BiVACOR
- Industry
- Medical Device
- Founded Year
- 2008
- Headquarters
- Houston, Texas, USA
- Employee Count
- 0
Key People
- Daniel Timms - Founder and CEO
- William Cohn - Board Member
- O. H. Frazier - Board Member
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: BiVACOR's leadership includes experienced professionals with significant backgrounds in medical device development.
The leadership team comprises individuals with extensive experience in the MedTech industry, including board members like William Cohn and O. H. Frazier, who have notable backgrounds in artificial heart research and cardiology.
- Clinical Need
-
Aspect: Very Strong
Summary: The demand for total artificial hearts is high due to the increasing prevalence of end-stage heart failure and the shortage of donor organs.
With the global burden of cardiovascular diseases rising and a persistent shortage of donor hearts, the need for effective total artificial heart solutions is more pressing than ever. BiVACOR's device offers a promising alternative for patients awaiting heart transplants.
- Competition
-
Aspect: Somewhat crowded
Summary: The artificial heart market features several established players, but opportunities exist for innovative solutions.
The market includes key players such as SynCardia Systems and CARMAT, each offering their own artificial heart solutions. However, BiVACOR's unique approach with a magnetically levitated impeller may provide a competitive edge.
- Technical Challenge
-
Aspect: Complex
Summary: Developing a reliable and biocompatible total artificial heart involves significant technical challenges.
Ensuring the device's long-term functionality, minimizing risks like clotting, and achieving biocompatibility are critical challenges in artificial heart development. BiVACOR's design aims to address these issues through innovative technology.
- Patent
-
Aspect: Strong
Summary: BiVACOR holds patents for its unique artificial heart design, providing a competitive advantage.
BiVACOR's patented technology, including the magnetically levitated impeller, differentiates its product from competitors and offers protection against market imitation.
- Financing
-
Aspect: Medium
Summary: BiVACOR has secured significant funding, including a $13 million grant from the Australian Government.
The $13 million grant from the Australian Government's Medical Research Future Fund supports BiVACOR's Total Artificial Heart program and product improvements. Continued investment will be necessary to advance clinical trials and market entry.
- Regulatory
-
Aspect: Running FIH
Summary: BiVACOR has received FDA authorization for human trials and has initiated first-in-human studies.
In November 2023, BiVACOR received FDA authorization under the investigational device exemption for use in human trials. A successful implantation was conducted in July 2024 as part of its first-in-human clinical study.
Opportunity Rollup
- Odds of Success
- 3.95
- Peak Market Share
- 5.2
- Segment CAGR
- 11.3%
- Market Segment
- Cardiac Assist Devices
- Market Sub Segment
- Total Artificial Hearts
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.26 |
| 2 | 0.78 |
| 3 | 1.82 |
| 4 | 3.64 |
| 5 | 5.20 |
Key Takeaway
BiVACOR's innovative total artificial heart addresses a critical need in the growing heart failure market, supported by experienced leadership and recent regulatory progress.