses myoblasts (muscle stem cells)
• Patient-derived; reduces risk of tissue rejection
• Committed to forming muscle, will not differentiate
into other cell types or over-proliferate
• Tolerates low-oxygen conditions present in scar tissue
 Large potential savings in healthcare costs
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Myoblast Transplantation Data Summary
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Dr. Race Kao 1988 The Physiologist canine study.
Dr. Doris Taylor 1998 Nature Medicine rabbit study.
Dr. Philipe Menasche June 2000 first surgical case LANCET.
Dr. Patrick Serruys May 2001 first cath case JACC.
350 patients in clinical trials to date.
84% cell treated patients improved. Only 16% worsened.
In comparison 69% of control pts on CHF drugs worsen.
Phase II/III double blinded, randomized, placebo controlled
results just published in American Heart Journal. Bioheart
MyoCell patients 95.7 meters improvement in exercise
capacity over placebo (-4) patients. End point goal was 16
meters. Beat primary end point goal by over 500%.
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Myoblast Engraftment Post-Transplantation
Human Heart, Proof of Concept
Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast
injections.
* Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy,
Lancet, Vol. 361, 2003: 491-492
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MyoCell: Heart Failure Treatment Process
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Cell
manufacturing
following thigh
muscle biopsy
Injection of skeletal
myoblasts into scar
tissue using
deflecting-tip
catheter
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1
Scar tissue
following heart
attack
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Competition
 Bioheart’s technology is the most advanced and
effective of all cell therapies for CHF.
 Bioheart has Intellectual Property and technological
exclusivity that protects freedom of operation.
 Myoblasts have been shown to be the only effective
cell-based therapy to grow new contractile muscle
(myogenesis) in true scar tissue for treatment of CHF.
 Adipose (fat) derived stem cells are preferable over
bone marrow stem cells in indications requiring
angiogenesis, because they are autologous, easy to
obtain and abundant.
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Bioheart Has Addressed CHF with Myocell
Trial
EU Phase I/II
MYOHEART
(US, Phase I)
SEISMIC
(EU, Phase II-a with
Control)
MARVEL Trial
(N. Am./EU: Phase
II/III, Double-blind,
Placebo-controlled)
# of Patients
Status
5 Phase I
15 Phase I/II
Completed
Q2 2003
20
Completed
Final Patient Treated
Q4 2006
40
(14 control)
Completed
Final Patient Treated
Q3 2007
160 anticipated
(50 controls)
Part 1 Results
Published, Part II
launching now
Primary Endpoints
• Serious
adverse events
• Global ventricular function
• Serious
adverse events
• Serious
adverse events
• LVEF
• Serious
adverse events
• 6-minute walk test
• Quality of life score
Including third-party studies, myoblasts have been evaluated in at least 12 clinical trials
involving more than 350 patients
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Bioheart MARVEL Program
Unique Features and Goals
SUBSTRATE
DESIGN
• Left ventricular
scar 2 to prior
myocardial
infarction
• Not suited to
other stem cell
products
• Blinded,
randomized,
placebo
controlled
• 1st trial of
catheter-based
therapy
ENDPOINTS
• Emphasis on
patient centered
outcomes
• Objective and
subjective
• Goal to fulfill
criteria for clinical
approval
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MARVEL Program Study Objectives / End Points
 Overall objective
• Assess the safety and efficacy of MyoCell® in CHF
patients post myocardial infarction(s) using the MyoStar®
and NOGA XP®
 Primary safety end point
• Incidence of SAEs at 3 and 6 months post implantation.
 Co-Primary efficacy end point
• Changes in 6-minute walk distance or quality of life.
 Secondary efficacy end points
• Changes in LVEF, LV volume, wall motion indices, BNP,
NYHA class, and frequency and nature of rehospitalizations.
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MARVEL-1: Mean Change in 6-Minute Walk Distance (meters)
p=0.50
n=6
n=7
n=6
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MARVEL-1 Arrhythmia Analysis: Myocell® Patients
Myocell® Txt
14 Patients
No Amiodarone
Txt
n= 7
4 Patients
4 Episodes VT
Amiodarone
started
0 Episodes VT
Amiodarone Started
at Implant or
Stopped
n=3
2 Patients
2 Episodes VT
Amiodarone
Started at Bx
n=4
0 Patients
0 Episodes VT
Amiodarone
continued
1 Patient
1 Episode VT
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Bioheart: The FDA Approved REGEN Trial
Next Generation: MyoCell® SDF-1
SDF-1
Cells
Damaged area
secretes chemokine
proteins
Increased muscle formation
Adult stem
cells
Endogenous circulating
stem cells attracted to
injury by chemokine
proteins
Increased blood vessel supply
Four years of sponsored animal studies have demonstrated that 2nd generation
MyoCell ® SDF-1 provides significantly higher levels of improvement than the first
generation MyoCell ® composition.
