Centerline Biomedical

Key People

• Gulam Khan - Chief Executive Officer
• Vikash Goel - Founder & Chief Technology Officer
• Indrani Egleston - Chief Financial Officer
• Patty Burns - Senior Vice President of Marketing
• Brian Wenzel - Vice President of Research & Development
• Sonya Snyder - Senior Vice President of Operations and Program Management
• Brent Runkle - Director of Human Resources and Administration
• Andrew Potthast - Director of Capital Sales

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises seasoned professionals with extensive experience in the medical technology sector.

The leadership includes individuals like CEO Gulam Khan, who has over two decades of executive leadership experience in the med tech industry, and CTO Vikash Goel, the founder with a strong technical background. This depth of experience is a significant asset for the company's strategic direction and operational execution.

Clinical Need

Aspect: Very Strong
Summary: The company's technology addresses critical challenges in endovascular procedures, including radiation exposure and procedural accuracy.

Centerline Biomedical's Intra-Operative Positioning System (IOPS) provides real-time 3D navigation, reducing reliance on traditional fluoroscopy, which exposes patients and clinicians to ionizing radiation. This innovation enhances procedural safety and accuracy, addressing a pressing need in vascular surgery.

Competition

Aspect: Somewhat crowded
Summary: The market for endovascular navigation systems includes several established players, but opportunities exist for differentiation.

The medical device industry features multiple companies offering navigation solutions for endovascular procedures. However, Centerline's IOPS stands out by providing real-time 3D visualization without radiation exposure, a feature not commonly available in competing products.

Technical Challenge

Aspect: Predictable
Summary: The development of the IOPS system involves complex technology, but the challenges are well-understood and manageable.

Integrating electromagnetic tracking with 3D vascular mapping requires sophisticated engineering. Centerline's team has demonstrated capability in developing and obtaining FDA clearance for the IOPS system, indicating a strong handle on the technical complexities involved.

Patent

Aspect: Very Strong
Summary: The company holds a robust intellectual property portfolio, providing significant competitive protection.

Centerline Biomedical has secured 29 issued and 48 pending patents, covering various aspects of their technology. This strong IP position not only protects their innovations but also adds value to the company in terms of potential licensing and partnerships.

Financing

Aspect: Well-funded
Summary: The company has successfully raised significant funding, indicating strong investor confidence.

In June 2022, Centerline Biomedical closed a $33 million Series B financing round led by Cleveland Clinic, with participation from GE Healthcare and other investors. This funding is instrumental in advancing their R&D pipeline and expanding market reach.

Regulatory

Aspect: 510k/PMA
Summary: The company's flagship product has received FDA 510(k) clearance, facilitating market entry.

The IOPS system has obtained FDA 510(k) clearance for use in endovascular interventions, allowing the company to market and sell the product in the U.S. This regulatory milestone is crucial for building credibility and driving adoption among healthcare providers.

Opportunity Rollup

Odds of Success

3.8

Peak Market Share

4.85

Segment CAGR

5.1%

Market Segment

Medical Devices

Market Sub Segment

Endovascular Navigation Systems

Key Takeaway

Centerline Biomedical's innovative IOPS technology addresses a critical need in endovascular procedures, offering significant clinical and operational benefits. With strong leadership, robust IP, and substantial funding, the company is well-positioned for success in a growing market.