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 RCT¹

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 study²

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 waveform³.

About Nalu Medical

Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.

About the Nalu Neurostimulation System

The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu System has been repeatedly recognized for its revolutionary technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.

Indications for Use

Spinal Cord Stimulation — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device. Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.

Nalu, the Nalu logo, and nPower are trademarks of Nalu Medical, Inc.

Disclaimers

The specific parameters used in the commercial use of the Nalu Neurostimulation System have evolved over time and are now different from the early set of programming parameters used in these clinical studies.

Any medical opinions expressed are those of the physician/medical providers. Individual experiences and outcomes may vary.

^1. Engle M, Sayal P, Liu E, et al. A report on the interim analysis of 6-month outcomes for the COMFORT PNS RCT. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.

^2. Desai MJ, Raju T, Ung C, et al. Exploring composite endpoints from the US nPower study. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.

^3. Desai, Mehul J et al. “A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.” Neuromodulation : journal of the International Neuromodulation Society vol. 26,1 (2023): 182-191. doi:10.1016/j.neurom.2022.10.053

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