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 […]
Implants
Roche, Genentech to reintroduce drug-eluting eye implant in U.S. following 2022 recall
Roche subsidiary Genentech today reintroduced its Susvimo therapy for delivery via ocular implant in the U.S. following a recall. The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. […]
Reflow Medical enrolls first patient in coronary sirolimus-eluting retrievable scaffold system study
Reflow Medical announced that investigators enrolled the first patients in a trial of its Spur sirolimus-eluting retrievable scaffold system. DEEPER CORONARY evaluates the Spur Elute stent as a primary treatment for in-stent restenosis (ISR) of the coronary arteries. Spur Elute offers a treatment by transferring a proprietary drug formulation to the diseased lesion without leaving […]
The biggest stories from the American Diabetes Association (ADA) 2024 Scientific Sessions
The American Diabetes Association took to Orlando, Florida, the past few days for its 84th Scientific Sessions as optimism grows over diabetes tech. Topics covered included expanding technologies to the type 2 diabetes population (90% of people with diabetes), GLP-1 drugs, automation, broadening user bases and more. The usual big-hitters stepped up to the plate […]
The steps ahead for the Eversense implantable CGM platform
As Senseonics and Ascensia Diabetes Care looked for someone to help scale their CGM business, they turned to someone had only just retired. After close to eight years as Tandem Diabetes Care CCO, Brian Hansen notified the company of his decision to step down last August. His final day landed on Dec. 31, but he […]
Senseonics expects a Q4 launch for 365-day CGM, offers full-year outlook
Senseonics (NYSE:SENS) today shared its full-year financial outlook and laid out expectations for a new product launch this year. The Germantown, Maryland-based company said the FDA review of its next-generation, 365-day, once-per-week calibration Eversense implantable continuous glucose monitor (CGM) is advancing as planned. It expects the progress to enable 510(k) clearance in the near future […]
Glaukos to exchange $230M in senior notes for common stock
Glaukos (NYSE:GKOS) announced today that it entered into exchange agreements to repurchase approximately $230 million. The company entered into separate, privately negotiated exchange agreements with certain holders of 2.75% convertible senior notes due 2027. Pursuant to these agreements, the company agreed to repurchase $230 million of existing convertible notes for aggregate consideration of shares of […]
FDA says Vivani Medical can begin study of long-term GLP-1-eluting implant
Vivani Medical (Nasdaq:VANI) announced today that the FDA approved an investigational new drug (IND) application for its long-term GLP-1 implant. The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month […]
Glucotrack has more data backing implantable glucose monitor, plans for human trials this year
Glucotrack announced the completion of a second long-term preclinical study for its implantable continuous blood glucose monitor (CBGM). The study further validates the CBGM’s sustained accuracy, the company says. It demonstrated a mean absolute relative difference (MARD) — a measurement of CGM accuracy — of 4.7% at day 90. MARD measures the average difference between […]
Medtronic, Arecor team up to develop insulin for implantable pumps
Arecor and Medtronic say they partnered to create a new type of insulin that would allow for the use of new insulin pump designs. These new insulin pumps in mind would sit under the skin, rather than on the surface of the skin. The research collaboration aims to develop a novel, high-concentration, thermostable insulin for […]
