RefleXion Medical has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its biology-guided radiotherapy (BgRT) to treat lung tumours.
BgRT incorporates positron-emission tomography (PET) imaging data to make tumours continuously transmit signals from their location.
The technology synchronises the data with linear accelerator to direct radiotherapy to tumours, with a latency less than fraction of a second.
Its ability to detect and treat the circulating tumours immediately has attracted the breakthrough designation, said the company
Also, it is the first and only technology intended for injected radiotracers to produce active signals from each tumour (emissions) to guide the radiotherapy.
City of Hope comprehensive cancer centre radiation oncology chair Terence Williams said: “Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs.
“The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies.”
The US agency’s Breakthrough Devices Programme identifies medical devices with potential to provide effective outcomes for severe disease, meeting certain criteria.
RefleXion said that BgRT is the first biology-guided radiotherapy system to enhance the cancer treatment from single tumour therapy to multiple tumours in a single day.
The technology is said to expand the treatment options for patients with all stages of cancer, including metastatic cancers.
According to RefleXion, recent lung cancer clinical trials showed significant improvements in overall and progression-free survival, radiotherapy plus drug therapy.
However, the approach is not capable of reaching more than one to three tumours.
BgRT is designed to address the limitation and deliver radiotherapy to more sites of disease, to provide improved outcomes for patients, said the company.
RefleXion president and CEO Todd Powell said: “By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumour motion with unprecedented precision.
“Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S.”
