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Overview

 

Bio Heart, Inc. BHRT

 

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 AdipoCell™ 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 AdipoCell™ 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.

 

 

Clinical Trials

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Products

 

Myocell

 

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. The procedure involves a physician removing a small amount of muscle from the patient's thigh. From this muscle specimen, muscle stem cells (also called myoblasts) are then isolated, expanded using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The cells are delivered by an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The muscle stem cells populate the regions of scar tissue and are intended to improve cardiac function by helping the heart muscle beat more efficiently.

 

The results of our Clinical Trial Marvel Part 1 were published in the American Heart Journal, the prominent peer reviewed medical journal. When compared with placebo, myoblast therapy was associated with sustained (six months) improvements in six minute walk distance of >90 meters, a clinically meaningful improvement. For congestive heart failure patients, this translates into returning to a more active lifestyle and a better quality of life.

 

Myocell SDF-1

 

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. By modifying the myoblasts to express SDF-1 prior to injection, the levels of SDF proteins in the heart can be increased. The presence of additional quantities of SDF-1 protein released by the myoblasts may stimulate the recruitment of the patient's existing stem cells to the cell transplanted area and, thereafter, the recruited stem cells will assist in the tissue repair and blood vessel formation process.  In preclinical studies, MyoCell SDF-1 provided a 54 percent improvement of heart function compared to 27 percent for the original MyoCell composition, while the placebo control treated animals declined by 10 percent. The preclinical studies also demonstrated that this product candidate can enhance blood vessel formation in damaged hearts.

 

Myocath

 

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.

 

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. These patients have demonstrated on average an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their six minute walk distance.

 

Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or AdipoCell™ 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 AdipoCell™ is accomplished through endocardial implantations with an injection catheter.

 

 

   Contact Info

 

    13794 NW 4th Street

    Suite 212

    Sunrise, FL 33325

 

 

    Website: http://www.bioheartinc.com

    Phone: 954-835-1500

    Email: bioheart@bioheartinc.com

 

 

 

 

 

 

 

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