SUNRISE, FL / ACCESSWIRE / January 29, 2015 / Bioheart, Inc., a Florida Corporation (OTCQB:BHRT), an emerging enterprise in the regenerative medicine / cellular therapy industry announced today an update and diversification plan for its clinical development pipeline. The company's update includes a realignment of its cardiovascular product candidates and diversification into the treatment of autoimmune diseases with a first generation, investigational research program to treat Rheumatoid Arthritis (RA).
Cardiovascular Product Candidates
Bioheart will advance its Myocell(TM) and Myocell(TM) SDF-1 programs forward for the treatment of chronic heart failure. The Myocell(TM) product candidate (known as the MARVEL clinical trial) will advance into US FDA phase 3 clinical evaluation for the treatment of chronic heart failure. The re-start of the Myocell(TM) clinical trial is conditional to re-engagement with the principle investigators and related institutional requirements and internal preparations. Additional information on the timing of patient enrollment will be given at a future date. The Company estimates that Myocell(TM) for the treatment of chronic heart failure could achieve market approval in 2019. Bioheart also plans to advance its Myocell(TM) SDF-1 program (known as the REGEN clinical trial), a second generation product, for the treatment of chronic heart failure forward. The Company is currently seeking a joint development partner to collaborate with the development of the Myocell(TM) SDF-1 program. A joint development partner may, among many attributes, augment the Bioheart research, development and clinical team, bring unique expertise, intellectual property and capabilities to the program, share program costs, accelerate the program to approval and accelerate potential market penetration. The company estimates that Myocell(TM) SDF-1 for the treatment of chronic heart failure could achieve market approval in 2021. According to the American Heart Association, about 4.9 million Americans are living with congestive heart failure. Of these, 2.5 million Americans are males and 2.4 million are females. Ten of every 1,000 people over age 65 have this condition. There are about 400,000 new cases each year. According to the US Center for Disease Control, cardiovascular disease and strokes account for an estimated $432 billion in healthcare and related costs. If approved by the US FDA, the Company believes that Myocell(TM) and Myocell(TM) SDF-1 could significantly improve the cardiovascular health of chronic heart failure patients and reduce the associated cost of treating these patients.
Also in the cardiovascular space, Bioheart plans to advance an Adipocell(TM) based product candidate forward for the treatment of Critical Limb Ischemia (CLI). Company sponsored investigator lead research in the treatment of CLI has produced positive outcomes. The development of CLI usually involves multiple sites of arterial obstruction that severely reduce blood flow to the tissues. CLI manifests itself clinically as rest pain, non-healing wounds or tissue necrosis. Severe cases of CLI can result in amputations. The Sage Group reported that an estimated 2 million people in the US have CLI and reflecting the aging population, this number is projected to grow to almost $2.8 million by 2020. The Company believes that with a device regulatory approach for Adipocell(TM), market approval could be achieved by 2017 for the treatment of CLI.
The Company has no further plans to advance its ANGEL and MIRROR clinical development programs.
Autoimmune Product Candidate
Bioheart is pleased to announce the diversification of its product development pipeline into the treatment of autoimmune diseases. The Company plans to evaluate several autoimmune disease targets with its Adipocell(TM) therapy platform, the first of which will be Rheumatoid Arthritis (RA). The Company believes, for example, that if its Adipocell(TM) first generation, investigational research program into the treatment of RA achieves proof of efficacy, an advanced clinical development program could produce an approved cellular therapy that would have a profound impact on the debilitating effects of RA. RA is a chronic disease that causes pain, stiffness, swelling, and loss of function in the joints. It occurs when your immune system, the system that protects your body from outside harm, mistakenly starts attacking healthy tissue. This causes inflammation that leads to swelling in the joints making them progressively less mobile. If not managed properly, over time, RA can cause joint damage and can even result in permanent joint destruction. According to the Arthritis Foundation, RA affects approximately 1.3 million Americans, but unlike osteoarthritis, RA is not associated with factors such as aging, obesity, or injury. The Company believes that market approval could be achieved by 2018 for the treatment of RA.
Product Development Pipeline Summary
Based on the above information, Bioheart's Product Development Pipeline is summarized as follows:
"Myocell(TM), Myocell(TM) SDF-1, and Adipocell(TM) are unique product candidates that could have a profound impact on improving the lives of millions of people," said Mike Tomas, Bioheart's President and CEO. "Success comes from focus. The opportunities in regenerative medicine are endless but as an emerging company, we need to improve the odds of fulfilling our mission by knowing what is achievable and achieving it. We believe that the financial resources generated through our educational, animal health and personalized medicine products and services coupled with appropriate financing can bring these exciting product development candidates to market."
Additional information regarding Bioheart's clinical development programs will be discussed at its upcoming February 4, 2015, 4:30 PM EST shareholder conference call and future SEC filings.
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.
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, 2014.
Media Contact:
Carissa Matton
Bioheart, Inc.
13794 NW 4th Street, Suite 212
Sunrise, Florida 33325
Phone: 772.285.8511
[email protected]
SOURCE: Bioheart, Inc.