Executive Summary

Founded in 1999, Bioheart, Inc. is committed to the development of effective cell technologies to treat cardiovascular diseases. Unlike other organs, the human heart does not have the ability to repair itself once it is damaged. Bioheart’s discoveries include multiple cell therapies in various stages of development that repair damaged hearts of patients suffering from chronic and acute heart damage.

Bioheart is focused solely 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. It is our belief that the unique qualities within the various cell types make them more advantageous to treat a particular disease.

Muscle stem cells (myoblasts) inherently are able to survive in a low oxygen environment better than any other cell type. They are 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. MyoCell® SDF-1 has received approval from the FDA to begin human clinical trials and is intended to be an improvement to MyoCell®.

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 in Tijuana. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCell™ in patients with chronic ischemic cardiomyopathy. The therapy involves the use of stem cells derived from the patient’s own fat (adipose tissue) obtained using liposuction. Transplantation of LipiCell™ is accomplished through endocardial implantations with an injection catheter.

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. The MyoCath is intended for use with commercially available Becton-Dickinson 1 milliliter and 3 milliliter syringes. Although we hope to prove that MyoCell can be administered with a variety of different catheters, MyoCath has been specifically designed to be used for the delivery of MyoCell and has been used as the delivery mechanism in the majority of our clinical trials to date.