A Perspective – Why the Big Deal about the First RefleXion X1 Deal
The lead-up to the first sale for any tech startup is filled with hope, pressure and anticipation. When the deal closes, it’s a celebrated win because it signals belief in the technology and lays the foundation for other sales.
In oncology, the stakes are high because technologies are expensive to procure, and customers are often reluctant to take a chance on a new vendor. “The first sale is one of the most important milestones in any medical technology company’s history because you need a technology that solves a need, a product that encapsulates that technology, the Food and Drug Administration’s OK to market it, and processes for manufacturing and delivering it to a customer,” says Sam Mazin, Ph.D., RefleXion’s co-founder and CTO.
The company finalized the first sale of its RefleXion X1 machine on April 9, 2020, with a large academic medical center in California that is a world leader in cancer research and treatment. Mazin says the sale of the first RefleXion X1 represents the culmination of the dedication of employees across the company who have worked tirelessly to transform an idea into a viable technology that will be a game-changer in cancer care.
For Mazin, the first sale is particularly heartening, as it is an important stepping stone on the path to one day using the RefleXion X1 to treat all stages of cancer.* Mazin began to think of this idea more than a decade ago when he attended a lecture on radiation physics as a postdoc focused on medical imaging in the Radiological Sciences Lab at Stanford. The lecture touched on the difficulty of seeing cancer tumors during treatment. Mazin began to think about whether individual tumor emissions could be used as a homing signal or biological marker to guide radiotherapy to the tumor’s location. By combining positron emission tomography (PET) with a linear accelerator (linac) to treat cancer, Mazin conceptualized turning cancer on itself to destroy it. His idea would entail using PET in an entirely new way.
The ultimate goal is to use the RefleXion X1 machine to treat multiple tumors in the same session, even those in motion, so that radiotherapy can treat stage 4 (metastatic) cancer patients in an efficient way. RefleXion aims to offer biology-guided radiotherapy (BgRT), which incorporates PET imaging data to enable tumors to continuously signal their location, and synchronize these data with the linac to direct radiotherapy to tumors with sub-second latency. Mazin believes BgRT will become a new treatment choice in the arsenal against cancer.
Mazin is ecstatic about partnering with his alma mater. “I feel so proud to see RefleXion’s first machine going to my academic home. I have to keep pinching myself to make sure this isn’t just some fantastic dream,” he says.
The journey to the first sale, which was years in the making, had challenges. It took several years to put together the first institutional financing in RefleXion’s early days to build the first proof-of-concept machine. Many technical problems had to be solved to enable rotating a 6-ton machine at 60 RPM, but the biggest one was designing and building the multi-leaf collimator (MLC) that directs the therapeutic radiation. RefleXion’s MLC has to switch exceedingly fast at 100 cycles per second. “We prototyped four different topologies and ended up with a stellar design based on a pneumatic-spring-resonance mechanism,” Mazin says.
Along the way, RefleXion has celebrated significant milestones. Assembling a 12-member consortium that includes clinical research partners and prospective users was an important milestone to draw on clinical thought leadership to help guide potential applications in metastatic disease and beyond. The opening of RefleXion’s state-of-the-art manufacturing facility for production in Hayward, California, enabled the company’s commercial phase. And not surprisingly, RefleXion’s first regulatory clearance from the FDA was a major milestone. “So much work went into the development, verification and validation testing of the RefleXion X1 to enable the clearance to happen,” he says.
It’s been magical for Mazin to see his idea blossom and materialize. “You hear stories about tough times in startups and founders and early employees wondering whether they are on the right path. With RefleXion, I never felt that way,” he says. “Although there were some difficult times, especially in the financially challenged early days, we were continuously getting signals that we were on the right path.”
He was, and remains, motivated by the positive feedback from clinicians who have said and continue to say RefleXion will have an important application in stage 4 cancer, as well as from the pharmaceutical companies that ultimately became investors. He appreciates the clinical and pharmaceutical supporters, but equally important, Mazin’s
grateful for RefleXion’s amazing team members that took big pay cuts to join the startup on this mission. “I am so proud of and inspired by my coworkers,” he says. “The realization of my idea into a medical product is something truly inspiring to behold. I am humbled by the amazing men and women I work with who have helped RefleXion get to this point.”
While he’s looking forward to the future sales that will help RefleXion join the ranks as an established vendor in the cancer care space, Mazin says, “Treating the first patient and making a positive impact on a person’s life is an event I can’t wait to experience.”
*The RefleXion X1 is cleared for SBRT, SRS and IMRT. BgRT requires additional regulatory review; this feature is not available for sale.