Post by Hot Christian Stocks on Mar 14, 2012 7:33:12 GMT -5
BHRT - Bioheart, Inc.
About Bioheart, Inc.
Bioheart 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
CONTACT
Bioheart, Inc.
13794 NW 4th Street, Suite 212
Sunrise, Florida 33325
Telephone: (954)-835-1500
Fax: (954)-845-9976
bioheart@bioheartinc.com
www.bioheartinc.com/
www.otcmarkets.com/stock/BHRT/quote
MANAGEMENT
Mike Tomas
Mike Tomas was appointed as the Company’s President and Chief Executive Officer, and as a director on June 19, 2010. Mr. Tomas has been President for the past nine years of The ASTRI Group, an early stage private equity investment company in Florida with an investment in Bioheart since 2001. In 2003, he joined Bioheart’s board as the independent representative of The ASTRI Group. ASTRI provides capital, business development and strategic marketing support to emerging private companies. Mr. Tomas will continue to serve as President of The ASTRI Group. Previously from 1983 to 2001, Mr. Tomas held ascending executive positions including Chief Marketing Officer at Avantel, a $1 billion dollar joint venture with MCI. Upon retiring from MCI and WorldCom, Tomas joined other ex-MCI executives and helped raise $40M in venture capital to form Ineto, an integrated customer communications software solution that was successfully sold in 2001. Today Mr. Tomas sits on the boards of Perimeter Internetworking (SaaS providing secure transfer of information for medical and financial institutions), Avisena (revenue cycle management for medical practices) and Total Home Health (Medicare-certified home care provider). Mr. Tomas is also the current chairman of the Global Entrepreneurship Center at Florida International University and a founding coach/mentor at the University of Miami’s Launch Pad at the Toppel Center. Mr. Tomas holds a Masters of Business Administration from the University of Miami and a Bachelors degree from Florida International University.
Howard J. Leonhardt
Mr. Leonhardt was appointed as a member of our Board of Directors on June 20, 2010. Mr. Leonhardt had served as our Chairman of the Board and Chief Executive Officer since the Company’s incorporation in August 1999, until March 2007. He resumed his position as Chief Executive Officer in July 2008 and served until August 2009. He has served as the company’s Chief Technology Officer since March 2007. Mr. Leonhardt also served as the company’s Executive Chairman from March 2007 until March 2008. In 1986, Mr. Leonhardt founded World Medical Manufacturing Corporation, or World Medical, and served as its Chief Executive Officer from 1986 until December 1998 when World Medical was acquired by Arterial Vascular Engineering, Inc., or AVE. AVE was acquired by Medtronic, Inc. in January 1999. Mr. Leonhardt was the co-inventor of World Medical’s primary product, the TALENT (Taheri-Leonhardt) stent graft system. From December 1998 until June 1999, Mr. Leonhardt served as President of World Medical Manufacturing Corporation, a subsidiary of Medtronic. Scientific articles written by Mr. Leonhardt have been published in a number of publications including Techniques in Vascular and Endovascular Surgery and the Journal of Cardiovascular Surgery. Mr. Leonhardt received a diploma in International Trade from the Anoka-Hennepin Technical College, attended the University of Minnesota and Anoka-Ramsey Community College and holds an honorary Doctorate Degree in Biomedical Engineering from the University of Northern California.
Catherine Sulawske-Guck
Ms. Sulawske-Guck was appointed Chief Operating Officer in July 2010. From January 2007 to June 2010, Ms. Sulawske-Guck served as our Vice President of Administration and Human Resources. Ms. Sulawske-Guck joined Bioheart in the full-time capacity as Director of Administration and Human Resources in January 2004 after having served us in a consulting capacity since December 2001. Prior to joining Bioheart, from May 1989 until November 2001, Ms. Sulawske-Guck served as Director of Operations and Customer Service for World Medical Manufacturing Corporation, a subsidiary of Medtronic.
Kristin Comella
Ms. Comella has over 12 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development, and senior management. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer. Ms. Comella was appointed as Bioheart’s Vice President of R&D and Corporate Development in December 2008. Since joining Bioheart in September 2004, she has played a major role in managing the product development, manufacturing and quality systems. In addition, Ms. Comella is currently and actively serving on multiple boards in the stem cell arena. Ms. Comella has over ten years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
Angel Rodriguez
Mr. Rodriguez joined Bioheart in April 2006 as our Controller. Mr. Rodriguez has 36 years of experience in the controllership function and business management, with more than 10 years experience as Controller of a Public Company. Prior to joining Bioheart Mr. Rodriguez held positions with Bradford Healthcare, Inc., Equinox Systems, Inc. and Fidelity National Leasing Corporation. Mr. Rodriguez has a B.A. in Accounting from the University of Puerto Rico.
