Vivani Medical (Nasdaq:VANI) announced today that it initiated screening and enrollment for a first-in-human trial of its GLP-1 implant. The company initiated its LIBERATE-1 trial at two centers in Austrlalia. It will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This study follows FDA approval for an investigational new drug (IND) application for […]
Implants
Senseonics highlights early success with Eversense 365 launch
Senseonics (NYSE:SENS) today announced significant progress with the launch of its Eversense 365 continuous glucose monitor (CGM). In September, the company won FDA clearance for the Eversense 365 one-year implantable CGM. With the clearance, it became the world’s first 365-day CGM system. Senseonics and its global distribution partner, Ascensia Diabetes Care, announced the launch for Eversense 365 […]
Glucotrack begins enrollment for first human trial of continuous blood glucose monitor
Glucotrack (Nasdaq:GCTK) announced today that it commenced patient enrollment for its short-term human clinical study. The study focuses on the company’s continuous blood glucose monitor (CBGM) and includes participants with both type 1 and type 2 diabetes. Rutherford, New Jersey-based Glucotrack expects data from the study in 6-8 weeks. Unlike traditional CGMs that measure glucose […]
Senseonics reports mixed Q3 results, positive Eversense 365 outlook
Senseonics (NYSE:SENS) shares dipped slightly before hours today on third-quarter results that came in mixed compared to the consensus forecast. Shares of SENS fell 2.5% to 34¢ apiece in pre-market trading today. The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker reported losses of $23.98 million. That equals 4¢ per share on sales of $4.26 […]
Abbott reports sustained benefits with Esprit drug-eluting stent
Abbott (NYSE:ABT) today announced data demonstrating the long-term effectiveness of its Esprit BTK drug-eluting stent. The everolimus-eluting resorbable scaffold system treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. The first-of-its-kind stent provides support to the vessel […]
Elixir Medical has positive data for drug-eluting bioadaptive implant
Elixir Medical announced positive data demonstrating the benefit of its DynamX coronary bioadaptor system in target lesion failure (TLF). Data highlighted the success of DynamX compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES). The study looked at complex patient populations within the INFINITY-SWEDEHEART randomized controlled trial. Data included an analysis of patients with acute […]
Senseonics announces $16M registered direct offering
Senseonics (NYSE:SENS) announced today that it entered into a definitive agreement to offer $16 million in common stock. Germantown, Maryland-based Senseonics plans to offer more than 45.7 million shares of common stock. It priced the shares at 35¢ per share in a registered direct offering. In a concurrent private placement, the company agreed to issue […]
SpyGlass Pharma shares positive data for drug-eluting intraocular lens
SpyGlass Pharma released 18-month follow-up data highlighting the potential of its intraocular lens (IOL)-based drug delivery platform. Data came from a first-in-human study of 23 patients with glaucoma or ocular hypertension. They received the IOL implant at the time of cataract surgery. The company reported a consistent sustained reduction of intraocular pressure (IOP) across all […]
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a “revolutionary advancement” in the mechanics, durability and drug delivery of peripheral drug-eluting stents. Tel Aviv, Israel-based Medinol […]
Vivani can begin first-in-human GLP-1 implant trial in Australia following regulatory approval
Vivani Medical (Nasdaq:VANI) today announced that Australian authorities approved a first-in-human clinical trial for its subdermal GLP-1 implant. The LIBERATE-1 trial will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold […]
