Two Stakeholders You Can’t Ignore

Key Learnings From Mike's Experience

• Start with identifying real clinical needs by talking directly to physicians. Understand their pain points, the number of patients impacted, and the clinical significance of the issue. Work closely with key opinion leaders (KOLs) in your field who can provide deep insights into care gaps and guide you toward viable solutions. While doing this, ensure your device aligns with what strategics are looking for—or be prepared to take it further on your own.

• Get a functional prototype into pre-clinical testing as soon as possible. Don’t over-refine—early testing reveals critical insights you won’t get from theory alone. Choose clinical sites that are credible, accepted by physicians, and see a high volume of relevant patients. Back your team with strong CRO support for navigating site-specific requirements.

• For capital, seek out firms in your field that are interested in early-stage deals, especially Series A. Present a clear, compelling story that outlines a feasible path to an exit within their typical timeline. Similarly, engage with strategics early and treat them as customers. Take the time to understand their pain points and key initiatives, even as those priorities evolve over time.

Mike Dineen, co-founder and CEO of Tioga Cardiovascular, started out as a pre-med student but shifted directions halfway through his undergrad after being drawn to the idea of combining medicine with business. After earning a BS in Biology and an MBA from Santa Clara University, he started in pharmaceutical sales at the Upjohn Company (now Pfizer). It wasn’t long, though, before his passion for innovation pulled him into the medical devices world, starting at Devices for Vascular Interventions (DVI), which ultimately exited to Guidant. 

His next stop was Target Therapeutics, where he witnessed the company’s acquisition by Boston Scientific, giving him a front-row seat to how startups scale and succeed. Inspired, he co-founded Radiant Medical, a startup focused on therapeutic hypothermia, followed by Aspire Medical, which developed a minimally invasive device for sleep apnea. Despite the financial crisis at the time, Aspire was acquired by Philips/Respironics.

Along the way, he met prolific entrepreneur Amr Salahieh, President and CEO of Shifamed, and joined two of Shifamed's portfolio companies: Maya Medical and later Kalila Medical, where he served as CEO. After taking a well-earned break to focus on family and explore van life, Mike co-founded Tioga Cardiovascular, another Shifamed portfolio company. 

The Tioga Cardiovascular team is developing a minimally invasive device to treat mitral regurgitation (MR), a common heart valve condition where blood leaks backward into the heart, often causing heart failure or shortness of breath. Current repair devices, like MitraClip and Pascal, don’t work for every patient and often leave residual issues. To fully treat the condition, physicians need a transcatheter mitral valve replacement (TMVR) option. 

TMVR is a promising technology that bypasses the need for open-heart surgery for patients with MR but as of today, it’s in its infancy. Most TMVR devices have high screen failure rate, where 80-90% of patients are excluded because the devices don't fit. Tioga Cardiovascular aims to solve this by creating a better delivery system and a shorter, more compact valve, making treatment accessible to more patients, and saving them from undergoing an open-heart surgery. 

In September 2024, Tioga completed its first-in-human procedure and has since performed three successful cases, with more patients currently being screened. Tioga plans to continue to gain early clinical experience in the upcoming year with sites outside the U.S.