Executive Summary

Our Company

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:

The Bioheart Advantage

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.

Additionally, Bioheart utilizes adipose (fat) tissue-derived stem cells (ADSCs) isolated by the TGI Cell Isolation System for the treatment of acute myocardial infarction or heart attacks. After a heart attack, the heart tissue is in a hibernating state in which there are some cardiac cells, some blood vessel cells and some necrotic (dead or dying) cells. The stem cells isolated from adipose tissue, when introduced post-heart attack into the body, have been shown to reduce damage and become cardiac and blood vessel cells.

The ADSCs are able to promote the formation of new or regeneration of blood vessels because they secrete growth factors that stimulate survival and proliferation of blood vessel cells. These characteristics make the ADSCs an ideal cell therapy to stimulate the recovery of injured tissue and blood flow in lower limb ischemia and chronic heart ischemia patients. By directly injecting ADSCs into areas of low blood flow in the lower limbs or the heart, these regions can become populated with newly formed (angiogenic) cells, thereby improving blood supply.

Bioheart is currently establishing five Centers of Excellence in Latin America to provide its ADSC and myoblast cell therapies to patients suffering from congestive heart failure, chronic heart ischemia and lower limb ischemia. Bioheart entered into its first agreement with a leading treatment facilitator, Regenerative Medicine Institute of Tijuana, Mexico. Therapies for patients will be made available at the Hospital Angeles Tijuana, a fully equipped state-of–the-art private specialties hospital. This will be the first of five Centers of Excellence with four additional Centers to be announced in the coming months. The TGI 1200 Cell Isolation System is also currently being utilized in clinical studies to treat chronic heart ischemia in Venezuela and critical limb ischemia in the Czech Republic. A clinical trial for its use in treating acute myocardial infarction is planned.

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