Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based neurostimulation company that has miniaturized neurostimulation implants for the management of chronic intractable pain for both Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS) indications, presented significant new data from several studies at the 2023 American Society of Pain and Neuroscience (ASPN) Conference in Miami Beach, Florida.
Interim analysis of 6-month outcomes from the COMFORT PNS RCT
The COMFORT RCT interim 6-month data show a 100% responder rate (≥50% reduction in pain) for subjects suffering from chronic peripheral neuralgia treated with the Nalu Peripheral Nerve Stimulation System (n=15). Additional highlights from the presentation include the following:
- 78% mean pain relief from baseline.
- 65% mean Oswestry Disability Index (ODI) score improvement.
- 100% improvement measured by Patient Global Impression of Change (PGIC) reported by patients.
The lead author, Dr. Mitchell Engle, noted, “Interim results show that the Nalu PNS System can provide sustained pain relief and functional improvement for patients with peripheral neuralgia. 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.”
Exploring composite endpoints from the SCS nPower™ US study
This study 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 (97%) of patients achieved a minimal clinically important difference (MCID) in one functional metric or more. Additional highlights from the presentation include the following:
- 88% reported improved Patient Global Impression of Change (PGIC).
- 94% reported improved Activities of Daily Living (ADL).
- 77% reported improved Quality of Life (QoL).
According to the lead author, Dr. Mehul Desai, “These data show that 86% of patients experienced ≥50% pain relief and MCID was achieved across a variety of functional endpoints. 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.
Source: https://www.businesswire.com/
