Bioheart Announces Positive 6 Month Data From Angel Phase I Trial
March 04 2014 - 8:00AM
Marketwired
Bioheart Announces Positive 6 Month Data From Angel Phase I Trial
SUNRISE, FL--(Marketwired - Mar 4, 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 6 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).
"The six month data has far exceeded our expectations. We
were excited to see that patients continued to improve from 3
months to 6 months demonstrating the power of a biological product
which can actually remodel tissue and change the course of a
disease," said Kristin Comella, Bioheart's Chief Science Officer.
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.
At the 6 month time point, patients are demonstrating an average
improvement in exercise capacity or a six minute walk test of
approximately 68 meters as compared to an average improvement of 47
meters at 3 months. Eighty percent of the patients showed an
improvement in their exercise capacity from 3 months to 6 months
post stem cell injection.
Another end point in the study is 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 ejection fraction. 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). The full six month data will be
presented at the upcoming Age Management Medicine Group conference
in Orlando on April 25th (www.agemed.org).
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, 2012, and its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2013.
Media Contact: Carissa Matton Bioheart, Inc. 13794 NW 4th
Street, Suite 212 Sunrise, Florida 33325 Phone: 772.285.8511
cmatton@bioheartinc.com
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