Artificial heart maker SynCardia beamed up by newcomer Picard Medical in VC-engineered deal

The ownership of SynCardia Systems, the sole manufacturer of the only FDA-approved total artificial heart, has changed hands—to a newcomer seemingly purpose-built for the effort.

Hunniwell Lake Ventures has formed the portfolio company Picard Medical, which announced that it has acquired SynCardia and its assets for an undisclosed amount.

Picard Medical takes its inspiration from the eponymous captain of the starship Enterprise, who—after being stabbed through the chest in a bar fight during his more rambunctious years—is known to carry an artificial heart of his own. (See “Tapestry”; season 6, episode 15.)

While little is known about Picard—its website says only “Coming Soon”—it has laid out plans to boldly go to larger international markets with SynCardia’s device, which has seen its share of troubles over the years.

SynCardia’s pump implant was designed to be a bridge to an eventual transplant, and it was based on the original line of Jarvik artificial hearts, which took decades to develop. The device—which totally replaces the two ventricles of a failing heart until a donor organ is available—relies on an external pneumatic driver and battery pack to power two pumps that circulate blood through the lungs and out to the rest of the body. 

First approved by the FDA in 2004, the SynCardia system has since been used in more than 2,000 people, the company said. 

RELATED: FDA warns of stroke, death risks linked to SynCardia artificial heart pump

But in 2015, the FDA warned transplant surgeons that SynCardia's portable, external driver model could fail suddenly, requiring the system to be quickly switched to a backup. Shortly before that, the FDA noted that researchers had found a higher rate of death and strokes with the company’s updated Companion 2 in-hospital driver hardware.

SynCardia filed for Chapter 11 bankruptcy in July 2016, after scuttling plans for an IPO the previous year. It was later purchased by Versa Capital Management—which, in addition to Hunniwell, is also listed as an investor in Picard Medical.

"We believe that with greater adoption of the [total artificial heart], fewer people will needlessly die because they lack access to human donor heart transplants," said Richard Fang, managing partner and founder of Hunniwell, and CEO of Picard Medical.

"To up the game, we are investing in next-generation technologies to address ever-broadening clinical needs, and make both the [total artificial heart] and drivers more user-friendly and accessible to a larger and growing number of patients globally," said Fang, who previously served as CEO of Reach Surgical, an instrument manufacturer based in Tianjin, China with offices in Shanghai and the U.S. 

RELATED: Bivacor lands $22M to begin human trials of its magnetic artificial heart

Picard Medical’s plan also includes seeking out new expanded uses for SynCardia’s mechanical heart, which has been studied as a destination therapy for patients with heart failure. Compared to the tens of millions of people facing late-stage cardiovascular disease, only about 5,000 heart transplants are performed worldwide annually, the company said, illustrating the need for organ-replacement technologies.

SynCardia’s device—available in different sizes for men, women and children—has also received a CE Mark in Europe, as well as approvals from Health Canada and other national authorities.