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Modular Medical, Inc. (NASDAQ: MODD, $.5244) is an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target the estimated $3 billion dollar adult “almost-pumpers” market with its user-friendly and affordable design. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Their mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond “superusers” and providing “diabetes care for the rest of us.” Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com. 

On October, 28, Modular Medical announced that it is continuing to progress toward CE Mark certification under the European Union Medical Device Regulation (“EU MDR 2017/745”). As part of this process, the Company is pleased to announce the successful completion of its Stage 1 ISO 13485:2016 audit, conducted by BSI, its Notified Body and Registrar. The audit evaluated Modular Medical’s quality management system (“QMS”) for compliance with ISO 13485:2016 and alignment with EU MDR 2017/745 requirements, to confirm that the Company’s QMS is robust and well-documented, with no major nonconformances identified. “This milestone reflects the dedication of our team and our commitment to bringing innovative, patient-friendly, insulin delivery solutions to market in Europe and beyond,” stated Jeb Besser, CEO of Modular Medical. Completion of the Stage 1 audit paves the way for Modular Medical to advance to its Stage 2 audit in early 2026 – the final step before achieving the required ISO 13485 certification. In parallel, the Company will begin preparations for its CE technical documentation review under EU MDR 2017/745, which is anticipated to commence later in 2026. Successful completion of these steps is required for Modular Medical’s planned commercial launch in the European Union. The Pivot insulin delivery system is not currently cleared for sale by the U.S. Food and Drug Administration or in any other market outside the U.S.

On October 6, Modular Medical announced the appointment of David Bosshard as Head of International Operations. With two decades of expertise in scaling similar tubeless insulin delivery systems across Europe and beyond, Mr. Bosshard will drive Modular Medical’s global strategy, leveraging his success in launching blockbuster products, such as Insulet’s Omnipod and Ypsomed’s YpsoPump, to position the Company for international growth in the rapidly expanding wearable diabetes technology sector.

On Sept. 29, Modular Medical announced the exercise of certain existing warrants issued in May 2023 and March 2025 (the “Existing Warrants”) at a reduced exercise price of $0.68 per share. The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (file no. 333-271413), as amended, and Form S-3 (file no. 333-286768). In consideration for the immediate exercise of 6,504,731 Existing Warrants for cash, the Company will issue new unregistered warrants to purchase up to 3,252,366 shares of common stock (the “New Warrants”). The New Warrants will have an exercise price of $0.84 per share and will be exercisable upon issuance and will have a term equal to five years from the date of issuance. The gross proceeds to the Company from the exercise of the Existing Warrants were approximately $4.4 million, prior to deducting servicing agent fees and offering expenses. The Company intends to use the net proceeds for working capital and general corporate purposes.

On Sept. 15, Modular Medical announced Institutional Review Board (“IRB”) approval to conduct an in-house feasibility study of its next-generation Pivot insulin delivery system using sterile saline (the “Study”). Pursuant to U.S. Food and Drug Administration (“FDA”) regulations, an IRB is a group that has been formally designated to review and monitor biomedical research involving human subjects. The Study will simulate real-world conditions by delivering sterile saline to adult participants for up to 90 days to gather critical data on device usability, extended wear performance and user feedback.

On September 11, Modular Medical announced the successful completion of a clinical study with the MODD1 pump. The MODD1 was worn by nine clinicians with Type 1diabetes who currently wear a continuous glucose monitor (“CGM”) and other pumps to provide the Company with real-world experience and feedback to make further refinements for the launch of its next-generation Pivot pump product. This MODD1 study was conducted to test and refine its ease of use for converting multiple daily injectors to this system and will continue as we prepare for the Pivot launch.

On August 26, Modular Medical announced that the MODD1 product cartridge production run has been completed and its manufacturing line is being converted to production for its Pivot product.“I want to congratulate our operational team for the successful validation of our MODD1 manufacturing process and production of human use cartridges,” said Jeb Besser, CEO of Modular Medical. “We will now begin converting our cartridge line to Pivot production, and we expect it to be ready to produce cartridges for our Pivot product upon receipt of clearance from the U.S. Food and Drug Administration (the “FDA”). We expect to submit the Pivot product to the FDA for clearance in October 2025. The Pivot will be the first tubeless, removable 3 milliliter patch to be available to the consumer when it is cleared. Along with these features, the ability to scale production is a key differentiator in the pump space, especially given the much higher volumes required for a patch pump. Modular Medical’s simple, low-cost platform was designed from the ground up for high volume manufacturing.”

