Cagent Vascular

Key People

• Carol A. Burns - CEO
• Peter Schneider, MD - Chief Medical Officer
• Robert Giasolli - VP of Research and Development

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced MedTech entrepreneurs with a track record of success.

Cagent Vascular's leadership includes CEO Carol A. Burns, Chief Medical Officer Dr. Peter Schneider, and VP of Research and Development Robert Giasolli, all of whom have extensive experience in the medical device industry. Their combined expertise positions the company well for innovation and market penetration.

Clinical Need

Aspect: Very Strong
Summary: The Serranator addresses a significant unmet need in the treatment of peripheral artery disease (PAD).

Peripheral artery disease affects a large patient population, and current treatments often fall short in efficacy. The Serranator's serration technology offers a novel approach to improving angioplasty outcomes, potentially reducing elastic recoil and minimizing dissections, thereby fulfilling a critical clinical need.

Competition

Aspect: Somewhat crowded
Summary: The market for angioplasty devices is competitive, but the Serranator offers unique features.

While there are numerous angioplasty devices available, the Serranator's serration technology differentiates it by providing more controlled lumen gain and reducing complications. However, the company must effectively communicate these advantages to gain market share in a crowded field.

Technical Challenge

Aspect: Predictable
Summary: The technology is innovative but based on established principles, making development challenges manageable.

The integration of serrated elements into balloon catheters is a novel application but leverages existing angioplasty techniques. This predictability in development reduces technical risks and facilitates regulatory approval processes.

Patent

Aspect: Strong
Summary: Cagent Vascular holds strong patents protecting its serration technology.

The company's proprietary serration technology is protected by patents, providing a competitive edge and potential barriers to entry for competitors. This intellectual property strengthens the company's market position.

Financing

Aspect: Well-funded
Summary: The company has secured significant funding to support commercialization and expansion.

With over $30 million raised in Series C financing led by U.S. Venture Partners, Cagent Vascular is well-capitalized to accelerate U.S. market adoption and expand its product portfolio. This financial backing supports ongoing operations and strategic initiatives.

Regulatory

Aspect: 510k/PMA
Summary: The Serranator has obtained necessary regulatory clearances for market entry.

The device has received FDA 510(k) clearance and CE Mark approval, allowing for commercialization in the U.S. and limited distribution in Europe. These approvals validate the device's safety and efficacy, facilitating market entry.

Opportunity Rollup

Odds of Success

3.5

Peak Market Share

4.4

Segment CAGR

4.4%

Market Segment

Peripheral Vascular Devices

Market Sub Segment

Angioplasty Balloons

Key Takeaway

Cagent Vascular's Serranator offers a novel solution for PAD treatment, supported by experienced leadership and strong financial backing, positioning it well in a competitive market.