Press Release:
Highway 12 Ventures Leads $10.3M Series D Financing of SynCardia,
Manufacturer of World’s Only FDA-Approved Total Artificial Heart
Capital Will Help Fund Two New Driver Systems to Quadruple Patient Implant and Discharge Capacity
The Freedom™ driver is designed to allow stable Total Artificial Heart patients to enjoy life at home and in their community while they wait for a matching donor heart.
TUCSON, Ariz. – June 24, 2009 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, today announced that it has raised $10.3 million in its Series D round of funding. Highway 12 Ventures led this round of financing.
“My partners and I believe that, with the release of the Freedom™ driver, SynCardia can dramatically improve the quality of life for tens of thousands of people worldwide who are suffering from biventricular heart failure,” said Mark Solon, Managing Partner of Highway 12 Ventures, who has joined SynCardia’s board of directors.
Proceeds from the financing 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.
The Companion Driver System is designed to support Artificial Heart patients from hospital implant until their condition stabilizes.
“For the first time in U.S. history, stable Total Artificial Heart patients will be able to enjoy life at home and in their community while they wait for a matching donor heart, thanks to the 12-lb Freedom discharge driver,” said Rodger Ford, President and CEO of SynCardia.
This summer, SynCardia 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.
This summer, 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.
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About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people 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.
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News
Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660
