USA— The U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for RefleXion Medical for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers.
The FDA has cleared SCINTIX biology-guided radiotherapy to be used on lung and bone tumors, which can be the result of either primary cancers or metastatic lesions that have spread from other parts of the body.
It has been granted the prestigious Breakthrough Device designation by the FDA for the treatment of lung tumors due to its remarkable ability to detect and treat multiple moving tumors simultaneously.
Scintix utilizes anatomic data from computed tomography (CT) and functional imaging data from PET to deliver personalized radiotherapy for cancer treatment.
Before treatment, the patient is injected with fludeoxyglucose F18 (FDGs) that interacts with the cancer cells, producing signals and emissions.
FDG is a radiotracer that combines a diagnostic radioisotope such as fluorine-18 with glucose, which cancer cells use at a higher rate than a healthy tissue does.
When the cancer cells consume the FDG, emissions are produced from the tumor. The RefleXion X1 machine equipped with SCINTIX technology detects these emissions and continuously constructs a map based on data from the patient’s cancer cells to determine the position and amount of radiation to be delivered in treatment.
SCINTIX technology detects emissions from the injected radiotracer and returns beamlets of radiation to tumors in just half a second to destroy them, turning cancer’s biological characteristics back on itself.
This sophisticated interplay between the tumor and the X1 requires the machine to rotate at a speed of 60 revolutions per minute, making it the first and only radiotherapy machine to ever reach such speeds, as per RefleXion.
The global radiotherapy devices market is expected to grow from US$4.76 billion in 2021 to US$5.21 billion in 2022 at a compound annual growth rate (CAGR) of 9.3%, as per Reportlinker.
However, the launch of advanced devices is likely to propel the revenues for the radiotherapy devices market shortly.
The high cost of radiotherapy is projected to limit the growth of the radiotherapy devices market as it uses complex machines and involves the services of skilled healthcare providers.
Looking ahead, RefleXion said it plans to adapt the technology to work with a broader range of radioactive drugs that are being designed to react to various types of cancer.
Benefits of RefleXion’s SCINTIX biology-guided radiotherapy
SCINTIX monitors the delivery of radiation dosage to cancer cells in real-time during radiotherapy, reducing the need for large doses of radiation to be delivered to the patient’s entire internal target volume.
It protects the surrounding healthy tissue from harm, lowering the patient’s risk of toxicity.
SCINTIX therapy aims to cure oligometastatic and polymetastatic diseases in a single session by reducing the volume of tissue treated with radiation.
SCINTIX radiotherapy treatment addresses the issues of targeting and motion management, which have long been obstacles to radiation therapy for metastatic diseases.
The SCINTIX biologic modality detects tumor motion from any type of movement, including internal involuntary motions like breathing and digestion, as well as unexpected patient movement.
RefleXion can potentially improve patient outcomes when combined with chemotherapy, immunotherapy, and targeted drugs.
The RefleXion X1 is the only dual-modality platform that can treat patients with certain solid tumors at any stage.
The RefleXion X1 with SCINTIX treatment is a one-of-a-kind hybrid platform that offers both biologic technology for tumors in motion as well as anatomic capabilities via its onboard fan-beam, kVCT.
This remarkable technology is able to track and monitor tumor motion from various sources, including internal bodily processes such as breathing and digestion, as well as unexpected movements from the patient, according to RefleXion.