Presidio Medical has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA), paving the way towards a pivotal study of its neuromodulation platform for treating chronic nociceptive lower back pain (LBP).
The US-based company’s ultra-low frequency (ULF) neuromodulation platform is designed to provide pain relief for nociceptive LBP by delivering ULF electric currents via spinal cord stimulation (SCS), targeting pain localised to the lower back by inhibiting neuronal pain responses.
Go deeper with GlobalData
Nociceptive pain relates to pain that occurs due to actual damage to the body, with burns, muscle strains, and trauma all being common causes. Pain in the body is otherwise referred to as neuropathic, whereby the pain originates in the nervous system.
With the IDE secured, Presidio said it will now initiate its pivotal, randomised controlled FULFILL trial at sites in the US and Australia.
Results from a first-in-human study of Presidio’s ULF platform were presented at this year’s North American Neuromodulation Society (NANS) 2025 meeting, which took place in Florida from 30 January to 1 February.
Sharing results from the prospective trial (NCT05837234), Dr Mark Russo, director at Hunter Pain Specialists in Australia and key investigator on the trial, stated that 53% of patients who received the treatment had “80% to 100% of their pain disappear”.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataPresidio CEO Michael Onuscheck commented: “The results from our first-in-human clinical trial in Australia were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform.”
Neuromodulation is a promising frontier in medical technology, with ongoing research and development aimed at enhancing treatment options for various neurological conditions.
Other companies working on devices for treating LBT include Irish company Mainstay Medical. In January, the manufacturer shared results from a one-year study of its ReActiv8 Restorative Neurostimulation system. Meeting its primary endpoint of change of mean improvement in the Oswestry Disability Index (ODI) score between treatment and control arms at the one-year follow-up, the system achieved statistical significance of ODI -19.7 ± 1.4 for the ReActiv8 arm versus -2.9 ± 1.4 in the control arm.
According to the World Health Organization (WHO), LBP affects around 619 million people worldwide, with a breakdown of the lumbar multifidus muscle (MF) thought to be a key driver of the pathology.
The WHO forecasts that LBP will increase to 843 million cases globally by 2050, driven by factors such as population growth and ageing, physical inactivity, obesity, and muscle weakness that may potentially be hereditary.
