Bioheart Files With the FDA to Begin the ANGEL Trial
December 06 2011 - 5:00AM
Bioheart, Inc. (BHRT.OB) announced that they have completed an
Investigational New Drug (IND) application to the FDA for the ANGEL
trial. The clinical protocol is designed to assess the safety and
cardiovascular effects of intramyocardial implantation of
autologous adipose derived stem cells (LipiCell) in patients with
chronic ischemic cardiomyopathy. Transplantation of LipiCell will
be accomplished through endocardial implantations with the MyoStar™
Injection Catheter under the guidance of the NOGA® cardiac
navigation system by Biosense Webster, Inc. – A Johnson &
Johnson Company.
The IND submission included results from an ongoing Phase I/II
trial in Mexico. Bioheart in collaboration with the
Regenerative Medicine Institute has successfully treated nine heart
failure patients using LipiCell. The therapy involves the use of
stem cells derived from the patient's own fat (adipose tissue)
obtained using liposuction. These patients have 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.
Bioheart's Chief Scientific Officer, Kristin Comella stated, "We
are looking forward to being one of the first companies to bring
these therapies to US trials. We have successfully
demonstrated the safety and efficacy of adipose cells in
preclinical studies as well as our clinical trial in
Mexico."
About Bioheart, Inc.
Bioheart is committed to maintaining our leading position within
the cardiovascular sector of the cell technology industry
delivering cell therapies and biologics that help address
congestive heart failure, lower limb ischemia, chronic heart
ischemia, acute myocardial infarctions and other issues. Our
goals are to cause damaged tissue to be regenerated, if possible,
and to improve a patient's quality of life and reduce health care
costs and hospitalizations.
Specific to biotechnology, we are focused on the discovery,
development and, subject to regulatory approval, commercialization
of autologous cell therapies for the treatment of chronic and acute
heart damage and peripheral vascular disease. Our 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
http://www.bioheartinc.com.
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, 2010, and its
Quarterly Report on Form 10-Q for the quarter ended September
30, 2011.
CONTACT: Bioheart, Inc.
Catherine Sulawsk-Guck
Chief Operating Officer
954-835-1500
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