BURLINGTON, Mass. — Fractyl Health Inc. has appointed Mike Zumdahl as senior vice president of market access and commercial strategy as the company prepares for a key data readout and potential regulatory submission for its Revita treatment later this year.
Fractyl, a clinical-stage metabolic therapeutics company focused on obesity and type 2 diabetes, said Zumdahl will help build reimbursement and health economics infrastructure ahead of anticipated topline data from the REMAIN-1 pivotal cohort in early fourth-quarter 2026. The company also expects to submit a potential De Novo marketing application for Revita in late fourth-quarter 2026.
Zumdahl previously served as vice president of global health economics, market access and government affairs at Inari Medical, where he led the function during the company’s growth and 2025 acquisition by Stryker. Most recently, he was president of Commercial Access Partners, advising medtech companies on go-to-market strategy, health economics and reimbursement.
“We are thrilled to welcome Mike to the Fractyl team at this critical inflection point. With nearly one million people per month discontinuing GLP-1 therapy in the U.S. and actively seeking a durable off ramp, building robust reimbursement and health economic infrastructure is essential for commercial success. Mike’s track record building market access for breakthrough procedural therapies at Inari and for helping launch the GLP-1 category at Novo Nordisk makes him the ideal leader to help define the post-GLP-1 weight maintenance category ahead of our REMAIN-1 pivotal data and potential De Novo marketing application later this year,” said Harith Rajagopalan, M.D., Ph.D., co-founder and chief executive officer of Fractyl.
Before joining Fractyl, Zumdahl led global health economics, market access and government affairs at Inari Medical before its approximately $4.9 billion acquisition by Stryker in February 2025. Fractyl said he helped build market access infrastructure for a novel procedural category at Inari.
Earlier in his career, Zumdahl began as a sales representative at GSK and later spent nearly a decade at Novo Nordisk in roles of increasing responsibility, including national accounts and government payers. At Novo Nordisk, he contributed to the company’s health economics and outcomes research strategy and value-based contracting for GLP-1 therapies.
“The post-GLP-1 weight maintenance problem represents the largest unmet need I have seen in metabolic disease in the last twenty years. I joined Fractyl to build the reimbursement architecture for a novel procedure in this category, and the commercial strategy to help more patients access the therapy,” said Mr. Zumdahl. “I’m energized to be working on this critically important unmet patient need, alongside Harith and the team, at this pivotal moment for the Company.”
