Pressreleaser | 30 Nov 2022 | Integrum

Integrum AB: Integrum provides an update on the clinical development programs of e-OPRA[TM] Implant System and Neuromotus[TM]

e-OPRA[TM] Implant System

The clinical development of e-OPRA™ Implant System focuses not only on providing prosthesis users with the benefits of a bone-anchored implant solution but also on the possibilities of mind-controlled artificial limb movement, as well as re-established sensory feedback to the central nervous system. e-OPRA[TM] is currently being evaluated in three clinical trials.

Two clinical trials are being conducted in the US, at the Brigham and Women’s Hospital in collaboration with Massachusetts Institute of Technology in Boston, and University of California in San Francisco,. The trials aim to evaluate the extent by which a person who has received the e-OPRA™ Implant System can exhibit full neural control over a neuro-mechanical prosthetic system, as well as the normalization in walking metrics. The functionality of the e-OPRA[TM ]Implant System is being evaluated at two levels: in patients who have undergone amputation above the knee, and in patients with below knee amputations.

The third trial is conducted at the Sahlgrenska University Hospital, in Sweden. This trial aims to evaluate potential improvements in prosthetic control in patients who have received e-OPRA[TM] Implant System following upper limb amputation. To assess prosthetic control performance, the trial will measure long-term myoelectric signal stability and sensory perception over twelve months.

Neuromotus[TM]

Integrum is developing additional indications for Neuromotus[TM], a novel non-invasive treatment of phantom limb pain (PLP) – a severe pain condition that develops in a considerable number of patients following limb loss. Neuromotus[TM ]is based on cutting-edge AI and imaging technology (AR/VR).

In a recently completed clinical trial, Neuromotus was evaluated in combination with two different virtual reality techniques: Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of phantom limb pain. More than 70 patients with both upper and lower limb amputations in seven countries (SE, SI, BE, NL, CA, IR, US) were enrolled in the trial. The results are currently being processed and will be presented in a scientific paper next year.

”Integrum takes pride in continuously advancing treatment possibilities for individuals with amputations and fine-tuning our innovative solutions to transform life for individuals living with mobility challenges. In collaboration with international thought-leaders, we are progressing in the development of e-OPRA[TM], the world’s first osseointegrated mind-controlled prosthesis, and Neuromotus, a novel therapy of phantom limb pain,” comments Rickard Brånemark, CEO of Integrum.