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Novocure receives CE mark approval for new Optune system

Oncology firm Novocure has received CE mark approval for its new second generation Optune system, allowing the firm to market the system in the European Union and Switzerland.

Optune

The firm has designed the new system to improve the convenience and manageability of tumor treating fields (TTFields) therapy.

Optune is a portable and non-invasive medical device developed for continuous use by patients. It delivers low intensity TTFields to the site of the tumor to break cell structures during division, causing cancer cell death.

Novocure’s new Optune system features a novel signal generation technology that provides a TTFields generator, which is half the size and weight of the generator currently in use. It weighs 1.3kg, including the battery, against the current version that weighs 3kg.

Novocure CEO Asaf Danziger said: "We are thrilled to offer the second generation Optune system to our European patients.

"We know how important ergonomics are to an optimal therapeutic experience and our new design will be much easier for patients to use."

Novocure has started selling the system in Germany this month and plans to distribute across the Europe by the end of this year.

The company plans to submit a premarket approval supplement application with the US Food and Drug Administration (FDA) for the newly designed Optune system.

According to the firm, in vitro and in vivo studies demonstrated that TTFields can be frequency-tuned to slow and reverse tumor growth in specific cancer cells based on their size and shape.

Earlier, the FDA approved TTFields therapy delivery system Optune (previously called NovoTTF-100A system) for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM, following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy.


Image: Novocure’s second generation Optune system. Photo: courtesy of Business Wire.