RefleXion – Biology-Guided Radiotherapy
How SBIR Helped RefleXion Launch Technology That Turns Cancer Against Itself
As a postdoctoral researcher in radiology, RefleXion Co-Founder and Chief Technology Officer Samuel Mazin, PhD, imagined a device that could be used not only to see cancer but also treat it in real-time. The innovation would integrate radiation therapy, which uses high-energy X-rays to treat cancer, around a PET scanner, which administers a radiopharmaceutical in the body to light up cancer cells. The device would detect the signals from the cancer cells and reflect the radiation back to where it’s coming from. It would be biology-guided radiotherapy.
“That was the germ of the idea that my co-founder, Akshay Nanduri, and I really began to pursue in earnest,” Mazin said. “We didn’t realize how long a pursuit that would be and how arduous, and we’re still on that journey, of course, as a company. But that’s how it started.”
SBIR Impact
The NCI SBIR program played an important role in RefleXion’s development. Early on, the co-founders needed $10 million to build a machine that would validate their new technology. Traditional radiation therapy machines rotate at about one revolution per minute. RefleXion had to build a machine that for the first time would rotate high-energy linear accelerators at one revolution per second to continuously construct a map from emissions data to target the locations for beamlets of radiation. Investors were skeptical. The company needed capital, but they also needed to validate the technology. The NCI SBIR program helped them achieve both.
In 2010, the co-founders got in touch with a program director at NCI SBIR who offered guidance that led to a Phase I grant—the first of four NCI SBIR grants awarded to the company over 10 years. “NCI SBIR bought us time to hit milestones, conduct simulations, and demonstrate to investors that we were making progress,” Mazin said. “Of course, investors also like to see matching funds. So, that’s another big plus to having an NCI SBIR grant.”
RefleXion Today
To date, the company has raised about $575 million in investor capital secured over the course of several funding rounds.
In 2020, the U.S. Food and Drug Administration (FDA) issued 510(k) clearance for RefleXion to use its technology for a more conventional, image-guided radiotherapy (IGRT) with an onboard CT scanner. Since then, the company has installed its RefleXion X1 machine in seven sites across the United States, where it has been used to deliver over 15,000 fractions of IGRT.
In 2023, the FDA cleared the company’s SCINTIXTM biology-guided radiotherapy to treat patients with lung and bone tumors, which may arise from primary cancers or from metastatic lesions spread from other cancers in the body. With SCINTIX, RefleXion aims to change the outlook for people with late-stage cancer whose treatment options are currently limited. In metastatic cancer, where patients can present with both lung and bone tumors, radiotherapy is often not considered as a treatment option due to the cumbersome clinical workflow and toxicity of treating more than one tumor in a treatment session. SCINTIX is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine where to deliver radiation, second-by-second, during actual treatment delivery.
RefleXion has future plans to adapt SCINTIX therapy to work with an array of novel disease-specific radiopharmaceuticals under development for different cancer types and hopes this type of treatment will see widespread adoption by clinics.
Bringing the technology to patients has been hugely rewarding to Mazin, who had an opportunity to meet the first patient treated with a RefleXion X1 machine in May 2021. “I shook the patient’s hand and thanked him for trusting us with his care. He thanked me as well,” Mazin said. “That simple ‘thank you’ was all I needed to justify 10 years of work.”
Learn more on RefleXion's website.