Cardiogenesis - General FAQ's

1. Why haven´t I heard of TMR? Why isn´t TMR used more frequently?
2. Is TMR approved by the FDA?
3. Is Cardiogenesis publicly traded?
4. What is PMC?
5. Is PMC available for sale in the United States?
6. What hospitals are using Cardiogenesis’ Ho:YAG laser revascularization systems?
7. What hospitals are currently involved in the PEARL trial?
8. Are there other companies that can perform minimally invasive TMR?

Answers

General Questions

1. Why haven´t I heard of TMR? Why isn´t TMR used more frequently?

A: Until recently, there was no data from randomized clinical trials showing the long term benefit of TMR therapy for severe angina. In late 2004, Keith Allen published two seminal papers showing quality of life and mortality benefits (see Clinical Benefits ) for patients with sever angina treated with TMR or TMR with bypass surgery.

Armed with this compelling data, Cardiogenesis is working hard to bring the proven benefits of complete revascularization to hospitals and physicians across the country.
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2. Is TMR approved by the FDA?

A: The Cardiogenesis Ho:YAG system and Sologrip III are currently approved for use in patients with severe angina who are refractory to medical therapy and who are not candidates for other forms of revascularization.  A post-market surveillance study is currently underway to continue to track the results of TMR laser therapy.
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3. Is Cardiogenesis publicly traded?

A: Yes.  Its ticker symbol is CGCP.PK.  For more information refer to the Investors section.
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4. What is PMC?

A: PMC is an acronym for Percutaneous Myocardial Channeling – the interventional equivalent of TMR. Sometimes PMC is will be interchanged with PMR (for Percutaneous Myocardial Revascularization) or PMLR (for Percutaneous Myocardial Laser Revascularization). Whatever it’s called, PMC uses endovascular techniques to treat ischemic areas of the myocardium with the aim of reducing angina pain.
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5. Is PMC available for sale in the United States?

A: Not at this time.  PMC is currently an investigational device not available for sale in the US.  PMC is available for sale outside the US under an approved CE mark in Europe.
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6. What hospitals are using Cardiogenesis’ Ho:YAG laser revascularization systems?

A: There are over 300 hospitals across the US currently utilizing Ho:YAG laser systems to treat patients with severe angina.  To find a hospital near you, use the Hospital & Physician Locator (a new window will open).
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7. What hospitals are currently involved in the PEARL Trial?

A: There are two arms to the PEARL (Port Enabled Angina Relief with Laser) Trial with unique hospitals are principle investigators.  A listing of the Trial sites is as follows.  For more information on the PEARL Trial for minimally invasive surgical TMR please visit our Therapy Delivery System pages.

8. Are there other companies that can offer minimally invasive myocardial revascularization?

A: No.  Cardiogenesis’ Ho:YAG laser systems are the only laser therapy systems to offer both minimally invasive TMR * and interventional * PMC for myocardial revascularization.

* CAUTION: Investigational Device.  Limited by Federal Law to Investigational Use.
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