Modular Med Inc Stock Price, News & Analysis

Modular Medical (Nasdaq:MODD) reported progress toward CE Mark certification for its Pivot insulin delivery system, following successful completion of a Stage 1 ISO 13485:2016 audit by BSI with no major nonconformances identified.

The company plans a Stage 2 audit in early 2026, the final step before ISO 13485 certification, and will begin preparations for a CE technical documentation review anticipated later in 2026. Successful completion of these steps is required for Modular Medical's planned commercial launch in the EU.

The Pivot system is not currently cleared for sale by the U.S. FDA or in any market outside the U.S.

Modular Medical (NASDAQ:MODD) appointed David Bosshard as Head of International Operations to accelerate global rollout of its next‑generation Pivot insulin delivery system. Bosshard brings two decades of experience launching tubeless patch pumps and previously helped grow Omnipod users to nearly 70,000 and launch YpsoPump across 20+ countries. Modular Medical is advancing Pivot through U.S. and CE Mark regulatory processes while building on its FDA‑cleared MODD1 pump and targeting the >$3 billion adult "almost‑pumpers" market. The Pivot system is not currently cleared for sale by the FDA. The company warned that regulatory, manufacturing, market acceptance, and other risks could affect outcomes.

Modular Medical (NASDAQ:MODD) has secured approximately $4.4 million in gross proceeds through the exercise of existing warrants at a reduced price of $0.68 per share. The company issued new unregistered warrants to purchase up to 3,252,366 shares at $0.84 per share, exercisable for five years.

The company targets the $3 billion adult "almost-pumpers" diabetes market with its Pivot pump technology. The funds will be used for working capital and general corporate purposes as Modular Medical pursues FDA clearance and commercialization of its Pivot product, which aims to provide affordable and user-friendly insulin delivery solutions.

Modular Medical (NASDAQ:MODD) has received IRB approval to conduct a feasibility study for its next-generation Pivot insulin delivery system. The study will evaluate the device's usability and extended wear performance by delivering sterile saline to adult participants for up to 90 days.

The Pivot pump builds upon MODD's FDA-cleared first-generation MODD1 patch pump, targeting the $3 billion adult "almost-pumpers" diabetes market. The company plans to use study insights to refine the Pivot pump before its anticipated 510(k) submission to the FDA in October 2025. The study aims to assess usability, identify wear challenges, and collect participant feedback to optimize design for everyday diabetes management.

Modular Medical (NASDAQ:MODD) has successfully completed a clinical study of its MODD1 insulin pump. The study involved nine clinicians with Type 1 diabetes who currently use CGM and other pumps, providing real-world experience and feedback for the company's next-generation Pivot pump development.

The MODD1 pump, which is the first FDA-cleared patch pump specifically designed for the $3 billion adult "almost-pumpers" market, focuses on user-friendliness and affordability. The company plans to submit its Pivot pump to the FDA for clearance in October 2025.

Modular Medical (NASDAQ:MODD) has announced the successful completion of its MODD1 cartridge production with over 6,000 units manufactured. The company is now transitioning its manufacturing line to produce cartridges for its upcoming Pivot product, which is expected to be submitted for FDA clearance in October 2025.

The Pivot will be pioneering as the first tubeless, removable 3 milliliter patch pump in the market. The company's manufacturing platform was specifically designed for high-volume production, addressing the increased demand requirements for patch pumps. Product launch is anticipated in Q1 2026, targeting adult "almost-pumpers" with its user-friendly and affordable design.

Modular Medical (NASDAQ:MODD) announced its participation at the ADCES Conference in Phoenix, where it will showcase its next-generation Pivot patch pump. The company plans to file for FDA clearance of the Pivot pump in October 2025.

In a significant development, MODD is collaborating with Level Ex to develop gamified training modules for the Pivot pump. Level Ex, known for creating the diabetes management game 'Level One', will integrate pump training into their platform. The training modules are expected to launch alongside the product in 2026.

The initiative aims to address pump adoption barriers through gamified learning, making diabetes management more accessible and user-friendly for "almost-pumpers". A preview trailer of the gameplay is available on Modular Medical's website.

Modular Medical (NASDAQ:MODD) has achieved a significant milestone with the first human use of its MODD1 insulin pump in a real-world setting. The device, which received FDA clearance, is specifically designed for the estimated $3 billion adult "almost-pumpers" market.

Under FDA institutional review board approval, the MODD1 pump is currently delivering insulin to a clinician with Type 1 diabetes. The company plans to expand testing to multiple clinicians across multiple sites in mid-August 2025. The MODD1's pump controller module, which is identical to their tubeless Pivot model, has successfully demonstrated insulin delivery capabilities.

Modular Medical (NASDAQ:MODD) has achieved a significant milestone by validating its MODD1 cartridge line for human-use production in the United States. The line has been operational since early July and will continue production until late August before transitioning to Pivot manufacturing.

The company's CEO Jeb Besser confirmed that despite initial equipment shipment delays to their Mexican manufacturing site, the controller line installation is progressing with validation expected in October 2025, followed by the MODD1 commercial pilot launch. The company's insulin delivery platform is specifically designed for high-volume manufacturing, targeting adult "almost-pumpers" with its user-friendly and affordable design.