An artificial heart maker in Tucson, Ariz., has raised $14 million to go small with its temporary Total Artificial Heart.
Syncardia wants to build a 50cc version of the device.
SWK Holdings Corporation contributed $10 million to this round. SWK is a publicly traded, specialized finance company with a focus on the global healthcare sector.
Athyrium Capital Management LLC contributed $4 million, in addition to a $15 million investment in March. Athyrium invests in several types of financial instruments including royalties, structured credit and equities as well as select special situations.
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The company raised $19 million earlier this year. According to the Phoenix Business Journal, SynCardia has tripled sales, hired 40 people and spent more than $2.5 million to expand its Tucson facilities and acquire new equipment and technology over the last three years.
“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 device replaces both failing ventricles and the four heart valves. Following surgery and recovery, medically stable patients are fitted with the portable driver – a portable power supply for the SynCardia Heart. The Freedom® driver is CE-approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. (the Freedom portable driver is an investigational device, limited by United States law to investigational use.)
Clinical trials of the Freedom driver are finished. The company is waiting to hear from the FDA whether it will be approved to market in the U.S.
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The FDA has approved a Humanitarian Use Device (HUD) designation for the 70 cc Total Artificial Heart to be used for destination therapy, (for older patients or people with noncardiac morbidity that makes them ineligible for organ donation.) The next step is for the FDA to approve a Humanitarian Device Exemption (HUD) application. Once approved, the HDE will allow up to 4,000 patients annually who are transplant-ineligible to receive the Total Artificial Heart.
With additional reporting by Lisa Zembal
