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Howard Leonhardt To Present 25 Years Of Experience With Stem Cell Transplantation At 28th Annual Interventional Cardiology Conference In Snowmass, Colo., On March 28

SNOWMASS, Colo., March 26, 2013 /PRNewswire/ -- Howard Leonhardt, founder of Bioheart, Inc. and Leonhardt Ventures will be presenting his team's experience with stem cell transplantation for heart failure treatment at the 28 th Annual International Symposium of Interventional Cardiology. The conference, which will explore a comprehensive approach to the percutaneous management of structural heart disease and coronary and peripheral vascular disease, will be held at the Westin Hotel in Snowmass Village, Colo., from March 24 - 29, 2013. Leonhardt's presentation, titled "25 Years' Experience With Myoblast Transplantation" and listed as Oral Abstract Session VI in the program, will take place Thursday, March 28, from 7 - 10 a.m.

Over the past 25 years, the team's research and trials in stem cell transplantation for treating heart failure have revealed the following:

  • Embyronic stem cells do not work in myocardial scar tissue. They form fibroblasts or more scar. They die out.
  • Cardiomyocytes die out when injected in myocardial scar tissue (they require too much oxygen and nutrients) and cannot be multiplied to therapeutic dosages. They are electrically unstable in scar tissue.
  • Adipose, blood, bone marrow, placenta and embryonic stem cells cannot grow new muscle in scar tissue.
  • Cardiac stem cells only work to form new muscle on the rim edge of a scar, not in the center.
  • Only myoblasts or immature myoblasts are able to form new contractile muscle in scar tissue.
  • Over 4,000 animal studies have been completed, with the nearly universal majority yielding positive results for myoblast transplantation.
  • More than 400 patients have been enrolled in clinical trials for myoblast transplantation since June 2000.
  • Direct needle catheter injection into scar tissue is far superior to coronary infusion or other methods.
  • Targeted cell delivery is not needed. The cells naturally spread all over scar tissue if they are injected anywhere near the scar tissue and migrate to the injured tissue areas.
  • In trials, 84% of myoblast-treated heart-failure patients have improved; only 16% worsened.
  • 69% of non-treated control or placebo patients in trials have worsened.
  • 33% of myoblast-treated patients with only one injection session exhibited substantial improvement in cardiac function.
  • Myoblast-treated patients improved 95.7 meters over placebo patients (-4 meters decline) in exercise capacity in controlled clinical trials. No other stem cell type, drug or device has ever beat 53 meters improvement in a controlled trial; cardiac resynchronization therapy (CRT) pacers achieved an improvement of 20 meters, cardiac stem cells increased exercise capacity by 53 meters, while drugs were associated with a 4-meter decline.
  • It is expected that repeat myoblast transplantation will reduce by half hospitalizations from heart failure. Heart-failure hospitalizations and associated care are the single leading drain on Medicare in the USA.
  • Myoblast-transplanted patients have a lower incidence of serious arrhythmias six months and one year after treatment than non-treated patients. Premature ventricular contraction (PVC) data demonstrates 0.05% for myoblast-treated patients and 3% for non-treated patients.
  • 33% of myoblast-treated patients improve two heart failure classes.
  • 33% of myoblast-treated patients have greater than 15% improvement in left ventricular ejection fraction (LVEF) via dobutamine stress echo studies.
  • Pressure-volume (PV) loop studies have demonstrated myoblast-treated patients have substantial positive reverse re-modeling.
  • Close to $300 million has been spent to date on myoblast transplantation for heart failure research. Bioheart and Leonhardt Ventures have supported close to 40% of this total.
  • Pre-treating scar with microRNAs, stromal cell-derived factor-1 (SDF-1) and hydrogel before cell transplantation can improve results.
  • Genetically modifying cells to over-express SDF-1 can double improvement results and the consistency of results. Myoblasts alone lead to 27% improvement, while SDF-1 myoblasts result in 54% improvement. 66% of test subjects received substantial new muscle formation with SDF-1 myoblasts compared to 33% with ordinary myoblasts.
  • New muscle formed with myoblasts is stretch-activated.
  • Injecting cardiac stem cells or induced pluripotent stem (iPS) cells at the rim edge of scar and myoblasts in the center of scar in combination may be worth studying.
  • Electrical stimulation before, during and after stem-cell transplantation can dramatically improve results.
  • Nutrient hydrogel can help improve myoblast cell engraftment in scar tissue.
  • Repeat injection sessions can dramatically improve results. It is believed now up to 36 sessions of percutaneous injections of 300 million cells each may be needed for full myocardial scar recovery.

For more information on the 28 th Annual International Symposium of Interventional Cardiology, see http://www.interventionalcardiol.com. To learn more about advances in regenerative medicine, visit http://www.bioheartinc.com and http://www.leonhardtventures.com.

About Leonhardt Ventures: Since 1983 Leonhardt Ventures http://www.leonhardtventures.com has a strong history of inventing, developing, backing and bringing to market leadership products for treating heart and cardiovascular disease. Over 200,000 patients have been treated to date with Leonhardt inventions. In the 1980s, the group developed market leadership in patented polyurethane balloon catheters including drug, stem cell and radiation delivery systems. In the 1990s, they developed over 20 additional devices including the first commercially successful stent graft for aortic aneurysm repair (TALENT – Taheri-Leonhardt Stent Graft). The team completed the first ever truly percutaneous repair of an aortic aneurysm without surgery in Melbourne, Australia, in 1995, and published the first paper on thoracic aortic dissection repair with stent grafts in The New England Journal of Medicine in 1999. Other firsts for the team include the first conformance-sealing stent graft, the first above renal fixation stent graft, the first customized-to-fit individual patient stent grafts, the first multi-stage low-profile stent graft, the first removable stent graft, the first foam and bioglue sealing cuff for stent grafts, and the first use of muscle stem cells to reinforce aortic wall necks after stent graft placement. The team developed and patented the first percutaneous heart valve, intravascular lung catheter, the Pro-Cell intracavity stem cell delivery system and the MyoCath line of stem cell delivery catheters. Leonhardt-patented inventions include the first heart pacemaker able to recruit repairative stem cells to damaged heart tissue (MyoStim Pacers). In 2001, the team led the world's first non-surgical case of stem cell repair of damaged heart muscle in a human patient with Bioheart MyoCell. That led to the first Phase III double-blinded, randomized, placebo-controlled trial for stem cells growing new contractile muscle in post-heart-attack tissue in advanced heart failure patients, with results published in the American Heart Journal: Bioheart MyoCell resulted in 95.7 meters improvement in exercise capacity over placebo (minus 4 meters decline). The team is preparing to complete the first-ever biological pacemaker implantation in a human patient within the next 12 months (BioPace).

About Bioheart, Inc.Bioheart is focused on completing its Phase II/III MARVEL study for MyoCell in treating advanced heart failure. The product candidate has been in clinical trials since May 2001. The company believes, after 10 years of clinical trials that followed pre-clinical studies dating to 1988, that it may be on the final leg toward qualifying to apply for a biologics license-approval FDA panel review. Approximately 130 more patients are needed in the randomized, double-blinded, placebo-controlled MARVEL Phase II/III Part II study. MyoCell is a clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.

For more information on Bioheart, visit http://www.bioheartinc.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. 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.

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