ARTICLE SUMMARY:
Sequel Med Tech, in collaboration with DEKA Research & Development, is preparing to launch the twiist automated insulin delivery system, a novel device that employs a “fundamentally different” mechanism of insulin delivery and is the first FDA-cleared AID to utilize Tidepool’s Loop algorithm. Although diabetes is the company’s first target, it has larger plans in the drug-delivery space.
Start-up Sequel Med Tech, based in Manchester, NH, received FDA clearance in March for a unique, wearable automated insulin delivery (AID) system called twiist and is preparing for a US launch later this year. FDA cleared for people aged six years and up with type 1 diabetes, the twiist system includes a next-generation insulin pump technology developed by DEKA Research & Development that employs a “fundamentally different” mechanism of insulin delivery capable of “directly measuring the volume and flow of insulin with every microdose.” It is also the first off-the-shelf AID to incorporate the Tidepool Loop AID algorithm, which originated as an open-source algorithm for the patient-led, do-it-yourself (DIY) AID movement.
Sequel is still in the process of integrating twiist with commercially available continuous glucose monitoring (CGM) devices (the FDA clearance was with Dexcom’s G6 CGM) but hopes to launch in the US in the second half of this year. To help ensure accessibility, it plans to bring twiist to market via the pharmacy channel and to price it in a way that makes it more affordable, according to Sequel co-founder and CEO, Alan Lotvin, MD.
