Navigation Links
Final Data From the Bioheart Seismic Trial Suggest Safety, Efficacy of Autologous Stem-Cell Therapy for Treating Congestive Heart Failure

Leading Expert Discusses Study During Late-Breaking Presentations at ACC

CHICAGO, April 1, 2008 /PRNewswire-FirstCall/ -- Bioheart, Inc. (Nasdaq: BHRT) announced today that final six-month, follow-up patient data was presented today during the late-breaking clinical trial sessions at the American College of Cardiology, suggesting that MyoCell(R) myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.

The findings from the SEISMIC(1) Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe, evaluated MyoCell myoblast clinical cell therapy delivered via the MyoCath(R), endoventricular needle-injection catheter in patients previously fitted with implanted cardiac defibrillators(ICDs), receiving standard medical therapy and who are experiencing congestive heart failure. On admission to the trial, patients were randomized on a two-to-one ratio into the treatment versus control groups with 26 patients receiving MyoCell therapy and 14 patients in the control group. All patients were experiencing congestive heart failure and were previously fitted with ICDs and receiving standard medical therapy. Both the MyoCell biologic therapy and the MyoCath needle-injection catheter, developed by Bioheart, Inc., are currently being studied as investigational products.

"The results from the SEISMIC Trial are encouraging," said Prof. Patrick W. Serruys, MD, PhD, Principal Investigator and Chief, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center - Rotterdam, the Netherlands. "While the study was specifically designed to show safety, the findings also suggest positive trends in clinical benefits when evaluating the treated group versus the control group at six months."

Patients in both groups were evaluated at three- and six-month intervals using a variety of tests, including digital imaging and standard quality of life measurement such as the six-minute walking test, New York Heart Association (NYHA) heart failure classification and Minnesota Living with Heart (MLHF) questionnaire. Final six-month results observed in the SEISMIC Trial include:
-- 84 percent of treated patients experienced improved or unchanged

six-minute walking test scores compared to 16 percent of the control


- 69 percent of the control group's results worsened, versus only

16 percent of the treated group

-- 94 percent of treated patients experienced improved or unchanged NYHA

classification compared to 58 percent of the control group

- 42 percent of the control group's results worsened, versus only

6 percent of the treated group

Prof. Serruys also noted that reports of arrhythmia among the patients evaluated in SEISMIC, both in terms of total number of episodes as well as timing of episodes, were no different between the treatment and control arms in the study. This suggests that MyoCell is not associated with a higher prevalence of arrhythmias; rather, that arrhythmias are an expected occurrence for this subset of heart failure patients.

"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL(2) Trial currently underway in the U.S. and Europe."

The MARVEL Trial, a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 330 patients in North America and Europe, is the largest trial of its kind to date. Enrollment in the MARVEL Trial began in October 2007, targeting patients who fall into Class II or III heart failure. The MARVEL Trial will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(3), in combination with the NOGA(R) XP Cardiac Navigation System. The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.


MyoCell clinical cell therapy, developed by Bioheart, Inc., is currently being studied as an investigational product in Europe and the U.S. MyoCell clinical cell therapy is intended to be used to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. The procedure involves a physician removing a small amount of muscle obtained from the patient's thigh. From this muscle specimen, autologous myoblasts (muscle stem cells) are then isolated, grown using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The myoblast cells are delivered via an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The myoblast-based muscle formation in the newly populated regions of scar tissue are intended to improve cardiac function by helping the heart muscle beat more efficiently.


Approximately nine million European patients and 5.2 million Americans(4) suffer from congestive heart failure, a progressively degenerative condition in which the heart is unable to adequately pump blood throughout the body resulting in fluid accumulation in the lungs, kidneys, and other body tissues. Patients suffering from this disease fatigue easily, and become increasingly less capable of normal activity as they progress through the various stages of the disease. Current standard of care typically involves drug therapy and/or the implantation of a pacemaker and/or defibrillator device to regulate heart function.


Bioheart, Inc. is a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell, is an innovative clinical cell therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells, or cells from the patient's body, for the purpose of improving cardiac function in chronic heart failure patients. The company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose cell treatment for acute heart damage, and MyoCell SDF-1, a therapy utilizing autologous cells genetically modified to express additional growth factors.

