Bioheart CTO Research Analysis Report July 2012 - Click Here
Bioheart, Inc. was founded in 1999 and is committed to the development of effective cell technologies to treat cardiovascular diseases. The company also has intelligent devices that help monitor heart failure and other cardiovascular diseases. Unlike other organs, the human heart does not have the ability to repair itself once it is damaged. Bioheart has multiple cell therapies in various stages of development that repair damaged hearts Bioheart has a comprehensive three step process focusing on the treatment and monitoring of patients suffering from chronic and acute heart damage:
Bioheart is solely focused on the treatment of cardiovascular related diseases. While most stem cell companies use one particular cell type to treat a variety of diseases, Bioheart utilizes various cell types to treat cardiovascular diseases. Bioheart believes that there are unique qualities within the various cell types that make them more advantageous to treat a particular disease. For instance, muscle stem cells (myoblasts) inherently are able to survive in a low oxygen environment better than any other cell type. They are thus best suited to survive and engraft in the low oxygen environment of chronically damaged, scarred heart tissue. Furthermore, myoblasts are committed to becoming muscle in any environment while other stem cells tend to become the cells in which they come into contact. When myoblasts are injected into scar tissue in the heart they develop into muscle while other stem cells will develop into more scar tissue. Bioheart’s MyoCell® therapy is composed of myoblasts which are injected into the scar tissue that has formed in the hearts of patients suffering from heart failure. The increased muscle formed by MyoCell® in these patients’ hearts has been shown to lead to improved cardiac function and an improved quality of life. Myoblasts are not only able to survive and form muscle within the scar tissue of the damaged heart, they can be modified genetically, to attract one’s own stem cells to assist with the regenerative process. Bioheart’s MyoCell® SDF-1 is a gene-modified myoblast composition. The product increases the production of SDF-1, a protein that is capable of enhancing the tissue repair process by attracting the body’s own stem cells. There are many other advantages to using myoblast cells for the indication of heart failure. One of these advantages is their ability to be easily expanded from one small muscle biopsy to billions of cells in the laboratory to replace the billions of cells that have been destroyed during a cardiac event.
Bioheart, Inc. was founded in early 1999 by Howard J. Leonhardt an inventor and entrepreneur with over 20 patents for treating heart and cardiovascular disease, most well known for the TALENT stent graft, the development of the first percutaneous heart valves, improved CRT/ICD pacemakers, cell delivery catheters and biological pacemakers. Leonhardt was Vice President of Emerging New Therapies at Medtronic, Inc. before breaking out to form Bioheart, Inc. Bioheart was founded in the same building with many of the same staff members and board members that built World Medical Mfg. Corporation from 2 employees to over 500 between 1988 and 1998. Leonhardt's first recruit to join the Bioheart team was Robert Lashinski the co founder of Arterial Vascular Engineering, Inc., a leader in developing stents and cardiovascular balloon catheters. Howard took on leadership of the development of the MyoCell cell composition in Sunrise, Florida and Robert put together a team of 16 Bioheart engineers and support staff in Santa Rosa, California to develop the MyoCath cell delivery catheter based on patents filed by both Leonhardt and Lashinski. Leonhardt began the process of developing the MyoCell cell composition for treating damaged hearts by recruiting 13 of the 15 most revered scientists and clinicians in the field to join Bioheart's Scientific Advisory Board. The company reviewed and tested many different cell types including embryonic, bone marrow derived, adipose (fat) tissue derived, placenta, cord blood, fibroblasts, heart muscle derived and skeletal muscle derived. The final list was reduced to bone marrow, adipose tissue and skeletal muscle derived cells. Comparative studies were completed at a number of institutions including McGill University in Montreal, University of Arizona and Duke University. The results demonstrated that only skeletal muscle derived stem cells could grow new contractile muscle in true scar tissue in heart and this cell type was chosen as Bioheart's flagship composition MyoCell. Race Kao, Doris Taylor, Stu Williams, Chuck Murry, Tomas Siminiak, Miranda Grounds, Ed Diethrich, Peter Law, Sam Ahn, Ray Chiu, George Magovern Sr., Stephen Ellis, Warren Sherman, Kumar Ravi, Patrick Serruys, Pieter Smits, Erik Duckers, Christoph Nienaber, Felipe Prosper, Jesus Herroros, Juan Chachques, Paulo Brofmann and Dan Burkhoff Jr. were early contributors to the research initiative. Bioheart Scientific Advisory Board Member Race Kao was the first to use skeletal muscle derived stem cells to repair damaged myocardial tissue in dogs in 1988 and published his work in The Physiologist in 1989. Doris Taylor, M.D., Ph.D. published the first landmark full publication in NATURE Medicine in 1998.
