Bioheart is commercialising MyoCell (adult muscle stem cells derived from thigh muscle) technology which allows adult muscle stem cells, also known as immature myoblasts, to be extr acted from a patient’s own thigh muscle, grown into therapeutic quantities and admi nistered to patients with failing hearts. Bioheart’s
MyoCell has been in clinical trials since 2001. Over 450 patients have been entered in various clinical trials utilizing immature myoblasts to date. With the FDA requiring only one Phase II and a pivotal trial before approving a successful stem cell therapy, the company has the potential to be yielding commercial revenues by 2014/15 . Bioheart has a broad pipeline of other patented complimentary technologies. Bioheart believes that it’s MyoCell is the only cell composition tested in advanced clinical trials to date that has demonstrated an ability to grow new contractile muscle in the center of heart scar tissue caused from a heart attack. Other pluripotent cell types such as embryonic, bone marrow, adipose tissue, blood, menstrual and placenta derived all cannot form contractile muscle in heart scar tissue.
Bioheart’s clinical team published in the October 2011 issue of the American Heart Journal their
MARVEL Phase II/III part I results. They beat their primary end point goal of 16 meters improvement in exercise capacity improvement over placebo by over 500%. Bioheart MyoCell patients improved
95.7 meters over placebo patients that came in at minus -4 meters decline. This study at 33 leading heart failure centers in the USA was randomized, double blinded and placebo controlled with 3 rd party core labs and CRO’s verifying all results.
The data suggests a powerful heart failure treatment, putting the company on track to launch the
MARVEL Phase III part II study this year .
To put this data in context please see below a comparison to other technologies tested in the same patient population. The scores are in meters improvement in 6 minute walk exercise capacity testing over placebo.
Bioheart MyoCell 95.7 meters
Mesob last MPC’s 52.0 meters
Medtronic CRT’s 20.0 meters
CHF Drugs - 4 meters decline
Mesoblast is valued at over $2 billion with their 52 meter improvement performance. Medtronic has nearly $2 billion in heart failure CRT/ICD sales. There is over $8 billion spent each year on CHF drugs that provide a minus 4 meters decline. Bioheart’s MyoCell substantially out performs all these leading technologies.
NATURE CLINICAL PRACTICE CARDIOVASCULAR MEDICINE ©2006
STEENDIJK ET AL. MARCH 2006 VOL 3 SUPPLEMENT 1
NaturePublishingGroup
Paul Steendijk*, Pieter C Smits, Marco Valgimigli, Willem J van der Giessen, Emile EM Onderwater and
Patrick W Serruys
Steady-state pressure–volume loops and end- systolic and end-diastolic pressure–volume relationships at baseline and 6- and 12-month follow-up for all individual patients are shown. The volumetric data show a significantly increased cardiac output at 6- and 12-month follow-up. This increase in cardiac output is

achieved by a reduction in end-systolic volume and a slight increase in heart rate (although these effects did not reach statistical significance), whereas end-diastolic volume remained unchanged. This suggests an improvement in systolic function, which is in line with the increase in ejection fraction (which was significant at 6-month follow-up), dP/dt MAX (which was significant at 12-month follow-up), and a tendency for improved stroke work at 6- and 12-month follow-up. The load-independent slope of the pressure–volume relationship showed a positive trend, but only preload recruitable stroke work reached statistical significance at 12 months. The position of the end-systolic pressure–volume relationship, quantified by ESV 120 , showed a significant reduction at both time points (P = 0.023 and P = 0.053, respectively), indicating improved systolic function.
EVIDENCE OF REVERSE REMODELING =
Baseline End Systolic Volume (ESV) 190mls
6 months post MyoCell (ESV) 150mls
12 months post MyoCell (ESV) 157mls
Applications in heart failure, in heart attacks and in chronic angina represent multi- billion dollar market opportunities. We see a US$6bn market in heart failure alone based on the current take-up of ICD and CRT-
D devices in Class III heart failure patients. We think the heart failure trial results not only explain the keen corporate interest which has seen over $107 million invested in Bioheart to date which has included as key investors: St. Jude Medical, Guidant, Abbott Labs, Boston Scientific, Presidential Capital, Magellan Group,
Ascent Medical Technology Fund, Astri Group, Advent Morro, Dan Marino Investments and Minnesota
Biomed Partners.
