Aegea Medical said today that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures. The PACE II study will look to enroll up to 50 women who were previously treated in the Menlo Park, Calif.-based company’s pivotal trial of the Adaptive Vapor Ablation tech and […]
Clinical Trials
Clearside Biomedical reports analyses from pivotal trial of eye drug
Clearside Biomedical (NSDQ:CLSD) touted new analyses of data from the company’s Phase III pivotal trial of suprachoroidal CLS-TA in people with uveitic macular edema. The company’s investigational treatment is a suspension of triamcinolone acetonide formulated to be delivered to the back of the eye via the suprachoroidal space. Get the full story at our sister site, […]
Genentech touts data for refillable eye implant in wet-AMD trial
Roche‘s (OTC:RHHBY) Genentech touted additional positive data last week from a Phase II study of its Port Delivery System, a refillable eye implant designed to deliver ranibizumab to treat wet age-related macular degeneration. The company first reported top-line results from the Phase II Ladder study in July. The implant is intended to allow wet-AMD patients to go for months […]
Fresenius Medical touts Crit-Line hemodialysis fluid management studies
Fresenius Medical Care‘s (NYSE:FMS) renal therapies group today released results from four studies of its Crit-Line monitor that looked to explore the relation between relative blood volume monitoring (RBV-M) and patient outcomes. Data from the studies were presented at the 2018 American Society of Nephrology’s Kidney Week Symposium in San Diego, Calif. Results from two […]
Humacyte launches Phase II vascular trauma Humacyl vessel trial
Humacyte said yesterday it launched a U.S. Phase II trial of its Humacyl investigational human acellular vessel exploring the systems’ use for vascular replacement or reconstruction in patients with life or limb-threatening vascular trauma. The Research Triangle Park, N.C.-based company said it hopes to enroll 40 adult patients at six U.S. sites for the trial, […]
GenSight Biologics launches trial for gene therapy, eye device combo
GenSight Biologics (EPA:SIGHT) said today that the first person was treated in a first-in-man trial evaluating GenSight’s gene therapy candidate, GS030-DP, in combination with a wearable optronic visual stimulation device, GS030-MD. Scientists are evaluating the drug-device combination in 18 people with retinitis pigmentosa. Get the full story at our sister site, Drug Delivery Business News.
Inovio touts intradermal delivery of HIV vaccine
Inovio Pharmaceuticals (NSDQ:INO) reported today that its synthetic HIV vaccine, Pennvax-GP, demonstrated durable antibody and T cell immune responses throughout a Phase I trial. The company found that Pennvax-GP plasmids delivered intradermally with Inovio’s Cellectra device triggered equivalent or superior immune responses in healthy volunteers compared to intramuscular delivery of the plasmids using the same device. […]
Avita launches pediatric burn trial
Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients. The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company […]
Study: Delaying thombectomy, even for minutes, can lead to lifelong consequences
Delaying endovascular thrombectomy treatment for patients with acute ischemic stroke can take time off of patient’s lives and cost hospitals extra, according to a new study reported by Medscape. Results from the study were presented by Dr. Wolfgang Kunz of Munich, Germany’s Ludwig Maximilian University during the 11th World Stroke Congress. Every hour of delay […]
Clerio Vision launches first-in-man trial of Liric laser vision correction
Early stage opthalmalogical device maker Clerio Vision said today it launched a first-in-human trial of its Liric non-invasive vision correction system and associated procedure, and that it already enrolled and treated five subjects in the study. The system uses femtosecond laser technology developed by Gerard Mourou and Donna Strickland at the University of Rochester intended […]
Novocure touts results from glioblastoma TTF trial analysis
NovoCure (NSDQ:NVCR) yesterday released results from a post-hoc analysis of its EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma, touting an association between higher doses of Tumor Treating Fields and improved overall survival. The analysis explored patient data from 317 qualified individuals in the TTF treatment arm of the St. Helier, Jersey-based company’s EF-14 phase […]