NovoCure (NSDQ:NVCR) said today that it applied for a supplemental pre-market approval from the FDA for the 2nd generation of its Optune device for treating glioblastoma, a form of brain cancer.
The FDA approved Optune’s 1st iteration in April 2011. It’s a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields,” to inhibit cancer cell replication and cause cancer cell death. NovoCure said it pared the weight of the newer version, which hit the European market last October, from 6 pounds to 2.7 pounds using digital signal generation technology.
“We’re making significant advancements in the technology used to deliver TTFields therapy,” COO Mike Ambrogi said in prepared remarks. “The big improvement with the 2nd-generation device is the reduction in size and weight achieved by digital signal generation technology. From a patient-convenience view, we believe it is a significant step forward.”
“Many of our European patients are pleased with the new ergonomic, lightweight Optune system, which they incorporate into their daily routines with more ease,” added CEO Asaf Danziger. “We will continue to improve all aspects of our Tumor Treating Fields delivery systems to enhance the quality of life of our patients.”
Last month, NovoCure touted positive data from a pivotal Phase III trial of the Optune device in combination with standard-of-care temozolomide for treating newly diagnosed glioblastoma, which was halted early for success.
The post Brain cancer: NovoCure looks to get 2nd-gen Optune device on the U.S. market appeared first on MassDevice.
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