FDA Approves Novocure’s Innovative HFE Transducer Arrays for Use With Optune Gio® for Glioblastoma
Novocure (NVCR) has received FDA approval for its new Head Flexible Electrode (HFE) transducer arrays, designed for use with Optune Gio® in treating adult glioblastoma multiforme (GBM). The new arrays feature flexible polymer material instead of ceramic discs, making them one-third lighter and 50% thinner than current arrays. This innovation aims to improve patient comfort during treatment. The company plans to transition U.S. Optune Gio users to the new HFE arrays through the first half of 2025 through a controlled plan.
Novocure (NVCR) ha ricevuto l'approvazione della FDA per i suoi nuovi array di trasduttori con Elettrodi Flessibili per Testa (HFE), progettati per essere utilizzati con Optune Gio® nel trattamento del glioblastoma multiforme (GBM) negli adulti. I nuovi array presentano un materiale polimerico flessibile al posto dei dischi in ceramica, rendendoli un terzo più leggeri e il 50% più sottili rispetto agli array attuali. Questa innovazione mira a migliorare il comfort del paziente durante il trattamento. L'azienda prevede di trasferire gli utenti statunitensi di Optune Gio ai nuovi array HFE attraverso un piano controllato nella prima metà del 2025.
Novocure (NVCR) ha recibido la aprobación de la FDA para sus nuevos arreglos de transductores con Electrodos Flexibles para Cabeza (HFE), diseñados para usarse con Optune Gio® en el tratamiento del glioblastoma multiforme (GBM) en adultos. Los nuevos arreglos cuentan con material polimérico flexible en lugar de discos de cerámica, haciéndolos un tercio más ligeros y un 50% más delgados que los arreglos actuales. Esta innovación tiene como objetivo mejorar la comodidad del paciente durante el tratamiento. La empresa planea transitar a los usuarios de Optune Gio en EE. UU. a los nuevos arreglos HFE mediante un plan controlado durante la primera mitad de 2025.
Novocure (NVCR)는 성인의 다형성 교모세포종(GBM) 치료에 사용하기 위해 Optune Gio®와 함께 사용할 새로운 두부 유연 전극(HFE) 트랜스듀서 배열에 대한 FDA 승인을 받았습니다. 새로운 배열은 세라믹 디스크 대신 유연한 폴리머 재질로 제작되어 기존 배열보다 무게가 1/3 가볍고 50% 얇아졌습니다. 이번 혁신은 치료 중 환자의 편안함을 개선하는 것을 목표로 하고 있습니다. 회사는 2025년 상반기까지 통제된 계획을 통해 미국의 Optune Gio 사용자들이 새로운 HFE 배열로 전환하도록 할 계획입니다.
Novocure (NVCR) a reçu l'approbation de la FDA pour ses nouveaux réseaux de transducteurs avec Électrodes Flexibles pour la Tête (HFE), conçus pour être utilisés avec Optune Gio® dans le traitement du glioblastome multiforme (GBM) chez les adultes. Les nouveaux réseaux présentent un matériau polymère flexible au lieu de disques en céramique, les rendant un tiers plus légers et 50% plus fins que les réseaux actuels. Cette innovation vise à améliorer le confort des patients pendant le traitement. L'entreprise prévoit de faire passer les utilisateurs américains d'Optune Gio aux nouveaux réseaux HFE à travers un plan contrôlé au cours de la première moitié de 2025.
Novocure (NVCR) hat die FDA-Zulassung für seine neuen Kopf-Flexibelelektroden (HFE) Transducer-Arrays erhalten, die für die Verwendung mit Optune Gio® zur Behandlung von adultem glioblastoma multiforme (GBM) konzipiert sind. Die neuen Arrays bestehen aus flexiblem Polymermaterial statt aus Keramikscheiben und sind ein Drittel leichter und 50% dünner als die aktuellen Arrays. Diese Innovation zielt darauf ab, den Komfort der Patienten während der Behandlung zu verbessern. Das Unternehmen plant, die Benutzer von Optune Gio in den USA bis zur ersten Hälfte des Jahres 2025 durch einen kontrollierten Plan auf die neuen HFE-Arrays umzustellen.
- FDA approval received for new HFE transducer arrays
- Product improvement with 33% lighter and 50% thinner design
- Planned controlled transition of existing users to new arrays through H1 2025
- None.
Insights
The FDA approval of Novocure's new HFE transducer arrays represents a significant improvement in the company's core GBM treatment technology. The one-third lighter and 50% thinner design directly addresses patient comfort issues, which could lead to better treatment adherence - a critical factor in TTFields therapy effectiveness. This product enhancement maintains the same therapeutic mechanism while potentially improving the patient experience.
The controlled transition plan through H1 2025 suggests a measured approach to market introduction, likely to ensure manufacturing capacity and smooth implementation. While this improvement may not immediately impact revenue, it strengthens Novocure's competitive position and demonstrates continued innovation in their flagship product line. The focus on patient comfort could lead to improved adoption rates and better patient retention in the long term.
New flexible arrays are lighter, thinner and designed to improve comfort for Optune Gio users
ROOT,
Optune Gio is a wearable, portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, which disrupt the rapid cell division exhibited by cancer cells.
The new HFE arrays utilize a flexible polymer material in place of the ceramic discs used in the current Optune Gio arrays, making them one-third lighter and
“At Novocure we recognize product innovation must deliver meaningful results for our patients,” said Mukund Paravasthu, Chief Operating Officer, Novocure. “The newly FDA approved HFE arrays are lighter, thinner and designed to be more comfortable, clear benefits for the patient. We look forward to introducing the new arrays in the
Novocure plans to convert Optune Gio users in the
Important Safety Information
What is Optune Gio® approved to treat?
Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.
Newly diagnosed GBM
If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if:
- Your cancer is confirmed by your healthcare professional AND
- You have had surgery to remove as much of the tumor as possible
Recurrent GBM
If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:
- You have tried surgery and radiation and they did not work or are no longer working AND
- You have tried chemotherapy and your GBM has been confirmed by your healthcare professional
Who should not use Optune Gio?
Optune Gio is not for everyone. Talk to your doctor if you have:
- An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
- A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.
What should I know before using Optune Gio?
Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Gio.
- Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment
What are the possible side effects of Optune Gio?
Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.
Please click here for the Optune Gio Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure’s global headquarters is located in Root Switzerland, with
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “could” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the
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Source: Novocure
FAQ
What are the key improvements in Novocure's (NVCR) new HFE transducer arrays?
When will Novocure (NVCR) implement the transition to new HFE arrays?
What condition does Novocure's (NVCR) Optune Gio treat?
