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 […]
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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 […]
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. “The patient I treated today was young, only 53 years old, and a perfect candidate for bioresorbable scaffolds,” Antonio Colombo of the Columbus […]
BioTime touts preclinical results for hydrogel drug-delivery implant
BioTime Inc. (NYSE:BTX) touted today positive preclinical results for its HyStem hydrogel drug-delivery technology, demonstrating that targeted intracerebral delivery of brain-derived neurotrophic factor may alleviate the effects of ischemic brain injury and reduce neuroinflammation. The study, published in the International Journal of Molecular Sciences, focused on the effects of BDNF on sensorimotor function, infarct volume and neuroinflammation […]
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. […]
Dexcom completes $850m debt offering
Dexcom (NSDQ:DXCM) said that it completed the sale of $850 million of 0.75% convertible senior notes due 2023. The San Diego, Calif.-based company expects to reel in roughly $836 million in net proceeds from the offering. Dexcom used $35.1 million of the offering’s proceeds to pay the cost of the convertible note hedge transactions as described […]
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. ResMed reported that Propeller’s products for people […]
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. The company’s device is designed […]
Diabeloop wins CE Mark for hybrid closed-loop diabetes management system
Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1. The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019. Diabeloop’s system connects Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitor, Kaleido’s patch insulin […]
Pulmatrix raises $3m in offering
Pulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at 32¢ apiece. The Lexington, Mass.-based company expects to reel in $3 million in total gross proceeds from the offering. Pulmatrix also agreed to issue unregistered warrants to the same investor in a private placement […]
