ROOT, Switzerland - Novocure (NASDAQ: NVCR) has received U.S. Food and Drug Administration (FDA) approval for its Head Flexible Electrode (HFE) transducer arrays designed for the Optune Gio® device, which is used in the treatment of glioblastoma multiforme (GBM) in adults. The announcement was made earlier today.
The Optune Gio® system, a portable medical device for cancer treatment, employs Tumor Treating Fields (TTFields) to disrupt cancer cell division through alternating electric fields delivered via wearable arrays. The new HFE arrays are constructed with a flexible polymer material, making them significantly lighter by one-third and 50% thinner compared to the ceramic discs used in the existing arrays.
According to Novocure's Chief Operating Officer, Mukund Paravasthu, the FDA-approved HFE arrays are designed to enhance patient comfort by being lighter and thinner. The company plans to transition U.S. users of Optune Gio® to the new arrays by the first half of 2025 through a controlled plan.
Optune Gio® is indicated for the treatment of GBM in patients who are 22 years of age or older. It is used in conjunction with temozolomide (TMZ) chemotherapy for newly diagnosed cases and as a monotherapy for recurrent GBM when standard medical therapies are no longer effective.
The device is not suitable for all patients; contraindications include those with certain implanted medical devices, skull defects, or sensitivities to conductive hydrogels. Pregnant women are also advised against using Optune Gio®. Side effects may include scalp irritation, headache, and other symptoms, and the device should only be operated after proper training by medical staff.
Novocure is a global oncology company focused on extending survival in aggressive cancers with Tumor Treating Fields technology. The company's headquarters are in Root, Switzerland, with additional facilities in the United States and Israel.
The information in this article is based on a press release statement.
In other recent news, NovoCure (NASDAQ:NVCR) Ltd. has reported significant developments in its financial and clinical performance. The company announced a 22% increase in net revenues for the third quarter, totaling $155 million, driven by a record number of active patients and improved U.S. approval rates. H.C. Wainwright has maintained a Buy rating for NovoCure, following the company's robust third-quarter financial results.
NovoCure's revenue growth was also boosted by the FDA's approval of Optune Lua for the treatment of post-platinum metastatic non-small cell lung cancer (NSCLC). The company's expansion in France has shown strong performance and expectations are set for the French market to mirror the size of the German market.
NovoCure is looking forward to national reimbursement in Italy and Spain, anticipating launches in these markets by 2025. Additionally, the company announced the upcoming retirement of CEO Asaf Danziger by the end of 2024, with CFO Ashley Cordova set to assume the role. These are among the recent developments that continue to shape NovoCure's trajectory.
InvestingPro Insights
Novocure's recent FDA approval for its Head Flexible Electrode (HFE) transducer arrays aligns with the company's focus on innovation in cancer treatment. This development could potentially strengthen Novocure's market position, despite recent financial challenges.
According to InvestingPro data, Novocure's revenue growth has been positive, with a 14.63% increase in the last twelve months as of Q3 2024, and a more impressive 21.81% quarterly growth in Q3 2024. This growth trajectory suggests that the company's products, including the Optune Gio® system, are gaining traction in the market.
However, investors should note that Novocure is currently not profitable, with an operating income margin of -26.0% in the last twelve months. An InvestingPro Tip highlights that analysts do not anticipate the company to be profitable this year, which is consistent with the negative earnings per share of -$1.39 reported for the same period.
On a positive note, Novocure maintains impressive gross profit margins, as indicated by another InvestingPro Tip. The company's gross profit margin stands at a robust 76.55% for the last twelve months, reflecting strong pricing power for its innovative medical devices.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Novocure, providing deeper insights into the company's financial health and market performance.
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