updated 1/10/2011 4:15:37 PM ET 2011-01-10T21:15:37

SUNRISE, Fla., Jan. 10, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT) announced today that Bioheart's primary focus is on completing clinical evaluation of its cell therapies for treating heart failure and related cardiac diseases.

Kristin Comella, Chief Scientific Officer of Bioheart, stated today, "We have FDA approval for two landmark clinical trials: the Phase II/III MARVEL study for MyoCell and the REGEN Phase I Dose Escalation Study for our 2nd generation product MyoCell SDF-1.  Thirty-five U.S. centers have signed up to participate in the MARVEL study which is intended to enroll 160 patients. These two studies focus on Class III heart failure patients."
Bioheart recently announced plans to initiate a third study that has been dubbed: the LVAD + Cell Bridge to Recovery Phase I/II study in Class IV advanced heart failure patients.  An advisory board consisting of prominent doctors in the U.S. has recommended three study groups: Group 1 = MyoCell SDF-1, Group 2 = MyoCell with 3 injection sessions, Group 3 = LVAD patients only.  The LVAD + Cells Bridge to Recovery trial is intended to permit the treatment of the patients that are in most need of recovery of their myocardial scar tissue.  The LVAD or left ventricular assist device serves to keep the patient alive during the time required to grow a sufficient volume of new contractile muscle within their heart with MyoCell injections. LVADs, like pacemakers or drugs, do not convert scar tissue back into living contracting muscle. Only myoblast injections are able to grow new muscle fibers.  The intention is to complete this study in partnership with an LVAD company.
In addition to these U.S. trials, Bioheart has two Centers of Excellence which are focused on treating patients using adipose derived stem cells.  The center in Mexico has recently completed 6 months follow up on the first 4 heart failure patients.  These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.  The cells are delivered directly into the heart using Bioheart's MyoCath injection catheter. In the fourth quarter of last year, a shelf life validation study was completed on the current lot of MyoCath catheters confirming the long term stability of the product.

Bioheart has also partnered with the University Hospital Ostrava which is currently enrolling and treating end stage critical limb patients who have been listed on the amputation list. These patients are being treated with adipose derived stem cells in the Czech Republic Center of Excellence.  Recently reported follow up showed that 75% of the patients demonstrated healing and pain reduction while only 25% of the patients required amputation.
Mike Tomas, President and CEO of Bioheart, stated, "We are committed to bringing these therapies to patients who need them and intend to continue these clinical trials."
Bioheart has been treating patients with cell therapy since 2001 and continues to lead the field with ground breaking trials and results:

  • Over 300 patients have been enrolled in myoblast therapy for heart failure clinical trials since 2000.
  • 84% of MyoCell treated patients have exhibited improvement while only 16% have worsened.
  • In Bioheart's Phase II SEISMIC study 94% of treated patients improved in heart failure class while only 6% worsened.
  • In Bioheart's Phase II/III MARVEL part I study, MyoCell treated patients improved 91.7 meters in exercise capacity testing while placebo patients on optimal heart failure drugs declined 4 meters.  
  • Pre-clinical studies at both Cleveland Clinic and the University of Florida demonstrated a 54% cardiac improvement in MyoCell SDF-1 treated animals, 27% with MyoCell and a 10% decline in placebo injected animals.  Histopathological examinations showed a greater volume of new muscle and new mature blood vessels in the MyoCell SDF-1 treated myocardial scars than in the other two groups.

About Bioheart, Inc:  

Bioheart, Inc. founded in 1999 seeks to be the "go to technology partner for heart failure specialists and their patients".  The company's flagship product, MyoCell, is an adult muscle stem cell composition, also known as immature myoblasts, derived and processed from patient's own thigh muscle. These cells are delivered to a patient's heart via the MyoCath needle tipped catheter or a similar device which is inserted through the patient's groin and is directed to the inside of the heart where the injections are made. MyoCell has been in clinical trials for treating advanced heart failure patients since early 2001. A 2nd generation composition MyoCell SDF-1 received FDA approval for clinical trials. This composition is made up of genetically modified cells that over express the stromal derived factor 1 protein that has been shown to improve blood vessel formation and muscle development. Bioheart, Inc. has also initiated clinical evaluation of methods of treating heart ischemia, acute myocardial infarctions and lower limb ischemia utilizing adipose (fat) derived cells.  Bioheart is focused on heart failure and has a building pipeline of product developments to assist care providers in treating and caring for these patients.

Forward-Looking Statements:

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, 2009, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010.

CONTACT: Bioheart, Inc.
         Catherine Sulawske Guck, Chief Operating Officer
         954 835 1500, email csguck@bioheartinc.com

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