NovoCure Limited announced that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio® for the treatment of adult patients with glioblastoma multiforme (GBM). Optune Gio is a wearable, portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, which disrupt the rapid cell division exhibited by cancer cells.

The new HFE arrays utilize a flexible polymer material in place of the ceramic discsused in the current Optune Gio arrays, making them one-third lighter and 50% thinner. Novocure plans to convert Optune Gio users in the U.S. to the new HFE arrays through the first half of 2025 through a controlled transition plan. Important Safety Information What is Optune Gio approved to treat?Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.

Newly diagnosed GBMIf have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide if: cancer is confirmed by healthcare professional AND have had surgery to remove as much of the tumor as possible Recurrent GBMIf tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if: have tried surgery and radiation and they did not work or are no longer working AND have tried chemotherapy and GBM has been confirmed by healthcare professional Who should not use Optune Gio?Optune Gio is not for everyone. Talk to doctor if have: An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly.

A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction Do not use Optune Gio if are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.