SynCardia, which makes the world's first and only total artificial heart for patients awaiting a transplant, expects to use part of the money to support the launch a smaller version of the approved device.
|SynCardia's Total Artificial Heart|
The maker of the world’s first and only approved total artificial heart announced Tuesday that it has raised $14 million.
SynCardia will use the money to support the launch of a smaller, 50cc version of the 70cc approved device as well as expand the availability of the 13.5-pound wearable Freedom driver, which powers the SynCardia Heart. The driver is approved in Canada and Europe. In a news release announcing the funding, the company said that FDA expects to approve the PMA supplement related to the driver once it gets more information.
“In 2013 we are setting another record for SynCardia Heart implants, nearly double what was then our 2011 record-breaking year of 81 implants," said Michael Garippa, President and CEO of SynCardia, in the news release. "As of Dec. 16, 155 SynCardia Total Artificial Hearts have been implanted this year."
“We are pleased to support SynCardia's continued clinical and commercial successes,” says Laurent Hermouet, a partner at Athyrium, in an announcement. "This latest financing will help reinforce SynCardia's supply chain and manufacturing capabilities ahead of new product launches and increased production levels."
The smaller version of the artificial heart - the 50cc one - is aimed at women and pediatric patients.
SynCardia’s Total Artificial Heart is able to provide immediate, safe blood flow of up to 9.5 liters per minute through each ventricle of the heart. This enable faster recovery of vital organs for patients, ultimately making them better candidates for heart transplant, according to the company. As of Tuesday, there have 1,262 implants of the SynCardia Total Artificial Heart worldwide.
|Interested in how funding and device development been affected by the Affordable Care Act? Register for the MD&M Executive Summit Feb.10-11, Anaheim Marriott.|