Modular Medical (NASDAQ: MODD) recently ramped up the news cycle with a flurry of regulatory milestones, engineering feats, and even a bit of C-suite global musical chairs—all tailored to make insulin delivery as easy as changing your socks (and almost as affordable).
Modular’s Latest Feats: FDA Race Initiated Post Shutdown
Modular Medical’s engineers just fired the starting gun on the FDA clearance race by submitting their next-generation Pivot tubeless insulin patch pump for 510(k) review as of this morning, November 14, 2025. The device, a “can’t-believe-it’s-not-wearable” patch, sports a 3ml removable reservoir and a detachable design. It seems to be perfect for adults who want to ditch hoses and controllers and finally shower—pump-free—without risking market volatility or their dignity. Jeb Besser, CEO of Modular Medical stated “The Pivot submission is an exciting milestone in our mission to deliver a differentiated tubeless patch pump experience to those who want a simple pump to manage the treatment of diabetes. Our Pivot patch pump offers a 3 ml reservoir, the flexibility of removing the pump and the ability to bolus without a separate controller, all without sacrificing the accuracy, communications and clinical reporting advantages of a true electronic pump. Convincing a person who requires daily insulin to adopt a pump, instead of multiple daily injections, can improve the patient and clinical experience, while potentially reducing healthcare costs and improving long-term patient outcomes. We believe our two-part Pivot patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated user experience and represents a unique approach to this market. On behalf of the board of directors, I would like to thank the entire Modular Medical team, and all of our stakeholders and shareholders for their support to allow us to achieve this major milestone. With the end of the U.S. government shutdown, we have now been able to submit the Pivot for 510(k) clearance to the FDA. We expect to receive initial questions from the FDA this quarter and are proceeding in parallel with the manufacturing preparation to be able to commercially launch our Pivot product upon clearance.”
A Grand Vision, or Just Patchwork?
Not only does Modular Medical claim the Pivot’s design is as simple as a Wall Street bonus structure, it’s going after the “almost-pumpers”—an untapped $3 billion diabetes market segment. The company teases a Q1 2026 commercial launch “upon clearance,” with the necessary disclaimer that FDA reviewers, like Wall Street analysts, are unpredictable.
Production: From Factory Floor to Patient Door
In a manufacturing triumph, Pivot cartridges controller validation was completed. Modular’s team boasted that this milestone “derisks” the path to commercialization. The rigorous process included a Stage 1 ISO 13485:2016 audit with no major nonconformances, an achievement that would make even an SEC examiner smile, or at least raise an eyebrow.
International Moves and Boardroom Shuffles
The company appointed David Bosshard as the new head of international operations, aiming to make Pivot a globe-trotter after charming regulators abroad. Management also touted ongoing progress toward a CE Mark for European entry, planning further audits through 2026. Rumor has it, if the Pivot pump could post on Instagram, it’d be hashtagging “#globalsupplychain”.
Clinical and Real-World Trials: Field-Tested by Docs
MODD’s clinical studies included real-world usage by nine savvy clinicians with Type 1 diabetes. Their feedback is fueling final tweaks before the big Pivot launch. Plus, a new IRB-approved feasibility study is set to test extended wear performance, because even pumps deserve a spa day.
Financing the Future
Behind every headline is a cash register: Modular Medical recently scored gross proceeds of ~$4.4M from the exercise of the Existing Warrants. Investors, clearly believers in patchwork solutions, see the potential to shake up a market used to patchy outcomes.
The Sum…
With diabetes prevalence rising globally, the Company believes it is well positioned to capture significant market share through its innovative patch pump technology. If Modular Medical succeeds, it might just give diabetes care a much-needed injection of simplicity—and the boardroom some reason to break out the (diet) champagne. In the meantime, MODD’s press office is believed to be keeping the insulin (and the news) flowing.
The Sources
- https://finance.yahoo.com/news/modular-medical-submits-pivot-tubeless-140000932.html
- https://www.morningstar.com/news/accesswire/1102238msn/modular-medical-submits-pivot-tubeless-insulin-patch-pump-for-fda-510k-clearance
- https://www.nasdaq.com/press-release/modular-medical-announces-ongoing-progress-obtain-ce-mark-2025-10-28
- https://www.drugdeliverybusiness.com/modular-medical-new-head-international-operations/
- https://www.biospace.com/press-releases/modular-medical-receives-irb-approval-for-pivot-insulin-delivery-system-feasibility-study
- https://www.biospace.com/press-releases/modular-medical-announces-completion-of-clinical-study-of-modd1-pump
- https://markets.financialcontent.com/stocks.theolympian/quote/news?CurrentPage=1&Symbol=NQ%3AMODD
- https://www.nasdaq.com/market-activity/stocks/modd/press-releases
- https://finance.yahoo.com/quote/MODD/press-releases/
- https://seekingalpha.com/symbol/MODD/press-releases
- https://uk.investing.com/news/company-news/modular-medical-submits-fda-application-for-tubeless-insulin-patch-pump-93CH-4372237
- https://money.tmx.com/en/quote/MODD:US/news
- https://ir.modular-medical.com/press-releases.php
- https://www.otcmarkets.com/stock/MODD/news/Modular-Medical-Appoints-David-Bosshard-to-Lead-its-International-Expansion-for-the-Pivot-Insulin-Delivery-System?e&id=3325150
- https://www.otcmarkets.com/stock/MODD/news/Modular-Medical-Announces-Ongoing-Progress-to-Obtain-CE-Mark?e&id=3340736
- https://www.cnbc.com/quotes/MODD
