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(TM)) in patients with chronic ischemic cardiomyopathy. LipiCell(TM) 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(TM) 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(TM) 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(TM) 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.
See the article here:
Bioheart Issues Shareholder Letter Announcing Progress and New Initiatives
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