BiVACOR Total Artificial Heart Successfully Implanted in Five Patients as Part of FDA Early Feasibility Study; FDA Greenlights Expansion of the EFS

HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR, a clinical-stage medical device company, announced today, the successful completion of the first phase of the FDA Early Feasibility Study, with five patients receiving the BiVACOR Total Artificial Heart (TAH) between July and November 2024. The study evaluates the safety and performance of the BiVACOR TAH System in patients as a bridge to donor heart transplant.

“The unique design and features of the BiVACOR TAH translated into an unparalleled safety profile without complications or stroke. Now that the first five patients have been implanted, we will continue to work with the FDA to provide the necessary data to expand our EFS study.”

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This study assessed the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular failure. The initial phase of the study supported patients with the BiVACOR TAH System for up to a month while they waited in the hospital for a donor heart to become available. Five patients were successfully implanted with the TAH, received a heart transplant, and were subsequently discharged from the hospital. This milestone has provided the FDA with the required data to greenlight the expansion of EFS to an additional fifteen patients.

“We are thrilled to share that the first patients implanted with the BiVACOR TAH achieved expected milestones utilizing the device as a bridge to heart transplant and experienced no complications,” said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. “This has been decades in the making, and to achieve such success during first-in-human trials is extremely encouraging. We are incredibly grateful to all the patients, their families, and clinical partners involved. Without them, we wouldn’t be able to get the TAH to the people that need it most.”

The BiVACOR TAH represents a paradigm shift in artificial heart design. The size of the BiVACOR TAH is suitable for most men and women. Despite its small size, the BiVACOR TAH is capable of providing enough cardiac output for an adult male undergoing exercise. Using magnetic levitation technology, the same principle used in high-speed trains, the product features a unique pump design with a single moving part: a magnetically suspended dual-sided rotor with left and right vanes positioned within two separate pump chambers, forming a double-sided centrifugal impeller that propels blood from the respective pump chambers to the pulmonary (lung) and systemic (body) circulations. The TAH has no valves or flexing ventricle chambers, but pulsatile outflow is readily achieved by transiently increasing the rotor speed each second. The non-contact suspension of the rotor via MAGLEV is designed to eliminate the potential for mechanical wear and provide large blood gaps that minimize blood trauma, offering a durable, reliable, and biocompatible heart replacement.

“It is incredibly rewarding to see our device provide such efficient support to the first US patients,” said William Cohn, MD, BiVACOR Chief Medical Officer and Heart Surgeon at the Texas Heart Institute. “The unique design and features of the BiVACOR TAH translated into an unparalleled safety profile without complications or stroke. Now that the first five patients have been implanted, we will continue to work with the FDA to provide the necessary data to expand our EFS study.”

The first and last of the five patients were implanted at The Texas Heart Institute (in partnership with St. Luke’s Medical Center and Baylor College of Medicine), with the additional implants also at Duke University Hospital, Banner-University Medical Center Phoenix, and Christ Hospital – Heart and Vascular Center.

The BiVACOR Total Artificial Heart is available for investigational use only and has not been approved for use outside of clinical studies.

About BiVACOR

BiVACOR® is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human EFS. Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. For more information, visit bivacor.com.