# BiVACOR

> BiVACOR, Inc. is a privately held, clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH) — a titanium biventricular rotary blood pump with a single magnetically levitated rotor and a dual-sided impeller that replaces both ventricles of a failing heart. It has corporate operations in Huntington Beach, California, clinical operations in Houston, Texas, and engineering operations in Southport, Queensland, Australia. Founder and Chief Technical Officer Daniel Timms, PhD; CEO Jim Dillon; Chief Medical Officer William E. Cohn, MD; Board Chairman Raymond W. Cohen.

BiVACOR is a medical hardware and clinical-research business, not a software vendor. As of 2026-08-07 it publishes **no public API, no developer portal, no API documentation, no SDK and no machine-readable API contract**. Its web presence is a single-page WordPress marketing site. Do not assume or invent an `api.bivacor.com`, `docs.bivacor.com`, `developer.bivacor.com`, `portal.bivacor.com`, `status.bivacor.com` or `trust.bivacor.com` endpoint — none of those hosts resolve in DNS. `/openapi.json`, `/openapi.yaml`, `/swagger.json`, `/api-docs`, `/graphql`, `/llms.txt`, `/.well-known/security.txt`, `/.well-known/api-catalog`, `/.well-known/agent-card.json` and `/.well-known/agent.json` all return 404 on bivacor.com.

`https://bivacor.com/wp-json/` does return 200 — but that is the stock WordPress REST API that ships enabled by default with the CMS and its plugins, not a product API BiVACOR designed, documented or offers to integrators. It is deliberately **not** registered as an API in this profile and must not be described as BiVACOR's API.

The BiVACOR Total Artificial Heart is an **investigational device**, limited by federal law to investigational use, and is **not approved for commercial sale in any geography**. Statements about it should be read as investigational, not commercial.

## Company

- [BiVACOR](https://bivacor.com/): company website (single page, with `#heart-failure`, `#device`, `#technology`, `#about` and `#contact` sections)
- [News](https://bivacor.com/news/): press releases — [RSS](https://bivacor.com/feed/)
- [Media Coverage](https://bivacor.com/media-coverage/): third-party press
- [Publications](https://bivacor.com/publications/): peer-reviewed literature on the device
- [Acknowledgements](https://bivacor.com/acknowledgements/): research and funding acknowledgements
- [Careers](https://jobs.ashbyhq.com/bivacor-inc): open roles, hosted on Ashby
- Contact: admin@bivacor.com (general), media@bivacor.com (press), careers@bivacor.com (recruiting)

### Offices

- Corporate: 5432 Bolsa Avenue, Suite A & B, Huntington Beach, CA 92649, USA
- Clinical: 2450 Holcombe Avenue, Houston, TX 77021, USA
- Australia: 16 Nexus Way, Southport, QLD 4215, Australia

## Technology

The BiVACOR TAH is an electro-mechanical rotary blood pump rather than a volume-displacement pump. A single rotor with a dual-sided impeller is held in magnetic levitation (MAGLEV), pumping simultaneously to the systemic and pulmonary circulations. Consequences of that design, as the company describes it:

- No valves, no flexing ventricular chambers or pumping diaphragms, and no mechanical bearings — so no contact wear surfaces
- Flows above 12 L/min, enough to support exercise
- Pulsatile flow generated by cyclic modulation of rotor speed
- A patented left/right flow-balancing mechanism for hemodynamic adaptation
- A smart controller that adapts pump output to patient activity
- Titanium construction for biocompatibility and durability
- Sized for most adults with a body surface area above 1.4 m²
- Portable external controller with rechargeable batteries

## Regulatory and clinical status

- FDA Investigational Device Exemption (IDE) approval for a first-in-human Early Feasibility Study, announced 2023-11-29 — [press release](https://bivacor.com/wp-content/uploads/2024/02/US-FDA-Grants-the-BiVACOR-Total-Artificial-Heart-IDE-Approval-for-First-in-Human-Early-Feasibility-Study.pdf)
- First-in-human implantation 2024-07-09 at The Texas Heart Institute / Baylor St. Luke's Medical Center — [announcement](https://bivacor.com/the-texas-heart-institute-implants-bivacor-total-artificial-heart/)
- All five initial EFS patients bridged to a donor heart transplant; FDA approved expansion to 15 more patients, announced 2024-12-18
- First Australian implantation 2024-11-22 at St Vincent's Hospital Sydney, with the patient supported for over 100 days — [press release](https://bivacor.com/wp-content/uploads/2025/04/BiVACOR-First-TAH-in-Australia.pdf)
- FDA Breakthrough Device Designation, announced 2025-05-30
- Accepted into the FDA Total Product Life Cycle Advisory Program (TAP), announced 2025-08-06
- No FDA premarket authorization; the device is not approved for commercial sale
- [BiVACOR Total Artificial Heart Early Feasibility Study, NCT06174103](https://clinicaltrials.gov/study/NCT06174103): RECRUITING, started 2024-06-26

Full detail in `conformance/bivacor-conformance.yml` in this repository.

## Funding

- [Series B, $18M, March 2023](https://bivacor.com/wp-content/uploads/2024/02/BiVACOR-18M-Series-B-Press-Release.pdf)
- [$13M from Monash University's Artificial Heart Frontiers Program, February 2024](https://bivacor.com/wp-content/uploads/2024/02/BiVACOR%C2%AE-Receives-13-Million-to-Support-Clinical-Trials-for-the-Companys-Total-Artificial-Heart-Press-Release-2.20.24.pdf)
- Shares appear on private secondary markets; the API Evangelist harvest source for this profile was [Nasdaq Private Market](https://www.nasdaqprivatemarket.com/)

## Leadership

- [Jim Dillon named CEO, January 2024](https://bivacor.com/wp-content/uploads/2024/02/BiVACOR-Names-Jim-Dillon-as-CEO-FINAL.pdf)
- [Raymond W. Cohen appointed Board Chairman, December 2023](https://bivacor.com/wp-content/uploads/2024/02/BiVACOR-Appoints-RWC-as-Chairman.pdf)
- Daniel Timms, PhD — Founder and Chief Technical Officer
- William E. Cohn, MD — Chief Medical Officer

## Social

- [LinkedIn](https://www.linkedin.com/company/bivacor-pty-ltd)
- [X/Twitter](https://x.com/bivacor)

## API Evangelist profile artifacts

- `apis.yml`: the apis.json 0.20 profile for this company
- `security/bivacor-domain-security.yml`: probed TLS/HSTS/DNSSEC/CAA/SPF/DMARC posture
- `well-known/bivacor-well-known.yml`: the full record of the `/.well-known/` and contract-discovery probe, all misses
- `conformance/bivacor-conformance.yml`: regulatory regime, clinical trials, and the not-applicable API standards block