BiVACOR's Total Artificial Heart Secures FDA IDE Approval for First-in-Human Trial

Nov 30, 2023 21:10 CST Updated 21:10

BiVACOR

Preclinical Artificial Heart Device Developer

Source of the article:Heart NotCome;Editor:Liu Xinyi

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Heart Future

On November 29, 2023, BiVACOR, Inc., a total artificial heart (TAH) research and development company, announced that the company has developedThe BiVACOR Total Artificial Heart (BTAH) has received FDA's Investigational Device Exemption (IDE), allowing the initiation of the first-in-human early feasibility study.

BTAH

# About Investigational Device Exemption (IDE)

Investigational Device Exemption is the FDA'sPreferential Regulatory Measures for Medical Devices Used Solely in Clinical TrialsThe main purpose is to allow medical devices in the research stage to be exempt from various regulations imposed on devices intended for market sale, enabling manufacturers of investigational devices to collect information on device safety and efficacy through clinical trials in a relatively simple manner, thereby providing data support for the device’s subsequent 510(k) or PMA application to the FDA.

# About BTAH (BiVACORTotal Artificial Heart (TAH)

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.

BTAH Total Artificial Heart 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).The size of BTAH is similar to an adult's fist, weighing only 512 grams (slightly heavier than an adult heart), with a small enough volume to be implanted in many women and some children, and capable of pumping sufficient blood for an adult male during exercise.

The biggest innovative design of BTAH lies in the internal magnetic levitation rotor, which adopts magnetic levitation (MAGLEV) technology. The rotating disk is fully suspended in the magnetic field, similar to the principle of magnetic levitation 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 parts in BTAH, extending the device's service life for up to at least ten years.

BTAH Rotating Disc with Left and Right Impeller Blades Installed on Both Sides

In addition, the non-contact suspension of BTAH provides a larger gap, thereby minimizing blood cell damage, eliminating mechanical wear, and reducing the risk of thrombosis. BTAH is manufactured through 3D printing and made of titanium, which has excellent biocompatibility.

# About BiVACOR

BiVACOR Focuses on Developing a Fully Artificial Heart. The company's core product is BTAH, designed to provide a long-term therapy for patients with severe biventricular heart failure. Founded in 2008 in the United States, the company is backed by an internationally renowned team of biomedical engineers and cardiac surgeons (including Founder and Chief Technology Officer Dr. Daniel Timms and Chief Medical Officer Dr. William Cohn).

The company has currently received a total of four funds, raising a total of 40 million US dollars (known), with the following details:

On March 2, 2023, the company raised 18 million US dollars in Series B financing, with OneVentures as the investor.

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 investments from OneVentures and Cormorant Asset Management in its Series B financing round, raising $19 million.

On May 17, 2018, the company announced that it had received an undisclosed amount of investment from OneVentures.

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