Sunrise, FL – March 19, 2015 – Bioheart, Inc., a Florida Corporation (BHRT.OB) and Ascyrus Medical, LLC, a Florida Limited Liability Corporation are pleased to announce that they have entered into an investment agreement. The investment agreement provides for Bioheart to obtain a consolidating ownership stake in Ascyrus Medical upon the achievement of certain business milestones. Bioheart has through June 30, 2015 to meet its milestone obligations.
Aortic surgeon Dr. Ali P. Shahriari organized Ascyrus Medical, LLC in January 2015 to address the unmet need for treating patients with aortic dissections and ascending arch aneurysms. An aneurysm is a sac formed by an enlarged or weakened wall of an artery. The aneurysm will enlarge and cause a rupture or a tear, called an aortic dissection, often resulting in a fatal outcome. The repair of an aortic dissection and ascending arch aneurysm requires open-heart surgery. In response to this medical need, Dr. Shahriari has invented and patented the Ascyrus Medical Hybrid Graft (AMHG). The AMHG enables surgeons easily to implant the graft, making the operation less hazardous. The most distinguishing feature of the AMHG is in its ability to reattach the dissection flap in the aorta, promote healing of the aortic wall. This unique proprietary approach cures the patient from long-term complications of an aortic dissection. According to the US Center for Disease Control and Prevention, Aortic disease is the 13th most common cause of death in the Western population. Ascending aneurysms and aortic dissections are detected in over 37,000 individuals annually in the US. The European market is slightly smaller in size, while Asia is the largest market.
“Regenerative medicine takes on many forms,” said Mike Tomas, President and Chief Executive Officer. “Although not a cellular therapy, the Ascyrus Medical Hybrid Graft is novel medical device capable of restoring a damaged aorta. We believe, inclusive of Dr. William P. Murphy, Jr., Bioheart’s Chairman and founder of the Cordis Corporation, that we are uniquely qualified to assist Dr. Shahriari and the Ascryus Medical team in meeting its product development and business goals. This investment agreement will enable Bioheart to share, if successful, in a significant and relatively short-term business opportunity. We greatly appreciate Dr. Shahriari’s trust in our abilities and we look forward to a long and prosperous relationship with Dr. Shahriari and Ascyrus Medical.”
“The Ascyrus Medical Hybrid Graft, when approved for commercialization, will save thousands of lives,” said Dr. Ali P. Shahriari, CEO, Ascyrus Medical, LLC. “We believe the AMHG is superior technology in its medical utility, ease of use and risk reduction. Inventing the AMHG is a single step in commercializing this novel and important 2 medical technology. Our developing partnership with Mike Tomas and the Bioheart team will enable Ascyrus Medical to expeditiously advance the AMHG through its clinical evaluation, regulatory approval and market penetration. The Bioheart / Ascyrus Medical partnership will save lives.”
About Bioheart, Inc.
Bioheart, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.
Our business includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.
US Stem Cell Training, (“SCT”), an operating division of Bioheart, Inc., is a content developer of regenerative medicine / cell therapy informational and training materials for physicians and patients. SCT also provides in-person and online training courses which are delivered through in-person presentations at SCT’s state of the art facilities and globally at university, hospital and physician’s office locations as well as through online webinars. Additionally, SCT provides hands-on clinical application training for physicians and health care professionals interested in providing regenerative medicine / cell therapy procedures.
Vetbiologics, (“VBI”), an operating division of Bioheart, Inc., is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. VBI provides veterinarians with extensive regenerative medicine capabilities including the ability to isolate regenerative stem cells from a patient’s own adipose (fat) tissue directly on-site within their own clinic or stall-side. VBI regenerative medicine technologies are designed, implemented and produced according to the highest standards. VBI follows the FDA guidelines for human cellular therapy production which means each product produced must be validated and must pass stringent criteria.
US Stem Cell Clinic, LLC, (“SCC”), a partially owned investment of Bioheart, Inc., is a physician run regenerative medicine / cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. SCC is operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and adipose tissue and also utilize platelet rich plasma.
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, forwardlooking 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.