SUNRISE, Fla., March 1, 2012 (GLOBE NEWSWIRE) --
Dear Shareholders,
It is with great enthusiasm that I am pleased to inform you about Bioheart's progress during 2011 and announce several new initiatives for 2012. We have boosted our senior management team, entered into several valuable partnerships and agreements, identified new markets and alternative sources of revenue and seen tangible results regarding continued clinical trials.
2011 was a year of steady, continuous movement for the company. We 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 intramyocardialimplantation of autologous adipose derived stem cells (LipiCell™) in patients with chronic ischemic cardiomyopathy. LipiCell™ is currently being evaluated in the Phase I/II trial in Mexico in which 15 patients have been treated. These patients are demonstrating improvements in ejection fraction and exercise capacity.
We generated over $1.4 million from investments and revenues this past year. Overall debt was reduced by almost $400,000 and our monthly burn rate was reduced by 20%. We renewed our $980,000 loan from Seaside National Bank and Trust with the continued support of long time shareholders, Dan Marino and Jason Taylor, who reaffirmed their support of Bioheart by guaranteeing the Seaside Loan.
We entered into an agreement to provide cellular products and services to the veterinary market. Under the agreement, the companies will offer culture expanded bone marrow and adipose stem cells for use in animals with degenerative diseases or acute injuries. We continue working with Airspeed under their license agreement to bring other Bioheart technologies to market such as the MyoStim™ line.
The results of our Clinical Trial Marvel Part 1 were published in the American Heart Journal, the prominent peer reviewed medical journal. When compared with placebo, myoblast therapy was associated with sustained (six months) improvements in six minute walk distance of >90 meters, a clinically meaningful improvement. For congestive heart failure patients, this translates into returning to a more active lifestyle and a better quality of life.
We've had tremendous activity and solid accomplishments to date in the first quarter of 2012. We entered into a $3M standby equity purchase agreement with a Florida investor that agreed to purchase up to $3M of BHRT common stock upon request, subject to certain conditions, including the registration of those shares on a registration statement. This was declared effective by the SEC on February 10, 2012.
Regarding LipiCell™ mentioned above, in February we acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field. The technology will allow us to broaden our portfolio of product candidates for cardiac patients in 2012.
We have also brought the ANGEL trial using LipiCell™ to the University of Miami and are working with Joshua Hare, M.D., Director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine to develop the clinical program.
Frank Young, who previously served as CFO with Bioheart from 2003 to 2005, has joined Bioheart as Financial Consultant to provide financial oversight of the company's capital fundraising efforts and cultivate relationships within the financial and health care communities. Frank has a proven track record launching and managing venture-backed companies across the healthcare industry and is a valuable addition to our team.
As you know, the Bioheart team is often asked to present at industry conferences. CSO Kristin Comella and I spoke on February 25 about the use of stem cells in degenerative diseases at the BioFlorida Saturday Exchange, a forum for life science professionals. Additional speaking opportunities are scheduled in the coming months.
Further, we are broadening communications through an increased social media presence, a re-design of our website and the creation of a periodic E-newsletter, all of which will keep you and the community updated on activities and accomplishments in the coming year.
Thank you for your continued support of Bioheart. Please contact me directly if I can answer any specific questions or concerns.
Yours sincerely,
Mike Tomas
President and CEO
About Bioheart, Inc.
Bioheart (OTCBB:BHRT) 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.
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.