Bioheart Announces Plans to Advance LVAD + Muscle Stem Cells Clinical Trial

SUNRISE, Fla., Dec. 8, 2010 /PRNewswire-FirstCall/ -- Bioheart, Inc. (OTC Bulletin Board: BHRT) announced today that at the American Heart Association Annual Meeting, it finalized the formation of a working group. The group's focus is to advance a BRIDGE TO RECOVERY clinical trial, combining a left ventricle assist device (LVAD) and Bioheart's MyoCell adult muscle stem cell composition and Bioheart's MyoCath needle tipped catheter delivery system.  

Initial participants in developing this proposed protocol design include:


Dr. Frank Pagani, University of Michigan

Dr. Warren Sherman, Columbia University

Dr. Ernst Schwarz, Ceders Sinai UCLA

Dr. Nabil Dib, University of California San Diego and Mercy Gilbert Hospital Phoenix

Dr. Carl Pepine, University of Florida Shands Hospital

Dr. Doris Taylor, University of Minnesota



The expected study design pending potential modification will include 3 treatment arms:

Group 1 - Patients receive MyoCell SDF-1 single dose via MyoCath catheter delivery after LVAD placement.

Group 2 - Patients receive MyoCell in multiple injection sessions over 6 months via MyoCath catheter delivery following LVAD placement.

Group 3 - Patients receive LVAD only.

The end points in the trial will include exercise capacity, functional improvements and success in weaning off the LVAD.

"At the AHA meeting, improvements in survival of heart failure patients were reported from trials with battery powered pacers and mechanical left ventricle assist heart pumps.  These devices help patients cope with their failing heart, but do little to repair damaged scar tissue in the heart, which is often the primary source of heart failure.  The MyoCell composition from Bioheart has demonstrated an ability to grow new contractile muscle in scar tissue and thus, may actually address the underlying problem.  Supporting the patient with an LVAD temporarily during the time period to make successive injections of muscle stem cells and progressively building up more new muscle over a 21-week period, makes great sense.   The hope of this trial is that, at the end of this period, the patients can have their LVADs explanted and return to a high quality of life," stated Dr. Carl Pepine, Director of Cardiology University of Florida and past President of the American College of Cardiology.  "The ability to recover back hearts that may go to transplant and to examine them fully adds extra scientific integrity to this proposed study design.  This study has the potential to be a landmark clinical trial in our field."

"We know that we can grow new strips of contractile muscle across myocardial scar tissue with each half hour minimally invasive injection session with our MyoCell.  After injections with MyoCell the patients hopefully will have enough strength that the LVAD can be removed.  The LVAD serves well to support these patients including reducing their risk of arrhythmias during the waited stages of muscle formation.  These two therapies together ideally complement each other," stated Howard J. Leonhardt, Founder of Bioheart, Inc., Chief Technology Officer and Chairman Scientific Advisory Board.

He further added, "Only myoblasts such as our MyoCell composition have demonstrated an ability to form surviving contractile muscle within scar tissue.  Cardiac stem cells, embryonic stem cells, bone marrow, blood, placenta, umbilical cord and adipose (fat) derived stem cells do not.  Most of these pluripotent stem cells become what they touch so in scar tissue they form fibroblasts or more scar tissue, not muscle like MyoCell does.  We believe Myoblasts are the ideal cell type for this application which this study is meant to further demonstrate."  

Bioheart's MyoCell has been in clinical trials for treating advanced heart failure since early 2001. The MyoCell composition is derived from selecting immature myoblasts (adult muscle stem cells) from a patient's own skeletal (thigh) muscle.  The process of selecting and expanding these cells is done in Bioheart's cGMP facility in Sunrise, Florida.  The cells are injected by a needle tipped catheter that is inserted through a very small puncture in the patient's groin through their femoral artery.  The catheter is directed to the inside of the left chamber of the heart where injections are made in the scar tissue within the heart.  Approximately 350 patients have been enrolled in various myoblast treated heart failure clinical trials since 2000.  Over 84% of MyoCell treated patients have exhibited improvement of symptoms while only 16% have declined.   Most recent Phase II/III results demonstrated MyoCell treated patients have improved 91.7 meters in exercise capacity testing while placebo injected patients declined – 4 meters.  

About Bioheart, Inc:  

Bioheart, Inc., founded in 1999, seeks to be the "go to technology partner for heart failure specialists and their patients."  The company's flagship product MyoCell is an adult muscle stem cell composition, also known as immature myoblasts, derived and processed from a patient's own thigh muscle. These cells are delivered to a patient's heart via the MyoCath needle tipped catheter or a similar device which is inserted through the patient's groin and is directed to the inside of the heart where the injections are made. MyoCell has been in clinical trials for treating advanced heart failure patients since early 2001. A 2nd generation composition MyoCell SDF-1 received FDA authorization for clinical trials. This composition is made up of genetically modified cells that over express the stromal derived factor 1 protein that has been shown to improve blood vessel formation and muscle development. Bioheart, Inc. has also initiated clinical evaluation of methods of treating heart ischemia, acute myocardial infarctions and lower limb ischemia utilizing adipose (fat) derived cells.  Bioheart is focused on heart failure and has a building pipeline of product developments to assist care providers in treating and caring for these patients.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release 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 September 30, 2010.

SOURCE Bioheart, Inc.




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