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 […]
Clinical Trials
MannKind reports positive data for inhaled insulin for children
MannKind today announced six-month results from its Phase 3 INHALE-1 study of Afrezza insulin inhalation powder in children. INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to […]
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 […]
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 […]
Luna Diabetes launches trial for ‘world’s smallest insulin patch pump’
Luna Diabetes announced that it launched its pivotal trial for Luna, the company’s miniature automated insulin delivery system. The company describes the system — designed to transform nighttime glucose management — as the world’s smallest patch pump. Luna delivers micro-doses of insulin while the user sleeps. According to the company, it offers the “simplest onboarding […]
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 […]
NIH launches effort to combat type 2 diabetes in young people
The National Institutes of Health (NIH) launched a nationwide consortium to address the rise in youth diagnosed with type 2 diabetes. According to a press release, NIH expects that trend — which it observed over the past two decades — to continue moving forward. It aims to advance understanding of the biologic, social, and environmental […]
Clearside Biomedical’s drug-device combo study meets endpoints
Clearside Biomedical (Nasdaq:CLSD) today announced that the ODYSSEY study of its drug-device combination achieved its primary and secondary outcomes. Alpharetta, Georgia-based Clearside develops the SCS Microinjector suprachoroidal injection device. It enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to […]
Trinity Biotech completes pre-pivotal study of next-gen CGM
Trinity Biotech today announced that it completed the first pre-pivotal clinical trial in Europe for its next-generation CGM technology. The study assessed the analytical performance of continuous glucose monitoring (CGM) technology enhancements implemented by Trinity. Dublin, Ireland-based Trinity added the improvements to the CGM technology it acquired from Waveform Technologies in January. Trinity implemented an […]
