Floreo nabs FDA breakthrough label for its VR software

Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. 

The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization. 

“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.

The TAP program, established at the start of 2023, provides opportunities for dialogues with industry stakeholders, like payers and providers, through the product life cycle. The goal is to guide the device to success by facilitating discussions between companies and payers on the necessary evidence for reimbursement in terms of volume and quality. A breakthrough device designation is required to apply for the TAP program.

The breakthrough label fast-tracks new technologies aimed at treating life-threatening or irreversible conditions by giving tech makers a direct communication channel with the FDA and moving subsequent regulatory submissions to the top of the review pile. To qualify for the Breakthrough Device Program, companies must demonstrate credible evidence that their technology addresses unmet needs and offers potential improvements over current standard treatments. 

Launched in 2016, Floreo develops clinically designed VR lessons that help teach life skills aimed at children with autism and other neurodevelopmental disorders. It works with healthcare providers and the education sector, with its products already on the market for use alongside educators and clinicians. It also has Medicaid waivers in several states. 

The FDA assessed the safety and effectiveness of Floreo based on past research and interim data from its pre-pivotal RCT conducted with Cortica, an autism care provider. The study compared the efficacy of Floreo’s intervention with a control group using a sham active VR experience in an autistic pediatric population.

Last year, the American Medical Association approved a CPT III code for VR use in therapy for the first time at Floreo’s request, the company has said. But the code is primarily a tracking one. “There’s no CMS-advised reimbursement rate on a CPT III code. It’s left to the will of the payer,” Ravindran explained. 

A CPT I code would mark technology like VR as standard treatment, which would have stronger requirements mandating reimbursement. By obtaining full market approval, Floreo hopes it will jump-start the creation of such a code, which “we think will be the mechanism for reimbursement long-term.”

Floreo expects to begin its pivotal trial, necessary for full market approval, early next year. Building on its trial from this year with Cortica, Floreo has now been able to size the pivotal trial and tweak a few things based on learnings related to challenges of implementation, Ravindran said. Some of those challenges include training of providers, equipment distribution and a tailored curriculum appropriate for every learner. 

Floreo has doubled its enterprise clients over the past year, per Ravindran. “This coming year has opportunities to not just get FDA clearance,” he said, “but continue to grow the product suite.”