Modular Med Inc Stock Price, News & Analysis

Modular Medical (NASDAQ:MODD) announced on December 9, 2025 that it has commenced an underwritten public offering of shares of its common stock and warrants to purchase common stock. The common shares and warrants will be issued separately but sold together in the offering. Modular Medical expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the aggregate shares and/or warrants. The offering is being made from an effective Form S-3 shelf registration (File No. 333-287313) declared effective by the SEC on May 22, 2025. Newbridge Securities Corporation is the sole bookrunner. The offering is subject to market conditions and may not be completed as proposed.

Modular Medical (NASDAQ:MODD) announced IRB approval on November 17, 2025 to run an in-house study delivering insulin with its next-generation Pivot™ tubeless patch pump to adult participants wearing continuous glucose monitors.

The Study will simulate real-world conditions to collect device function, usability data, and participant feedback while the company awaits FDA feedback on a recent Pivot 510(k) submission. The Pivot system is not currently cleared for sale by the FDA.

Modular Medical (NASDAQ:MODD) submitted its next-generation Pivot tubeless insulin patch pump for FDA 510(k) clearance on November 14, 2025 and expects to commence commercial launch in Q1 2026 upon clearance. The Pivot features a 3 ml removable reservoir, a two-part detachable design (removable for showering/activities) and bolus capability without a separate controller. Manufacturing conversion is validated and on track for launch readiness. The company noted an FDA submission delay due to the U.S. government shutdown and expects initial FDA questions in Q4 2025. The Pivot is not currently cleared for sale by the FDA.

Modular Medical (Nasdaq:MODD) announced successful validation of its Pivot controller line, a manufacturing milestone supporting planned Q1 2026 commercial launch for the Pivot tubeless, removable 3 milliliter patch pump. The company said the validated line demonstrates readiness for high-volume human-use production and aims to address a roughly $3 billion market for adult “almost-pumpers” with an affordable, easy-to-learn design. Modular Medical described the validation as derisking its path to commercial manufacturing, while noting Pivot is not currently cleared by the FDA and the launch remains subject to forward-looking risks.

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.