The key milestone in HeartWare’s US regulatory activities is the application to the United States Food and Drug Administration (“FDA”) for an Investigational Device Exemption (“IDE”), to allow use of HeartWare’s HVADTM device in a US clinical trial.
HeartWare expects to file its IDE with the FDA in October. The FDA will ordinarily ask questions after the first submission and we anticipate there will be a round of questions prior to the granting of the IDE. We expect to gain approval from the FDA to commence our US clinical trial in late 2007 or, more likely, early 2008.
We expect to begin our US trial with the participation of five leading US cardiac transplant centres. Discussions with these centres are well advanced.
We will provide further detail regarding our US study and the participating hospitals once we have made our IDE submission in October.
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