Modular Medical, Inc. reports developments tied to its diabetes-focused medical device business and its Pivot tubeless insulin patch pump. The company is a development-stage insulin delivery technology company using patented technologies to support insulin pump adoption among people with diabetes. Pivot is described as a two-part tubeless patch pump with a removable 3 mL reservoir, disposable battery, and smartphone connectivity for bolus and monitoring.
Recurring MODD news includes FDA 510(k) clearance for Pivot, manufacturing validation, commercial-readiness updates, investor presentations, Nasdaq listing compliance, reverse stock split actions, shareholder voting matters, capital-structure disclosures, governance updates, and operating and financial results.
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.
Modular Medical (NASDAQ:MODD) has appointed Jeff Goldberg to its Board of Directors. Goldberg brings extensive experience in healthcare, life sciences, and medical device leadership, particularly in generic insulin development. He currently serves as Chairman of Lannett Company and has a notable background working with MiniMed founder Alfred E. Mann. As President and CEO at IncuMed, Mann's incubator, Goldberg oversaw drug-device combination products, including an insulin patch-pump program.
Goldberg's appointment aligns with Modular Medical's focus on developing user-friendly and affordable insulin delivery technology, as the company has already received FDA clearance for its patch pump designed for "almost-pumpers". His experience in regulatory strategy, operations turnaround, and successful exits positions him well to contribute to Modular Medical's mission of simplifying diabetes care worldwide.
Modular Medical (NASDAQ:MODD) has announced an upcoming webinar presentation featuring CEO Jeb Besser, scheduled for May 28, 2025, at 9 a.m. Pacific / 12 p.m. Eastern. The presentation, titled "Making Diabetes Management Simpler: The New Era of Insulin Therapy," will focus on the company's FDA-cleared patch pump technology designed for "almost-pumpers." The company addresses a significant market opportunity, with 1.9 million Type 1 Diabetes patients in the US, where currently only one-third use insulin pumps despite 100% requiring daily insulin injections. The event will be hosted by Tribe Public's Managing Member John F. Heerdink, Jr., and will include a Q&A session.
Modular Medical (NASDAQ:MODD), a company specializing in insulin delivery technology, has announced its participation in the upcoming Lytham Partners Spring 2025 Investor Conference on May 29, 2025. The virtual event will feature a webcast presentation at 11:00 a.m. ET, which will be accessible through the conference website and available for replay afterward.
CEO Jeb Besser will conduct one-on-one meetings with investors throughout the conference. The company, known for developing the first FDA-cleared patch pump specifically designed for adult "almost-pumpers" with user-friendly and affordable features, invites interested parties to arrange meetings through Lytham Partners.