Modular Medical Prepares for Pivot Pump FDA Filing and Market Debut – ( $MODD $TNDM )

By John F. Heerdink, Jr.

Modular Medical (NASDAQ: MODD), a leader in innovative insulin delivery technology, is targeting the $3 billion adult “almost-pumpers” diabetes market with user-friendly, affordable patch pumps designed to simplify care for a population too often left behind by complex, expensive systems. Founded by Paul DiPerna—a seasoned medical device professional and microfluidics engineer who previously founded Tandem Diabetes (TDNM) and invented its celebrated t:slim insulin pump—Modular Medical leverages years of pioneering experience in diabetes technology.

Board Expansion and Leadership

In May 2025, Modular Medical appointed industry veteran Jeff Goldberg to its Board of Directors to accelerate market access and product strategy. Goldberg, who has held executive roles in both generic insulin innovation and drug-device combination product launches, brings a wealth of regulatory and operational knowledge. His track record, which includes serving as Chairman of Lannett Company and leading post-restructuring efforts and new insulin launches, aligns closely with Modular Medical’s disruptive approach to advancing diabetes care.

Regulatory Progress and Product Pipeline

On September 15, Modular Medical received IRB approval to initiate a pivotal 90-day feasibility study for its next-generation Pivot patch insulin pump—setting the company on a clear regulatory path toward its October 510(k) FDA submission and a potential commercial launch in 2026. CEO Jeb Besser underscored the platform’s focus on simplicity and affordability, spotlighting the large segment of adults who need, but often avoid, pump therapy due to legacy system limitations.

Product Transition and Market Focus

With the completion of MODD1 cartridge production in August, Modular Medical rapidly moved manufacturing resources toward the new Pivot system. This operational shift demonstrates a clear intent to capture the mainstream “almost-pumper” adult market with a solution that is lightweight, disposable, and easy to learn—a stark contrast to traditional, more cumbersome pumps.

Partnerships and Training Innovation

To further broaden adoption, the company partnered with Level Ex, introducing gamified educational modules for both clinicians and patients. These interactive tools, spotlighted at the ADCES 2025 conference, address barriers rooted in training and system complexity, aiming to streamline onboarding for providers and users alike.

Strategic Position

With Goldberg’s appointment and a leadership bench anchored by Paul DiPerna’s legacy in inventing industry-defining diabetes technologies, Modular Medical is well-positioned to democratize insulin delivery—offering affordable devices to wider segments of the population. Growing investor interest and strong early adopter feedback signal optimism as the company eyes global regulatory expansion and broad commercialization. Learn by viewing their latest powerpoint presentation.