Radiaction Retrospective: One year since receiving FDA clearance, what’s next?

It’s been a year since Radiaction Medical received FDA clearance for its innovative scatter radiation-blocking technology, bringing a new level of protection and convenience to the people caring for patients in American cardiology labs and electrophysiology settings worldwide. This achievement kicked off a productive year for the company and a busy one for the growing Radiaction team. Putting it into perspective with an eye toward a bright future, CEO Jonathan Yifat shared his thoughts and vision for what’s next:

How has Radiaction Medical evolved over the last year?

We’ve been growing. Our global headcount is up 30 to 40%, and most of our attention has been on building out our marketing, sales, and clinical teams in the US. At our headquarters in Israel, we’ve been expanding operations, R&D, and manufacturing activities and getting used to demands from our sales team to build more systems at greater scale.

We installed a system at our first Excellence Center in Poland. It was especially inspiring to see physicians who don’t know us personally embracing our technology solely because it works and integrates seamlessly into their clinical workflow. Shortly thereafter, we had our first US installation in the United States, followed by a second product’s FDA clearance in September that significantly increased our market access. We conducted studies and published papers demonstrating Radiaction’s performance and ran larger-scale trials in hospitals with great results.

We’ve also been grappling with post-COVID issues such as supply chain delays and reduced budgets for hospital equipment, but so is everybody else, and rolling up our sleeves to deal with those challenges is some of the most fun we have. Reaching the important milestones we hit in the last year required an intense, sustained effort from the entire Radiaction Medical team, and they’ve made me very proud.

How is the technology being received by medical staff?

Overall, medical staff responded quickly and positively to our technology and the chance to meaningfully increase protection for their own health and that of their colleagues. But it’s the little things physicians have said about the Radiaction system that continue to ring in my ears and keep driving me forward. For instance, when the system is deployed and protecting staff in the cath lab, a blue indicator light shines. Ashish Bhatia, MD, an electrophysiologist in Buffalo, New York, said, “Seeing the blue light gives me a lot of comfort. It makes me feel safe.”

The safety he feels is more than a feeling. It’s a measurable reality. With Radiaction’s help, Dr. Bhatia and his healthcare colleagues across the globe don’t have to suffer life-threatening, career-ending levels of scatter radiation during procedures where fluoroscopes are used.

This potential to save health, lives, and careers has kept us running for years, and it’s why we feel compelled to expand market access with our various FDA clearances. It’s also deeply gratifying to have our faith in this technology validated by the people we designed it for.

What did last year’s FDA clearance mean for Radiaction?

Having an FDA clearance means we have a product certified as safe, effective, and fully authorized for use — that is, it means market expansion and potential success for us as a company. It’s also an internationally recognized symbol of quality in drugs and medical devices. Our longtime focus on the US market is partly why we attracted so much investment, so it was a big deal to get the FDA’s nod. Also, going through the process forced us to build our product to the high levels of standards required for FDA clearance. This took us longer, but it was clearly worth the effort. It’s why we can focus on sales and customer service now, but it also means facing higher expectations than ever before.

What's in store for Radiation Medical in the coming year?

We’ve stretched our team across continents and sites, but we’re growing in parallel and recruiting wherever we need support. Over the next few months, we will continue to be busy with planned product installations and clinical validations, which we predict will double going into fall. We’re also generating a lot of interest among American physicians, our most effective allies in reaching the hospital administrators who make final purchasing decisions.

We’ll continue to be smart about keeping the company lean, but we want to get out there and conquer as much as possible. Trying to strike that balance can be a challenge amid all the excitement -- we don't want to overextend ourselves. Still, we will continue to focus on ensuring the success of every system installation and provide the highest level of support to our customers as they introduce our advanced radiation protection technology into their clinical workflows.

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