Heart health tech company BiVACOR and The Texas Heart Institute announced that they successfully implanted the company's first Total Artificial Heart in a human at Baylor St. Luke’s Medical Center in the TMC.

The milestone is part of an FDA-approved early feasibility study that will test the safety and performance of the TAH device, which is based on a magnetically levitated rotor that takes over functions of a failing heart while a patient is awaiting a heart transplant, according to a statement from the organizations.

The "bridge-to-transplant" device could support an active adult male, as well as many women and children suffering from severe biventricular heart failure or univentricular heart failure.

"With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” Dr. Joseph Rogers, president and CEO of THI and national principal investigator on the research, says in a statement. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”

BiVACOR received approval from the FDA for the early feasibility study in late 2023 and has four other patients enrolled in the study. At the time the study was approved, 10 hospitals were enrolled as possible sites.

“I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute ... our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial,” Daniel Timms, PhD, founder and CTO of BiVACOR, adds.

About 100,000 patients suffering from severe heart failure could benefit from BiVACOR’s artificial heart, the company says. Globally, only about 6,000 heart transplants are performed each year, while 26 million people worldwide are affected by heart failure.

BiVACOR was founded in 2008 and maintains its headquarters in Houston, along with offices in Huntington Beach, California, and Brisbane, Australia.

To date, the company has raised nearly $50.8 million, according to CB Insights. The company raised $18 million in 2023, and $22 million in 2021.

Earlier this year, BiVACOR named a new CEO in Jim Dillon, a longtime executive in the medical device sector.

Last summer, Rogers joined the Houston Innovators Podcast to share his excitement with THI's innovations.