The manufacturer of the SynCardia temporary CardioWest(TM) -- SynCardia Systems, Inc. -- has raised $10.3 million in its Series D round of funding led by Highway 12 Ventures.
The financing proceeds will support the launch of two new drivers for powering the Total Artificial Heart. In July, SynCardia anticipates that the Companion Driver System will receive the CE Mark for use in Europe. The Companion Driver is designed to support Artificial Heart patients from hospital implant until their condition stabilizes. Once stable, patients will be transferred to the 12-lb Freedom discharge driver, currently under development.
SynCardia also plans to submit an application to the FDA to conduct an IDE clinical study of the Freedom driver in the U.S. and a Design Dossier to the Notified Body for the CE Mark in Europe.
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SynCardia will submit a Pre-Market Approval supplement to the FDA for use of the Companion Driver in the U.S. In addition to the Total Artificial Heart, the Companion Driver is designed to power SynCardia's future family of pulsatile devices, including the 50cc Total Artificial Heart, 10cc VAD, 30cc VAD and 60cc VAD.
About SynCardia Systems, Inc.
SynCardia Systems, Inc. (www.syncardia.com), based in Tucson, Ariz., is the privately held manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart. Originally designed as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
About Highway 12 Ventures
Highway 12 Ventures is a leading early-stage VC fund investing in high-growth, entrepreneurial companies in the Intermountain West. With over $100 million under management, it is Idaho's largest venture capital firm. Highway 12 Ventures is part of the Village Ventures nationwide network of venture capital funds. For more information, visit www.highway12ventures.com.