BiVACOR's maglev titanium heart: first human implant, 105 days, then a donor heart

Clinical-stage medical device company building a titanium total artificial heart, first as a bridge to donor-heart transplant and eventually as a permanent therapy.

That a pulseless heart with one maglev-levitated rotor — no valves, no bearings, no wear — can keep transplant patients alive where every multi-part heart has failed.

A decade on Australian government grants before US backing; part of Australia's A$50M Artificial Heart Frontiers Programme, including a $13M MRFF grant to BiVACOR (Feb 2024); VC rounds incl. OneVentures (2018); a $50–60M Series C planned.

Biomechanics engineer Daniel Timms started designing a maglev artificial heart for his PhD in 2001 after his plumber father Gary developed heart failure; Gary died in 2006, the year Timms' design kept a sheep alive. He spent roughly a decade on grants and charity before Texas Heart Institute surgeons Bud Frazier and Billy Cohn backed the project — THI still holds equity in the company.

FDA approved an early feasibility study (NCT06174103). First implant on 2024-07-09 at Baylor St. Luke's, Houston: a 650-gram titanium pump with no pulse; the patient shed 8.6 kg of fluid and walked. Duke implanted the second (2024-10) and St Vincent's Sydney the third (2024-11-22). The Australian recipient left hospital with the device in February 2025 — the first person ever discharged on it — and received a donor heart in March after 105 days on the pump.

Every prior artificial heart died of wear in flexing diaphragms and valves; levitating the single moving part attacks that failure mode directly instead of hardening against it.

Reframing the clinical requirement — flow over pulse — let the design sidestep a decade of orthodox objection instead of fighting it on its own terms.

Bridge-to-transplant was the right wedge: a defined population, a hard endpoint, and a regulator pathway (early feasibility study) sized to a startup's capital.

First-in-human credibility compounds: the same clinicians who took equity (THI) performed the implants, aligning the institution's incentives with the device's success.

Contrarian engineering wins trials, not debates: Timms stopped arguing whether a pulseless body works and proved flow is what matters. Government grants, not VC, carried the riskiest decade.

As of 2025-05-30, the FDA had reviewed data from the first five implant patients, cleared BiVACOR to expand the feasibility study by 15 more, and granted the device breakthrough designation, which buys priority regulatory interaction. The company is developing a wireless power source so recipients are not tethered to an external controller, and plans a $50–60M Series C to carry the device toward market — with an IPO as the eventual goal, kept private for now to retain control through the rocky clinical road.