Bioheart raised $10 million at an $80 million valuation in 1999 and completed animal and lab studies from 1999 to May of 2001 when clinical studies began in Europe. The historic first ever non-surgical stem cell heart repair case in the world was completed in Rotterdam, The Netherlands on May 23rd, 2001 by a team sponsored by Bioheart, Inc. comprised of Patrick Serruys, Pieter Smits, Kumar Ravi, Warren Sherman and Doris Taylor. The historic case was broadcast live to the EuroPCR Meeting in Paris and was viewed by more than 10,000 people. The original pilot study led by Patrick Serruys and Pieter Smits was published in 2003 in the Journal of American College of Cardiology Journal of the American College of Cardiology in 2003 (Smits et al., JACC, Vol. 42, No. 12, 2003: 2063-2069). The Bioheart team went on to complete the MYOHEART Dose Escalation study in the USA at 5 centers; Columbia, Mayo Clinic, Cleveland Clinic, Atlanta Cardiovascular Research Institute and Duke University. The SEISMIC Phase II study was published in 2010 in the Journal EuroIntervention. The MARVEL Phase II/III study with 33 top U.S. heart failure centers participating was published in October of 2011 in the American Heart Journal. Bioheart beat it's primary end point goal of 16 meters improvement in exercise capacity by more than 500%. Bioheart MyoCell patients achieved 95.7 meters improvement over placebo injected patients on optimal CHF drugs that declined minus 4 meters. Many other Bioheart endorsed independent trials have taken place in Europe, Asia and South America. Over 450 patients have entered these clinical trials since 2000. In these studies approximately 84% of skeletal muscle derived stem cell treated patients have improved and only 16% have worsened. 68% of control patients in these studies not receiving cell composition treatment have worsened. Based on these encouraging results Bioheart has raised over $107 million in paid in capital to date including investments from; St. Jude Medical x 2, Boston Scientific Guidant X 3, Advent Morro, Presidential Capital, Magellan, Astri Group, Ascent Medical Technology Fund and Dr. William P. Murphy the Founder of Cordis Corporation that now serves as Chairman of our Board of Directors. Bioheart has a partnership with Johnson & Johnson Cordis Biosense Webster for our MARVEL clinical trials. We have a working partnership with Abbott Laboratories which provides a "big stick" protecting our estate of cell delivery catheter patents. We have a license relationship with Ono Pharmaceuticals of Japan for our 2nd generation MyoCell SDF-1 composition. In 2008 Bioheart successfully completed the only biotech IPO in the USA on NASDAQ that year. Bioheart working with The Cleveland Clinic, The University of Florida and Ono Pharmaceuticals of Japan has developed our 2nd generation MyoCell SDF-1. This cell composition is the same as our original MyoCell except that the cells are modified to over express the stromal derived factor 1 protein for about 21 days. This change has doubled the cardiac improvement to 54% from 27% as demonstrated in 7 years of pre-clinical studies at the University of Florida and at Cleveland Clinic. The FDA recently approved this 2nd generation composition to enter clinical trials in the USA. All of our clinical studies to date have been completed with only one short injection session. A team in Spain led by Dr. Felipe Prosper demonstrated in large animal pre-clinical studies published in the European Heart Journal that repeat injections with Bioheart's MyoCell can provide even stronger improvement than a single injection session. Bioheart plans to introduce repeat injections clinically soon. Bioheart has a deep pipeline of patented technologies including the MyoStim Pacemaker which is believed to be a superior CRT/ICD pacemaker that has the added ability to recruit stem cells to a damaged heart with a homing signal and convert those cells into beating heart muscle. The device also has the capability to help fibrillating hearts recover to normal heart beat with low voltage pulses instead of high voltage shocks. This product is being developed with funding and collaboration from Airspeed Equity Holdings LLC of San Diego, California. Bioheart also has numerous patents related to the development of a biological pacemaker, BioPace, which is also being developed with this same group. The Bioheart research team has a steady stream of new patents constantly being issued such as U.S. 7686799 A deployment system for a myocardial cellular material inventors Howard J. Leonhardt and Robert Lashinski just issued March 30th, 2010.
