SOURCE: Bioheart, Inc.

Bioheart, Inc.

October 13, 2014 08:00 ET

Bioheart Announces Positive 12 Month Preliminary Data From Phase I Angel Trial

SUNRISE, FL--(Marketwired - Oct 13, 2014) - Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of degenerative diseases, released today preliminary 12 month data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).

At the 12 month time point, patients are demonstrating a statistically significant average improvement in ejection fraction (EF) by echocardiogram. At the 3 month time point, 100% of the patients demonstrated either improvement or stayed the same. After 3 months, patients showed an average absolute improvement of 3 percentage points in EF. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01) and at the 12 month follow up patients showed this same level of improvement (p=0.01).

"This preliminary data shows the potential for this therapy to benefit patients suffering from congestive heart failure," said Kristin Comella, Bioheart's Chief Science Officer. "We are looking forward to expanding this trial to include more clinical sites and patients."

This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell™) in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.

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.

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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, 2012, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013.

Contact Information

  • Media Contact:
    Carissa Matton
    Bioheart, Inc.
    13794 NW 4th Street, Suite 212
    Sunrise, Florida 33325
    Phone: 772.285.8511
    cmatton@bioheartinc.com