The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
Two companies presented highlights of studies that demonstrated outstanding results for novel devices at last weekend’s American Diabetes Association’s (ADA) 83rd Scientific Sessions, while Embecta Corp. and Senseonics Holdings Inc. provided updates that position them well for long-term performance. Glyconics Ltd. revealed a fingernail scanning device that simplifies screening for diabetes and Fractyl Health Inc. showed that its Revita procedure reduced blood glucose levels and promoted weight loss.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
Ascensia Diabetes Care Holdings AG aims to reduce the pain associated with continuous glucose monitoring (CGM) just a bit with a new cost structure for Senseonics Holdings Inc.’ Eversense E3 CGM. The system, which lasts a ground-breaking six months without replacement, received FDA clearance in February.
At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022.
Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.
Senseonics Holdings Inc. is one of the latest med-tech companies to release its quarterly numbers, revealing sales of $261,000, a decline of -94.3% year-over-year. That figure may have fallen below SVB Leerink Research’s estimate of $1.6 million and consensus at $1.4 million “given the company's well-telegraphed ongoing strategic review,” wrote Danielle Antalffy in a note. Still, Senseonics had some good news, which Antalffy heralded as “very positive.” That came in the form of a financial and strategic partnership with Ascensia Diabetes Care that revolves around a global commercialization and distribution agreement and a concurrent financing deal.
Trying to build out a new med-tech product category is a time-consuming and costly endeavor. Senseonics Holdings Inc. has long pursued the vision of extended-use, implantable continuous glucose monitoring. Since it was founded in 1996, the Germantown, Md.-based company has already spent roughly half a billion dollars to get there.