On August 8, Modular Medical announced its participation at the Association of Diabetes Care & Education Specialists (“ADCES”) Conference, which is being held in Phoenix, Arizona from August 8 to August 11, 2025. With over 11,000 members, the ADCES is a national network of diabetes care and education specialists working to optimize clinical outcomes for people with diabetes. “The ADCES conference is an ideal location for us to showcase our next-generation patch pump, branded as Pivot, for which we plan to file for U.S. Food and Drug Administration (“FDA”) clearance in October 2025. Diabetes care and education specialists are crucial in offering and prescribing pumps to achieve improved clinical outcomes, and we believe they will appreciate the user-friendly design of the Pivot pump and our focus on making diabetes care simpler to learn and manage for our targeted audience of Almost Pumpers,” stated Jeb Besser, CEO of Modular Medical. Modular Medical will also showcase the first playable level of the new Pivot pump gamified training module, which is being developed by Level Ex. Level Ex (powered by Relevate) is the developer of numerous medical games, including Level One, a game designed to teach the basics of caring for diabetes. Level One is endorsed by Breakthrough T1D, a leading global type 1 diabetes research and advocacy organization. Gamification has been proven to make medical training more effective, be more efficient for the clinician and dramatically improve retention of knowledge. Complexity, including support for technology, is a key issue in pump uptake and continues to serve as a barrier to adoption, impacting both the patient and provider.

On August 6, Modular Medical, Inc. announced the first human use of the MODD1 pump to deliver insulin to a person with diabetes in a real-world setting. The MODD1 is delivering insulin to a clinician with Type 1 under institutional review board approval from the United States Food and Drug Administration, which is necessary because the reusable controller line is being validated for human use.

On August 4, Modular Medical announced that the MODD1 cartridge line has been validated for human-use production in the United States. “This is an important milestone for scaling up our manufacturing infrastructure to support our commercial pilot for MODD1 and, eventually, our 3ml Pivot tubeless patch pump launch,” stated Jeb Besser, CEO of Modular Medical. “While we encountered significant delays with the initial shipment of equipment for the manufacturing line to our contract manufacturing site in Mexico, all equipment for the controller line has been installed and validation is underway. We continue to target controller line validation in October for MODD1 with the commercial pilot for MODD1 to follow immediately thereafter.” The ability to scale production is a key differentiator in the pump space, especially given the much higher volumes required for a patch pump. Modular Medical’s simple, low-cost platform was designed from the ground up for high volume manufacturing.

After the close May 28, Modular Medical announced the appointment of Jeff Goldberg to its Board of Directors. Mr. Goldberg brings decades of experience in health care, life sciences, and medical device leadership, including development of generic insulin. Mr. Goldberg began his work in medical technology alongside pioneering medical entrepreneur, and founder of MiniMed, Alfred E. Mann. Mr. Goldberg currently serves as Chairman of Lannett Company, Inc., a generic pharmaceutical manufacturer where he has helped execute a post-restructuring turnaround. During his tenure, Lannett has made significant strides in launching a generic insulin product – progress that aligns closely with Modular Medical’s commitment to innovation and affordability in diabetes care. In addition to his work at Lannett, Mr. Goldberg previously served as President and CEO within Alfred E. Mann’s incubator, IncuMed, where he oversaw multiple portfolio companies focused on drug-device combination products, including an insulin patch-pump program. His tenure with Mr. Mann’s enterprises included pivotal roles in regulatory strategy, operations turnaround, and successful exits, underscoring his ability to guide early-stage technologies to commercial viability. Mr. Goldberg also serves on the boards of several health-care and consumer-focused companies, including ATI Physical Therapy, Cano Health, and Eating Recovery Centers. He holds a JD from UCLA School of Law and an AB from Harvard College. Mr. Goldberg stated,  “Modular Medical is advancing a truly disruptive approach to insulin delivery. I’m excited to join the board and contribute to the Company’s journey toward simplifying treatment for people living with diabetes, particularly as the industry shifts toward more accessible and patient-friendly solutions.”