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REGEN Trial – MyoCell SDF-1
 7 years of preclinical testing in animals at both Cleveland
Clinic and the University of Florida has demonstrated
double the cardiac improvement over standard myoblasts.
MyoCell SDF-1 54% improvement. Myoblasts unmodified
27%. Control placebo injections minus 10%.
 FDA clearance received for a 15 patient, 3 center Phase I
study
– Dose Escalation – 3 cohorts: 200 million, 400 million and 800
million cells
 Historic first ever FDA approval for clinical trials for a
combination gene and cell therapy for a major indication of
use.
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Bioheart, Inc - MyoCath® SR-200 Injection Catheter System
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Manufacturing MyoCell
Currently at Bioheart’s Headquarters in Florida
 Current facility sufficient for next two years and able to be expanded
 Capacity
• One Shift: 15 patients/month
• Two Shifts: 25 patients/month
• Three Shifts: 30-60 patients/month
 Ability to add capacity in Florida if expanded with additional suites
Other Locations to be Ramped Up as OUS business grows
 Korea
 Jordan
 The Netherlands
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Repeat injections even more improvement
• European Heart Journal (2010) 31, 1013–1021
doi:10.1093 Repeated implantation of skeletal myoblast in
a swine model of chronic myocardial infarction Felipe
Prosper et al.
• A significantly greater increase in the DLVEF was detected
in animals that received three doses vs. a single dose of
SkM. A correlation between the total number of
transplanted cells and the improvement in LVEF and DLVEF
was found (P , 0.05). Skeletal myoblast transplant was
associated with an increase in tissue vasculogenesis and
decreased fibrosis (collagen vascular fraction) and these
effects were greater in animals receiving three doses of
cells.
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Repeat Injections Even More Improvement
• Control placebo LVEF 40.6 down to 37.7 P value 0.880
>> Myoblast injection results…
• 1 injection session LVEF 45.1 up to 56.2 P value 0.113
• 2 injection sessions LVEF 41.3 up to 56.4 P value 0.02
• 3 injection sessions LVEF 39.3 up to 65.6 P value 0.01
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Bioheart TGI System Process
First objective: Reduce the damage to the heart by
reducing scar size.
1
2
3
Adipose cells
extracted
Cells processed in the
hospital in less than 2
hours using the system
and disposables to extract
endothelial progenitor and
stem cells
Selected cells
infused via catheter
Animal test results have shown a 90% reduction in scar size.
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Pacemaker
Features:
1. Grows new blood vessels
2. Grows new muscle
3. Increases contraction strength of muscle
4. Converts pluripotent stem cells into heart
muscle cells (cardiomyocytes)
5. Ensures heart remains on beat
6. Reduces the risk of sudden death
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MyoStim
Pacemaker
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5 Sequences of MyoStim Stimulator
• The MyoStim Implantable Heart Tissue Stimulator - This product is designed to
improve upon current CRT/ICD pacemakers in treating patients with heart
failure and arrhythmias. The stimulator runs five (5) programs in sequence; (1)
The Kanno program stimulates angioenesis (new blood vessel growth). (2) The
Chachques-Leonhardt program recruits stem cells to injured heart tissue areas.
(3) The Leonhardt-Chachques program differentiates recruited and/or injected
stem cells to beating heart muscle. (4) The Leonhardt program senses
arrhythmia's-fibrillation and delivers a low voltage pulse to restart a patient's
heart back to a normal beat (replaces outdated high voltage shock ICD
systems). (5) The final program is a standard synchronization pacing program
that double ensures that newly created muscle, in the previous scarred areas of
the heart, beats in synchrony with the rest of the heart. The stimulation pulses
also duly serve to increase the contraction twitch strength of the muscle to
improve cardiac output. This product will require clinical trials of approximately
300 patients. Nearly half of the 30 to 50 million patients worldwide in heart
failure are expected to be candidates for this product in the future.
• Market: $6 billion +
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Enhancement of Myoblast Transplantation with
Electrical Stimulation
Fast twitch to Slow twitch Conversion of Myoblasts
No Electrical
Stimulation
100%
90%
80%
99%
With Electrical
Stimulation
70%
60%
66%
50%
40%
Based on early observations from Dr. Juan C. Chachques, MD, PhD
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Lab Stimulator
Features:
1. Doubles the production of cell cultures w/
half the amount of growth factors & media
2. Converts pluripotent stem cells to
cardiomyocytes (beating heart muscle cells)
3. No use of animal based products (FDA
mandate)
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Human Cell Cultures at 3 weeks
Without Stimulation
With Stimulation Double The Quantity
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BioPace Biological Pacemaker
• Cultured sino atrial node and atrial cells pre-conditioned
with electrical stimulation.
• Your own natural pacemaker can out perform any battery
powered pacemaker in a steel can with steel leads.
• Technology has already been validated in large animal preclinical studies King et al.
• 3 issued U.S. patents to Bioheart.
• Schedule plan is to complete historic first clinical patient by
end of next year.
• Expectation is to obsolete electronic pacemakers by the
end of the decade.
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