A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. The results of the study prompted investigators for two trials to stop their studies. Meanwhile, leaders in […]
Drug-Device Combinations
Intersect ENT launches trial of drug-coated sinus balloon
Intersect ENT (NSDQ:XENT) said today that it enrolled the first patient in a trial of its Ascend drug-coated sinus balloon. The Menlo Park, Calif.-based company’s device is designed to deliver mometasone furoate directly to a person’s sinuses at the time of dilation. Get the full story at our sister site, Drug Delivery Business News.
Tidepool raises $6m to develop automated insulin delivery app
Tidepool said this week that it raised $6 million from JDRF and the Leona M. & Harry B. Helmsley Charitable Trust to support the development of Tidepool Loop – a hybrid, closed-loop automated insulin delivery app. Tidepool, a non-profit diabetes data management group, is working to create an FDA-regulated app that is compatible with multiple insulin […]
Impel NeuroPharma raises $68m for CNS drug-device tech
Impel NeuroPharma said today that it raised $67.5 million in a Series D financing round, with investments from KKR, Norwest Venture Partners, Vivo Capital, 5Am Ventures and venBio Partners. The Seattle-based company plans to use the round’s proceeds to support clinical development efforts for its intranasal drug-delivery device technology. Get the full story at our sister site, […]
Novocure touts analysis of pivotal glioblastoma trial results
Novocure (NSDQ:NVCR) today touted the results of a retrospective sub-group analysis of its EF-14 Phase III pivotal trial in patients with newly diagnosed glioblastoma. The analysis, which was published in the Journal of Neuro-Oncology, demonstrated that more time on Novocure’s Optune device predicted increased survival in people who received Optune plus temozolomide compared to those who received […]
Alimera Sciences wins Health Canada nod for diabetic macular edema implant
Alimera Sciences (NSDQ:ALIM) said last month that it won approval in Canada for its intravitreal implant designed to treat diabetic macular edema. The Iluvien device is a sustained release implant that delivers fluocinolone acetonide and is indicated to treat diabetic macular edema in people who have been previously given corticosteroids and did not have a clinically […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer. Get the full story at our sister site, Drug Delivery Business News.
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. […]
Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results […]
ResMed puts $225m on the table for Propeller Health
ResMed (NYSE:RMD) said today that it inked a deal to acquire Propeller Health and its digital medicine platform for $225 million in cash. Propeller Health, which sells small sensors that attach to inhalers and track medication use, will operate as a standalone business under ResMed’s respiratory care portfolio. Get the full story at our sister site, Drug Delivery […]
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. Get the full story at our sister […]