Sirtex Medical (ASX:SRX) saw shares tumble more than 25% today after a trial of its radioactive microspheres reported no effect in improving survival in patients with colorectal cancer. Results from the Foxfire analysis study indicated that the use of SIR-Spheres Y-90 microspheres in combination with chemotherapy did not improve overall survival in patients with unresectable […]
Clinical Trials
Nemaura touts data for Memspatch insulin micro-needle device
Nemaura Pharma‘s Memspatch insulin micro-needle device compared well against a pen injector in an 18-patient clinical trials, according to the company. The group of Type I diabetic patients were given insulin using either the Memspatch device or a traditional pen injector. Researchers evaluated the patient’s pain levels using a number pain rating score from 0 […]
Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These […]
Study: Rivanna’s anesthesia placement device boosts accuracy, efficacy
Rivanna Medical touted data from 3 trials today showing that its Accuro automatic spinal navigation system boosts the accuracy of epidural and spinal anesthesia placement compared to traditional techniques, even for residents-in-training. Accuro is a pocket-sized ultrasound system that automatically detects spinal midline, epidural depth and trajectory. One trial at the University of Virginia Medical […]
First patient transfused with Intercept red blood cells in Phase III trial
Cerus (NSDQ:CERS) said today that the 1st patient was transfused in Puerto Rico in a clinical trial comparing red blood cells processed with its Intercept blood system to conventional red blood cells. Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed to inactivate a broad range of viruses, bacteria, parasites […]
AdvaMed unveils new tools to assess medical device value
AdvaMed today launched a new value initiative that includes extensive tables of questions to help medical device companies formulate value-based arguments. The value framework also includes tools specifically designed for diagnostic technologies, as well as report on understanding evidence and use cases. “Value” has become an important word in medtech in recent years as government and […]
HRS 2017: First ever nasal spray used to treat rapid heart rate condition
Data from a 100-patient clinical trial showed that a fast-acting nasal spray therapy, etripamil, was effective at stopping a common rapid heart rate condition, researchers said today at the annual Heart Rhythm Society conference in Chicago. Paroxysmal supraventricular tachycardia is traditionally treated with adenosine, calcium channel blockers or beta blockers, which is administered using an IV […]
OncoSec inks deal with Merck to study drug-device therapy for metastatic melanoma
OncoSec Medical (NSDQ:ONCS) said today that it inked a clinical trial collaboration and supply agreement with Merck (NYSE:MRK) to evaluate the combination of its ImmunoPulse IL-12 electroporation device with Merck’s Keytruda therapy in a Phase II clinical trial. The trial aims to evaluate the drug-device combination in patients with metastatic melanoma – specifically patients who experienced disease […]
Patients with Parkinson’s disease help shape clinical trial design
Margaret Sheehan isn’t a scientist, but she is 1 of many patient scientists joining an effort to incorporate Parkinson’s patients’ preference into the design of clinical trials for new treatments. Sheehan, a Virginia-based lawyer, has had Parkinson’s disease since 2004. She told Drug Delivery Business News that when the folks at the Medical Device Innovation Consortium presented last spring […]
Cerus lands $47m for Intercept red blood cell system
Cerus (NSDQ:CERS) said today that it exercised $46.6 million in additional options from its contract with the Biomedical Advanced Research & Development Authority, a part of the U.S. Dept. of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed […]