Privately held SynCardia Systems, Inc. announced today that it had raised $14 million to fund the rapid growth of the only approved medical device that eliminates the symptoms and source of end-stage heart failure, the SynCardia temporary Total Artificial Heart. The SynCardia Total Artificial Heart is the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart.
"SWK is very pleased to provide SynCardia this new capital in order to help further the growth of the company's Total Artificial Heart," Brett Pope, CEO of SWK Holdings Corporation, says of its $10-million financing. "We are very gratified to help expand the availability of this lifesaving device." "In 2013 we are setting another record for SynCardia Heart implants, nearly double what was then our 2011 record-breaking year of 81 implants," says Michael Garippa, President and CEO of SynCardia. "As of Dec. 16, 155 SynCardia Total Artificial Hearts have been implanted this year." The financing positively affects the development of the new, smaller 50cc version of the approved 70cc SynCardia Total Artificial Heart, the availability of the Freedom portable driver and the use of SynCardia technology for destination therapy.
"We are pleased to support SynCardia's continued clinical and commercial successes," says Laurent Hermouet, a partner at Athyrium.
"This latest financing will help reinforce SynCardia's supply chain and manufacturing capabilities ahead of new product launches and increased production levels." The $4 million provided by Athyrium Capital Management in last week's funding supplemented $15 million in long-term growth capital it provided to SynCardia in March 2013.
Wedbush PacGrow Life Sciences acted as exclusive placement agent for the offering.
The new financing allows SynCardia to accelerate the development and launch of its 50cc Total Artificial Heart* through an FDA-approved clinical study. Together, the 50cc and 70cc sizes of the Total Artificial Heart will fit almost all women and men, as well as many pediatric patients. With this expanded product line, SynCardia anticipates the tripling of the market size and sales potential for the SynCardia Total Artificial Heart.
The funds also will help the company meet the increasing demand for the Freedom portable drivers. In a letter dated Oct. 21, 2013, the FDA determined that the Freedom PMA supplement is approvable with the submission of additional information. The 13.5-pound wearable Freedom driver, which powers the SynCardia Heart while giving patients nearly unrestricted mobility, is already approved by Health Canada and has a CE Mark for Europe.
SynCardia is an innovative, 85-employee company focused on advanced medical technology targeting the NYHA Class IV heart failure market.
There are 93 SynCardia Certified Centers worldwide where the SynCardia Heart is immediately available with an additional 35 hospitals undergoing the company's four-phase certification program. As of Dec. 16, 2013, there have been 1,262 total implants of the SynCardia Total Artificial Heart worldwide.
*The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.