Board of Directors
William P. Murphy, Jr., M.D.
Mark P. Borman
Bruce C. Carson
Charles Hart
Howard J. Leonhardt
Richard T. Spencer, III
Mike Tomas
Samuel S. Ahn, M.D., MBA
Bioheart’s lead product candidate is MyoCell®, a muscle stem cell therapy that is intended 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 from the patient's thigh. From this muscle specimen, muscle stem cells (also called myoblasts) are then isolated, expanded using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The cells are delivered by an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The muscle stem cells populate the regions of scar tissue and are intended to improve cardiac function by helping the heart muscle beat more efficiently. MyoCell is currently being investigated in a clinical trial called the MARVEL Trial, which is a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 160 patients in North America, and 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™ injection catheter, in combination with the NOGA® XP Cardiac Navigation System.
In addition to MyoCell, we have multiple cell therapies and related devices for the treatment of chronic and acute heart damage in various stages of development. We have also acquired the rights to use certain devices for the treatment of heart damage. We intend to allocate our capital, material and personnel resources among MyoCell and the other product candidates described below, a number of which may have complementary therapeutic applications. For each product candidate, we have developed or are in the process of developing a regulatory approval plan. Assuming such proposed plans are able to be followed, we do not anticipate that the regulatory approval of MyoCell will be necessary for our further development of our other product candidates.
Myocell®
MyoCell and MyoCell SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Myocell SDF1
MyoCell and MyoCell SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Myocath
MyoCath – minimally invasive needle catheter
Bioheart Patent Information
Patent
Subject Matter
Related
Product(s)
Expiration Date Assuming No Patent Extension
US5,130,141 Compositions for and methods of treating muscle degeneration and weakness MyoCell; MyoCell
SDF-1
July 14, 2009
US5,972,013 Direct Pericardial Access Device with Deflecting Mechanism and Method MyoCath;
MyoCathII Sep. 19, 2017
US6,241,710 Hypodermic Needle with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019
US6,547,769 Catheter Apparatus with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019
US6,855,132 Apparatus with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019 (with 101 day adjustment: Mar. 30, 2020)
US6,949,087 Apparatus with Weeping Tip and Method of Us MyoCath II Dec. 20, 2019
We own or hold licenses or hold sublicenses to an intellectual property portfolio consisting of approximately 19 patents and 19 patent applications in the United States, and approximately twelve patents and 57 patent applications in foreign countries, for use in the field of heart muscle regeneration. Our intellectual property strategy emphasizes method, product and device patents. We rely primarily on one U.S. patent for MyoCell, or the Primary MyoCell Patent, one U.S. patent for MyoCath, or the Primary MyoCath Patent and a number of patents for MyoCath II. We rely on three pending U.S. patent applications and corresponding foreign patent applications for MyoCell SDF-1 and three U.S. patents for BioPace. For most of our other product candidates, we rely on one primary patent, multiple patents in combination and/or proprietary processes. The following provides a description of our key patents and pending applications and is not intended to represent an assessment of claims, limitations or scope.
Clinical Trials Conducted for US FDA Approval
The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with advanced heart failure after receiving injection of adult muscle stem cell therapy in their damaged heart muscle. We have been cleared by the U.S. Food and Drug Administration (the “FDA”) to proceed with a multicenter Phase II/III trial of MyoCell® in North America and Europe (the “MARVEL Trial”). The MARVEL Study is partitioned into two stages: MARVEL Part 1 and MARVEL Part 2. MARVEL Part 1 is complete and the data on the first 20 patients was analyzed and presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Boston, Massachusetts. The data displayed overall positive clinical results.
If the results of the MARVEL Clinical Program demonstrate statistically significant evidence of the safety and efficacy of MyoCell, we anticipate having a basis to ask the FDA to consider the MARVEL Trial a pivotal trial.
If the REGEN Trial exhibits the same level of increased efficacy vs. MyoCell alone in humans as was seen in animals, consideration will be given to including MyoCell with SDF-1 in the MARVEL trial, which is currently on hold pending the REGEN Trial.
The SEISMIC (European), MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue from the sale of MyoCell cell-culturing services for treatment of patients by interventional cardiologists.
www.bioheartinc.com/clinicalprograms.html
www.bioheartinc.com/videos.html
About Bioheart, Inc.
