Bioheart (OTC: BHRT; Twitter: $BHRT)

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Bioheart (OTC: BHRT; Twitter: $BHRT) seeks to be the "go to technology partner for heart failure specialists and their patients".

Transcript of Bioheart (OTC: BHRT; Twitter: $BHRT)

    • BIOHEART INC.
    • April 2011
    • OTC: BHRT.OB
  • 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, 2010.
  • Company Thesis
    • Bioheart is dedicated to the discovery and development of myoblast and stem cell therapies for heart damage:
    • MyoCell
      • An autologous cell therapy comprised of muscle derived stem cells for congestive heart failure.
    • MyoCell SDF-1
      • An autologous cell and gene therapy comprised of muscle derived stem cells transduced to express the protein stromal derived factor 1 for congestive heart failure.
  • Heart Disease is the Leading Cause of Death Worldwide
    • According to the American Heart Association, approximately 5.7 million Americans suffer from congestive heart failure (CHF).
    • The cost of hospitalization and treatment for heart failure is twice that of all forms of cancer combined.
    • Treatment with drugs and devices is available but not all patients return to a normal lifestyle.
    • Myoblasts represent the most advanced cell therapy that can effectively be targeted to this patient population.
  • 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
  • Myoblast Engraftment Post-Transplantation Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast injections. Human Heart, Proof of Concept * Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy, Lancet, Vol. 361, 2003: 491-492
  • MyoCell: Heart Failure Treatment Process Scar tissue following heart attack Injection of skeletal myoblasts into scar tissue using deflecting-tip catheter Cell manufacturing following thigh muscle biopsy 1 3 2
  • Bioheart Has Addressed CHF with Myocell Including third-party studies, myoblasts have been evaluated in at least 11 clinical trials involving more than 345 enrollees and more than 255 treated patients Trial # of Patients Status Primary Endpoints EU Phase I/II 5 Phase I 15 Phase I/II Completed Q2 2003
    • Serious adverse events
    • Global ventricular function
    MYOHEART (US, Phase I) 20 Completed Final Patient Treated Q4 2006
    • Serious adverse events
    SEISMIC (EU, Phase II-a with Control) 40 (14 control) Completed Final Patient Treated Q3 2007
    • Serious adverse events
    • LVEF
    MARVEL Trial (N. Am./EU: Phase II/III, Double-blind, Placebo-controlled) 150 anticipated (50 controls) Stage 1 Results Announced First Patient Enrolled and Treated Q4 2007
    • Serious adverse events
    • 6-minute walk test
    • Quality of life score
  • Journal of the American College of Cardiology, Vol. 42, No. 12, 2003, Serruys, Smits et al. Study sponsored by Bioheart, Inc. LVEF Measured via LAO LV Angio. 3 month, p=0.009; 6 month, p=0.23. N = 5. Percutaneous Intramyocardial Transplantation of Autologous Myoblasts: Bioheart First-In-Man Experience LVEF (%)
  • Percutaneous Intramyocardial Transplantation of Autologous Myoblasts BIOHEART Phase I/II Trial Results for these trials were not statistically significant due, in part, to the limited number of patients treated. Baseline 6 Months 12 Months N = 13 N = 13 N = 13 LVEF: Mean Baseline = 34.4% + 7.4 Mean 12-Month Follow-up = 36.6% + 9.6 NYHA Class Improvement
  • Measurements via PV Loop, n=5. 33 41 190 150 4.6 5.6 Percutaneous Intramyocardial Transplantation of Autologous Myoblasts BIOHEART Phase I/II Trial LVEF CO LVESV
  • Bioheart Percutaneously Delivered Myoblasts Clinical Trial Data Summary EU FIM, Phase I/II Adjudicated Data (n = 5+15) Safety 2 patient deaths (10%) Efficacy 4/5 of patients improved one heart failure class 1/3 of patients improved two heart failure classes 1/3 of patients experience ~ 35% relative improvement in LVEF 15.3% improvement in Wall Motion Score Index via stress echo 13% reduction of LVED volume
    • 7 arrhythmic events reported
      • 5 possibly related to cell
      • therapy (25%)
      • All occurred during first
      • 3 mos. post implant
      • Anti-arrhythmic medication
      • not prophylactically prescribed
    • PVCs peaked at 3-weeks but were
    • reduced from 1.89% at baseline
    • to 0.04% at 12 mo. follow-up
    Bioheart Phase I/II Trial (005/006).
  • * All 5 treated patients withdrew due to changes in German biopsy regulations. ** Both control patients withdrew after knowledge of randomization allocation. Bioheart Percutaneously Delivered Myoblasts EU Phase II Trial (SEISMIC) 47 Patients Randomized: ICD Patients: 31 MyoCell , 16 Standard Medical Therapy Treatment Arm ( MyoCell 150 - 800 x 10 6 ) 26 ICD Patients Control Arm (Standard Medical Therapy) 14 ICD Patients Baseline Evaluation Screening: 62 ICD Patients 15 Screen Fails 5 Withdrawals* 2 Withdrawals**
  • SEISMIC NYHA heart failure class Improvement Myoblast therapy Control therapy N=26 N=23 N=22 N=20 N=14 N=9 N=12 N=13 BL 1 mo 3 mo 6 mo BL 1 mo 3 mo 6 mo
  • SEISMIC +60.3 m + 54.1 -0.2 m 177.1 Treatment N=26 N=21 N=19 Control Control N=14 N=12 N=13 448 m 441 m 406 m 466 m 6-Minute Walk Test Improvement Difference Between Baseline and 6 Months
  • SEISMIC Response to Treatment NYHA HF / 6MWT / MLFQ / LVEF
  • MYOHEART US Phase I Study Flow Clinical Sites: Columbia Presbyterian, Cleveland Clinic, Mayo Clinic, Minneapolis Heart, St. Joseph s / ACRI Core Lab: Gentiae Clinical Research 2 injections (.25 cc) 6 injections (.25 cc) 18 injections (.25 cc) First Cohort (n=5) 25 x 10 6 cells 30 - Day Safety Evaluation Second Cohort (n=5) 75 x 10 6 cells 30 - Day Safety Evaluation Third Cohort (n=5) 225 x 10 6 cells 30 - Day Safety Evaluation Fourth Cohort (n=5) 675 x 10 6 cells 27 injections (.50 cc)
  • MYOHEART 6MWT Average 6 Minute Walk Test All Cohorts 6MWT (meters) N=20 422 474 471 N=18 N=15 47 36 N=15 6MWT (meters) N=18 All Patients Paired Analysis p = .0074 p = .2126 474 N=17 42 p = .1367 N=17
  • MYOHEART MLHFQ Average Minnesota Living with Heart Failure Score All Cohorts MLHF Score N=20 51 34 33 N=19 N=18 -14 -16 N=19 N=18 All Patients Paired Analysis p = .0016 p = .0004 MLHF Score 30