Novocure announced that the US Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) system through a premarket approval (PMA) supplement.
The NovoTAL System allows certified physicians to use the individual MRI data of recurrent glioblastoma multiforme (GBM) patients to optimize the field distribution and intensity of Tumor Treating Fields (TTFields) therapy.
Novocure chief science officer and head of research and development Dr Eilon D Kirson noted with the NovoTAL System, certified physicians generate individualized transducer array plans for their recurrent GBM patients.
"Physicians can now use clinical information and personalized patient characteristics in the transducer array planning process, which is essential for optimizing treatment with NovoTTF Therapy. Not only can physicians optimize transducer array placement at the start of NovoTTF treatment, but can adjust array placement as tumor characteristics change over time," Dr Kirson added.
The NovoTAL System consists of a dedicated workstation and specialized, PMA supplement-approved software that enables physicians to determine optimal transducer array layouts based on morphological measurements of the head, tumor size and location, and the distribution of TTFields within the brain.
The NovoTAL System is a workstation-based propriety software tool that uses MRI head morphology, tumor size and location measurements, and tissue dielectric properties to optimize TTField distribution and intensity within the target tumor.
The NovoTAL System has received FDA PMA supplement approval for use by physicians certified to prescribe the NovoTTF-100A System.
NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use throughout the day by patients.
In vitro and in vivo studies have shown that that use of the NovoTTF-100A System slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate.
The NovoTTF-100A System weighs about six pounds (3kg) and creates a low intensity, alternating electric field within a tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
In patients with recurrent glioblastoma brain tumors, the system has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy.
The NovoTTF-100A System has received marketing approval in the US and is a CE Marked device cleared for sale in the EU, Switzerland, Australia and Israel.