Bioheart 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
CONTACT
Bioheart, Inc.
13794 NW 4th Street, Suite 212
Sunrise, Florida 33325
Telephone: (954)-835-1500
Fax: (954)-845-9976
bioheart@bioheartinc.com
www.bioheartinc.com/
www.otcmarkets.com/stock/BHRT/quote
MANAGEMENT
Mike Tomas
Mike Tomas was appointed as the Company’s President and Chief Executive Officer, and as a director on June 19, 2010. Mr. Tomas has been President for the past nine years of The ASTRI Group, an early stage private equity investment company in Florida with an investment in Bioheart since 2001. In 2003, he joined Bioheart’s board as the independent representative of The ASTRI Group. ASTRI provides capital, business development and strategic marketing support to emerging private companies. Mr. Tomas will continue to serve as President of The ASTRI Group. Previously from 1983 to 2001, Mr. Tomas held ascending executive positions including Chief Marketing Officer at Avantel, a $1 billion dollar joint venture with MCI. Upon retiring from MCI and WorldCom, Tomas joined other ex-MCI executives and helped raise $40M in venture capital to form Ineto, an integrated customer communications software solution that was successfully sold in 2001. Today Mr. Tomas sits on the boards of Perimeter Internetworking (SaaS providing secure transfer of information for medical and financial institutions), Avisena (revenue cycle management for medical practices) and Total Home Health (Medicare-certified home care provider). Mr. Tomas is also the current chairman of the Global Entrepreneurship Center at Florida International University and a founding coach/mentor at the University of Miami’s Launch Pad at the Toppel Center. Mr. Tomas holds a Masters of Business Administration from the University of Miami and a Bachelors degree from Florida International University.
Howard J. Leonhardt
Mr. Leonhardt was appointed as a member of our Board of Directors on June 20, 2010. Mr. Leonhardt had served as our Chairman of the Board and Chief Executive Officer since the Company’s incorporation in August 1999, until March 2007. He resumed his position as Chief Executive Officer in July 2008 and served until August 2009. He has served as the company’s Chief Technology Officer since March 2007. Mr. Leonhardt also served as the company’s Executive Chairman from March 2007 until March 2008. In 1986, Mr. Leonhardt founded World Medical Manufacturing Corporation, or World Medical, and served as its Chief Executive Officer from 1986 until December 1998 when World Medical was acquired by Arterial Vascular Engineering, Inc., or AVE. AVE was acquired by Medtronic, Inc. in January 1999. Mr. Leonhardt was the co-inventor of World Medical’s primary product, the TALENT (Taheri-Leonhardt) stent graft system. From December 1998 until June 1999, Mr. Leonhardt served as President of World Medical Manufacturing Corporation, a subsidiary of Medtronic. Scientific articles written by Mr. Leonhardt have been published in a number of publications including Techniques in Vascular and Endovascular Surgery and the Journal of Cardiovascular Surgery. Mr. Leonhardt received a diploma in International Trade from the Anoka-Hennepin Technical College, attended the University of Minnesota and Anoka-Ramsey Community College and holds an honorary Doctorate Degree in Biomedical Engineering from the University of Northern California.
Catherine Sulawske-Guck
Ms. Sulawske-Guck was appointed Chief Operating Officer in July 2010. From January 2007 to June 2010, Ms. Sulawske-Guck served as our Vice President of Administration and Human Resources. Ms. Sulawske-Guck joined Bioheart in the full-time capacity as Director of Administration and Human Resources in January 2004 after having served us in a consulting capacity since December 2001. Prior to joining Bioheart, from May 1989 until November 2001, Ms. Sulawske-Guck served as Director of Operations and Customer Service for World Medical Manufacturing Corporation, a subsidiary of Medtronic.
Kristin Comella
Ms. Comella has over 12 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development, and senior management. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer. Ms. Comella was appointed as Bioheart’s Vice President of R&D and Corporate Development in December 2008. Since joining Bioheart in September 2004, she has played a major role in managing the product development, manufacturing and quality systems. In addition, Ms. Comella is currently and actively serving on multiple boards in the stem cell arena. Ms. Comella has over ten years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
Angel Rodriguez
Mr. Rodriguez joined Bioheart in April 2006 as our Controller. Mr. Rodriguez has 36 years of experience in the controllership function and business management, with more than 10 years experience as Controller of a Public Company. Prior to joining Bioheart Mr. Rodriguez held positions with Bradford Healthcare, Inc., Equinox Systems, Inc. and Fidelity National Leasing Corporation. Mr. Rodriguez has a B.A. in Accounting from the University of Puerto Rico.
