NovoCure (NSDQ:NVCR) said today it won FDA premarket approval for its 2nd-generation Optune system designed to treat glioblastoma patients.
The Optune is 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.
The next-generation device is smaller, lighter and features a tumor treating field generator that is less than half the weight and size of the 1st-generation Optune system, NovoCure said.
“From the start, Novocure’s mission has been to improve the lives of cancer patients. The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives. We have received positive feedback from our second generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States,” COO Mike Ambrogi said in a press release.
The St. Helier, N.J.-based company said it reduced the weight of the system from 6 to 2.7 pounds by utilizing novel digital signal generation technology. Other improvements inlcude an easy-grip texture, battery indicator, light-detecting sensor and a “no-stop swap” feature for changing batteries.
“We are happy to receive FDA approval of our 2nd generation Optune system. We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience,” CEO Asaf Danziger said in prepared remarks
The company said it commercialized the devices in Germany in October last year, and will begin commercialization in the U.S. over the next several weeks.
In April, NovoCure said that the Radiation Therapy Oncology Group Foundation won FDA investigational device exemption to conduct a Phase II pilot test of NovoCure’s Optune in conjunction with bevacizumab to treat bevacizumab-refractory recurrent glioblastoma.
