Dexcom Inc. ends 2022 on a high note with broad clearance from the U.S. FDA for its G7 continuous glucose monitoring system (CGM). The long-awaited 510(k) clearance encompasses use in people with all types of diabetes age two and older, positioning Dexcom to take advantage of expanded coverage of CGMs to include individuals on basal insulin-only for Medicare beneficiaries as proposed by CMS in October.
Medtronic plc’s insulin pump adds more than six hours to the time-in-range for people with type 1 diabetes compared to the current standard of care, a recently published study found. The closed loop system also provides a far simpler method for controlling blood glucose levels compared to the multiple daily insulin injections and intermittent scans from a continuous glucose monitor widely employed today. The Adapt study results appeared in Lancet Diabetes & Endocrinology on Sept. 1.
A rash of recent announcements in the diabetes market speak to the brisk pace of developments and keen competition in the field. Dexcom Inc. reported good news in the U.K. and Europe, offset by delays in the U.S., while Insulet Corp. gave investors assurance that it was moving full speed ahead in the release of its Omnipod artificial pancreas system. On the pharma side, Arecor Therapeutics plc signed a contingent agreement to acquire Tetris Pharma Ltd. and commercialize Ogluo in the U.K., E.U. and other countries.
Microtech Medical (Hangzhou) Co. Ltd. raised around HK$1.98 billion (US$254.53 million) via its listing on the Hong Kong stock exchange, becoming the latest in a flood of med-tech companies listing in the city.
Commercial continuous glucose monitors (CGMs) require some access to a patient’s blood, typically through tiny needles embedded in a wearable patch sensor. But Movano Inc. is working to develop a CGM that is based on radio frequency technology to monitor glucose levels via a noninvasive, external wearable, likely in a form factor akin to a watch or a wrist-worn fitness wearable.
The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.
Royalty deals by an investor into a particular pharmaceutical company program are not unheard of. This structure allows the investor to secure a portion of that specific anticipated upside, while enabling the pharma to fully fund R&D for that program without having to sacrifice other priorities to do so.