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Who is Bioheart? A South Florida-based biotechnology company, Bioheart is creating clinical therapies from adult stem cells derived from either muscle or fat tissues. The company has conducted four clinical trials to date and has FDA authorization in process for two new studies.
Sixteen reasons why you should be optimistic about Bioheart (BHRT.ob):
1. Bioheart is part of a wave of the future that is capitalised at only US$3.6bn globally.
Stem cells, which are cells with the ability to develop into many different cell types, or promote the growth of new cells, have demonstrated over the last ten years that they can potentially cure a wide variety of diseases. This makes stem cell technologies such as those owned by Bioheart increasingly powerful in terms of the upcoming commercial payoff from new drugs. Currently the entire listed stem cell sector of 15 companies is capitalised at ~US$3.6bn
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, reflecting the early stages of what we anticipate will be one of the most commercially significant areas of healthcare in the 21 st
Century.
2. There is solid science behind Bioheart
’s technology.
Bioheart has pre-clinical data back to 1988 and clinical data from 2001. Bioheart’s Research Scientists, Scientific Advisory Board Members and Clinical
Investigators have published over 100 studie s supporting Bioheart’s technologies.
3. Favourable clinical data is starting to emerge
– Bioheart beat the primary end point of it’s last study by over 500% - The primary end point goal was 16 meters improvement in exercise capacity over placebo and
Bioheart’s MyoCell came in at 95.7 meters improvement.
Note
– The closest competitor to Bioheart MyoCell = C-Cure by Cardio3 (cardiac stem cells) achieved
53 meters improvement in 6 min. walk compared to Bioheart MyoCell’s 95.7 meters.
4. Bioheart has received investment and has partnered with industry leaders which point towards reduced risk. Bioheart has an intellectual property agreement with Abbott Laboratories which puts a “big stick behind it’s estate of stem cell delivery catheter patents. Bioheart has had an on going clinical trial collaboration agreement with Johnson & Johnson Cordis Biosense Webster whereby they provide substantial support to our MARVEL clinical trial equating to about 20% of the total cost of the trial.
Bioheart has received two $1 million+ investments from industry leader St. Jude Medical and three substantial investments from industry leader Boston Scientific Guidant. The angel network known as
Minnesota Biomed Partners has invested over $30 million in Bioheart participating heavily in every round of financing the company has undertaken. This group includes many former Medtronic, St. Jude, Guidant,
Boston Scientific executives and investors that all reside in the Minneapolis area. Robert Lashinski one of the co-founders of Arterial Vascular Engineering one of the most successful coronary stent companies, now a unit of Medtronic, has made substantial investments in Bioheart and has served for many years as a valued advisor. Norm Dann one of the foundational executives of Medtronic’s growth years has made important investments in Bioheart and has served with us as has Manny Villafana the former Medtronic executive whom was also the founder of both St. Jude Medical and Guidant as well as ATS Medical. Dr.
William P. Murphy the founder and former Chairman and CEO of Cordis Corporation, one of the most successful firms in the history of cardiology, now a unit of Johnson & Johnson has made repeated substantial investments in Bioheart and currently serves as our Chairman of the Board.
5. Bioheart has a deep pipeline of patents and undeveloped technologies.
6. Bioheart expects to have revenue stream soon from licensing it’s MyoStim heart pacemaker patents to Airspeed Equity Holdings in San Diego.
7. Bi oheart expects to have a revenue stream soon from licensing it’s BioPace biological pacing patents to Airspeed Equity Holdings in San Diego.
8. Bioheart’s MyoCell has shown that it can provide even greater improvement with repeat injections as published in the European Heart Journal by Dr. Felipe Prosper and his team from
Spain.

