Cleerly

Key People

• James Min - Founder & CEO
  Email: jm@cleerlyhealth.com
• Brandon Atkinson - Chief Operating Officer
• Jim Hartman - Chief Revenue Officer
• James P. Earls - Chief Medical Officer
• Kimberly McCombs - Chief Strategy Officer
• Nick Nieslanik - Chief Technology Officer
• Udo Hoffmann - Chief Medical, Scientific and AI Officer
• Amit Relia - Chief Regulatory Officer

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with backgrounds in medical technology and healthcare.

Cleerly's executive team includes individuals with significant experience in the MedTech industry, such as James Min, who has a background in cardiovascular imaging, and other leaders with expertise in technology and healthcare operations. This collective experience enhances the company's ability to navigate the complexities of the healthcare market and drive innovation in heart disease diagnostics.

Clinical Need

Aspect: Very Strong
Summary: Heart disease remains the leading cause of death, highlighting a critical need for innovative diagnostic solutions.

With heart disease being the leading cause of death globally, there is a pressing need for advanced diagnostic tools that can accurately assess and monitor coronary artery disease. Cleerly's AI-driven platform offers a non-invasive, precise method for evaluating heart health, potentially transforming patient care and outcomes.

Competition

Aspect: Somewhat crowded
Summary: The market includes several players offering AI-driven cardiovascular diagnostics.

The field of AI-driven cardiovascular diagnostics is becoming increasingly competitive, with companies like HeartFlow and Elucid also developing similar technologies. While Cleerly's approach and technology may offer unique advantages, the presence of multiple players in the market could pose challenges in terms of market share and differentiation.

Technical Challenge

Aspect: Predictable
Summary: The technology involves complex AI algorithms but is based on established imaging techniques.

Cleerly's platform leverages AI to analyze coronary computed tomography angiography (CCTA) images, a well-established imaging modality. While developing and validating AI algorithms is inherently complex, the use of existing imaging techniques provides a solid foundation, making the technical challenges more predictable and manageable.

Patent

Aspect: Strong
Summary: Cleerly has secured patents to protect its AI-driven diagnostic methods.

By obtaining patents for its AI-driven diagnostic methods, Cleerly has established intellectual property that can serve as a barrier to entry for competitors. This protection enhances the company's ability to maintain a unique position in the market and capitalize on its innovations.

Financing

Aspect: Well-funded
Summary: Cleerly has raised significant funding from reputable investors.

With total funding of approximately $410 million from investors like Insight Partners, Battery Ventures, and Fidelity, Cleerly is well-positioned to invest in product development, clinical trials, and market expansion. This financial backing provides the resources necessary to advance its mission and compete effectively in the market.

Regulatory

Aspect: 510k/PMA
Summary: Cleerly's solutions have received FDA clearance for diagnosing symptomatic patients.

Achieving FDA clearance for its diagnostic solutions allows Cleerly to market its products for clinical use, ensuring compliance with regulatory standards. This approval is crucial for building trust with healthcare providers and patients, facilitating adoption and integration into clinical practice.

Opportunity Rollup

Odds of Success

3.7

Peak Market Share

4.7

Segment CAGR

4.4%

Market Segment

Cardiovascular Devices

Market Sub Segment

Diagnostic Imaging

Key Takeaway

Cleerly is well-positioned to address a critical need in heart disease diagnostics with its AI-driven platform, supported by a strong team and substantial funding, though it faces competition and regulatory challenges.