Nalu Announces Publication of the Largest Long-Term Report of Real-World Data (RWD) on a Permanent PNS Device
This analysis includes data from 2,273 patients implanted with the Nalu micro-IPG™ PNS System, making it the largest published real-world dataset on a permanent PNS device. The large sample size and a responder rate of 94% as measured by the highly respected Patient Global Impression of Change (PGIC) constitute solid evidence of reliable, exceptional effectiveness.
These RWD results confirm the outstanding 1-year published findings of the COMFORT Randomized Controlled Trial (RCT) 2 and the magnitude of the sample size supports generalizing those findings to the population at large. Combined with published data reporting a 50% reduction in total healthcare costs among patients receiving Nalu PNS therapy, 3 these findings provide strong real-world evidence that supports expanded coverage of PNS by private insurers.
According to John Hatheway, MD, lead author of the paper, 'The consistent improvements observed across a large, diverse sample of real-world clinic patients treated in multiple anatomic regions and nerve combinations emphasizes the broad applicability of PNS therapy delivered by the Nalu micro-IPG PNS system.'
Tom West, President and CEO of Nalu, notes that, 'These real-world results provide unmistakable evidence that the Nalu micro-IPG PNS System is dramatically reshaping pain management. No permanent PNS system has undergone greater scrutiny or shown comparable performance. We are thrilled to see that our groundbreaking technology is able to provide reliable long-term pain relief to such a broad spectrum of patients.'
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 and ranking number 19 in the 2023 Deloitte Technology Fast 500. 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 micro-IPG are trademarks of Nalu Medical, Inc.
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This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document. 1 Annualized sales for the first and second quarters of 2025
