Novocure (NSDQ:NVCR) today touted positive top-line data from its Phase II pilot mesothelioma trial and revealed that it plans to submit a humanitarian device exemption application to the FDA for approval. The St. Helier, N.J.-based company reported that patients who received treatment with its “Tumor Treating Fields” system plus chemotherapy experienced clinically meaningful improvements in overall […]
Clinical Trials
Nuvo launches pivotal trial for PregSense home maternity monitor
Pregnancy care device developer Nuvo Group said late last week it launched a trial of its PregSense maternal fetal monitoring system to compare it against cardiotocography, which is currently the standard of care. The Israel-based company’s PregSense device is a sensor-based wearable monitoring technology designed to measure markers of fetal and maternal wellbeing from metrics including […]
Ivantis touts 1-year head-to-head Hydrus, Glaukos iStent study data
Ivantis today released one-year results from the study of its Hydrus Microstent comparing it to Glaukos‘ (NYSE:GKOS) iStent trabecular micro-bypass stents, touting the Hydrus’ ability to reduce reliance on medication and intraocular pressure. Results from the trial were presented at the American Society of Cataract and Refractive Surgery annual meeting in Washington D.C. by Dr. David […]
Glaukos touts 2-year iStent inject pivotal trial data, levies infringement suit against Ivantis
Glaukos (NYSE:GKOS) today released two-year data from the FDA investigational device exemption pivotal trial of its iStent inject trabecular micro-bypass system, and announced a patent infringement suit it filed against Ivantis. Results of the 505-patient study were presented at the American Society of Cataracts and Refractive Surgery annual meeting by Dr. Thomas Samuelson of the Minnesota Eye […]
Avita Medical touts pivotal trial of ReCell burn injury device
Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints. The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted. Get the full story at […]
OncoSec looks to boost effects of immunotherapy with intratumoral delivery
Thousands of cancer patients have been treated with immune checkpoint inhibitors since the first of its kind was approved in 2011. The product is designed to block the production of proteins that prevent the body’s immune system from acting in the presence of cancer. Although checkpoint inhibitors hold immense promise for some patients, many fail to […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk. The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain […]
Spineology touts 1-year OptiMesh lumbar interbody fusion study results
Spinal tech developer Spineology today released 12-month results from a study of its OptiMesh deployable implant designed for use in instrumented lumbar interbody fusion procedures to treat degenerative disc disease. Results from the Scout trial were presented at the annual meeting of the International Society for the Advancement of Spine Surgery in Toronto, the St. Paul, Minn.-based […]
TransMedics wins FDA approval for OCS Lung transplant system
TransMedics said today that it won pre-market approval from the FDA for its OCS Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation. The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the […]
NeuroMetrix touts Quell user-response study data
NeuroMetrix (NSDQ:NURO) yesterday released results from a clinical study of its Quell wearable device, touting its ability to treat chronic pain. Results from the trial were published in the Journal of Pain Research, the Waltham, Mass.-based company said. In the retrospective study, researchers examined data from 713 subjects using its Quell device to treat chronic pain […]
Titan Spine touts NanoLock research review publication
Titan Spine today touted results from a research review of spinal implant surface technology, including its NanoLock surface tech, touting its ability to improve osteogenic response. The review was published in the journal Spine, the Mequon, Wisc.-based company said. The NanoLock surface technology features micro and nano-scaled architecture the company claims can improve osteogenic responses. […]