Bridging the Gaps as a Startup Medtech CEO

Carol Burns, CEO of Cagent Vascular, is a serial entrepreneur with an impressive track record in the medtech industry. Throughout her career, she has played a pivotal role in all phases of medical device development, from early-stage proof of concept to successful commercialization.

Starting as a critical care nurse, she built a strong foundation of medical knowledge before transitioning into sales. Her talents were recognized by a medical device company, leading her to move to the West Coast and eventually enter the world of startups. This allowed Carol to gain invaluable experience in various aspects of running a startup and hone her expertise across the broader medical device space.

Her expertise led up to developing relationships with Dr. Peter Schneider and Robert Giasolli, who approached her with an opportunity to join their company, Intact Vascular, as CEO. With Carol taking the helm, the company achieved great success and exited to Philips. After that milestone, the trio collaborated once more to establish Cagent Vascular.

Cagent has developed an innovative angioplasty balloon called the Serenator. The device is equipped with serrated metal strips embedded into its surface. When used in peripheral artery procedures, these serrations generate point force across the lesion that push the artery open with a force that’s a thousand times greater than a conventional balloon catheter. This compelling technology offers significant benefits, including improved lumen gain with minimal dissection.

The company received 510(k) clearance from the FDA and CE Mark certification and began selling the product in January 2021, primarily focusing on the US market, with some presence in Germany.

Driven by her commitment to improving patients' lives, Carol focuses on developing devices that physicians want to use and that generate returns for investors. Her tireless energy and strategic approach have helped her navigate the fast-paced world of startups and identify technologies with the highest potential for success.

In this interview, Carol shares her insights on the importance of reducing risk early in the development process and how to effectively pitch medtech investors. She emphasizes the value of listening to clinical investigators to generate meaningful data for publication, even when faced with limited resources.

Key Learnings From Carol’s Experience

• A strong, diverse team is the foundation of any successful medtech startup. Having a group of passionate professionals who are committed to the company's vision and ready to contribute their skills and expertise fosters innovation and quick wins.

• In the early stages of a medical device startup, it’s crucial to focus on the core aspects of the product and its clinical applications, establishing a solid footing for future development.

• Persistence and strategic thinking are vital during the fundraising process. Nurturing relationships with potential investors and consistently providing them with updates on the company's progress can ultimately yield fruitful connections and secure the necessary funding.