Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. Get the full story […]
Clinical Trials
Nemaura readies CE Mark submission for non-invasive glucose monitor
Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U. The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive […]
Study: Legacy pacers, ICDs found safe for 1.5T MRI scans
Pacemakers and implantable cardioverter defibrillators not marked as MRI-safe could still be mostly safe to use during imaging sessions with 1.5T MRI machines, according to a new study reported on by Healio. Results from the study were recently published in The New England Journal of Medicine. In the prospective, nonrandomized study, researchers aimed to explore […]
Zimmer Biomet touts pilot data for nStride knee injection
Zimmer Biomet (NYSE:ZBH) last week touted data from a pilot study of its nStride autologous protein solutions kit for treating osteoarthritis of the knee. The nStride APS kit allows surgeons to concentrate anti-inflammatory cytokines and growth factors from a patient’s blood sample, which are then injected into the knee. The 46-patient Progress II study randomized subjects […]
Nanobiotix’s nanoparticle-immunotherapy trial wins FDA approval
Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody. The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and neck […]
Aura Biosciences raises $30m for nanoparticle cancer treatment
Aura Biosciences has closed a $30 million Series C round with funding from new investors like Arix Bioscience and Lundbeckfonden Ventures, as well as existing investors, including the estate of former-Genzyme CEO Henri Termeer, who died earlier this year. The privately-held biotech is developing a light-activated nanoparticle therapy for patients with ocular melanoma. Aura said it […]
Bristol-Myers Squibb taps Taris’ drug-release tech for bladder cancer trial
Bristol-Myers Squibb (NYSE:BMY) and Taris Biomedical have inked a deal to combine Taris’ investigational GemRIS drug-releasing tech with the pharma company’s PD-1 immune checkpoint inhibitor, Opdivo, in a Phase Ib muscle invasive bladder cancer trial. As part of the collaboration, Bristol-Myers has also made an equity investment in Lexington, Mass.-based Taris. Get the full story at our sister […]
Study: Novocure’s Optune, drug combo adds months to the lives of GBM patients
Novocure (NSDQ:NVCR) touted today the final analysis of a pivotal Phase III trial that evaluated Optune combined with temozolomide in newly-diagnosed glioblastoma patients. The analysis, published today in the Journal of the American Medical Association (JAMA), showed that Novocure’s Optune-temozolomide combo extended overall survival and progression-free survival by 37% compared to temozolomide alone. Get the full story […]
Glaukos wins FDA nod for IDE trial of iStent SA
Glaukos (NYSE:GKOS) said today it won FDA investigational device exemption to launch a pivotal study of its iStent SA trabecular micro-bypass system designed to treat glaucoma. The San Clemente, Calif.-based company’s iStent SA is designed to reduce intraocular pressure in psuedophakic, mild-to-moderate open-angle, pigmentary or psuedoexfoliative glaucoma patients, the company said. The system includes 2 micro-scale […]
Study: OrthAlign handheld nav tool reduces fluoroscopy time during THA procedures
OrthAlign’s handheld orthopedic navigation system was reportedly shown to reduce fluoroscopy time in direct-anterior approach total hip arthroplasty procedures. The company’s HipAlign system, which uses imageless technology including sensors that help create a reference plane and provide hip positioning data intraoperatively, was tested by Dr. Edwin Su from New York’s Hospital for Special Surgery. Dr. […]
Sensorion, Cochlear collab to study combo therapies for patients with cochlear implants
Sensorion, a biotech working on therapies for inner ear diseases, said today that it inked a deal with Cochlear Ltd (ASX:COH) to study combination therapies for patients with cochlear implants. According to the deal, the companies will combine Sensorion’s SENS-401 compound with cochlear implants in preclinical studies starting next year. The drug-device therapies could be in clinical […]