BiVACOR Submits IPO Prospectus Following FDA Breakthrough Designation for World’s First Titanium Total Artificial Heart

Jun 03, 2025 17:00 CST Updated 17:00

BiVACOR

Preclinical Artificial Heart Device Developer

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Heart Future

Recently,BiVACOR Announced itsWorld's First Titanium Alloy Total Artificial Heart（Total Artificial Heart，TAH) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The device is intended forProvide Long-Term Support for End-Stage Biventricular Heart Failure Patients。

FDAThe Breakthrough Devices Program aims to expedite the development and review of medical devices that may significantly improve the health of patients with life-threatening or irreversibly debilitating diseases, achieved through prioritized regulatory interactions and an accelerated approval pathway. This designation reflectsFDAYesBiVACORRecognition of technical potential, believing it can meet the unmet needs of end-stage heart failure patients.

This milestone was reached inBiVACORSuccessfully CompletedFDAEarly Feasibility Study (Early Feasibility Study, AbbreviationEFS) Achieved after the first phase.

2023Year11Month29Day,BiVACORTheTAHObtainedFDAResearch Device Exemption（IDE, investigational device exemption), the early feasibility study for the first human use can begin.

2024Year7Month，BiVACORTheTAHTheFirst Human Implant SurgerySuccessfully Completed at the Texas Heart Institute in the United States。

In2024Year7To11During the month, there were a total of5Name of the patientImplanted with a total artificial heart. These patients were supported for up to a month while waiting for a donor heart transplant.No strokes or device-related complications were reported.Based on these positive safety and performance data,FDAApproval to expand the trial scale, from2025To be included again starting later this year15Patient.

Heart failure affects more than620Thousands of patients in the U.S. progress to irreversible biventricular heart failure each year. However, the number of available donor hearts remains stagnant, with only about 6,000 heart transplants performed annually in the U.S.Example.BiVACORThis critical gap is being addressed by filling it with a durable artificial alternative, which is designed to provide ultimate long-term support.

BiVACORTheTAHCurrently in the research phase, it has not yet been approved for commercial use.

# Expert and Executive Evaluation

BiVACORChief MedicalCardiothoracic SurgeonWilliam Cohn Believes: "In the past four decades, we have seen various artificial heart technologies, but this is the first one I've encountered."Combine engineering elegance, efficiency, and safety with true clinical feasibilityThe system. The early results are very impressive, with no strokes, no device-related complications, and a safety profile that stands out in the field. With this breakthrough progress, we are moving into the next phase, riding the momentum, and have real motivation to bring it to more patients."

BiVACORFounder and Chief Technology OfficerDaniel Timms "This is not just a regulatory milestone. It is a validation of the concept of a fully implantable total artificial heart that we have proven over decades — not only is it possible, but it is necessary. Patients with biventricular heart failure have been overlooked for too long. Early results from our clinical trials indicate that we can offer these patients a second chance without the limitations of older technologies. The Breakthrough Device Designation puts us on a faster track to achieving this goal."

# Product Introduction

Some of the key manufacturers operating in the total artificial heart market are BiVACOR, CARMAT, SynCardia Systems, ReinHeart TAH GmbH, ABIOMED, Abbott, Cirtec, LivaNova, Jarvik Heart, and CryoLife, among others.

BiVACORTheTAH isThe first implantable total artificial heart based on rotary blood pump technology, which can be used for long-term treatment of severe biventricular heart failure patients (not a true replacement for the human heart).。

Its size is similar to an adult's fist, and its mass is only512g(Slightly heavier than an adult heart), it is small enough to be implanted in many women and some children, and capable of pumping sufficient blood for an exercising adult male.

The biggest innovative design of this product lies inInternal Magnetic Suspension RotorThe design adopts magnetic levitation (MAGLEV) technology, with the rotating disc fully suspended in the magnetic field. Its principle is similar to the magnetic levitation operation mode of maglev trains. It can fine-tune the control of circulation through differential fluid output and dynamically adapt to any changes in the patient's physiological condition. This magnetic levitation technology also reduces friction or mechanical wear of internal components, extending the service life of the device for at least ten years.

BiVACORTheTAH Rotating Disc with Left and Right Impeller BladesPumping more than 12 liters of blood per minute, which can meet the needs of patients who want to engage in moderate exercise.

In addition, itsNon-contact SuspensionProvides a larger gap, thereby minimizing blood cell damage and eliminating mechanical wear.Reduce the risk of thrombosis.

BiVACORTheTAH'sThe manufacturing method is3D Printing, the selected material isTitanium, with excellent biocompatibility.

▲BiVACOR TAH Demonstration

# AboutBiVACOR

BiVACOR Founded in2008Year, headquartered in Huntington Beach, California, is a clinical-stage medical device company developing aFully Implantable Magnetic Levitation Total Artificial Heart, intended to provide long-term support for patients with end-stage biventricular heart failure.

The company was founded by biomedical engineers.Daniel TimmsFounded by a Ph.D., and supported by includingWilliam E. CohnDr. andO.H.（Bud）FrazierSupported by leading experts in cardiovascular medicine, including doctors, the study is being conducted in the United States.FDAApproved Early Feasibility Study.

The company has currently received a total of five funds, with the following details:

2024Year2Month, the company announced that it has received from the Australian government1300Million USD, through the Future Fund for Medical Research provided by BiVACOR (MRFF) Funding Plan (AHFP) SupportBiVACORThe Total Artificial Heart Program and Future Product Enhancements.
March 2, 2023`, Company`Raised $18 million in Series B financing, with investment from OneVentures.
On May 20, 2021, the company announced that it had received a grant of $3 million from the National Institutes of Health (NIH). The company also announced that it had secured an investment of $19 million in its Series B financing round from OneVentures and Cormorant Asset Management.
On May 17, 2018, the company announced that it had received an undisclosed amount of investment from OneVentures.

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