PET-guided radiotherapy green light in hand, RefleXion raises $105M for commercial push

After winning an FDA clearance earlier this year for its image-guided radiation treatment for cancer, RefleXion Medical has raised $105 million to boost commercialization efforts as well as develop new applications for its approach.

The equity round was led by returning investor The Rise Fund, an offshoot of the firm TPG, and was joined by newcomers in Pictet and Square Point Capital, as well as previous backers in Ally Bridge, Pfizer Ventures and Johnson & Johnson Innovation, T. Rowe Price Associates, Venrock, Catalio and Hillenbrand.

The former Fierce 15 winner’s fundraising follows a banner year in 2022, which saw it collect $80 million in venture capital dollars that March, as well as sign on to a $125 million loan just a few months later, in preparation for the FDA’s green light.

The agency issued a de novo clearance to RefleXion’s Scintix system this past February—for treating cancers in the lung and bone, including distant and multiple metastatic tumors—about a year after handing down a breakthrough tag

Previously known as BgRT, for biology-guided radiotherapy, the treatment relies on active PET scans and injectable radioactive tracers to light up the locations of cancer cells in real-time, and then target them for radiation delivery. 

This allows the company’s X1 machines, each equipped with a linear accelerator, to adjust its dosage and trajectory automatically to account for the body’s involuntary movements. The X1 also has a clearance from the FDA to deliver image-guided radiotherapy against solid tumors located anywhere in the body without the use of a PET tracer.

“RefleXion is singularly focused on expanding the world of radiotherapy to include patients with all stages of disease, not just early stage patients,” said Matthew Hobart, co-managing partner of TPG Growth, on behalf of TPG’s Rise Fund. “We are delighted to see RefleXion reach a stage where they can accelerate their impact and deliver treatment and outcomes at scale.”

RefleXion announced that its Scintix system had treated its first cancer patient in August, at Stanford Medicine Cancer Center, with the company’s CEO, Todd Powell, describing it as a “watershed moment” in tackling the challenges posed by treating metastatic disease.

“Clinical literature and emerging practice guidelines are beginning to incorporate the importance of treating all visible disease in certain cancers. Scintix was conceived with that end in mind, and to work in combination with drug therapies to improve outcomes, especially for patients with advanced-stage cancers,” Powell said.

At the time, RefleXion said it had plans to roll out its X1 machines to multiple cancer centers throughout the country, including sites in California, Pennsylvania, Texas, New Jersey, Connecticut and Oregon by the end of this year.