Accuray's (ARAY) Treatment Options to be Boosted Post FDA's Nod
Accuray Incorporated ARAY recently received the FDA’s approval for its VitalHold breast package on the Radixact System. The VitalHold technology is expected to be available to customers in the United States, European Union and other regions, subject to regulatory approvals.
VitalHold facilitates deep inspiration breath hold (DIBH) treatments using the Radixact System's fixed beam angle delivery mode (TomoDirect) and a fully integrated and automated surface-guided radiation therapy (SGRT) solution, featuring the Catalyst+ HD system from C-RAD.
The latest regulatory clearance is expected to significantly strengthen Accuray’s TomoTherapy platform on a global scale.
Significance of the Approval
Per estimates by the National Cancer Institute, breast cancer is the most common cancer diagnosed in U.S. women, other than skin cancers. Radiation therapy plays a critical role in the management of early-stage, locally advanced and metastatic breast cancer cases. It is utilized in approximately 87% of breast cancer patients and accounts for more than 25% of cases in most radiation therapy departments.
DIBH treatments are often used to help minimize radiation dose to organs at risk and reduce associated complications later in life. SGRT enables medical care teams to effectively position the patient and monitor the accuracy of that positioning throughout the treatment. Per Accuray, the addition of the new functionality will enable the Radixact System to offer a comprehensive toolset for breast cancer treatment.
Per Accuray’s management, the VitalHold for the Radixact System is expected to provide clinicians with additional choice and flexibility when treating the full spectrum of breast cancer cases in their daily practice. Following the FDA’s approval, Accuray expects to offer its customers a wider range of radiation treatment delivery techniques in one device, the Radixact System.
Industry Prospects
Per a report by Precedence Research, the global radiation therapy market was estimated at $7.25 billion in 2022 and is anticipated to reach $14.89 billion by 2032 at a CAGR of 8%. Factors like the increased prevalence of cancer, the growing adoption of radiotherapy in cancer treatment and technological advancements are likely to drive the market.
Given the market potential, the latest regulatory approval is expected to provide a significant boost to Accuray’s business globally.
Recent Developments
This month, Accuray reported its fourth-quarter fiscal 2023 results, wherein it registered a solid overall top line. Robust Product and Services revenues and performances in the majority of geographies were also seen. The uptick in gross orders and the global installed was registered. Continued strong demand for Accuray’s Radixact innovations, including ClearRT, Synchrony and VitalHold, was also recorded by Accuray.
In May, Accuray announced that new data presented at the European Society for Radiotherapy and Oncology meeting reinforced the benefits of its CyberKnife and TomoTherapy platforms, including the latest generation Radixact System.
Comparison With Peers
Accuray’s peer, Myriad Genetics, Inc. MYGN, reported its second-quarter 2023 results, wherein it registered an uptick in its overall top line. It also recorded a robust improvement in its testing volume, excluding contributions from the SneakPeek Early Gender DNA Test. MYGN’s Hereditary cancer test volumes year-over-year growth was also solid and was the third consecutive quarter of double-digit year-over-year growth.
In July, Myriad Genetics announced that its MyRisk Hereditary Cancer Test with RiskScore now incorporated breast density using Tyrer-Cuzick version 8 to provide patients and providers with a more comprehensive look at their five-year and remaining lifetime risk for breast cancer.
Another key player in oncology treatment, Thermo Fisher Scientific Inc. TMO, reported its second-quarter 2023 results in July, wherein TMO witnessed an uptick in its core organic and Specialty Diagnostics segment’s revenues.
In June, Thermo Fisher announced the launch of the Gibco OncoPro Tumoroid Culture Medium Kit, the first commercially available culture medium specifically developed for the expansion of patient-derived tumoroids, or cancer organoids, from multiple cancer indications.
This apart, another renowned name in the oncology space is NovoCure Limited NVCR, which reported its second-quarter 2023 results in July. NVCR witnessed a solid uptick in received prescriptions during the quarter. During the earnings release, NovoCure announced that in July, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial, a randomized, phase 3 study testing the safety and effectiveness of Tumor Treating Fields (TTFields) therapy concomitant with pembrolizumab and platinum-based chemotherapy in patients with metastatic NSCLC.
The same month, NovoCure announced the results of a pre-specified interim analysis for the phase 3 PANOVA-3 clinical trial evaluating the safety and efficacy of TTFields therapy together with nab-paclitaxel and gemcitabine for the treatment of patients with unresectable, locally advanced pancreatic cancer.
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