Modular Med Inc Stock Price, News & Analysis

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) will present research data at the American Diabetes Association's 85th Scientific Sessions, taking place June 20-23, 2025, in Chicago. The company will showcase a poster (783-P) examining pump delivery of GLP-1R agonist in diet-induced obese mice, comparing pump-delivered exenatide to intermittent semaglutide dosing. The study aims to address GLP-1 therapy challenges, particularly gastrointestinal tolerability issues that often lead to treatment discontinuation. Modular Medical, known for its FDA-cleared patch pump designed for "almost-pumpers," suggests that personalized GLP-1 titration and dosing, including mealtime bolus options, could improve treatment outcomes and patient tolerance. The presentation is scheduled for June 22, 2025, from 12:30 PM to 1:30 PM in the Poster Hall.

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.

Modular Medical (Nasdaq:MODD) has secured $12 million through a private placement of units, priced at $1.92 per unit. Each unit comprises two common stock shares and one warrant to purchase common stock at $1.12 per share, exercisable for four years. The company will issue 12,495,312 shares and warrants for 6,247,656 shares.

The funding will support supply-chain optimization and margin improvement for their MODD1 product ahead of broad commercial launch. Additionally, the company plans to submit a tubeless version of MODD1 to the FDA in Q3 2025 and pursue CE mark certification for overseas markets.

A concurrent direct placement offering of up to 446,429 additional units aims to raise up to $500,000 under the same terms. Company officers and directors will participate, purchasing 374,478 units at the same price as other investors. Newbridge Securities served as the sole placement agent.

Modular Medical (NASDAQ:MODD) has engaged BSI Group as its notified body to pursue CE Mark clearance for its MODD1 insulin pump in the European market. The company, which has already secured FDA clearance for its patch pump, is targeting Q1 2026 for European regulatory approval.

Unlike the U.S. process, EU clearance requires a third-party notified body to conduct audit steps and certify compliance with CE mark standards. Once obtained, the CE mark allows the device to be marketed and sold in Europe and other regions that recognize this certification.

The MODD1 aims to address European market challenges including high pump costs, environmental impact, and usage complexity. The company positions its device as a solution offering simplicity, cost-effectiveness, lower carbon footprint, reusable electronics, and an attractive form factor to encourage adoption among multiple daily injectors.