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. Impel’s INP104 product is in a Phase […]
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 […]
Nemera organizes an expert review on the present & future of inhalation products
(Press Release) – “Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts – Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a roundtable organized by Nemera in Paris to review the advantages and limitations of inhalation devices. Inhalation treatments, composed of solid particles or liquid droplets are generally administered […]
Vast Therapeutics closes Series A for nitric oxide powder tech
Vast Therapeutics said today that it finished a Series A round with investment from Japan-based Shionogi & Co. The company plans to use the round’s proceeds to bring their nitric oxide powder technology through preclinical testing and first-in-human clinical safety and efficacy trials. Vast Therapeutics’ technology, which was in-licensed from the University of North Carolina at […]
Pops Diabetes wins FDA clearance for blood glucose monitoring system
Pops Diabetes Care said this week that the FDA cleared its Pops! one blood glucose monitoring system. The Minneapolis-based company’s device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! one system also allows users to review their blood glucose trends and […]
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. […]
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. […]
