Newel's VR therapy for chronic pain nears EU market

Newel Health has been granted EU medical device certification for its virtual reality-based digital therapeutic (DTx) for chronic pain, clearing the way for a launch in Europe.

Rohkea has been given MDR Class IIa certification for use in helping patients overcome fear of movement caused by chronic musculoskeletal pain, according to the Italian digital health company, which says it can now bring the product to market.

Rohkea (formerly ODD-403) was originally developed by Finnish pharma company Orion Corp, which licensed exclusive worldwide rights to develop, manufacture, and commercialise the app to Newel Health last year.

Rohkea – a Finnish word meaning brave or bold – encourages patients with chronic pain to navigate a virtual, open-world landscape using their whole bodies, carrying out tasks such as writing or drawing on an easel, picking fruit, packing and fitting items into a box, and solving puzzles using physical movements.

The idea is that engagement with the game elements in a VR setting distracts patients from the risk of pain, allowing them to increase both the intensity and range of movement they can manage over time.

Newel Health's chief executive, Ervin Ukaj, who took the helm of the company in April last year and previously held senior roles at Novartis, said the certification is a "significant milestone" and means it 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."

In the VIRPI clinical trial published in 2022, subjects with chronic musculoskeletal pain who used Rohkea for six to eight weeks reported greater reductions in fear of movement and better patient global impression of change (PGI-C) clinical status scores when compared with a placebo VR app and a group that just continued standard care.

The commercial version of the product is delivered through a 12-week programme in patients' own homes with the help of a virtual mentor. Newel Health said it plans to focus the rollout initially on healthcare systems and pain management clinics "seeking evidence-based, scalable solutions for chronic pain management."

The company is also developing a wearable, artificial intelligence-driven DTx for Parkinson's disease, called Soturi, which is being tested in a clinical trial to see if it can be used to enhance the efficacy of Parkinson's therapies.

The final patient in the NWL-SOT-CS-001 study, which is funded by the Michael J Fox Foundation, completed their last visit in October and data analysis is expected to conclude in the next few weeks.

It also has a DTx to help patients manage high blood pressure, Amicomed, which also has medical device certification.