Production Milestone Further Positions Modular Medical for U.S. and EU Growth – ( $MODD $LLY $MDT $PODD )

By John F. Heerdink, Jr.

Modular Medical (NASDAQ: MODD) has announced a series of transformative developments positioning the company at the forefront of diabetes technology innovation.

Robust Manufacturing Momentum

In August, Modular Medical completed a pivotal production milestone, finalizing over 6,000 MODD1 cartridges and seamlessly transitioning manufacturing to prepare for the upcoming Pivot pump launch. The company’s ability to validate and scale its cartridge production line—despite supply chain challenges—underscores its operational agility and focus on high-volume manufacturing crucial to capturing share in the growing insulin pump market. Modular’s production partner is Phillips Medisize, a Molex company, which has been instrumental in providing Modular Medical with manufacturing and assembly expertise, while drawing upon its global and diversified supplier base to design and develop manufacturing capability.

Clinical Validation and Real-World Progress

August also marked the first human use of the MODD1 pump, deployed by a clinician with Type 1 diabetes, with a broader clinician rollout imminent. This milestone represents significant real-world validation as the company moves toward broad commercialization and regulatory expansion, including a targeted Q1 2026 EU clearance for MODD1.

Next-Generation Pivot Pump Headlining Innovation

At the Association of Diabetes Care & Education Specialists (ADCES) Conference, Modular Medical unveiled the next-generation Pivot patch pump—a tubeless, removable, 3-milliliter device with the potential to set a new bar in patch pump technology. With over 11,000 members, the ADCES is a national network of diabetes care and education specialists working to optimize clinical outcomes for people with diabetes. Modular medical confirmed plans for a special 510(k) FDA filing for Pivot in October, with U.S. launch anticipated following regulatory green lights in Q1 2026.

Jeb Besser, CEO of Modular Medical stated, “The ADCES conference is an ideal location for us to showcase our next-generation patch pump, branded as Pivot, for which we plan to file for U.S. Food and Drug Administration (“FDA”) clearance in October 2025. Diabetes care and education specialists are crucial in offering and prescribing pumps to achieve improved clinical outcomes, and we believe they will appreciate the user-friendly design of the Pivot pump and our focus on making diabetes care simpler to learn and manage for our targeted audience of Almost Pumpers.”

Digital Health Synergies and Gamified Training

Modular Medical is not just designing hardware; it’s marrying tech and training by introducing a gamified onboarding app developed with Level Ex, scheduled to coincide with the Pivot launch. This initiative aims to simplify insulin pump adoption for the underserved “almost-pumper” population-adults managing diabetes who remain hesitant to adopt traditional insulin pump therapy, and lower barriers to advanced diabetes care. The U.S. market for the untapped “almost-pumper” is estimated to be ~$3B.

Strategic Regulatory and Market Expansion

Beyond U.S. ambitions, the company engaged BSI Group to pursue European regulatory clearance and is partnering with Nudge BG for a breakthrough automated insulin delivery system that eliminates mealtime announcements—targeting both Type 1 and the accelerating Type 2 diabetes segments. Modular Medical’s innovations align with major trends in diabetes treatment, as seen in its GLP-1 proof-of-concept study for weight loss and diabetes management.

Recently, it was reported that Eli Lilly’s (LLY) GLP-1s, Mounjaro and Zepbound outselling Novo Nordisks’s (NVO) Ozempic and Wegovy. The GLP-1 Receptor Agonist Market was also recently been valued at USD $62.86 Billion in 2025 and is believed to be set to grow at 17.5% CAGR through 2034.

Financial Strength and Capital Influx

On the financial front, Modular Medical secured $12 million in new funding earlier this year via private placement, supporting supply-chain optimization, margin improvement, and global scale-up ahead of product launches. The company’s cash position is positioning it to accelerate commercialization and ride the expanding wave of pump adoption among both clinicians and patients.

Investor Confidence and Market Outlook

Leadership remains bullish, with insiders recently increasing their equity stakes, reflecting confidence in the trajectory of the company as it approaches key regulatory catalysts and market inflection points. As Modular Medical nears FDA submission for Pivot, investors are eyeing breakthrough adoption, robust revenue potential, and sector leadership in next-generation diabetes care devices

The Sum…

In summary, Modular Medical (NASDAQ: MODD) is executing with discipline and vision, turning regulatory, clinical, and operational milestones into tangible momentum as it marches toward commercial launch in both U.S. and European markets—a high-conviction story for those seeking exposure to medtech disruption in diabetes care.

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