Business Description

of the patient to our product, prescription assistance, establishing insurance reimbursement, streamlined training and day-to-day use with strong clinical support, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” to expand the category into the mass market. Our product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets for those individuals requiring multiple daily doses of insulin. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration, or the FDA, for our initial insulin pump product, the MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. In August 2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient. In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot™, and began converting our cartridge manufacturing line to Pivot production. Our Pivot product is a tubeless insulin delivery system that integrates the infusion set under the removable pump into a true tubeless patch. The Pivot is expected to provide us with cost and usability improvements and improved manufacturability, allowing our marketing to be focused on low cost, ease of use and learnability. We submitted a 510(k) premarket notification to the FDA for our Pivot product in November 2025, and, in April 2026, we received FDA clearance to market and sell our Pivot pump in the United States. We do not intend to commercialize our MODD1 product. In June 2026, we announced commercial availability, and commenced initial shipments of, our Pivot insulin delivery system in the United States. We intend to expand commercial activities across metropolitan markets by late 2026. We also intend to obtain Conformite Europeenne , or CE, mark clearance for our Pivot product, which would allow us to market and sell in Europe and certain other international markets. We expect to obtain CE mark clearance by the second quarter of 2027. Differentiation We believe that there are a number of shortcomings and issues with currently available insulin pumps that prevent a substantial number of people, estimated to be almost two-thirds of individuals with diabetes, who require insulin on a daily basis from choosing an insulin pump to treat their diabetes. We believe that, by tailoring our insulin pump to address such factors, we can expand the scope and adoption rate of insulin pump usage by the less capable, less motivated sector of the market. We believe that to achieve broader market acceptance, an insulin pump must be easier to learn to use, be less time-consuming to operate, more intuitive to both patients and physicians, and meet the standards for coverage by insurance providers so that co-payments required from patients are affordable and the hurdles to insurance coverage are significantly reduced. Among the more prominent issues are: ● Complexity: Many existing pumps are highly complex and require significant technical expertise to use effectively. We believe such pumps were designed for “super users,” who have high levels of motivation and technical competence. The complexity of pumps can be daunting to less technically inclined, less motivated users. ● Cumbersome : We believe that a majority of existing pumps are bulky and difficult to manage, requiring a means of carrying the pump around and up to 48 inches of tubing to the injection site to connect the catheter to a pump. The tubing and the cartridge, which holds the insulin, must be replaced every few days. This requires users to carry spare parts and other equipment adding to the difficulty of using the pump. In comparison, our product only requires a cartridge change every few days. ● Cost : Costs associated with insulin pump therapy can be high and prohibitive, especially for those on fixed or limited incomes. These costs vary by pump and insurance coverage, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to possible additional co-payments on consumables, can easily place current pumps out of reach for many patients. The leading patch pump on the market today also discards all the electronics required for pumping and communication every three days, creating a higher cost architecture and significant waste.…