Board of Directors
William P. Murphy, Jr., M.D.
Mark P. Borman
Bruce C. Carson
Charles Hart
Howard J. Leonhardt
Richard T. Spencer, III
Mike Tomas
Samuel S. Ahn, M.D., MBA
Bioheart’s lead product candidate is MyoCell®, a muscle stem cell therapy that is intended 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 from the patient's thigh. From this muscle specimen, muscle stem cells (also called myoblasts) are then isolated, expanded using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The cells are delivered by an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The muscle stem cells populate the regions of scar tissue and are intended to improve cardiac function by helping the heart muscle beat more efficiently. MyoCell is currently being investigated in a clinical trial called the MARVEL Trial, which is a randomized, double-blind, placebo-controlled, multi-center Phase II/III Trial involving 160 patients in North America, and 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™ injection catheter, in combination with the NOGA® XP Cardiac Navigation System.
In addition to MyoCell, we have multiple cell therapies and related devices for the treatment of chronic and acute heart damage in various stages of development. We have also acquired the rights to use certain devices for the treatment of heart damage. We intend to allocate our capital, material and personnel resources among MyoCell and the other product candidates described below, a number of which may have complementary therapeutic applications. For each product candidate, we have developed or are in the process of developing a regulatory approval plan. Assuming such proposed plans are able to be followed, we do not anticipate that the regulatory approval of MyoCell will be necessary for our further development of our other product candidates.
Myocell®
MyoCell and MyoCell SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Myocell SDF1
MyoCell and MyoCell SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Myocath
MyoCath – minimally invasive needle catheter
Bioheart Patent Information
Patent
Subject Matter
Related
Product(s)
Expiration Date Assuming No Patent Extension
US5,130,141 Compositions for and methods of treating muscle degeneration and weakness MyoCell; MyoCell
SDF-1
July 14, 2009
US5,972,013 Direct Pericardial Access Device with Deflecting Mechanism and Method MyoCath;
MyoCathII Sep. 19, 2017
US6,241,710 Hypodermic Needle with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019
US6,547,769 Catheter Apparatus with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019
US6,855,132 Apparatus with Weeping Tip and Method of Use MyoCath II Dec. 20, 2019 (with 101 day adjustment: Mar. 30, 2020)
US6,949,087 Apparatus with Weeping Tip and Method of Us MyoCath II Dec. 20, 2019
We own or hold licenses or hold sublicenses to an intellectual property portfolio consisting of approximately 19 patents and 19 patent applications in the United States, and approximately twelve patents and 57 patent applications in foreign countries, for use in the field of heart muscle regeneration. Our intellectual property strategy emphasizes method, product and device patents. We rely primarily on one U.S. patent for MyoCell, or the Primary MyoCell Patent, one U.S. patent for MyoCath, or the Primary MyoCath Patent and a number of patents for MyoCath II. We rely on three pending U.S. patent applications and corresponding foreign patent applications for MyoCell SDF-1 and three U.S. patents for BioPace. For most of our other product candidates, we rely on one primary patent, multiple patents in combination and/or proprietary processes. The following provides a description of our key patents and pending applications and is not intended to represent an assessment of claims, limitations or scope.
Clinical Trials Conducted for US FDA Approval
The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with advanced heart failure after receiving injection of adult muscle stem cell therapy in their damaged heart muscle. We have been cleared by the U.S. Food and Drug Administration (the “FDA”) to proceed with a multicenter Phase II/III trial of MyoCell® in North America and Europe (the “MARVEL Trial”). The MARVEL Study is partitioned into two stages: MARVEL Part 1 and MARVEL Part 2. MARVEL Part 1 is complete and the data on the first 20 patients was analyzed and presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Boston, Massachusetts. The data displayed overall positive clinical results.
If the results of the MARVEL Clinical Program demonstrate statistically significant evidence of the safety and efficacy of MyoCell, we anticipate having a basis to ask the FDA to consider the MARVEL Trial a pivotal trial.
If the REGEN Trial exhibits the same level of increased efficacy vs. MyoCell alone in humans as was seen in animals, consideration will be given to including MyoCell with SDF-1 in the MARVEL trial, which is currently on hold pending the REGEN Trial.
The SEISMIC (European), MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue from the sale of MyoCell cell-culturing services for treatment of patients by interventional cardiologists.
www.bioheartinc.com/clinicalprograms.html
www.bioheartinc.com/videos.html