Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Stanford uses CRISPR to correct sickle cell, human trials planned
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 not just on the chalkboard,” senior author Dr. Matthew Porteus told the news outlet. “We think we have a complete data set to present to the FDA to say we’ve done all pre-clinical experiments to show this is ready for a clinical trial.” Read more
4. Inspire Medical Systems raises $13m for sleep apnea device
Inspire Medical Systems has raised $12.5 million in a new round of equity financing, according to an SEC filing posted today.
Inspire Medical developed and produces a sleep apnea implant, a pacemaker-like system designed to stimulate nerves to keep airways open during sleep. Read more
3. Positive 1-month safety results for Medtronic’s Navigate bronchoscopy trial
Medtronic today released 1-month data from the Navigate trial of its superDimension LungGPS system, touting the device as safe and effective based on the preliminary results.
A total of 1,289 patients have been enrolled in the trial to date, which spans 37 sites across Europe and North America. The trial looks to evaluate the performance of Fridley, Minn.-based Medtronic’s LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. Read more
2. 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 data from the 1,900-patient Bionics study, comparing the Elunir/Bionir stent with the zotarolimus-eluting Resolute stent made by Medtronic; Medinol said yesterday that Japan’s Pharmaceutical & Medical Devices Agency granted clinical trial notification for the single-arm, 100-patient JNIR study to confirm Elunir/Bionir’s safety and efficacy in the Japanese clinical environment with a primary endpoint of target lesion failure. Read more
1. Third-quarter sales surge more than 50% for Mazor Robotics
Third-quarter sales for Mazor Robotics rose nearly 54% as the robot-assisted surgery company sold more guidance systems than during all of last year.
Caesarea, Israel-based Mazor posted losses of -$5.2 million, or -11¢ per share, on sales of $7.6 million for the 3 months ended Sept. 30, keeping the bottom line flat compared with Q3 2015. Read more