RefleXion overcomes 'unprecedented hurdles' to land FDA nod for biology-guided radiotherapy tech

Just over a year after being recognized by the FDA for the potential “breakthrough” nature of its radiation therapy technology, RefleXion Medical has gotten the go-ahead from the agency to begin rolling out the system across the U.S.

The FDA has cleared the Scintix biology-guided radiotherapy approach—previously known by its BgRT acronym—for use in treating patients with lung and bone tumors, RefleXion announced this month. That includes tumors that either originated in those areas or metastasized there from other parts of the body, opening up radiotherapy treatments to a wider range of patients rather than only those with localized, typically early-stage cancers.

The regulator bestowed its breakthrough-device designation upon the Scintix system at the end of 2021, with a specific focus on its ability to attack tumors in the lungs.

The technology is embedded into RefleXion’s X1 machines. Patients are injected with a radioactive drug before entering the machine, and, as the drug reacts with their cancer cells, the system’s positron emission tomography and linear accelerator technologies are able to pinpoint the second-by-second locations of those cells. That information then guides both the location and the amount of radiation delivered by the machine.

The PET-guided radiotherapy aims not only to track the movements of multiple tumors in real time, even as patients breathe, digest and shift positions, but also to minimize damage to the surrounding anatomy.

Alongside its first FDA authorization, the Scintix system was cleared for use with the most common PET tracer, fluorodeoxyglucose F 18. 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.

The FDA’s breakthrough designation gives a device or technology priority in the review process and opens up an easier channel of communication between a company and the agency. Even with the label, however, RefleXion’s road to regulatory clearance wasn’t an entirely smooth one.

“Our regulatory pathway encompassed unprecedented hurdles as medical device and pharmaceutical teams within the FDA worked together to create a new classification regulation for this breakthrough device and therapy,” CEO Todd Powell said in the company’s release.

That echoed how the development process itself had “demanded that we fundamentally rethink how to design a machine capable of delivering cancer treatment to patients that were not considered candidates for radiotherapy because of the extent of their disease,” per Powell.

With the FDA’s blessing now secured, however, the CEO said that RefleXion will “begin full commercialization and patient treatments in the coming weeks.”