From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 […]
Clinical Trials
Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system
Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids. The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device […]
Biosensors International launches US pivotal for BioFreedom DCS
Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent. The Singapore-based company’s Leaders Free II study is an ongoing trial examining the use of the BioFreedom DCS in patients at high bleeding risk who receive an ultra-short dual anti-platelet drug regimen of 1 per month. “We […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
InVivo wins Health Canada nod for cervical neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it won Health Canada approval to initiate a clinical study of its neuro-spinal scaffold in patients with acute, complete AIS A cervical spinal cord injuries. The Cambridge, Mass.-based company said it is in late stage conversations with several site research ethics boards, and expects to announce the 1st Canadian site for the […]
6 visual impairment breakthroughs you need to know
About 285 million people have some form of visual impairment in the world, according to the World Health Organization. Of that number, 39 million are considered blind, and 246 million have low vision. Three-fifths of all vision impairment can be prevented or cured. Uncorrected refractive errors are one of the main causes of vision impairment in […]
FDA green-lights Aegis Medical trial for Sierra ligation device
Aegis Medical Innovations said today it won FDA investigational device exemption approval to begin a clinical trial of its Sierra Ligation System designed for left atrial appendage closure. In the trial, Vancouver-based Aegis Medical aims to explore the safety and procedural success of the minimally invasive Sierra procedure in closing off the left atrial appendage in patients […]
Do patient advocacy organizations have a conflict of interest?
At least 83% of U.S. patient advocacy organizations receive financial support from medical device, drug and biotechnology companies, according to new research out of the University of Pennsylvania’s Department of Medical Ethics and Health Policy. The Penn research team – which included Matthew McCoy, Harald Schmidt and Ezekiel Emanuel – examined websites and annual reports for 104 organizations […]
Origin treats first patients in study of nitric oxide for diabetic foot ulcers
Origin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers. The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, […]
Progenitor cell therapy improves motor function in patients with spinal cord injury
Shares in Asterias Biotherapeutics (NYSE:AST) jumped 11% today to $3.53 apiece after the company reported positive data for its AST-OPC1 progenitor cell therapy in patients with spinal cord injuries. The Phase 1/2A clinical trial includes 6 patients in the AIS-A 10 million cell cohort. The company’s AST-OPC1 progenitor cell therapy is derived from human embryonic […]
InVivo Therapeutics enrolls 13th patient in neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that it enrolled a new patient in the Inspire study of its neuro-spinal scaffold, bringing the total number treated up to 13. The Cambridge, Mass.-based company’s neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. The procedure was […]