CroValve
- Industry
- Medical Devices
- Founded Year
- 2016
- Headquarters
- Dublin, Ireland
- Employee Count
- 0
Key People
- Dr. Lucy O'Keeffe - CEO
- Dr. Martin Quinn - Co-founder
- Dr. Paul Heneghan - Co-founder
- Prof. Bruce Murphy - Co-founder
- Gavin Kenny - R&D Director
- Helen Scotch - Vice President of Clinical and Regulatory Affairs
- Dr. Azin Parhizgar - Board Member
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with significant backgrounds in medical device development and commercialization.
The presence of multiple successful MedTech entrepreneurs in the leadership team provides a strong foundation for strategic decision-making and innovation.
- Clinical Need
-
Aspect: Very Strong
Summary: Tricuspid regurgitation affects over 1.6 million people in the U.S., with limited treatment options available.
The high prevalence of tricuspid regurgitation and the lack of effective treatments underscore the urgent need for innovative solutions like the DUO System.
- Competition
-
Aspect: Very crowded + Strategics
Summary: The market includes established players like Edwards Lifesciences and Abbott with approved devices.
The presence of major companies with approved devices indicates a highly competitive landscape, requiring strategic differentiation for success.
- Technical Challenge
-
Aspect: Moderate
Summary: The DUO System employs a novel approach that combines repair and replacement techniques.
Integrating repair and replacement methods in a single device introduces moderate technical challenges that must be addressed through rigorous testing and validation.
- Patent
-
Aspect: Strong
Summary: The company has secured patents for its unique DUO System design and delivery method.
Holding patents for the DUO System's design and delivery method provides a barrier to entry for competitors and supports the company's market exclusivity.
- Financing
-
Aspect: Well-funded
Summary: The company has raised significant funding, including a $16 million Series B round and EIC Accelerator funding.
The substantial financial backing enables the company to advance its clinical programs and scale operations effectively.
- Regulatory
-
Aspect: Pivotal Trial
Summary: The DUO System is undergoing early feasibility studies in the U.S. and Europe.
The initiation of feasibility studies marks a critical step toward obtaining regulatory clearance and eventual market entry.
Opportunity Rollup
- Odds of Success
- 3.35
- Peak Market Share
- 3.9
- Segment CAGR
- 15.1%
- Market Segment
- Cardiovascular Devices
- Market Sub Segment
- Transcatheter Heart Valves
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.19 |
| 2 | 0.58 |
| 3 | 1.36 |
| 4 | 2.73 |
| 5 | 3.90 |
Key Takeaway
CroValve's innovative DUO System addresses a significant unmet need in tricuspid regurgitation treatment, but faces challenges in a competitive market.