ROHKEA® VR Therapy Achieves MDR Class IIa Certification, Marking Major Milestone in Digital Therapeutics for Chronic Pain
Newel Health announces that ROHKEA® VR Therapy has received MDR Class IIa certification as a medical device, paving the way for its European commercialization. This certification validates ROHKEA®’s intended use is to provide an automated intervention based on cognitive behavioral therapy to help patients overcome fear of movement caused by chronic musculoskeletal pain.
ROHKEA® is originally developed by Finnish pharmaceutical company Orion. Newel Health has the exclusive global rights to develop, manufacture and commercialize ROHKEA®.
“This MDR certification is a significant milestone for Newel Health,” said Ervin Ukaj, CEO at Newel Health. “It reflects the dedication and collaboration of our teams and our shared vision to improve the lives of people living with chronic pain. With this approval, we can now bring ROHKEA® to patients across Europe, offering a proven and accessible solution to help them regain confidence in their movement and improve their quality of life”.
ROHKEA® is a novel virtual reality-based digital therapeutic that combines cognitive behavioral therapy with physical activation exercises in an immersive environment. Delivered through a 12-week program with a virtual mentor, it provides therapy for chronic musculoskeletal pain patients in their homes. The recent MDR Class IIa certification complements ROHKEA®’s clinical validation from the VIRPI study, which demonstrated significant reductions in fear of movement and marked improvements in Patient Clinical Global Impression of Change compared to placebo controls.
“ROHKEA®, a virtual reality-based medical device software, shows how foundational scientific ideas can evolve also into novel digital opportunities to help the patients.” said Sammeli Liikkanen, Director of Digital Medicine at Orion Corporation. “We’re pleased to see our development work culminate in this certification, enabling Newel Health to bring this important therapy to market.”
“Cognitive behavioral therapy is a well-established first-line treatment for chronic pain management, but accessibility has been a persistent challenge,” said Professor Christopher Eccleston, lead Clinical Advisor for the project. “ROHKEA® represents a breakthrough in pain treatment delivery – its automated, immersive approach allows clinicians to provide evidence-based therapy at scale, potentially transforming how pain management services are delivered to patients.”
Newel Health plans to initially focus on healthcare systems and pain management clinics seeking evidence- based, scalable solutions for chronic pain management.
