Bioheart Inc.

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Description

We are a biotechnology company focused on the discovery, development and commercialization of therapies using cells derived from a patient's body, and related devices, for the treatment of heart damage. Our lead product candidate is MyoCell, an innovative clinical therapy designed to populate regions of scar tissue within a patient's heart with living muscle tissue for the purpose of improving cardiac function. The core technology used in MyoCell has been the subject of human clinical trials conducted over the last seven years and animal studies conducted over the last 18 years. Our clinical trials of MyoCell include the SEISMIC Trial, a fully enrolled 46 patient Phase II clinical trial in various countries in Europe, the MYOHEART Trial, a completed 20 patient Phase I dose escalation trial in the United States and other earlier European clinical trials which included a total of 23 patients. Interim results of the SEISMIC Trial were recently announced and we have submitted to the FDA the protocol for a 450 patient, multicenter Phase II trial of MyoCell in the United States, or the MYOHEART II Trial. We have designed the MYOHEART II Trial so that upon approval of the protocol, if any, we anticipate asking the FDA to consider it a pivotal trial. The SEISMIC Trial and the MYOHEART II Trial have been designed to test the safety and efficacy of MyoCell in treating severe non-acute damage to the heart in patients in Class II or Class III heart failure according to the New York Heart Association, or NYHA, heart failure classification system.

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