When Yoram Wasserman and his team finished engineering Novocure’s first generation Optune® System more than 10 years ago, he already knew how he wanted to improve the device in the future.
At the time, Novocure was beginning clinical trials and needed a mobile device to deliver Tumor Treating Fields (TTFields) therapy to patients. He envisioned making the device lighter and smaller, and in order to do that, he would have to change the technology the device uses to produce the energy necessary to generate TTFields. The first generation Optune System was approved by the U.S. FDA for recurrent glioblastoma (GBM) in 2011 and for newly diagnosed GBM together with temozolomide in 2015.
“I had it in my mind, but the technology wasn’t there,” said Yoram, Novocure’s Vice President of Engineering.
Chief Operations Officer Mike Ambrogi said employees that work directly with patients always ask patients for feedback about the system. Patients most commonly expressed interest in a lighter and smaller device.
Several years ago, Yoram determined that technology had evolved enough to switch Optune from analog amplification to digital amplification, which would allow for a more efficient system and a reduction in weight and size. Yoram and his team began designing the software and hardware for the new system.
Novocure engineers created a system that’s smaller and less than half the weight of the first generation Optune System. Including its battery, the second generation Optune System weighs 2.7 pounds, compared to the first generation system that weighs 6 pounds. The second generation Optune System offers additional features, including an easy-grip texture designed for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.
I had it in my mind,
but the technology
vice president of engineering
“I’ve worked with a lot of engineers, but the guys who designed this second generation system are top notch,” Mike said. “They did a fantastic job. It’s a very solid design.”
In 2015, Novocure received the CE mark on the second generation Optune System in Europe and conducted a patient user study in Germany.
“The patient user study was an outstanding success,” Mike said. “We then knew that the device met
Novocure then began rolling out the new device to patients in Europe. In December 2015, the company
filed a premarket approval (PMA) supplement application for the second generation Optune System with the U.S. FDA. On July 13, 2016, the FDA approved the PMA supplement enabling Novocure to make the new device available to glioblastoma (GBM) patients in the U.S. Within one month of the approval, Novocure converted 90 percent of existing U.S. patients to second generation Optune System.
Kathryn Singleton, Novocure’s Director of U.S. Customer Services, said Novocure has received exceptional feedback from patients regarding second generation Optune System.
“The most rewarding aspect is seeing and hearing the feedback from patients and caregivers,” Kathryn said. “We’re listening to our patients and the second generation is a true testament to that.”
Director of U.S. Customer Services