San Francisco, California, January 10, 2020 – Thermalin Inc., a privately held biotechnology company with its main laboratories in Cleveland, Ohio today announced the completion of a working prototype system for its StampPump, a postage-stamp-sized glucose management system for people with type 1 (T1D) or type 2 diabetes mellitus (T2D). The prototype system will be presented to prospective device and pharmaceutical partners at meetings scheduled during and after the 38th Annual J.P. Morgan Healthcare Conference.
When it reaches the market, StampPump will be a wearable, skin-adhering, miniaturized (36 x 33 x 6.5 mm, 8 g) closed-loop insulin delivery system that is easily placed using a disposable applicator, delivers insulin for a full week, and is discarded after use. The device will have multiple sensors onboard to improve closed-loop control and will also be connected via Bluetooth to both an external continuous glucose monitor (CGM) and a mobile device and through that device to the cloud. StampPump is only possible because Thermalin has created and is developing T-1123, a novel insulin analog that is extremely stable (projected to be stable at 30 °C/86 °F for at least six times as long as existing pump insulins) and ultra-rapid acting even at five times normal insulin concentration–both firsts for any insulin formulation. These characteristics allow StampPump to carry up to 600 units of the T‑1123 insulin analog in a 1.2 ml reservoir that is filled at the time of manufacture.
Thermalin’s StampPump prototypes to be presented include 3D mechanical prototypes of the applicator and wearable device as well as a demonstration system that contains working versions of the sensing, computing, insulin-storing, and pumping elements that will be part of the final system. The microprocessor of the demonstration system receives glucose data via Bluetooth from a Dexcom CGM emulator device to determine how much insulin to deliver using a microelectromechanical systems (MEMS)-based micropump on a silicon chip. These prototypes were developed using small business (SBIR) grants received from NIH/NIDDK and DARPA.
Dwight Meglan, Ph.D., Thermalin’s Chief Engineer, said “These prototypes represent the end result of a year’s worth of engineering and demonstrate the feasibility of successfully developing this breakthrough device.”
Thermalin is developing next-generation insulin solutions for people with T1D and T2D. Thermalin’s programs include (1) clinical candidate T-1123—a stabilized insulin analog that is ultra-rapid at both U-100 and U-500, (2) StampPump—a miniaturized glucose management system that will deliver the concentrated, ultra-rapid-acting formulation of T-1123, (3) basal and mix insulins that never need refrigeration, and (4) a glucose-responsive insulin that protects against hypoglycemia by losing potency when glucose levels are below normal. For more information, please visit www.thermalin.com. For background on insulin therapy for diabetes, please visit www.thermalin.com/background.