Novocure Secures CE Mark for New Array

Rhea-AI Summary

Novocure has received CE Mark approval for its new flex array, a polymer-based transducer designed for enhanced delivery of Tumor Treating Fields (TTFields) therapy in glioblastoma patients. The flex array is over 50% thinner and 30% lighter than current models, aiming to improve patient comfort and therapy efficacy. A limited market release in Europe will commence, with insights from initial patient experiences guiding future regulatory filings. This innovation indicates Novocure's commitment to advancing cancer treatment while potentially optimizing treatment outcomes.

Positive

• Received CE Mark for the new flex array, indicating regulatory approval.
• Flex array is over 50% thinner and 30% lighter than current commercial arrays, enhancing patient comfort.
• Aimed to optimize Tumor Treating Fields therapy delivery, potentially improving clinical outcomes.

Negative

• None.

New arrays are lighter, thinner and more flexible than current commercial arrays and have the potential to optimize Tumor Treating Fields dose

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced receipt of CE Mark for its new polymer-based transducer array, called the flex array, designed for more efficient Tumor Treating Fields delivery and greater comfort for patients with glioblastoma. The new arrays are more than 50% thinner and more than 30% lighter compared to current commercial arrays.

“Novocure is committed to improving the patient experience and clinical outcomes through innovation, and the new arrays represent a meaningful milestone reached in our product development journey,” said Mukund Paravasthu, Novocure’s Senior Vice President, Product Development. “Through product innovation, our goal is to deliver higher intensity TTFields to targeted regions without adding toxicity. We believe the new arrays have the potential to meaningfully improve both patient comfort and efficacy of our therapy.”

With CE Mark for the new arrays, the company will begin a limited market release in Europe. Initial patient experience will inform regulatory filings and launch plans in additional active markets.

About Tumor Treating Fields Therapy
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. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its 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 PARP inhibition 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 Tumor Treating Fields 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 and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

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 trial 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 “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 as well as issues arising from the COVID-19 pandemic 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 24, 2022 and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221111005113/en/

Investors:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427



Media:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What is the significance of Novocure receiving CE Mark for NVCR's flex array?

The CE Mark signifies regulatory approval for Novocure's flex array, allowing for its use in Tumor Treating Fields therapy in Europe, potentially improving treatment for glioblastoma patients.

How does the new flex array compare to current commercial arrays for NVCR?

The flex array is over 50% thinner and 30% lighter than existing arrays, designed to improve patient comfort and optimize the delivery of Tumor Treating Fields.

When will Novocure's flex array be available in the market?

Novocure plans to commence a limited market release of the flex array in Europe, with initial patient experiences informing further regulatory filings.

What is Tumor Treating Fields therapy related to NVCR?

Tumor Treating Fields (TTFields) therapy uses electric fields to target and kill cancer cells, designed to complement other cancer treatments.