The FDA has given the green light to an expanded indication to GT Medical’s GammaTile cancer therapy, broadening its use to patients newly diagnosed with malignant brain tumors.
About the size of a postage stamp, the bioresorbable GammaTile is designed to be placed within the brain after excision surgery, to deliver local doses of radiation at the site of any remaining cancer cells. This allows radiation treatment to begin immediately, rather than waiting weeks for the surgical wound to heal.
Built out of collagen and the radioisotope Cesium-131, the 3D implant had previously received agency clearance for patients with any type of recurrent brain tumor, and it became commercially available in January of last year.
“This is a significant step forward that expands our ability to improve the lives of patients with brain tumors,” GT Medical President and CEO Matthew Likens said in a statement.
“Patients receiving GammaTile Therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence,” Likens added.
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In a clinical trial, the GammaTile delayed local recurrence by about 10 months, while increasing overall survival. Additionally, local control was seen in about 90% of patients who underwent total gross resection, with no increases in wound complications or hospital stays.
The GT Medical estimates that about 700,000 people in the U.S. are living with some type of brain tumor. Last February, the Tempe, Arizona-based company raised $10 million in a series A round in February 2019.