•Control placebo LVEF 40.6 down to 37.7 P value 0.880
>> Myoblast (MyoCell) injection results utilizing Bioheart MyoCath …
•1 injection session LVEF 45.1 up to 56.2 P value 0.113
•2 injection sessions LVEF 41.3 up to 56.4 P value 0.02
•3 injection sessions LVEF 39.3 up to 65.6 P value 0.01
9. Bioheart’s 2 nd generation MyoCell SDF-1 developed in collaboration with The Cleveland Clinic and the University of Florida has demonstrated an ability to provide double the cardiac improvement of it’s first generation composition. The FDA has already approved this 2 nd generation composition to enter clinical trials after 7 years of pre-clinical studies.
10. Bioheart’s management team and board of directors has succeeded numerous times before in bringing products from concept to market leadership in the cardiovascular space. This includes a part in developing the World Medical TALENT stent graft, AVE stents and Cordis pacemakers, catheters and stents.
11. Bio heart’s Scientific Advisory Board is comprised of the 27 of the leading scientists and clinicians in the world working on stem cell repair of damaged hearts since 1988.
12. Bioheart’s MARVEL clinical investigation team is comprised of 33 of the leading heart failure centers in the USA including Cleveland Clinic, Mayo Clinic, Columbia, University of Miami and The
Texas Heart Institute.
13. Bioheart is further along in clinical trials than any other firm focused on repairing hear scar tissue in advanced heart failure patients.
14. April of 2012 Bioheart won South Florida’s Technology Leadership award.
15. Unlike other stem cell firms Bioheart is FOCUSED on the heart. Heart failure is the leading cause of hospitalization in the USA and is the single leading financial drain on Medicare. Bioheart believes it can cut those costs in halve with it’s technology focus over time.
16. With funding in place Bioheart is only 24 months away from a potential FDA approval for it’s
MyoCell.
COMPANY DESCRIPTION
The South Florida –based Bioheart (BHRT.ob) is a biotechnology company commercialising the therapeutic use of immature myoblasts
– a kind of adult muscle stem cell. The company has completed and published successful clinical trials in 2003 a pilot study in Europe, a Phase I MYOHEART dose escalation study in the
USA in 2007, the Phase II SEISMIC study in 2009 and the Phase II/III MARVEL part I study in 2011. It is expected that the current MARVEL Phase III part II study will lead to a Biologics License Approval panel meeting with the FDA within 24 months after funding is secured.
VALUATION
Bioheart has raised of $107 million in capital and has secured over $30 million in loans and grants since it’s founding in 1999. The Bioheart stock price held steady at about $8 per share for most it’s history from 1999 through to 2008. A NASDAQ IPO was completed in February of 2008 at $5.23 a share. Of the over 2000 shareholders of Bioheart only a small percentage have sold off shares prior to our anticipated FDA approval for MyoCell. The current trading share price of under $1 per share is believed to be strongly under valued considering the October 2011 American Heart Journal published MARVEL Phase II/III results.
RISKS

We see the main risks in Bioheart as being clinical risk
– ie; that products may have adverse events in the final leg of clinical trials and financial risk. Although the company has had a long 13 year history of raising capital to fund operations, research and clinical trials as needed, the conditions of the current marketplace make capital raising more difficult than it was in the past and there is an element of fatigue amongst the current shareholders related to the long road to FDA approval. Another major risk facing the company is that prospective licensing partners may drive too hard a bargain for BHRT shareholders to enjoy a strong return. Bioheart now faces many more stem cell competitors, albeit none muscle forming in scar tissue, than it did when it was founded in 1999.
Written by: Howard J. Leonhardt, founder of Bioheart, Inc., Chief Technology Officer and Chairman
Scientific Advisory Board. Inventor with 20 patents for products for treating heart and cardiovascular disease. Developer of the TALENT stent graft, percutaneous heart valve technology, artificial lung catheter, various cell delivery and cardiovascular balloon catheter systems, biological pacemaker & stem cell recruiting pacemaker. Advisory Board Member of Cell Therapy Foundation, University of Florida Center for
Entrepreneurship and Innovation, University of Northern California, Florida International University Center for Entrepreneurship, Anoka Technical College.