The first successful human artificial heart implant was performed on 61-year-old dentist Dr. Barney Clark back in 1982. Clark lived for 112 days.
The heart that was implanted into Clark three decades ago was a far cry from today’s artificial heart technology. The Total Artificial Heart, the device currently used to replace both failing heart ventricles and the four heart valves in patients suffering from biventricular failure, has since become an indispensable tool in heart transplants.
A team of three professionals is largely responsible for the success of this cutting-edge technology: interventional cardiologist Dr. Marvin Slepian, heart surgeon Dr. Jack Copeland, and biomedical engineer Richard Smith. The trio privatized SynCardia, the company responsible for The Artificial Heart in 2001 after years of regulatory red tape and insufficient funding.
Despite not being profitable until 2011, the company now boasts revenue of over $25 million and has enjoyed a three-year growth rate of more than 400 percent. The Tucson-based company is one of the companies vying for a spot on the 2013 Inc. 5000. As applications arrive, we thought it would be worthwhile to shine a spotlight on some of these fast-growing private companies. (For more information and to apply, go here.)
In the mid 1980s, Copeland, a young surgeon at the University Medical Center in Arizona, was hopeful that the first prototype of the artificial heart would serve as a bridge in successful heart transplants. But in 1990 the FDA closed the company that owned the artificial heart technology. The University Medical Center (now the University of Arizona Medical Center) and nonprofit MedForte Research Foundation agreed to take over the business with Copeland’s help. But UMC was forced to pull its funding only nine years into development.
Determined to keep the technology afloat, Copeland teamed up with Smith, who Copeland had worked with since the mid 80s. The duo approached Slepian, an inventor and serial entrepreneur, for help launching the business. The first task: securing funding from Robert Sarver, owner of the Phoenix Suns.
Getting funding, it turned out, was only half the battle. When CEO Michael Garippa came on board in 2010, SynCardia had no real sales effort in place, no customers in the pipeline, and a limited clinical team. Garippa redirected staff, hired additional employees, and managed field personnel to get The Artificial Heart into more hospitals.
Now, 130 hospitals have purchased the device, up from 30 when Garippa took the reins three years ago. “That growth is proof that hospitals recognize the need for an additional tool in the toolbox,” Garippa says.
SynCardia only sells their artificial heart to specific hospitals--heart transplant centers and cardiac surgery facilities. Garippa says there are 500 customers in the world for The Artificial Heart, and right now they are doing business with 130--a market penetration of more than 25 percent.
Only 75 percent of males and 25 percent of females can use the current device, because it’s too big. A new, smaller version, is working its way through the regulatory process now. Garippa says he expects the device to be fully approved in Europe later this year and in an FDA trial by the third quarter of 2013.