RefleXion Medical

RefleXion Medical has completed a prototype of its biologically guided radiotherapy device and hopes to build a clinic-ready device by the end of 2018. Credit: RefleXion Medical
 
Sam Mazin
CEO: Sam Mazin
Based: Hayward, California
Founded: 2009
Company website

The scoop

RefleXion Medical is working on a new treatment option for metastatic cancer—by transforming a treatment that has been used for more than 100 years. Radiation therapy, a noninvasive treatment, is a common way to target localized tumors. But this, by definition, makes it unsuitable for treating cancer that has spread. Drugs are often the only option for patients whose cancer has metastasized.

Traditionally a two-step process, radiotherapy requires a patient to first undergo a CT or MRI scan, which a physician will use to determine where to deliver radiation. But this method has limitations that RefleXion is aiming to surmount with its biologically guided radiotherapy device.

RefleXion bumped its Series B to $52 million in July after raising $11.6 million in a 2014 Series A round. It counts Johnson & Johnson Innovation, Sofinnova Partners and Pfizer Venture Investments among its backers.

What makes RefleXion fierce 

The company is combining radiotherapy and positron emission tomography (PET) imaging in a single machine. PET imaging involves giving the patient a radioactive tracer that collects in areas of cancer and emits signals that show the location of the tumor. But instead of waiting for the whole image to resolve, RefleXion’s device delivers therapy in response to each individual signal the tracer emits, firing back a “beamlet of radiation” along each emission path.

Combining PET imaging and radiotherapy is not a new concept, but no one has devised a way to do it that enables the use of biological signaling in real time. PET imaging typically takes a few minutes to generate an image, which is “not acceptable” in radiation therapy, CEO Sam Mazin said. It is too slow to account for the motion from a patient’s breathing and other bodily functions. To sidestep this problem, RefleXion’s tech uses coincident PET photon pairs to guide radiotherapy beams toward a tumor as a tracer emits signals in real time.

In addition to enabling the real-time imaging and treatment of tumors, the technology also allows multiple tumors to be treated in parallel. This transforms radiation therapy—which can only treat tumors one at a time—into a new option for patients with metastasized cancer, a patient group that generally has few treatment options. And this is what drives pharma interest in RefleXion, Mazin said.

“We’re helping to provide another option--a local therapy option—not to necessarily replace chemotherapy, but to add another treatment modality and help reduce the overall cancer burden,” Mazin said.

Another challenge with radiotherapy is that it’s invisible, Mazin said. During the whole process, there’s never a point where the physician can confirm the radiation was actually delivered to the tumor. “What we’re doing here is closing the feedback loop,” he said. “The cancer is actually talking to the machine [and] the tumor is guiding its own treatment, saying ‘I’m over here, shoot at me.’”

The biologically guided system may offer other benefits, too. In addition to telling the machine where to direct therapy, biological signals may also be used to adapt each patient’s treatment, making it more effective. For instance, the tracer could concentrate more in some areas of the tumor, causing them to light up more brightly, perhaps prompting a physician to alter how the radiation is being delivered. He or she may want to boost radiation to the more metabolically active parts of the tumor, Mazin said.

What to look for 

Having built a prototype device in 2015, RefleXion is now working on a clinic-ready device to prove its concept, which should be ready by the end of 2018. The company is “actively talking” to various groups across the U.S., including cancer centers and academic groups, to de-risk the technology on the clinical side, Mazin said. He hopes some of these talks will expand into partnerships over the next 18 months.

RefleXion is hoping to file a submission with the FDA at the end of 2018, and is waiting for the agency to confirm that 510(k) clearance is the appropriate path for the device. As far as money goes, RefleXion doesn’t plan to seek funding anytime soon. Its $52 million haul will be enough to propel it to market, Mazin said. — Amirah Al Idrus, @FierceBiotech

RefleXion Medical