Biotech Survives Difficult Opening to 2008 - Click here
3rd Party Endorsements of Bioheart's MyoCell Technology for Safety and Efficacy
All centers that presented our myoblast transplantation data to their institutional review boards approved Bioheart's MARVEL Phase II/III study. These I.R.Bs carefully evaluated all safety and efficacy data before granting their approvals. Before the launch of the trial we held a panel meeting of leading experts including Dr. Carl Pepine the past President of the American College of Cardiology. After careful review of all available data the panel put out a press release endorsing the MARVEL trial (see below).
Duke Cardiovascular Research Insitute, Cleveland Clinic and Northwestern University served as 3rd party core lab verifiers of the MARVEL Data Published in the American Heart Journal October 2012.
MARVEL Phase II/III Study Part I I.R.B. approvals include:
Minneapolis Heart Institute - Dr. Tim Henry St. Josephs Research Institute Atlanta - Dr. Nic Chronos Columbia University - Dr. Warren Sherman Rush-Presbyterian Chicago - Dr. Gary Schaer University of Iowa - Dr. Philip Horwitz Scripps San Diego - Dr. Richard Schatz Florida Hospital Center - Dr. Andrew Taussig Arhythmia Center Wisconsin - Dr. Imran Niazi University of Florida Shands - Dr. Douglas Chapman and Dr. Carl Pepine Moran Heart Institute Fort Lauderdale - Dr. Alan Niederman and Dr. Zach Zacharia Mayo Clinic - Dr. David Fortuin Case Western Cleveland - Dr. Daniel Simon Lindner Clinical Trial Center Cincinnati - Dr. Dean Kereiakas Duke University - Dr. Chris O'Conner, Dr. Tom Povsic Cleveland Clinic - Dr. Stephen Ellis U of Pittsburgh - Dr. Jun Soop Lee Texas Heart Institute - Dr. Emerson Perin New Jersey Heart Institute - Dr. Darius Sholevar Swedish Medical Center Seattle - Dr. Mark Reisman Newark Beth Israel NY - Dr. Mark Zucker Gagnon Heart Institute NJ - Dr. Barry Cohen University of Miami - Dr. Joshua Hare University of Alabama - Dr. Jose Tailaj Emory University Atlanta - Dr. Arshed Quyyumi Baptist Hospital Alabama - Dr. Farrell Mednelsohn Stern Cardiovascular Ctr. Memphis - Dr. Frank McGraw University of Oklahoma - Dr. Rubin Germany University of California San Diego - Dr. Anthony DeMaria Arizona Heart Institute - Dr. Edward Diethrich Mercy Gilbert and UCSD - Dr. Nabil Dib Ohio State University - Dr. Vincent Pompei Oeschner Medical Center New Orleans - Dr. Stephen Ramee, Dr. Mark Grise and Dr. Chris White Brooke Arm Medical Center Houston - Dr. Eckard
Expert Panel Meeting Participants
Warren Sherman, MD, Director, Stem Cell Research and Regenerative Medicine, Columbia University Medical Center
Christopher O'Connor, MD, Director Heart Center, Duke University Medical Center
Thomas Povsic, MD, Ph.D., Assistant. Professor of Medicine, Duke University Medical Center
Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine
Doris Taylor, Ph.D., Director, Center for Cardiovascular Repair, University of Minnesota
[PDF] Noverra Research ANALYSIS on Bioheart Inc. (OTC: BHRT) www.vantagewire.com/_.../Bioheart%20Watchlist%20Report... - Canada File Format: PDF/Adobe Acrobat - Quick View Mar 1, 2012 – Bioheart describes the MyoCell therapy as an autologous cell therapy comprised of ... The MARVEL Trial is a 330 patient Phase II/III trial in North America ...were published in the American Heart Journal, a prominent peer ...http://www.vantagewire.com/_resources/company_profile/bhrt/Bioheart%20Watchlist%20Report%20(Noverra).pdf