SUNRISE, FL--(Marketwired - May 05, 2014) - Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, announces an update on the phase I safety trial using adipose derived cells.
Approximately four years ago in April, 2010, Bioheart initiated a study using adipose derived stem cells (AdipoCell™) in congestive heart failure patients. In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, five congestive heart failure patients were successfully treated in the initial pilot trial at Hospital Angeles Tijuana. Patients underwent a mini-lipoaspiration procedure where 60ccs of fat were removed. This fat was processed to obtain the stromal vascular fraction (SVF) which contains mesenchymal stem cells, progenitor/endothelial cells, pericytes, hematopoetic stem cells and more. The SVF was injected into the damaged areas of the heart using Bioheart's MyoCath® catheter allowing for a minimally invasive delivery. Patients were followed on protocol for 6 months and demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.
The patients were recently contacted to assess quality of life. The patients have reported that they are in good spirits and doing well. According to the American Heart Association, about half of the people who develop heart failure die within 5 years of diagnosis. The most compelling data from this trial is the strong safety profile. All adverse events were adjudicated by an independent data safety monitoring board and deemed not related to the therapy. In addition, the four year information from the original pilot study demonstrates preliminary long term safety of the AdipoCell product.
"We are pleased that we have been able to help these patients who have very limited options. We are looking forward to collecting additional data on the AdipoCell product and providing these therapies to more patients," said Kristin Comella, Bioheart's Chief Science Officer.
Bioheart's AdipoCell product is currently being studied in a variety of indications including erectile dysfunction, chronic obstructive pulmonary disease and dry macular degeneration.
About Bioheart, Inc.
Bioheart, Inc. is dedicated to advancing the field of regenerative medicine by offering the highest quality technology, cellular treatments and training. Specific to biotechnology, Bioheart, Inc. specializes in the discovery, development and commercialization of autologous cellular therapies that treat a wide variety of degenerative diseases.
Bioheart, Inc. is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry by delivering stem cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions, chronic and acute heart damage, peripheral vascular disease and other issues. Bioheart's goals are to improve a patient's quality of life by regenerating their damaged tissue, when possible, and by reducing health care costs and hospitalizations. Bioheart's leading product, 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.
For more information on Bioheart, visit www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. 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.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is 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, 2013, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013.