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Bioheart Announces Clinical Study for Degenerative Disc Disease
|By Marketwired .
|March 26, 2014 02:15 PM EDT
SUNRISE, FL -- (Marketwired) -- 03/26/14 -- Bioheart, Inc. (OTCQB: BHRT), a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, announced that it will enroll patients in a new study for degenerative disc disease (DDD). The study will enroll up to 100 patients to determine the safety and efficacy of adipose derived stem cells or AdipoCell in patients with DDD.
Robert Silbert, MD of Physical Medicine/Rehab Associates in Indianapolis, Indiana is the principal investigator for the study. "Degenerative disc disease can be debilitating for many patients. Regenerative medicine offers new hope for these patients. It may stop or reverse the pain, disability, and the loss of material between the vertebrae," said Dr. Silbert.
Bioheart has initiated this new study for DDD which will include a randomized control arm. The study has been reviewed and approved by the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS). The ICMS IRB is committed to providing peer review of proposed studies of cell-based medical therapies based upon appropriate clinical translation, patient care and safety.
About Bioheart, Inc.
Bioheart, Inc. is committed to maintaining its 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. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, Bioheart is 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. Its 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.
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org.
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.
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