Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. Get the full story at our sister site, […]
Clinical Trials
7 medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
This company helps cell therapies travel around the world
With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient’s own cells to genetically engineer a cancer-killing cellular therapy that is then delivered back to the patient. We are so grateful that we […]
Pixium Vision wins French approval for Prima sub-retinal implant study
Pixium Vision (EPA:PIX) said today it won approval from France’s regulatory agency to launch a feasibility clinical study of its next-gen Prima sub-retinal implant in patients with advanced dry age-related macular degeneration. The Prima system is a next-gen wireless implant with a micro photovoltaic chip designed to be implanted under the retina to convert pulsed near-infra-red invisible […]
FDA committee backs Novo Nordisk’s once-weekly type II diabetes drug
An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug. Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece. Get the full story at our sister site, Drug Delivery Business News.
FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product. The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both […]
Second Sight wins go-ahead for German Argus II study in better-sighted RP patients
Second Sight Medical (NSDQ:EYES) said today it won approval from Germany’s BfArM regulatory body to initiate a 10-patient study exploring the use of its Argus II retinal prosthesis system in better sighted retinitis pigmentosa patients and individuals with tunnel vision. The Argus II induces visual perception in patients with retinitis pigmentosa by stimulating of the retina’s […]
Researchers combine a smart phone, insulin pump and CGM in diabetes study
In a study published this week in Diabetes Care, researchers combined an insulin pump, a continuous glucose monitoring receiver and a smart phone with cloud-based algorithms to automatically monitor and adjust a patient’s glucose levels. The team pointed towards a number of systems that are designed to function as an artificial pancreas, but still require that […]
NanOlogy takes nanoparticle tech into Phase II trials
In the last two weeks, NanOlogy has launched trials evaluating its cancer-fighting paclitaxel nanoparticle suspension in patients with prostate cancer and in patients with ovarian cancer. The Texas-based company’s nanoparticle tech is based on a production process that cuts the size of chemotherapy crystals by up to 400 times, creating stable nanoparticles with increased surface area and […]
BrainStorm enrolls first ALS patient in late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that the first patients have been enrolled in its Phase III trial evaluating NurOwn as a treatment for amyotrophic lateral sclerosis, or ALS, at Massachusetts General Hospital and UC Irvine Medical Center. The trial, which is slated to enroll 200 patients, is designed to include the pre-specified patient subgroups who […]
ReWalk Robotics aims for 2018 release for Restore softsuit robotic exoskeleton
ReWalk Robotics (NSDQ:RWLK) said today it completed all internal processes related to its Restore robotic rehabilitation softsuit exoskeleton and is ready to initiate clinical trials of the device in 2018, with hopes for a commercial launch in the same year. The Restore softsuit is designed to transmit power to key joints in the legs with cable technologies, […]