Novocure Announces CE Mark and First Patient Use of Second Generation Optune System
Novocure (NASDAQ: NVCR), a commercial stage oncology company, announced today the placement of the CE mark on, and first patient use of, the newly designed second generation Optune system. The application of CE mark enables Novocure to distribute the second generation Optune system in the European Union and Switzerland. Novocure has initiated roll-out in Germany this month and intends a broader European roll-out by the end of the year.
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Second generation Optune, including battery (Photo: Business Wire)
The Optune system was newly designed with the patient in mind and is intended to improve the convenience and manageability of Tumor Treating Fields (TTFields) therapy. The size, shape and display are more user-friendly and streamlined, and novel signal generation technology provides a TTFields generator that is half the size and weight of the generator currently in use. The second generation Optune system weighs 1.3 kilograms (2.7 pounds), including the battery, versus the current version that weighs 3 kilograms (6 pounds).
"We are thrilled to offer the second generation Optune system to our European patients," said Asaf Danziger, Chief Executive Officer of Novocure. "We know how important ergonomics are to an optimal therapeutic experience and our new design will be much easier for patients to use."
"Novocure's second generation Optune system is an important breakthrough for glioblastoma patients. The lightweight and streamlined design will make it easier for patients to adapt the treatment to their daily lives," said Dr. med. Martin Misch, Department of Neurosurgery, Charité Universitatsmedzin Berlin. "The new device is an important step for patients receiving Optune therapy."
The newly designed Optune system is not yet available in the United States (US). Novocure intends to file a premarket approval supplement application with the US Food and Drug Administration (FDA).
About Tumor Treating Fields Therapy
TTFields therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Optune is a portable, non-invasive medical device designed for continuous use by patients. Optune delivers low intensity TTFields to the site of the tumor to interrupt cell structures during division, causing cancer cell death. In vitro and in vivo studies have shown that TTFields can be frequency-tuned to slow and reverse tumor growth in specific cancer cells based on their size and shape. In patients with recurrent glioblastoma brain tumors, Optune has shown clinical efficacy comparable to that of active chemotherapies with better quality of life and without many of the side effects of chemotherapy.
In the US, the FDA has approved the TTFields therapy delivery system, Optune (previously known as 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 device 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 Optune under the supervision of a physician properly trained in use of the device.
In the European Union and Switzerland, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union and Switzerland, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure's US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Ashley Cordova, 212-767-7558