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Overview
BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH) to replace a failing heart. The device is a compact, titanium implant that uses a single magnetically levitated rotor to pump blood to the lungs and the rest of the body, eliminating valves and mechanical bearings to reduce blood damage. It serves as a bridge-to-transplant and aims to become a long-term (permanent) alternative to heart transplantation. BiVACOR operates in the cardiovascular medtech space, pursuing regulatory approval through preclinical and clinical trials, including an FDA Breakthrough Device Designation and an Early Feasibility Study. Its strategy includes expanding from Australia to the US, securing funding, and advancing toward commercialization to address the large unmet need in end-stage heart failure.
About BiVACOR
Industries
Robotics & Automation
Healthcare
Company Size
51-200
Company Stage
Grant
Total Funding
$46.7M
Headquarters
Houston, Texas
Founded
2008
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Simplify's Take
What believers are saying
- Five of five U.S. patients bridged to transplant by August 2025 without pump replacement.
- The 2026 clinical trial recruits four major centers: Duke, Banner, The Christ Hospital, Texas Heart.
- Australia’s MRFF and NIH grants fund wireless power development and clinical expansion.
What critics are saying
- The 15-patient expansion increases visibility; one stroke, hemolysis, or infection can halt approvals.
- Patients need anticoagulation, transplant eligibility, and chest fit; exclusions shrink the addressable pool.
- No commercial approval exists in 2026; late-stage trial failure would kill BiVACOR’s standalone thesis.
What makes BiVACOR unique
- BiVACOR’s single-maglev-rotor titanium TAH removes valves, bearings, and mechanical wear points.
- July 9, 2024 first-in-human implant and five-patient bridge-to-transplant run built credibility.
- FDA Breakthrough Device and TAP acceptance in 2025 signal unusually close regulator engagement.
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Funding
Total Funding
$46.7M
Above
Industry Average
Funded Over
7 Rounds
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Health Savings Account/Flexible Spending Account
Life Insurance
Employee Assistance Program
401(k) Company Match
Paid Vacation
Growth & Insights and Company News
6 month growth
↓ -6%1 year growth
↓ -5%2 year growth
↓ -9%May 30, 2025 - BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The Texas Heart Institute, in collaboration with BiVACOR(R), has made a historic stride in cardiac care with the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH).
GOLD COAST, Australia HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR®, a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements. Led by Monash University, the AHFP is comprised of a consortium of research centers in Australia in collaboration with BiVACOR. The $13 million (USD) grant comes from a larger $50 million (AUD) grant from the MRFF to the AHFP to develop and commercialize devices to treat the most common forms of severe heart failure and bring new solutions to underserved patients. The award will support clinical work of the BiVACOR Total Artificial Heart (TAH) and begin development for the integration of wireless power sources for the device
Jim Dillon, a longtime executive in the medical device sector, has been hired to lead BiVACOR and join its board of directors.
At the same time, Bivacor also received $3 million in Small Business Innovation Research grant funding from the National Heart, Lung, and Blood Institute at the U.S. National Institute of Health.
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About BiVACOR
Industries
Robotics & Automation
Healthcare
Company Size
51-200
Company Stage
Grant
Total Funding
$46.7M
Headquarters
Houston, Texas
Founded
2008
BiVACOR is Hiring for 14 Jobs on Simplify!
Find jobs on Simplify and start your career today