Novocure Announces First Commercial License of the NovoTAL? (Transducer Array Layout) System - Applied Clinical Trials

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Novocure Announces First Commercial License of the NovoTAL? (Transducer Array Layout) System The NovoTAL System Enables Certified Physicians to Plan and Individualize NovoTTF" Therapy for Recurrent Glioblastoma Patients


Novocure Announces First Commercial License of the NovoTAL™ (Transducer Array Layout) System

The NovoTAL System Enables Certified Physicians to Plan and Individualize NovoTTF™ Therapy for Recurrent Glioblastoma Patients

PR Newswire

NEW YORK, Feb. 18, 2014 /PRNewswire/ --  Novocure announced today that Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center has licensed the NovoTAL (Transducer Array Layout) System. The NovoTAL System allows certified physicians to use a recurrent GBM patient's MRI data to optimize the distribution and intensity of NovoTTF Therapy.

Beth Israel Deaconess Medical Center is a major research center working to further advance the understanding of the mechanisms of action and the clinical applications of TTFields in patients with brain tumors.

"I believe the NovoTAL System will facilitate the research, improvement and application of TTFields therapy at Beth Israel Deaconess Medical Center," said Dr. Eric T. Wong, Director of the Neuro-Oncology Unit.

"We are delighted to partner with Beth Israel Deaconess Medical Center on this important milestone. Certified physicians can now use a patient's clinical information and MRI data in the transducer array planning process, which is essential for optimizing NovoTTF Therapy," said Peter Melnyk, Chief Commercial Officer at Novocure. "We will be licensing the NovoTAL System to additional certified centers across the United States in the upcoming months."

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.

About the NovoTAL System
The NovoTAL System is a workstation-based propriety software tool that uses MRI head morphology, tumor size and location measurements, and the dielectric properties of different brain tissues to optimize TTFields distribution and intensity within the target tumor. The NovoTAL System received FDA PMA supplement approval for use by physicians certified to prescribe the NovoTTF-100A System.

About the NovoTTF-100A System
NovoTTF-100A System is a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that 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 (three kilograms) 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 United States (U.S.) and is a CE Marked device cleared for sale in the European Union, Switzerland, Australia and Israel.

Approved Indication
The FDA has approved the 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. The system is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Patients should only use the NovoTTF-100A System under the supervision of a physician properly trained in use of the system. Full prescribing information is available at www.novottftherapy.com  or by calling toll free 1-855-281-9301.

About Novocure™
Novocure Limited is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called NovoTTF Therapy. Novocure U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com.

Media Contact:
Peter Melnyk, Novocure
pmelnyk@novocure.com
(212) 767-7534

SOURCE Novocure

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