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Modular Medical, Inc. (NASDAQ: MODD, $.6996) 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 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.

On June 16, Modular Medical announced its participation in the American Diabetes Association (“ADA”) 85th Scientific Sessions, that took place June 20-23, 2025, at the McCormick Place Convention Center in Chicago, Illinois. The Company featured a poster, number 783-P, titled “Elucidating the potential benefit of pump-delivered subcutaneous GLP-1R agonist: an exploratory study in the diet-induced obese mouse,” to be presented by David Maggs, MD, FRCP during the General Poster Session on Sunday, June 22, 2025, from 12:30pm to 1:30pm in the Poster Hall. The presentation highlighted data from an exploratory study evaluating the effects of pump-delivery of a short-acting GLP-1RA on weight, food intake, and glucose tolerance in a diet-induced obese (“DIO”) mouse.“We are excited to share our findings from this novel study in the DIO mouse comparing the pump delivery of exenatide to intermittent dosing of semaglutide,” said Jeb Besser, CEO of Modular Medical. “Given the high rate of gastrointestinal tolerability challenges and resultant discontinuation that is characteristic of GLP-1 therapy, we believe that a personalized approach to GLP-1 titration and dosing, including a mealtime bolus option, would give patients an opportunity to reach their treatment goals, while experiencing easier therapy initiation and a more tolerable maintenance regimen.”

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.”