SUNRISE, Fla., March 9 Bioheart, Inc., (OTC Bulletin Board: BHRT.OB) announced today that four members of its Board of Directors have added to their ownership positions in the company through Bioheart's PIPE ("Private Investment in Public Equity").
Peggy Farley, Chief Operating and Financial Officer asserts, "Bioheart's lead position in cell therapies for cardiovascular disease, along with its potential for generating revenues, is the reason for my confidence in the company's future earnings and therefore, the ultimate return on my investment. Adding to my existing investment in Bioheart allows me to take advantage of what I appraise as an unwarranted downturn in the company's stock price."
Bioheart's PIPE, an investment vehicle whose participants must meet the SEC's definition of accredited investors, enables the purchase of specially priced units consisting of 10 restricted common shares and 3 warrants. The restricted common shares are priced at a 10% discount to an average closing price for BHRT.OB shares for the five days prior to the subscription agreement being submitted. That same benchmark is used for the warrants--which are priced at 20% above.
Dr. William P. Murphy Jr., now retired, but who was the Founder and former Chairman of Cordis, now a division of Johnson & Johnson, who also increased his stake in the company through the PIPE vehicle, explained his motivation: "The Company has just announced its first FDA approved clinical trial to test generation 2 of MyoCell, our treatment for patients suffering from Congestive Heart Failure (CHF). This Phase I REGEN trial is designed to test the safety and effectiveness of myoblasts that have been gene-modified to induce a greater than usual release of SDF-1, the protein that attracts stem cells to parts of the body needing repair. They have been seen to accelerate MyoCell's effectiveness in regenerating muscle in the heart."
Bioheart recently announced the commencement of its Phase I REGEN trial, the first trial of a combined cell and gene therapy approved by the FDA. The Company's TGI system for obtaining stem cells from adipose (fat) tissue is currently being used in several countries to treat lower limb ischemia, chronic heart ischemia, and will soon be used for other indications.
Ms. Farley added, "U.S. regulatory acceptance for the Bioheart therapy for either of two conditions, congestive heart failure or lower limb ischemia, that cause so much suffering and emotional trauma, would translate into substantially lowering the $22.5 billion catastrophic cost to patients, insurers and government payors for these conditions. With several such therapies in the pipeline, I believe that Bioheart's research and products are in the forefront for treatment of CHF and all other serious cardiovascular issues."
Chuck Hart and Mark Borman are two directors who are also participating in the PIPE. Mr. Hart advocates that the next generation of heart treatments will very quickly become accepted and mainstreamed as stem cell research becomes a basic scientific tool. He said: "I am honored to be involved with a technology that will help millions of people."
Ms. Farley and Dr. Groth, Bioheart's Chairman and CEO, are venture capitalists and have invested two of their funds in Bioheart. Ms. Farley's career has included chairing and managing two investment management firms over the past 25 years.
Promising Results from Company's MARVEL Trials on MyoCell
The company recently announced positive clinical results for MyoCell following the first part of its Phase II/III, double-blinded, placebo-controlled clinical trial called MARVEL. Over the 6-month observation period in this trial, the most pronounced changes were seen in the cell-treated groups. The six minute walk distance (6MWD), an established parameter of efficacy utilized in heart failure studies, one of the primary end points in the trial, increased on average by more than 91 meters, or 35%, in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen. This suggests that patients with heart failure could return to a more active lifestyle after receiving Bioheart's treatment. No stem cell related safety issues such as arrhythmias, or irregular heartbeat, were observed. An arrhythmia event is disturbing but not serious. In the MARVEL trial pre-treatment with amiodarone enabled patients to avoid arrhythmias.
TGI 1200 Cell Isolation System Seems to Improve Effects of Ischemia
Other Company pipeline product candidates include the TGI 1200 Cell Isolation System, which takes advantage of an easily accessible source of regenerative cells from adipose or fat tissue. Bioheart is currently utilizing the regenerative cells isolated by the TGI 1200 System in a variety of clinical applications including chronic heart ischemia in Venezuela and for critical limb ischemia in the Czech Republic.
A large quantity of stem cells can be obtained from a patient's adipose tissue without pain and other side effects, quickly and cheaply. Adipose stem cells are capable of promoting blood vessel formation and assisting with the healing of damaged blood vessels. The procedure for getting adipose derived stem cells from the patient is simple and easily tolerable by the patient even immediately following a heart attack. Fat tissue, itself, is plentiful within the patient's own body and there is an abundance of stem cells within fat tissue. The stem cells can be separated from the fat cells very quickly with the TGI system, making treatment after an event, like a heart attack, able to be done immediately so that the healing process can begin and scarring can be avoided. In contrast, the alternative procedure is to use bone marrow to obtain stem cells, which often yields a low volume of stem cells and is extremely painful.
The CE-marked TGI 1200 System is a fully automated and easy-to-use system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour. The compact desktop unit requires no tissue pre-processing, and fits easily into any clinical environment. The instrument allows for point-of-care recovery of an average of 30 to 40 million regenerative cells per 60cc of a patient's processed fat. These cells can then be used at the site of injury or disease to amplify the body's own repair process by accelerating the healing and repair of damaged and diseased tissue to prevent scarring and loss of function.
Lower limb ischemia is pain, often severe enough to be intolerable, due to limited or inefficient blood circulation. Diabetic patients, universally, are fifteen times more susceptible to limb amputation than other patients as a result of lower limb ischemia. These patients can now be treated using the new therapy. Bioheart, in collaboration with University Hospital Ostrava in the Czech Republic, has already begun treating patients with critical limb ischemia utilizing ASCs. Bioheart is working to place the TGI systems throughout the Czech Republic for additional indications including acute myocardial infarction and chronic heart ischemia, and is developing treatment plans targeted for patients with these heart issues.
Over 500,000 New Cases of Heart Failure Annually in the U.S. Alone
Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life. This disease affects over 5 million people in the United States. Over 500,000 new cases are diagnosed annually in the U.S., making heart failure the most rapidly growing of all cardiovascular disorders. According to statistics provided by the American Heart Association, in the US, approximately $22.5 billion are the direct and indirect annual costs of heart failure treatment. Persons over the age of 65 experience heart failure as the number one cause of hospitalization and the number one cause of death.
About Bioheart, Inc.
Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. The company works to prevent the worsening of any condition with devices that monitor and diagnose cardiac illness. Our goals are to cause damaged tissue to be regenerated, 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. 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.
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our ability to establish a distribution network for and commence distribution of certain products for which we have acquired distribution rights; (iv) our ability to timely and successfully complete our clinical trials; (v) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; (ix) our ability to protect our intellectual property rights; and (x) intense competition. The Company is also 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, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2009, March 31, 2009, June 30, 2009, and September 30, 2009.
Contact: At the Company: Karl E. Groth, Ph.D., Chairman and Chief Executive Officer (954) 835-1500
SOURCE Bioheart, Inc.