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The TGI 1200 Cell Isolation system is a CE marked, compact, fully automated cell isolation system for the rapid processing of patient-derived adipose (fat) tissue to separate, isolate and produce large yields of endothelial progenitor cell, mesenchymal stem cells and other regenerative stem cells. The fat tissue is extracted from the patient using a minor liposuction-like procedure and processed using the TGI 1200. The TGI 1200 System produces the regenerative stem cells in about one hour.
Bioheart is developing a cellular therapy for the treatment of acute myocardial infarction (heart attack), composed of cells isolated from a patient’s own fat tissue utilizing the TGI 1200 Cell Isolation System. Unlike MyoCell, which is intended to be used to treat severe heart damage months or even years after a heart attack, Bioheart’s Acute Cell Therapy is being designed to be used for the treatment of muscle and blood vessel damage immediately following a heart attack. We hope to demonstrate that the injection of endothelial progenitor, mesenchymal stem cells and other regenerative stem cells derived from fat tissue by the TGI 1200 Cell Isolation System is a safe and effective means of limiting or reversing some of the effects of a heart attack and preventing or slowing a patient's progression heart failure. Fat tissue is an abundant and readily available source of regenerative stem cells and is easily extractable from a patient using minimally invasive techniques. If approved, we intend to market Bioheart’s Acute Cell Therapy primarily to interventional cardiologists.
In addition, the TGI 1200 Cell Isolation System can be utilized in a variety of other indications including lower limb ischemia and chronic heart ischemia. The adipose derived stem cells can help develop new blood vessels and assist with the blood flow to ischemic tissue.
Bioheart is currently marketing these systems outside the US in countries recognizing the CE Mark approval.
Candidate |
Proposed Use or Indication |
Status/Phase |
||
|---|---|---|---|---|
| TGI 1200 Cell Isolation System Acute Cell Therapy |
Fully automated instrument for the rapid processing of patient derived fat tissue to isolate regenerative stem cells. Autologous cell therapy for the treatment of acute myocardial infarction (heart attack) to limit heart damage and increase blood flow. Also utilized to increase blood flow to the lower limbs of patients suffering from peripheral vascular disease. |
CE Mark Heart Attack: Preclinical; Peripheral Vascular Disease: Clinical |