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 […]
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. […]
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 […]
Eyenovia touts publication of intraocular pressure data for micro-dose tech
Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure. In the trial, participants successfully self-administered using Eyenovia’s device 88% of the time after limited […]
Propeller Health touts link between air pollution, rescue inhaler use in nationwide asthma study
Propeller Health today touted results from a nationwide study that indicated a direct association between daily air pollution and rescue inhaler use. Results from the study, which spanned five years and involved more than 2,800 individuals with asthma, were published in the Proceedings of the National Academy of Sciences, the Madison, Wisc.-based company said. Researchers in […]
Eyenovia launches Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said today that it enrolled the first patient in the first of two Phase III trials of the company’s MicroStat program. The Mist-1 and Mist-2 trials are slated to study the safety and efficacy of the company’s 2.5% phenylephrine, 1% tropicamide eye solution, delivered as a micro-dose using the Optejet device. The company […]
Intersect ENT touts pooled analysis of steroid-releasing sinus implants
Intersect ENT (NSDQ:XENT) last week touted the publication of a pooled analysis of the company’s Propel Contour and Propel Mini steroid-eluting sinus implants. The company’s devices are designed to prop open the sinus ostia following endoscopic sinus surgery. As the implant dissolves, medicine is delivered directly to the sinus lining. The analysis, published in the International Forum […]
Lyndra touts positive results for long-acting drug-delivery tech
Lyndra Therapeutics reported positive results from a pharmacokinetics study of its once-weekly drug-delivery capsule, touting that it successfully transitioned a once-daily therapy to a weekly dosage form. The Watertown, Mass.-based company’s oral drug-delivery technique is designed to provide sustained release of one or more drugs for up to a week. Lyndra’s star-shaped capsule opens when […]
Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. “Several studies have shown the safety and durability […]
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