|SynCardia raised $14 million to support its Total Artificial Heart.--Courtesy of SynCardia|
SynCardia Systems in Arizona is doubling down on efforts to develop a smaller, next-generation version of its artificial heart for children and smaller adults, and it also wants to expand the use of its existing implant on both sides of the Atlantic. A $14 million funding infusion will help make this happen.
SWK of Dallas contributed the bulk of the financing, with the difference coming from Athyrium Capital Management's Athyrium Opportunities Fund.
SynCardia already has Health Canada, CE mark and FDA approval for its Total Artificial Heart. But it is trying to win PMA approval in the U.S. of its Freedom portable driver, a wearable device designed to give patients much more mobility that's already approved in Canada and Europe. Execs are also trying to gain expanded approval of the implant as a destination therapy and not just a bridge to transplant.
New funding will help support that process, but the bulk of the cash will back a clinical study for its 50-cc Total Artificial Heart, a smaller device designed to help fit eligible pediatric patients, plus smaller adults. This device has Humanitarian Use Device designation in the U.S., which grants it limited use as a destination therapy and a bridge to transplant in adults with end-stage heart failure as well as pediatric patients, the company said. It needs the FDA's Investigational Device Exemption approval to begin a formal study for each indication.
In March, SynCardia reeled in $19 million in financing toward development of its next-generation device.
SynCardia President and CEO Michael Garippa said in a statement that SynCardia had been involved with 155 Total Artificial Heart implants as of Dec. 16, 2013, setting it on track to break its 2011 record of 81 implants.
Records aside, SynCardia does face some looming competition, including U.S. startup Cleveland Heart and Carmat, a French device company hoping to complete artificial heart trials in 2014. Abiomed ($ABMD) has its own artificial heart, but these days the company is better known for devices designed to aid ailing hearts.
- read the release