Glucomodicum Oy tapped contract manufacturer Phillips-Medisize LLC to develop its needle-free continuous glucose monitor (CGM), Talisman, which is based on Glucomodicum’s magnetohydrodynamic (MHD) platform technology that measures glucose levels from interstitial fluid. The wearable CGM – the size of a smartwatch – combines MHD technology with biosensors and algorithms so health care professionals can monitor patients’ diabetes.

Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.

Merck KGaA has signed an agreement with French company Biocorp SA to develop a version of its Mallya smart device for monitoring human growth hormone (HGH) treatment. Mallya is a clip-on device for pen injectors that collects the dose and time of each injection and transfers the information in real time to a companion software using Bluetooth technology. The device is CE marked (Class IIb) and was first launched in France in 2020.

The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.

Rokit Healthcare Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Dfurege, its artificial organ platform to treat diabetic foot ulcers. “We hope that having a South Korean approval for this platform will be a boost for our planned IPO,” Seok Hwan You, CEO at Rokit, told BioWorld.

Smart Meter LLC has launched its Iglucose blood glucose monitoring system for managing gestational diabetes. According to the CDC, every year, 2% to 10% of, or 700,000, pregnancies in the U.S. are affected by gestational diabetes, with incidences increasing worldwide. Usually tested around week 24 of pregnancy, gestational diabetes can cause severe complications in women including preeclampsia, hypoglycemia and babies born large for gestational age.

Better Therapeutics Inc. has closed on a $50 million debt facility that advances the company’s push into the market for digital therapeutics for type 2 diabetes, a market that seems poised to expand drastically in the next few years. The $50 million debt facility by Hercules Capital is just one of several important financial benchmarks for Better, which is also planning to go public thanks to a merger with a special purpose acquisition company (SPAC) that may raise well in excess of $100 million, all of which seem to promise a bright future for Better and those with type 2 diabetes.

Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.

PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.

Fractyl Health Inc. closed $100 million in new financing Wednesday to expand and accelerate clinical development efforts to reduce dependence on insulin among type 2 diabetes patients. The startup, which changed its name from Fractyl Laboratories Inc., will use the financing to support additional late-stage clinical studies for determining the potential of its Revita DMR.