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 secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; and (ix) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including Post-Effective Amendment No. 5 to its Registration Statement on Form S-1 (Registration No. 333-140672) filed on February 13, 2008.


(1) SEISMIC: Safety and Effects of Implanted (Autologous) Skeletal

Myoblasts (MyoCell(R)) using an Injection Catheter

(2) MARVEL: A Phase II/III, Double-Blind, Randomized, Placebo-Controlled

Multi-center study to Assess the Safety and Cardiovascular Effects of

MyoCell Implantation by a Catheter Delivery System in Congestive Heat

Failure Patients Post-Myocardial Infarction(s)

(3) The MYOSTAR(TM) Injection Catheter is not available for sale in the

U.S. It is in use in IND investigations

(4) Heart Association Heart Disease Statistics - 2007 Update

MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.

MyoStar and NOGA XP are trademarks of Cordis Corporation, a Johnson & Johnson company

For more information, visit

Contact: William Kline Lytham Partners, LLC

Chief Financial Officer Joe Diaz

Nicholas Burke Joe Dorame

VP - Financial Operations Robert Blum

(954) 835-1500 (602) 889-9700

SOURCE Bioheart, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Final Data From the SEISMIC Trial Suggest Safety, Efficacy of Autologous Stem- Cell Therapy for Treating Congestive Heart Failure
2. Nventa Enrolls and Initiates Dosing of Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial
3. Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting
4. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
5. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
6. Hope for Emphysema Sufferers: Clinical Trial That May Help Patients Breathe Easier Begins at Central DuPage Hospital
7. TAXUS(R) Stent Demonstrates Similar Outcomes in Diabetic Patients Compared to Non-diabetics in Pooled Analysis of TAXUS IV and V Trials
8. Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific Innovation
9. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
10. CVBT Appoints Dr. Nabil Dib as Principal Investigator for Phase II Heart Trial
11. ThromboGenics Completes Patient Enrolment in the Phase IIb Trial of Microplasmin in Vitrectomy (MIVI III)
Post Your Comments:
(Date:11/24/2015)... DELHI , November 25, 2015 ... invoked due to repeated failure of IVF cycles. After ... Bhatia was totally dejected and had lost all hopes that she would be ... first Indian miracle child conceived after failure of over ... to abroad (UK) before they decided to take one last attempt ...
(Date:11/24/2015)...  In the pharmaceutical industry, companies want to rapidly ... uncover new insights, tactics and strategies that will improve ... --> However, organizations often find it is difficult ... that all rules and regulations are met to ensure ... to efficiently launching market research projects is the conflicting ...
(Date:11/24/2015)... , November 24, 2015 --> ... report "Spine Biologics Market by Product Type (Bone Graft, Bine ... Discectomy and Fusion, Posterior Lumbar Interbody Fusion), End User, and ... global market was valued at $1.90 Billion in 2014 and ... CAGR of 4.4% during the forecast period of 2015 to ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... ... Serenity Point Rehabilitation, a holistic treatment center for substance abuse located in ... staff members at their recovery center. The videos highlight some of the various aspects ... things that make their recovery program so unique. , “Making the decision to seek ...
(Date:11/24/2015)... ... November 24, 2015 , ... Cold Shoulder , LLC launched their Pro Vest, the latest ... hit their goal of $20,000 in under 10 hours. , The campaign, ... PRO Weight Loss Vest to the market. , The PRO Vest provides consumers with a ...
(Date:11/24/2015)... ... ... Dr. Rodney E. Willey , has answered a new calling – to relieve snoring ... treatment for snoring and sleep apnea through oral appliance therapy. He is ... in the US, one of four in the Illinois area. , Dr. Willey’s ...
(Date:11/24/2015)... ... ... Bibliomotion is thrilled to announce the launch of UNCONVENTIONAL ... Nancy M. Schlichting, Chief Executive Officer of Henry Ford Health System (November ... of patients and their families, shaped my desire to improve the system of care. ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... products, announces Innovative Blending, a household invention that revolutionizes the vending machine industry ... Smoothie Bars market is worth $2 billion," says Scott Cooper, CEO and Creative ...
Breaking Medicine News(10 mins):