Nalu Medical, a company that has miniaturised neurostimulation implants for the management of chronic intractable pain for both peripheral nerve stimulation (PNS) and spinal cord stimulation (SCS) indications, presented new data from several studies at the recent American Society of Pain and Neuroscience (ASPN) conference (13–16 July 2023, Miami Beach, USA).
These presentations included an interim analysis of six-month outcomes from the COMFORT PNS randomised controlled trial (RCT), which showed a 100% responder rate (≥50% reduction in pain) for subjects suffering from chronic peripheral neuralgia treated with the Nalu PNS system (n=15).
Additional highlights from the presentation included 78% mean pain relief from baseline; 65% mean Oswestry disability index (ODI) score improvement; and 100% improvement measured by patient global impression of change (PGIC) reported by patients.
“Interim results show that the Nalu PNS system can provide sustained pain relief and functional improvement for patients with peripheral neuralgia,” said lead author Mitchell Engle (Institute of Precision Pain Medicine, Corpus Christi, USA). “These results are best-in-class for this type of treatment. I am anticipating the final analysis of this study, which will provide pain management physicians with the clinical evidence they need to recommend the Nalu PNS system to their patients.”
Another key presentation at ASPN 2023 pertained to the SCS nPower US study, and explored how multiple endpoints may be an indication of valid clinical benefit. In addition to 86% of subjects implanted with the Nalu SCS system reporting significant pain relief in back and leg(s), the vast majority of patients (97%) achieved a minimal clinically important difference (MCID) in one functional metric or more.
Further highlights from the presentation included an 88% reported improved PGIC; 94% reported improved activities of daily living (ADL); and 77% reported improved quality of life (QoL).
“These data show that 86% of patients experienced ≥50% pain relief and MCID was achieved across a variety of functional endpoints,” said lead author Mehul Desai (International Spine, Pain & Performance Center, Arlington, USA). “This indicates that treatment with the Nalu SCS system provides a robust, holistic treatment response.”
Nalu attributes results of this study to advanced engineering and the patented pulse stimulation pattern (PSP) waveform, which leverages multiple mechanisms of action in a single waveform, a company press release notes.