|SynCardia raised $19 million to support its Total Artificial Heart.--Courtesy of SynCardia|
Arizona's SynCardia Systems has reeled in another $19 million, money the company will use to develop a next-generation Total Artificial Heart.
Athyrium Opportunities Fund kicked in $15 million of the latest round, with previous investors making up the rest. SynCardia already has FDA approval and a CE mark for the original Total Artificial Heart, and the latest cash will help it launch a portable power supply for the device and develop a smaller version of the tech for pediatric patients, CEO Michael Garippa said.
And SynCardia should speed through the regulatory process with the next-gen Total Artificial Heart: The FDA has designated it a Humanitarian Use Device, putting it on the fast track to approval and giving the company the chance to keep up its quick growth rate.
"In 2012, we generated $25 million in revenue and a record-breaking 125 implants at more than 50 SynCardia Certified Centers worldwide," Garippa said in a statement.
The device is indicated as a bridge to transplant for end-stage heart failure patients, but SynCardia plans to ask for the FDA's blessing to use the smaller version as a destination therapy, which could further expand Total Artificial Heart's sales. So far, the device has been implanted in more than 1,100 patients around the world, the company says.
- read SynCardia's announcement