Pi-Cardia

Industry
Medical Equipment Manufacturing
Founded Year
2009
Headquarters
Rehovot, Israel
Employee Count
0

Key People

Assessment

Team
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with a track record in medical device innovation.

The presence of multiple successful MedTech entrepreneurs, including CEO Erez Golan and Chairman Jacques Sguin, enhances the company's credibility and potential for success.

Clinical Need
Aspect: Very Strong
Summary: Pi-Cardia addresses a significant unmet need in treating aortic valve stenosis with non-implant solutions.

The company's Leaflex and ShortCut devices offer innovative, less invasive alternatives for patients unsuitable for traditional valve replacement, fulfilling a critical clinical need.

Competition
Aspect: Somewhat crowded
Summary: The market for aortic valve treatments is competitive, with several established players.

While Pi-Cardia's non-implant approach is unique, it competes in a market with existing solutions from major medical device companies, posing challenges for market penetration.

Technical Challenge
Aspect: Moderate
Summary: Developing catheter-based solutions for valve modification presents moderate technical challenges.

The technology requires precise engineering and validation to ensure safety and efficacy, but the company's progress in clinical trials indicates manageable technical hurdles.

Patent
Aspect: Strong
Summary: Pi-Cardia holds strong patents for its leaflet modification technologies.

The company's proprietary technologies, including Leaflex and ShortCut, are protected by patents, providing a competitive edge in the market.

Financing
Aspect: Well-funded
Summary: The company has secured significant funding from reputable investors.

With a $27 million financing round led by Sofinnova Partners and participation from other investors, Pi-Cardia is well-positioned to advance its clinical programs and product development.

Regulatory
Aspect: Pivotal Trial
Summary: Pi-Cardia's devices are undergoing pivotal clinical trials to establish safety and efficacy.

The successful completion of pivotal studies is crucial for regulatory approval and market entry, and the company's progress indicates a clear path toward these milestones.

Opportunity Rollup

Odds of Success
3.55
Peak Market Share
4.4
Segment CAGR
15.1%
Market Segment
Cardiovascular Devices
Market Sub Segment
Transcatheter Heart Valves
Year Post Launch Market Penetration (%)
1 0.22
2 0.66
3 1.54
4 3.08
5 4.40

Key Takeaway

Pi-Cardia's innovative non-implant solutions address a significant clinical need in a growing market, but success will depend on navigating competitive pressures and achieving regulatory milestones.