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Wednesday, 13 July 2016

2nd generation Novocure device (Optune) approved by FDA


Novocure Receives FDA Approval for Second Generation Optune System


Released : 07/13/2016

Second generation Optune system is less than half the weight and size of first generation Optune system

New system aims to make Optune therapy even easier for glioblastoma (GBM) patients

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its premarket approval (PMA) supplement application for Novocure’s second generation Optune system. The new smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to glioblastoma (GBM) patients in the United States.

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6 comments:

  1. Michael W13 July 2016 at 14:39

    That's great news. Jeremy has been looking forward to a smaller version of Optune. Hauling the large batteries and the charger on trips was a bit of a pain in the butt.

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    1. daninha2117 August 2016 at 21:01

      Michael, does your son have problems with sores caused by the optune? My husband's head gets very irritated (red) with some superficial open sores that burn. We are changing the arrays daily and putting some cortisone on it for a few hours which helps a little. The other issue is that he is so itchy that I constantly see some arrays lifted up and not sticking to his head. Any info you have is appreciated it.

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    2. Michael W17 August 2016 at 22:31

      Jeremy had one semi-persistent sore, a rather small one. Other than that, no skin irritation. Itching was not a problem either. The only problem was even normal days in the sun, normal meaning not excessively hot, would cause the alarm to go off. We wondered how people that live in warm climates wear the device.

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  2. JudeGilford13 July 2016 at 16:29

    Agreed. Happy to see this news.

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  3. Unknown14 July 2016 at 14:40

    It will be interested to learn how airlines will handle the new batteries. Given the new batteries last 6-7 hours (twice as long as generation 1) and their much smaller size, perhaps travel will be allowed and much easier to handle with Optune. I believe usage will increase as well, given the smaller and much lighter device and batteries.

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  4. Michael W14 July 2016 at 23:21

    My son has never had any difficulty with the airlines and batteries. He fly's frequently. Seems to me there should have been an issue, but fortunately there has not been.

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