Bioheart Commenced Successful Regenerative Stem Cell Treatments with Latin American Patients Having Congestive Heart Failure

SUNRISE, Fla., April 14 /PRNewswire-FirstCall/ -- Bioheart, Inc. (OTC Bulletin Board: BHRT) announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart's Center of Excellence program with Regenerative Medicine Institute.

The therapy employed stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction.  Stem cells were separated from the adipose tissue utilizing the fully-automated TGI 1200 Cell Isolation System. The separation process takes about an hour. No tissue pre-processing is required with this system. The recovered stem cells were injected into the patients' hearts utilizing Bioheart's MyoCath® needle injection catheter.    

Dr. Karl Groth, Bioheart's Chairman and Chief Executive Officer explained, "These procedures validate Bioheart's innovation of effective treatments for the most serious cardiac health issues confronting people around the world.  Our mandate is to bring Bioheart's solutions wherever they are needed and can be utilized."

These first two Latin American patients and other patients treated in Tijuana with Bioheart's cell therapies through Regenerative Medicine Institute will be followed at intervals of three and six months, and then a year, to assess their progress.  The principal endpoint will be improvement in the six minute walk distance, a key measure for cardiac well being.  Also measured will be improvement in the heart's viability, strength, and ability to function.  The key to reversing the impact of heart disease is reduction in scar tissue. The therapy encourages the regeneration of heart muscle tissue, allowing new vibrant tissue to grow and enabling the pumping of blood by the heart to improve.  The new tissue integrates into the scarred areas that are inactive, causing activity.  Stem cells and myoblasts, which are muscle stem cells, are the bases for Bioheart's therapies.  

In March, Bioheart entered into the first of its five planned agreements in Latin America to establish Centers of Excellence for the introduction of its therapies. The Regenerative Medicine Institute of Tijuana, Mexico is the first of these programs and provides therapies for congestive heart failure and peripheral arterial disease (PAD) patients at the Hospital Angeles Tijuana, a fully equipped state-of–the-art private specialties hospital.

Dr. Warren Sherman of Columbia University Medical Center's Stem Cell Research Institute was present at the procedures and assisted with the technology transfer.  He, along with Dr. Christopher O'Conner, and Dr. Thomas Povsic, MD, PhD, of Duke University's Clinical Research Institute, have, with Bioheart, established an Academic Advisory Committee to monitor Bioheart's Centers of Excellence and gather data on the results seen by each Center.  These results will, over time, become a compendium and form a nexus for future cell therapy research.

About Bioheart's program enabling treatment to be conducted in Centers outside the US, Dr. Sherman says, "I have come to believe that valuable knowledge can be gained from small-to-moderate sized clinical studies conducted outside of the US.  Depending on objectives and design, the costs and logistics of certain studies can be burdensome, or even prohibitive to conduct in the US.  The two key points here are, first and foremost, to ensure the rights and safety of patients, wherever a clinical trial is done. And secondly, that data arising from the study be complete and transparent. Without both elements in-place, a study will unlikely add to our knowledge of stem cell repair, or advance the field. To my eyes, Bioheart's initiative ensures that the integrity of both treatment and data collection is preserved, and I anticipate the scientific community will eagerly follow the program's progress." 

Recent studies have identified adipose tissue as an alternate source of stem cells. The procedure for obtaining adipose derived stem cells from the patient is a relatively simple process and tolerated by most patients even immediately following a heart attack.  Fat tissue can usually be found in abundance within the patient's own body and has a greater number of stem cells than bone marrow.  The TGI 1200 Cell Isolation System can isolate stem cells in about an hour, allowing for immediate clinical, point-of-care treatment after an event like a heart attack, which is important to the effectiveness of the treatment.  In contrast, the procedure for obtaining stem cells from bone marrow can be painful and often yields a low volume of stem cells.

Anton Krucky, CEO of Tissue Genesis, commented on Bioheart's successes with the use of the TGI system:  "We are excited about the momentum that Bioheart is gaining in the use of Tissue Genesis' methods and technologies.  Their recent successes in Europe and South America give us a great deal of confidence in Bioheart's ability to deliver cardiovascular regenerative medicine services to the Americas."

In addition to offering treatment for congestive heart failure with the TGI system, the Regenerative Medicine Institute will be using the system to treat lower limb ischemia using a similar process.  The TGI 1200 Cell Isolation System is currently being utilized in clinical studies to treat chronic heart ischemia in Venezuela and critical limb ischemia in the Czech Republic.

Dr. Javier Lopez, Regenerative Medicine Institute's President, stated:  "It is valuable to be able to help those in our country who are suffering from congestive heart failure and other cardiovascular problems that can be resolved with Bioheart's therapies and enables our Institute to be in the forefront of treatment centers around the world."

The final step for incorporating Bioheart therapies into its program will be adding MyoCell®, Bioheart's muscle stem cell therapy for CHF.  MyoCell® is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

About the TGI 1200 Cell Isolation System  

The CE-marked TGI 1200 Cell Isolation System is a fully automated and simple system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour.  The compact desktop unit requires no tissue pre-processing, and fits easily into any clinical environment.  The instrument allows for point-of-care recovery of an average of 50 million regenerative cells per 60cc of a patient's processed fat.  These cells can then be used at the site of injury or disease.  Regenerative cells may amplify the body's own repair process, accelerate healing, repair damaged and diseased tissue, and prevent scarring and loss of function.

About Heart Failure

Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life. This disease affects over 5 million people in the United States. Over 500,000 new cases are diagnosed annually in the U.S., making heart failure the most rapidly growing of all cardiovascular disorders. According to statistics provided by the American Heart Association, the approximate direct and indirect annual cost of heart failure treatment in the U.S. is  $22.5 billion. Persons over the age of 65 experience heart failure as the number one cause of hospitalization and the number one cause of death.

About Bioheart, Inc

Bioheart is committed to maintaining a leading position within the cardiovascular sector of the cell technology industry delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.  The Company works to prevent the worsening of any condition employing devices that monitor and diagnose. Bioheart's expertise is regenerating damaged tissue, if possible, and improving a patient's quality of life in addition to reducing health care costs and hospitalizations.

Specific to biotechnology, the Company is focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease, subject to regulatory approval.  MyoCell, the Company's principal therapy, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

For more information on Bioheart, visit www.bioheartinc.com.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would", "estimate", or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our ability to establish a distribution network for and commence distribution of certain products for which we have acquired distribution rights; (iv) our ability to timely and successfully complete our clinical trials; (v) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; (ix) our ability to protect our intellectual property rights; and (x) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2009.

Contact:

At the Company:

Karl E. Groth, Ph.D., Chairman and Chief Executive Officer

kgroth@bioheartinc.com

(954) 835-1500  



SOURCE Bioheart, Inc.



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