US Stem Cell Inc (USRM)

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In total Leonhardt Ventures and Howard Leonhardt have directly invested in or borrowed to Bioheart, Inc. over $6 million since its founding. Leonhardt Ventures via its network of recruited angel investors has raised over $85 million of Bioheart’s record setting $107 million in paid in capital as of June 30th 2014. This $107 million has been raised from over 470 investors since 1999, primarily accredited angels, which makes Bioheart’s financing the most successful stem cell research crowdfunding campaign of all time. A great show of confidence in this technology that has stood the test of time. Institutional non-angel investors include; St. Jude Medical (2X), Boston Scientific Guidant (4X), Magellan Group, Presidential Capital, Ascent Medical Technology Fund, Advent Morro, Tyco Ventures, Robin Hood Investments, NorthStar Investments & Minnesota Biomed Partners. Bioheart sold a license to Leonhardt and other patented stem cell delivery catheter technologies (4+ patents) to Abbott Laboratories for $900,000. Under this agreement with Abbott Laboratories they are responsible to defend Bioheart, Inc. against infringers at their expense. Bioheart, Inc. has a collaborative Phase II/III clinical trial support agreement with Cordis Johnson & Johnson related to their MyoStar NOGA system. Dr. William P. Murphy the original Founder of Cordis Corporation, one of the pillar leaders of cardiology, now owned by Johnon & Johnson, is a major shareholder and Bioheart’s long standing Chairman of the Board.

“Bioheart has under promised and over delivered on their MyoCell technology for treating advanced heart failure. Their goal was to beat the performance of CHF drugs and CRT pacers that achieve respectively minus 4 meters decline and 16 to 20 meters improvement in exercise capacity. Bioheart’s 1st gen. MyoCell came in at 95.7 meters improvement over placebo in the controlled, randomized, double blinded Phase II/III MARVEL part I clinical trial - with 33 U.S. centers*. Now entrolling patients in the Phase III MIRROR Trial. No other cell type has beat 63 meters improvement. Cardiac and adipose derived cells score at about 53 meters improvement. Allogenic bone marrow derived cells achieve only 10 meters improvement.” Howard Leonhardt, Executive Chairman of Leonhardt Ventures commented “The 2nd generation Bioheart MyoCell SDF-1 with repeat delivery, nutrient hydrogel and electrical stimulation support is expected to provide even superior results, based on over a dozen years of pre-clinical studies. Bioheart’s MyoCell is the only cell type that has demonstrated an ability to form new contractile muscle in the depths of heart scar tissue. There is over $8 billion spent on CHF drugs each year providing no improvement and only slowing down slightly decline. What is needed is a product like Bioheart’s MyoCell and MyoCell SDF-1 designed to convert heart scar tissue to beating muscle and thus providing true strong improvement. “

Link to the 33 U.S. heart failure centers in the Phase II/III Bioheart MyoCell MARVEL Clinical Trial - http://www.clinicaltrials.gov/ct2/show/study/NCT00526253?term=MARVEL+BIOheart&rank=1&show_locs=Y#locn Published Phase II/III MARVEL results - http://www.ahjonline.com/article/S0002-8703(11)00562-X/abstract Phase II SEISMIC results summary - http://www.prnewswire.com/news-releases/final-data-from-the-bioheart-seismic-trial-suggest-safety-efficacy-of-autologous-stem-cell-therapy-for-treating-congestive-heart-failure-56970902.html Howard Leonhardt founded Bioheart, Inc. in early 1999. This was shortly after merging World Medical Mfg. Corp., a company he founded in 1988, into Arterial Vascular Engineering, Inc of Santa Rosa, California in April 1998, which subsequently sold to Medtronic in November 1998. World Medical Mfg. Corp. developed and patented the world’s leading endovascular stent graft system for repairing aortic aneurysms without surgery, that still holds market leading position today. They also developed and patented the first stem cell delivery catheters and percutaneous heart valves which were also sold to Medtronic, Inc. Bioheart, Inc. completed the first-in-man historic muscle stem cell repair of a damaged heart without surgery in May 2001 and has been in clinical trials since that time. Leonhardt remained as full time CEO of Bioheart, Inc. up to March 2007 when he transferred to the Chief Technology Officer position. Bioheart, Inc. completed a $76 million valuation IPO on NASDAQ in February 2008. The only biotech IPO in the whole USA that year. Leonhardt moved to California in 2008 following the IPO and opened up a self funded independent research lab, incubator and accelerator that has focused on developing electronic devices designed originally with intent to primarily help Bioheart's cell compositions improve even further on their results in subsequent clinical trials. These include;