Subject: BHRT is the Right Company Right Now in the Medical Market

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BHRT is the Right Company Right Now in the Medical Market

Bioheart Inc.
13794 NW 4th Street
Suite 212
Sunrise, FL 33325
Phone: (954) 835-1500
bioheartinc.com
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Value Proposition:

Well positioned Company in a multi-billion dollar market.
BHRT is one of the oldest regenerative bio tech companies established in 1999. BHRT has four main offerings: Myocell, Myocell SDF-1, Myocath and Adipocell all in various stages of development. Bioheart’s lead product candidate is MyoCell®, a muscle stem cell therapy that is intended to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. MORE


MyoCell SDF-1 has received approval from the FDA to begin human clinical trials and is intended to be an improvement to MyoCell. The myoblast cells to be injected are gene-modified prior to injection by an adenovirus vector so that they will release extra quantities of stromal derived factor - 1 or SDF-1 protein. Following injury which results in inadequate blood flow to the heart, such as a heart attack, the human body naturally increases the level of SDF-1 protein in the heart. MORE

The MyoCath is a disposable needle injection catheter used for the delivery of biologic solutions to a targeted treatment site within the myocardium, the inner wall of the heart. It provides for multiple injections to a pre-determined needle insertion depth with a single core needle of 25 gauge diameter that can be advanced and retracted from the tip of the catheter. MORE

Adipocell: Adipose (fat) tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. In collaboration with the Regenerative Medicine Institute in Tijuana, Mexico, congestive heart failure patients are being treated in a Phase I/II trial at Hospital Angeles Tijuana. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or AdipoCell™ in patients with chronic ischemic cardiomyopathy. MORE

Established and diversified management team:
Mike Tomás, CEO of BioHeart, is considered by many in the industry as one of the most experienced marketers and operating executives for IT/Communications and Biotech/Life Sciences private equity and venture groups portfolio companies. Upon retiring as Chief Marketing Officer of Avantel, MCI/Worldcom's Global Ventures 1B dollar investment with Banamex (at the time, the largest bank in Latin America), Mr Tomás joined other former-MCI executives (including MCI CEO Jerry Taylor) and helped raise venture capital to form Ineto, an integrated customer communications software solution that was named on Red Herring magazine’s “Top Ten to Watch” list.

Kristin Comella, Chief Science Officer of BioHeart. Ms. Comella has over 15 years’ experience in corporate entities with expertise in regenerative medicine. She was recently named number 24 according to Terrapin’s list of the Top 50 Global Stem Cell Influencers. Ms. Comella has pioneered a variety of stem cell therapies including cord blood derived cells, bone marrow cells, muscle cells and adipose cells for use in many different applications. She has developed a wide range of regenerative products and techniques that have been successfully implemented into the clinic. She also led the team that gained the first ever FDA approval for clinical trials using a combined cell and gene therapy product. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer and board member.

Right company at the right time
The past 12 months have been huge for the Bioheart. Myocell started its phase III clinical trials, Adipocell products were introduced and gained approval for four different clinical studies. Revenues have increased and been booked. Product revenues during the first quarter of 2014 were 322,572 dollars, compared to 4,192 dollars during the first quarter of 2013. In addition, this is a 98% increase over the fourth quarter revenue of 157,055 dollars. Continued Revenue growth expected from new programs and products coming online in 2014.

Profile:

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.

Continue Reading Profile
BHRT Chart

OTCQB: BHRT

Market Value:
9,421,200 a/o May 23, 2014

Shares Outstanding:
466,396,016 a/o May 06, 2014

Shareholders of Record:
1,565 a/o Mar 25, 2014

Short Interest:
6,088 (100%)
Apr 30, 2014

Transfer Agent:
Continental Stock Transfer & Trust Company

AUDIO INTERVIEW:

5/28/14

RECENT NEWS:


A New Audio Interview With Kristin Comella, Chief Science Officer for Bioheart, Inc., is Now at SmallCapVoice.com


Bioheart to Present at the World Stem Cells & Regenerative Medicine Congress

Bioheart Reports Significant Revenue Increases

KEY EXECUTIVES:

Mike Tomas

President
Chief Executive Officer

Kristin Comella
Chief Scientific Officer

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