Think Commercially from Day One

Key Learnings From James's Experience

• The right market is one that’s big enough to scale, growing fast, and underserved with limited competition. Once you’ve chosen your market, your next priority should be simplifying the user experience, whether that’s physicians, patients, or hospital staff. Create efficiency to make adoption easier. This is the formula to attract investor interest and long-term growth opportunities.

• Startups often focus too much on clinical work and fail to prepare for the transition to commercialization. By laying the proper groundwork early, you avoid scrambling later when it’s time to launch. Think about who you need to convince to move the needle and match your hiring to your market goals. For example, building a market versus taking a share requires an entirely different skill set.

• Choose a market that excites investors. Build a functional, aligned board by understanding the motivations and goals of each fund represented. Consider how your current raise fits into the bigger picture, whether that’s preparing for an IPO or trying to exit early. Finally, hit operational milestones, de-risk the company, and maintain open communication with strategics to strengthen your position for future M&A opportunities.

James Reinstein, CEO of Conformal Medical, spent 17 years at Boston Scientific, holding various commercial leadership roles, including overseeing multiple geographies in Asia. He later joined Cyberonics, a neurostimulation company, where he helped lead a turnaround, growing its market cap from $200 million to $3 billion. James had expected to step into the CEO role there, but he decided it was time to chart his own course.

James moved to California to lead Aptus, his first experience with startups, which Medtronic later acquired for $120 million. After that, he led multiple startups, co-founded a boutique advisory firm, and briefly ran Cutera, an aesthetics company, before realizing the aesthetics field wasn’t for him. A chance referral eventually brought him to Conformal, where he now leads the company’s efforts in developing left atrial appendage occlusion (LAAO) technology for patients with atrial fibrillation (Afib). 

Many patients with Afib take anticoagulants (blood thinners) to reduce the risk of clot formation that can lead to strokes, but some cannot tolerate these medications due to side effects or personal preference. LAAO devices, such as Boston Scientific’s Watchman and Abbott’s Amulet, offer an alternative by sealing off the LAA, reducing stroke risk without the need for long-term anticoagulants. 

The Conformal CLAAS® AcuFORM™ LAAO system simplifies the process with just two adaptable sizes, removing the complexities of size selection. It also eliminates the need for transesophageal echocardiography (TEE) under general anesthesia, instead relying on intracardiac echocardiography (ICE) performed through the groin with local anesthesia. This reduces the clinician requirement from three to one and makes the procedure safer and more efficient. 

Currently, Conformal has enrolled over 420 patients in a 1,600-patient IDE trial in the U.S., with a European trial, the GLACE study, also underway.