Modular Medical Sets New Benchmarks in Insulin Delivery Innovation – ($MODD $TNDM)

By John F. Heerdink, Jr.

Modular Medical (NASDAQ: MODD) is making a series of dynamic moves in diabetes care, boasting both technological milestones and strategic leadership shifts as it capitalizes on the untapped “almost-pumper” market—adults managing diabetes who remain hesitant to adopt traditional insulin pump therapy. The U.S. market for the untapped “almost-pumper” is estimated to be ~$3B. HCPs fairly consistently indicated that about 25% of their MDI population are “almost pumpers”, meaning
that they have considered going on a pump, understand pump therapy benefits, but want something
simpler that doesn’t have all the “bells and whistles”.

Pivoting Toward Simplicity with Next-Gen Patch Pumps

Announced at the Association of Diabetes Care & Education Specialists (ADCES) conference in Phoenix this August, the company’s new Pivot tubeless patch pump aims squarely at simplifying insulin delivery. Compared to traditional pumps, Pivot emphasizes a user-friendly interface integrated with smartphone controls and relies on a single-use, disposable battery, thereby eliminating complexities that deter broader adoption. The pivotal FDA submission is scheduled for October, with commercial rollout expected in 2026. This launch builds upon the success of Modular’s MODD1 patch pump, which received FDA clearance nearly a year ago. MODD1 employs microfluidics for low-cost, precise insulin delivery and is tailored for easy prescription—featuring a 300-unit reservoir and intuitive cell phone monitoring. The MODD1 cartridge line has been fully validated for human-use production in the United States, overcoming previous manufacturing delays, and is heading for scaled commercial deployment.

Clinical Milestones and Study Insights

Modular Medical crossed a critical developmental threshold in August by successfully delivering insulin via MODD1 to a clinician with Type 1 diabetes, under FDA institutional review board oversight. This real-world use signals the transition from prototype phase to clinical application, with plans to expand trials across multiple sites within weeks. The shared controller platform powering both MODD1 and Pivot allows cost and development efficiencies.

Further, in June, the firm presented new data supporting pump-delivered GLP-1 agonists at the American Diabetes Association’s 85th Scientific Sessions. The study highlighted the pump’s potential to mitigate the gastrointestinal side effects common to GLP-1 therapies and demonstrated notable weight-lowering effects in animal models—reinforcing the versatility of its device platform.

Near Term Milestones From MODD’s Latest Powerpoint Presentation

Manufacturing validation for commercial MODD1 production (Q3 2025)
- Cartridge (Completed!)
- Controller second half of quarter
ADCES Pivot coming soon introduction (August 7-8, 2025, Completed!)
Special 510(k) Pivot submission (September/October 2025)
Limited commercial use of MODD1 (September/October 2025)
Pivot commercial launch (Q1 2026)

Numerous Industry Validations

Manufacturing partnership with Phillips-Medisize, a $4 billion annual revenue corporation.
Former CEO of Insulet, Duane DeSisto on Board of Directors.
Partnered with Nudge BG on easier to use insulin delivery algorithm that should eliminate
meal announcement and carbohydrate counting. Nudge BG founder was lead author of IP
sold to Insulet for $23M.
Collaboration with Glooko for patient data upload-download. Glooko’s platform has been
deployed in 8,000 clinical locations in 30 countries.
Paul DiPerna, Modular Founder, Chairman & CTO- Led over 10 projects to FDA approval
- Founder Tandem Diabetes (TNDM:NAS)
  - Designer and lead developer of t:slim pump, a leading insulin pump in type 1 diabetes

Financial Traction and Insider Confidence

Securing $12 million via a private placement in March was a pivotal move for Modular Medical, underpinning supply-chain optimization and margin improvements for MODD1 ahead of broad commercial rollout. The funds were also earmarked for ongoing regulatory filings (MODD1 and CE mark efforts for global reach) and general operational needs. Insider participation in this raise signals internal confidence in the company’s trajectory, especially with several directors and officers acquiring units directly.

Market Signals

Modular Medical’s multi-pronged momentum—combining product innovation, validation, clinical progress, and financial fortification—positions it as a player to watch in the diabetes device sector, particularly as healthcare continues to favor platforms that blend simplicity, cost efficiency, and robust clinical data.

The Technicals

Despite recent volatility, Modular Medical’s stock reportedly shows periodic short-term technical buy signals, with increased trading volume and insider buying reinforcing investor sentiment. Analysts note ongoing challenges including operating losses and dilution risks, but the favorable cash-to-debt ratio and healthy current liquidity provide a buffer for near-term execution.

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