Allurion Technologies (NYSE:ALUR) today announced the relaunch of its Allurion Balloon in France following regulatory clearance to resume sales. Natick Massachusetts–based Allurion develops the AI-powered gastric balloon for weight loss. The swallowable balloon requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying […]
Weight loss
Fractyl Health announces layoffs as it pivots to gene therapy
Fractyl Health (Nasdaq:GUTS) wants to focus more on certain therapies, leading the company to cut nearly a fifth of its entire workforce. Our sister site, Drug Delivery Business News, reports today that Fractyl plans to pause investment in its Revita programs for type 2 diabetes to extend its cash runway through 2026. Revita, a diabetes reversal […]
Allurion submits weight loss balloon modules to the FDA for premarket approval
Allurion Technologies (NYSE:ALUR) announced today that it submitted three modules for its weight loss balloon to the FDA for premarket approval (PMA). Natick, Massachusetts-based Allurion expects to file the fourth and final module of the PMA early next year. That module contains clinical data from the company’s AUDACITY trial. AUDACITY evaluates the balloon in 550 […]
Teleflex says data shows enhanced outcomes with its Titan SGS stapler
Teleflex today announced data from a retrospective analysis linking its Titan SGS stapler to enhanced outcomes. Wayne, Pennsylvania-based Teleflex said the data demonstrated improved clinical outcomes and significant procedural efficiency benefits. The analysis compared the Titan SGS stapler to multi-fire surgical staplers in patients undergoing laparoscopic sleeve gastrectomy (LSG). Five surgeons at a Corewell Health […]
Allurion could face NYSE delisting
Allurion Technologies (NYSE:ALUR) announced that it received notice from the New York Stock Exchange that it fell out of compliance with listing standards. The NYSE notified Allurion that its stock’s average closing price fell below $1 per share over 30 consecutive trading days ending Aug. 8. This notice does not result in the immediate delisting […]
Allurion pulls weight loss balloon from the French market
Allurion Technologies (NYSE:ALUR) announced today that it suspended sales of its Allurion Balloon from the market in France. The company agreed to suspend sales following a request from the National Medicines Safety Agency (ANSM) in the country. It now proceeds with the withdrawal of its devices from the market, pending the implementation of an action […]
Vivani expects to start long-term GLP-1 implant trial this year
Vivani Medical (Nasdaq:VANI) today announced that it expects to initiate the first clinical study of its long-term GLP-1 implant this year. The company anticipates a fourth-quarter start for its NPM-115 program in Australia, pending regulatory clearance there. This program looks at the investigational six-month GLP-1 implant for chronic weight management. The company intends to evaluate […]
Allurion study says balloon delivers 22% weight loss at one year
Allurion (NYSE:ALUR) today announced data highlighting the success of its balloon technology for weight loss. Natick Massachusetts–based Allurion develops a gastric balloon for weight loss. The swallowable balloon requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying and passing out naturally. Allurion […]
Allurion appoints new chief operating officer
Allurion (NYSE:ALUR) today announced it appointed Ojas Buch as chief operating officer, effective immediately. Buch will lead the company’s research and development, manufacturing and operations, quality and regulatory, business development, and innovation functions. The company said he will provide strategic and execution-focused guidance to help the company achieve major milestones for its Allurion Gastric Balloon. “We […]
Click Therapeutics buys shuttered Better Therapeutics’ assets
Click Therapeutics announced today that it acquired the assets of Better Therapeutics to accelerate its digital therapeutic development initiatives. Better Therapeutics’ assets include digital therapeutics for obesity and cardiometabolic disease. The company offered the AspyreRx (BT-001) FDA-authorized prescription digital therapeutic (PDT) for type 2 diabetes. Its assets also include BT-004, a liver disease therapeutic that […]
Allurion closes $48 million financing
Allurion (NYSE:ALUR) announced today that it closed a financing of convertible senior secured notes worth $48 million. The company entered into the financing with certain entities managed by RTW Investments. It intends to use proceeds to repay obligations under its existing term loan with Fortress Credit Corp. This reduces the company’s interest expense and increases […]
