U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
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.
The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance.
At the American Diabetes Association (ADA) Annual Meeting this weekend, Medtronic plc provided an update for investors and showcased results from its devices that all demonstrated better time in range for users. The Dublin-based company provided strong results with the U.S. FDA warning letter now behind it and the 780G Minimed pump and Guardian 4 sensor launches well underway.
Dexcom Inc. rolled out its plans for 2024 and 2025 at an Investor Day event held at the beginning of the American Diabetes Association Annual Meeting in its hometown of San Diego on June 23. The company is looking to expand from diabetes into metabolic health more broadly and previewed several new products designed to appeal to a wider market.
Novo Nordisk A/S has entered into exclusive negotiations for a controlling stake in Biocorp SA, suppliers of Mallya, a Bluetooth-enabled smart add-on device for insulin pen injectors. The takeover will be phased over several stages. Novo Nordisk has initially negotiated with Bio Jag SAS, Biocorp’s principal shareholder, to purchase its entire stake in Biocorp, representing 45.3% of the share capital and 62.19% of the voting rights. Certain minority shareholders, including Nyenburgh Holding BV, Greenstock EIG and Vatel Capital SAS, who together account for 19% of Biocorp’s shares, have agreed to transfer their shares to Novo Nordisk once acquisition of the Bio Jag stake is complete.
A one-hour procedure pioneered by Endogenex Inc. could make insulin use obsolete in people with type 2 diabetes. The recellularization via electroporation therapy (ReCET) procedure uses a specialized catheter to deliver electric pulses to the duodenum. Recently presented results of the EMINENT trial showed that 86% of patients who underwent the procedure and then began treatment with semaglutide were able to discontinue insulin use at six months and remain off insulin for at least a year following the procedure.
Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company.
In collaborating with Novo Nordisk A/S, privately held Aspect Biosystems Ltd. entered its biggest ever deal that could bring in more than $2.6 billion while advancing its 3D, bioprinted tissue therapeutics technology. The two companies will collaborate to develop up to four diabetes and/or obesity products, a Novo specialty, using implantable bioprinted tissues to replace, repair or supplement human biological functions. The initial target will be type 1 diabetes.