Hayward, Calif.-based Reflexion Medical Inc. has received the green light from the U.S. FDA to market its Reflexion X1 system for standard radiation therapy treatments. The company, which also is breaking new ground with the development of biology-guided radiotherapy (BgRT), aims to eventually bring multi-tumor precision radiotherapy to all stages of cancer treatment.

The FDA cleared the Reflexion X1 for stereotactic body radiotherapy, stereotactic radiosurgery and intensity modulated radiotherapy. The clearance allows physicians to treat a single tumor with precise beam shaping and radiation dose delivery.

According to Reflexion, the X1 is the only machine to combine high-quality, fan-beam computed tomography with a linear accelerator to reduce motion noise that can interfere with the accurate dosing of a patient’s tumor. The system’s unique design revolves up to 60 times faster than current radiotherapy machines and regulates the firing of radiation doses from 100 points per beam station.

Combined, these advances could reduce some of the side effects associated with radiation therapy by better pinpointing the targeted tumor and limiting radiation exposure of surrounding structures.

Reflexion X1s to roll out next quarter

“We are at the forefront of an enormous change in expanding the use of radiotherapy from a treatment solely for early-stage cancer patients to an entirely new group of patients who need it most, those with advanced-stage cancer,” said Todd Powell, Reflexion’s CEO and president. “This initial marketing clearance of our Reflexion X1 machine is a steppingstone on the path to our goal of providing BgRT as a novel treatment modality that will expand the overall radiotherapy market significantly.”

The company currently is ramping up commercial operations in its new manufacturing facility, with initial X1 shipments slated for the second quarter of the year. The 50,000-square-foot plant, which opened in May 2019, includes six state-of-the-art linear accelerator testing vaults for the X1 machine, as well as manufacturing, quality control and a radiation oncology suite for clinical training.

BgRT

Founded in 2009 with the aim of exploiting each cancer’s unique biology to target and destroy it, Reflexion’s long-term strategy is invested in the development of BgRT. The modality uses a tumor’s individual biology to guide radiation dose delivery, even when tumors are moving – for example, as a result of breathing or digestion – by picking up a cancer cell’s signal and zapping back with radiation. The technology uses positron emission tomography to guide personalized radiotherapy. In addition, the platform permits the treatment of multiple tumors during the same session, an advantage in treating metastatic disease.

“Transitioning this company from a research effort to what is, as of today, a commercial entity has been a thrilling 10-year journey,” said Sam Mazin, founder and chief technology officer of Reflexion. “We will celebrate this milestone and then quickly turn our sights to bring our biology-guided radiotherapy to market.”

To commercialize the X1 BgRT capability will require additional 510(k) clearance. Last year, Reflexion secured a $60 million senior secured term loan from Oxford Finance LLC to advance the FDA process and subsequent commercial launch. Combined with three earlier funding rounds, the company has raised a total of about $223 million for its BgRT approach.

Competition in the space

Reflexion’s X1 faces competition from other companies that are already in the space. One of those is Viewray Inc., which won FDA clearance of the MRIdian Linac machine in 2017. The technology, which combines MRI guidance with linear accelerator radiation, enables real-time visualization of tumor movement during radiation treatment.

Another player is Varian Medical Systems Inc., whose Calypso anchored beacon transponder gained clearance in 2018. The transponder is used in conjunction with Varian’s medical linear accelerator to precisely target lung tumors by detecting minute movements of the tumor and allowing clinicians to adjust the target.

Additionally, Xstrahl Inc. last fall introduced advanced image-guidance capabilities for its superficial and orthovoltage radiotherapy systems. The Xsight image-guidance system is available as an add-on for Xstrahl’s 150kV and 200kV treatment systems and can be retrofitted to many other systems. It is integrated with the company’s Concerto cancer information system to display fixed or moving images before and following treatment.

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