Navigation Links
Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy
Date:7/7/2009

SUNRISE, Fla., July 7 /PRNewswire-FirstCall/ -- Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today that the panel discussion on myoblast (muscle stem cell) therapy between distinguished physicians and scientists is available for playback at the following site:

http://www.bioheartinc.com/news.php#060409

After reviewing supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of experts strongly endorses moving forward to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure to mainstream use with FDA approval and CMS reimbursement. The MARVEL II program aims to streamline both screening and follow-up to facilitate enrollment and to enhance safety monitoring.

During the panel discussion, Dr. Christopher O'Connor, Director Heart Center, Duke University Medical Center commented on the MARVEL program "We believe it is an endeavor worthy of strong support. It is hopeful that MARVEL II, which is one stage of the broader MARVEL program, will meet a key efficacy end point - the six-minute walk." Dr. Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine, discussed the difficulties of stem cell therapy in scar tissue. "Cells of the myoblast variety seem to be able to overcome this barrier...and this is what's so exciting about the myoblast trials that Bioheart has proposed. We are very encouraged and would like very much to continue these trials."

Highlights from the call include Dr. Doris Taylor's, Director, Center for Cardiovascular Repair, University of Minnesota, recollection of the more than 20 years of research in this field. "I'll never forget the home run. We were able to show that we could grow new muscle in the center of ischemic myocardium and improve functional outcome." Dr. Nabil Dib, Director, Cardiovascular Research, Mercy Gilbert & Chandler Medical Centers, added that "Myoblast transplantation to patients with congestive heart failure and specifically to scar tissue (not living tissue) has shown that the cells survive, engraft and form new muscle and they do excrete fatigue resistant proteins similar to the heart muscle protein." Dr. HJ Duckers, Interventional Cardiologist, Thoraxcenter, Rotterdam discussed the history of the Bioheart trials in Europe to date and added that "the myoblast therapy is at this time point the only stem cell therapy that is making the claim to actually induce neomyogenesis and that is why it deserves our attention."

Dr. Warren Sherman, Director, Stem Cell Research and Regenerative Medicine, Columbia University Medical Center, discussed the anticipated MARVEL study, "this study, once completed, will be the bench mark and we are all very optimistic. Thomas Povsic, Assistant Professor of Medicine, Duke University Medical Center worked directly with the investigational sites on the MARVEL study and commented on "the enthusiasm by the investigators that were involved in the study to get patients in and the enthusiasm that the patients have to get into this study."

Bioheart's latest Phase II/III MARVEL study has undergone interim analysis and although data are not disclosed due to pending publication confidentiality, the panel of experts has reviewed these data and has unanimously and enthusiastically endorsed moving forward to finish the pivotal studies to bring this product to FDA approval based on their review.

Research by these experts and others has shown that myoblasts may have an advantage over other cell types in treating heart failure as they can survive in low oxygen environments (such as the damaged areas of the heart), they are committed to becoming muscle, and they are the only progenitor cell in the human body that normally develop the ability to contract making them more likely to restore contractile function of the damaged heart.

About Bioheart, Inc.

Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(R), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.

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, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2008; June 30, 2008 and September 30, 2008.

    Contact:
    At the Company:
    Howard J. Leonhardt, Chief Executive Officer
    (954) 835-1500


'/>"/>
SOURCE Bioheart, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial
2. New Report Shows Record Number of Medicines in Development to Treat Leading Causes of Cancer
3. Abbotts Market-Leading XIENCE V(R) Shows Increasing Clinical Advantages Over TAXUS(R) Express2(TM)/TAXUS(R) Liberte(TM) Between Two and Three Years
4. Dr. James F. Pingpank to Present at Leading Regional Therapies Conference
5. RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial
6. PAREXEL Strengthens Leading Presence in Latin America With a New Location in Peru
7. Durezol(TM) in the Treatment of Uveitis and Ganciclovir in the Treatment of Herpetic Keratitis: Studies of Treatments for Leading Causes of Blindness to Be Presented
8. Nuvo Research presents positive Phase III study results for Pennsaid at leading rheumatology conference
9. News Media Advisory: Worlds Leading Surgical Oncologists to Gather at McLaren Regional Medical Center to Present Latest Work on Breast, Gastrointestinal Cancer Treatments
10. Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged in Phase II/III Marvel Trial of Myogenic Cells for Treating Advanced Heart Failure
11. Leading Cardiologist Joins Ontario Research Firm to Conduct New Clinical Trial on the Effect of Pantethine on Cholesterol Levels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/17/2017)... 17, 2017  Noble Capital Markets announced today that ... (Nasdaq: EPIX ). The report was issued ... , PhD. ESSA Pharmaceuticals is a clinical ... cancer (CRPC). Its lead compound EPI-506, is a small ... of the androgen receptor, thereby has potential to overcome ...
(Date:2/16/2017)... Quest Diagnostics (NYSE: DGX ), ... announced that it has been named one of the ... The annual survey designated Quest Diagnostics as ... Pharmacy and Other Services" industry to attain Most Admired ... attain the designation. This is the second consecutive year ...
(Date:2/16/2017)... Feb. 16, 2017  Aralez Pharmaceuticals Inc. (NASDAQ: ... company, today announced that executive management will participate in ... held February 22-23, 2017. Adrian Adams , Chief ... at 1:35 p.m. local time on Wednesday, February 22, ... for the event may be accessed from the Investors ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... February 17, 2017 , ... For ... assistance management solution to the exhibit floor for the 2017 HIMSS Conference ... , From Feb. 19–23, 2017, more than 40,000 healthcare industry professionals are expected ...
(Date:2/17/2017)... Seattle, WA (PRWEB) , ... February 17, 2017 ... ... health management organizations, has been named a finalist in the 8th Annual DecisionHealth ... impacting America's healthcare delivery system. Qualis Health’s work is recognized across multiple award ...
(Date:2/17/2017)... ... 2017 , ... Pharmica Consulting attended CHI's 8th Annual SCOPE ... trial planning and management. Pharmica discussed the importance of effective project management, data ... by Pharmica’s booth were able to demo its cloud-based Resource Management Tool, ...
(Date:2/17/2017)... ... February 17, 2017 , ... Top neuroendocrine cancer doctors, nurses and specialists from ... February 21 - 23 in Beaver Creek, CO. It was announced today by Cindy ... year in Beaver Creek, hosting over 60 faculty members and addressing unmet needs of ...
(Date:2/16/2017)... ... 17, 2017 , ... For some cancer survivors, the memories ... Physician researchers at The Marcus Institute of Integrative Health at Thomas Jefferson ... reducing symptoms of traumatic stress in cancer patients and published their results ...
Breaking Medicine News(10 mins):