Filterlex Medical Ltd.

Key People

• Sigal Eli - Founder and CEO
  Email: sigal@filterlex.com
• Dr. Giora Weisz - Co-founder and Chief Medical Officer

Assessment

Team

Aspect: First-time 10+ yrs
Summary: The leadership team comprises experienced professionals with extensive backgrounds in medical device development and commercialization.

The founders have vast clinical knowledge and extensive experience in medical device development, commercialization, and marketing. This depth of experience is crucial for navigating the complexities of bringing a medical device to market.

Clinical Need

Aspect: Very Strong
Summary: The CAPTIS device addresses a significant clinical need by reducing the risk of stroke and other complications during left-heart procedures.

During catheter-based procedures like TAVR, embolic particles can cause neurological deficiencies. The CAPTIS device offers full-body embolic protection, addressing this critical issue and potentially improving patient outcomes.

Competition

Aspect: Somewhat crowded
Summary: The embolic protection device market has multiple players, but CAPTIS offers unique features.

While there are several embolic protection devices available, CAPTIS's unique designrequiring no additional arterial access and not interfering with procedure workflowprovides a competitive edge. However, market penetration will depend on demonstrating superior efficacy and ease of use.

Technical Challenge

Aspect: Predictable
Summary: The device's design and deployment are straightforward, minimizing technical risks.

The CAPTIS device is designed to be easily and intuitively deployed and retrieved, securely positioned in the aorta without requiring additional arterial access. This simplicity reduces technical challenges and facilitates integration into existing procedural workflows.

Patent

Aspect: Strong
Summary: The company has secured strong patent protection for its technology.

Filterlex Medical has developed a distinctive, triple-action design for the CAPTIS device, providing full-body embolic protection by deflecting, capturing, and removing embolic particles. This innovation is protected by strong patents, enhancing the company's market position.

Financing

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

Filterlex Medical has raised substantial funds, including a $6 million Series A1 investment and a 7 million commitment from the European Innovation Council. This financial support enables the company to advance its clinical programs and pursue regulatory approvals.

Regulatory

Aspect: Running FIH
Summary: The company has successfully completed its first-in-human study and is progressing towards regulatory approvals.

The successful completion of the first-in-human study is a significant milestone. However, additional clinical trials and regulatory approvals are required before the CAPTIS device can be commercialized.

Opportunity Rollup

Odds of Success

3.95

Peak Market Share

5.7

Segment CAGR

4.4%

Market Segment

Cardiovascular Devices

Market Sub Segment

Embolic Protection Devices

Key Takeaway

Filterlex Medical's CAPTIS device addresses a critical need in TAVR procedures, supported by a strong team and solid funding, but faces challenges in a competitive market and regulatory landscape.