Our principal objective is to become a leading company that discovers, develops and commercializes novel, autologous cell therapies and related devices, for the treatment of chronic and acute heart damage. more...
MyoCell® & Myocell® II
MyoCell and MyoCell II w/SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
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TGI 1200
Bioheart TGI-1200 Adipose Tissue Processing System - Used to treat heart ischemia, Acute MI heart tissue preservation, lower limb ischemia & diabetic foot ulcers. More Info >
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 330 patients in North America and Europe, 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 II w/SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Bioheart 3370®
Bioheart 3370 Heart Failure Monitoring Systems – CE Mark and U.S. FDA 510K approved for sale. Competes head to head with Alere Medical and Cardiocom whom will have nearly $200 million in sales this year.
Read More About Bioheart 3370®
Myocath/Myocath II
MyoCath – minimally invasive needle catheter
TGI 1200
Bioheart TGI-1200 Adipose Tissue Processing System - Used to treat heart ischemia, Acute MI heart tissue preservation, lower limb ischemia & diabetic foot ulcers. CE Mark approved.
Myocell SDF1
MyoCell and MyoCell II w/SDF-1 and other related myoblast therapy clinical and pre-clinical studies for treating advanced heart failure in post MI patients.
Biopace
Cell-therapy treatment for chronic abnormal heart rhythm due to electrical disturbances in the upper chambers of the heart.
Allocell
Cell-therapy treatment for chronic heart damage using myoblasts obtained from third person donors, or allogenic myoblasts.
T-PLS
Bioheart AnC Bio TPLS Twin True Pulsatile Percutaneous Life Support System – Blood/heart pump, oxygenator, cooling system for cardiac surgery, Acute MI heart tissue preservation, stroke brain tissue preservation, lower limb ischemia, diabetic foot ulcers. Competes head to head with Impella and Abiomed. CE Mark approved for sale. 510K U.S. approval 2009.
SVAD
Bioheart BHK SVAD and LVAD – Left Ventricle Assist Devices. SVAD has external battery and actuator and is lowest priced LVAD in the world by long margin. Pump itself matches Thoratec HeartMate II. CE Mark and FDA approval pending. Combination studies with cells to be initiated shortly.
Cardiobelt™ ECG
Bioheart CardioBelt ECG Acquisition System is easy to use and provides the accuracy and reliability that physicians have come to expect from high-end devices. FDA 510K approved.
Read More About Cardiobelt ECG
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 |
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| US5,972,013 | Direct Pericardial Access Device with Deflecting Mechanism and Method | MyoCath; MyoCath II | 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.
Patent Application |
Subject Matter |
Related Product(s) |
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|---|---|---|---|---|
| WO 04/056186 (US03/34411) (PCT) | Cell-Based Vascular Endothelial Growth Factor Delivery. | MyoCell SDF-1 |
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| US2004/0037811 | Stromal Cell-Derived Factor-1 Mediates Stem Cell Homing and Tissue Regeneration in Ischemic Cardiomyopathy | MyoCell SDF-1 |
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| WO 04/017978 (US03/26013) (PCT) | Stromal Cell-Derived Factor-1 Mediates Stem Cell Homing and Tissue Regeneration in Ischemic Cardiomyopathy | MyoCell SDF-1 |