Researchers from the Stanford University School of Medicine have reportedly used CRISPR, a gene-editing tool, to repair the gene that causes sickle cell disease. The team is planning the 1st human clinical trial using this technique to correct cells with sickle cell disease, according to Reuters. “What we’ve finally shown is that we can do it. It’s […]
Clinical Trials
Japan OKs Medinol stent trial
Medinol said yesterday that Japanese regulators approved a clinical trial of its Elunir drug-eluting stent that it plans to add to an ongoing U.S. trial of the device. The thin-strut, ridaforolimus-eluting Elunir stent (previously known as Bionir) features an elastomeric coating that’s designed to be more flexible than prior-generation polymer coatings. Last month, Medinol presented 1-year […]
First patient receives Pixium bionic vision implant
Pixium Vision (EPA:PIX) said today that the 1st patient in the UK was implanted with its IRIS II bionic vision system. The epi-retinal implant has 150 electrodes and a bio-inspired camera intended for patients who have lost sight due to retinitis pigmentosa. The French company said the implantation and activation was performed in September by principal […]
Mast Therapeutics touts interim data from pulmonary hypertension study
Mast Therapeutics (NYSE:MSTX) touted interim data from a Phase II study of its AIR001 candidate in patients with pulmonary hypertension (PH) and PH associated with heart failure with preserved ejection fraction. Positive interim results from the ongoing trial were published in the Journal of Clinical Investigation. The San Diego-based company enrolled 50 patients to study its nebulized […]
InVivo adds 26th clinical site for spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it added a new site to the ongoing Inspire clinical study of its neuro-spinal scaffold designed to treat patients with complete thoracic AIS A spinal cord injuries.. The new site is located at the Allegheny General Hospital in Pittsburgh, Penn., and brings the total number of centers in the trial up to […]
TCT 2016: The best of the rest
The annual Transcatheter Cardiovascular Therapeutics conference went down in Washington, D.C., this week, with late-breaking study results beginning Oct. 29. After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, […]
Prioritizing patient preference & risk in device trials
Patients with a rare, chronic disease can find themselves in a conundrum when seeking treatment: Researchers can’t find enough patients to enroll in a statistically rigorous clinical trial and there is uncertainty in the regulatory path. Frustrated by the lack of treatment options on the market, patients may be willing to accept a certain level of […]
Baxter launches pivotal trial for citrate anticoagulant-renal replacement solution combo
Baxter (NYSE:BAX) said today it launched a Phase 3 clinical trial of an investigational drug combining a citrate anticoagulant and renal replacement solution. The trial will explore whether the use of the citrate anticoagulant lengthens the extracorporeal circuit life in acute kidney patients undergoing continuous renal replacement therapy, the company said. ”One potential obstacle in delivering […]
E-Qure wins FDA nod for bio-electrical signal wound therapy
Chronic wound treatment device developer E-Qure said today it won FDA investigational device exemption approval to conduct a clinical trial of its novel Bio-Electrical Signal Therapy device. The New York-based company said its Bio-electrical Signal Therapy device is designed for non-invasively treating hard-to-heal chronic wounds, including pressure ulcers, diabetic foot ulcers, venous stasis ulcers and […]
TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of […]
Motus GI touts Pure-Vu clinical data
Despite a 24-hour liquid diet and a purgative to clean the bowels to prepare for a colonoscopy, patients are poorly prepped in 20% of the 15 million colonoscopies performed worldwide each year, according to Motus GI CEO Mark Pomeranz. This can mean that patients need to return for a 2nd visit and doctors can miss cancerous lesions. […]