CARLSBAD, Calif. (BUSINESS WIRE) May 8, 2025 — Publication of the Nalu Real-World Data (RWD) paper in the Chronic Pain and Management Journal is a significant milestone, establishing Nalu peripheral nerve stimulation (PNS) as a medically necessary treatment for chronic pain.¹

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.

CARLSBAD, Calif. (BUSINESS WIRE) Apr 3, 2025 — Nalu Medical, Inc. (“Nalu”) announced today the appointment of Raymond W. Cohen to serve as chairman of its board of directors.

Raymond Cohen served as the chief executive officer and member of the board of directors of Nasdaq-listed Axonics, Inc., a medical device company he co-founded in 2013 and took public in late October 2018. Axonics ranked No. 1 on the Deloitte Technology Fast 500™ and the Financial Times ranking of the fastest growing companies in the Americas in 2021 and 2022. Cohen retired from Axonics following the November 2024 close of its $3.7 billion sale to Boston Scientific Corporation (NYSE: BSX).

Following the sale of Axonics, Cohen was named chairman of the board of SoniVie, Ltd., a privately held, Israel-based developer of a renal denervation system to treat hypertension. Cohen was instrumental in the March 2025 announced sale to BSX for $600 million. In addition, Cohen serves on the board of directors of Kestra Medical Technologies (Nasdaq: KMTS), a commercial stage company manufacturing and marketing a wearable defibrillator product for patients at temporary risk of cardiac arrest. Kestra completed an oversubscribed IPO in early March, raising $232 million in gross proceeds.

Tom West, Nalu CEO and president, said, “We look forward to benefiting from Mr. Cohen’s broad experience in growing MedTech companies and his expertise in neuromodulation as we seek to significantly increase adoption of our peripheral nerve stimulation system.”

About Raymond W. Cohen

Raymond Cohen is an accredited public company director with more than 40 years of experience in the life sciences industry. He received the 2024 MedTech MVP Award and was also named Businessperson of the Year in 2024 by the Orange County Business Journal. In 2021, Cohen received a lifetime achievement award from SoCalBio for his four decades of work in medical technology. In late 2020, Cohen was named Entrepreneur of the Year by Ernst & Young for the Pacific Southwest United States.

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, 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 Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS) 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.

CARLSBAD, Calif. (BUSINESS WIRE) Jan 21, 2025 — Nalu Medical announces the FDA clearance for expanded labeling of its Peripheral Nerve Stimulation (PNS) System, now approved for whole-body MRI-conditional use. This clearance provides physicians with greater flexibility in treating chronic pain, minimizing MRI-related limitations. With the Nalu Neurostimulation System’s new and expanded MRI-conditional status, pain specialists can confidently offer personalized care without compromising future diagnostic imaging needs.

“This FDA clearance strengthens our mission to make peripheral nerve stimulation therapy appropriate for a broader patient population,” said Tom West, CEO and President of Nalu Medical. “With this expanded MRI-conditional labeling, more individuals seeking relief from chronic pain who may require a future MRI scan, can confidently receive the near-term relief of Nalu’s clinically proven PNS therapy.”

Dr. John A. Hatheway, Medical Director at Northwest Pain Care, PS, emphasized the significance of this expansion: “Whole-body MRI conditionality for the Nalu PNS System allows us to safely expand Nalu therapy usage to a wider audience with fewer restrictions. This means more patients who might previously have been unsuitable for the therapy can now benefit from Nalu’s differentiated neurostimulation technology.”

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 is 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, micro-IPG and the Nalu logo are trademarks of Nalu Medical, Inc.

CARLSBAD, Calif. (BUSINESS WIRE) Jan 8, 2025 — Nalu Medical, Inc. (“Nalu”), a leader in peripheral nerve stimulation, announced the publication of a study in Pain Management journal showing that the use of Nalu PNS therapy in chronic pain patients is associated with lower healthcare resource utilization (HCRU) and a significant reduction in associated costs., including a 61% overall reduction in outpatient costs.¹

This independently analyzed real-world study conducted by research firm OM1 evaluated medical claims data in a comprehensive database of more than 340 million patient lives (OM1’s Real-World Data Cloud, OM1, Boston, MA). The study compared patients’ healthcare-related cost estimates 12 months before versus 12 months after implant with a Nalu micro-IPG PNS System in patients receiving an implant between 2019 and 2023.

Patients treated with the Nalu PNS System experienced a 50% reduction in total medical costs in the 12-month period post-implant compared to the 12-month period pre-implant. This led to cost savings of $13,776 per patient in the 12-month post-implant period.

“We are excited to provide the first report of healthcare economic data for a permanent PNS device,” said Hemant Kalia, MD, MPH, FIPP, FACPM, of Invision Health, Rochester, NY, an author of the paper. “As responsible practitioners, it is important that we show healthcare savings in addition to improved patient outcomes in order to ensure patient access to this important therapy.”

Key findings:

• 61% reduction in mean total outpatient costs: outpatient costs significantly decreased, highlighting potential savings for both patients and healthcare systems.
• 38% reduction in the amount of additional services costs: costs associated with additional services such as imaging and procedures saw a notable decline.
• 31% decrease in the number of patients using opioids: the Nalu PNS System may contribute to reduced reliance on opioids for pain management.

“These findings show that the Nalu PNS System not only improves patients’ lives by reducing chronic pain, but also significantly reduces healthcare costs,” said Tom West, Nalu CEO. “The data clearly demonstrate the substantial value of Nalu PNS therapy to private and public payors looking to optimize cost of care. This is a highly effective, clinically proven, opioid-free, long-term solution for patients seeking relief from chronic neuropathic pain.”

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.

1. Kalia H, Thapa B, Staats P, et al. Real-world healthcare utilization and costs of peripheral nerve stimulation with a micro-IPG system. Pain Manag. Jan 6 2025:1-10. doi:10.1080/17581869.2025.2449810

CARLSBAD, Calif. (BUSINESS WIRE) Dec 3, 2024 — One-year data from the Nalu COMFORT randomized control trial (RCT) published in the peer-reviewed Regional Anesthesia & Pain Medicine journal confirm the consistent performance of Nalu peripheral nerve stimulation (PNS) technology in delivering pain relief that lasts and functional improvement that is truly meaningful.¹ Results at 1 year reinforce earlier 3- and 6-month findings, demonstrating that Nalu technology is clearly appropriate for confident, routine application.

Durable Reduction of Pain

1-year results include the following highlights (N=61)¹:

• 87% of patients experienced 50% or more pain relief.
• 69% average pain reduction.
• 95% of patients reported overall improvement.

The publication of robust 1-year data helps position the Nalu Neurostimulation System as the standard of care in PNS and furthers the efforts of Nalu to achieve unencumbered access to PNS. It is anticipated that broadening coverage to include commercial payors will provide access to PNS for patients who do not have the full coverage enjoyed by Medicare and Medicare Advantage plan participants.

According to Tom West, Nalu CEO and President, “These results confirm that Nalu patients achieve significant and durable improvement in pain, quality of life, and functionality. The COMFORT 1-year outcomes are significantly better than results for other permanent PNS RCTs, and the data are consistent with the impressive results reported in Nalu real world experience. These results underscore the undeniable value and clinical impact of our technology in providing lasting relief for those suffering from chronic, intractable pain.”

Significant Improvement in Overall Health Status

In addition to significant reduction in pain levels, the majority of patients achieved the minimal clinically important difference (MCID) at 1 year for the various patient-reported outcomes (N=61)¹:

• 78% of patients reported a reduction in depression.
• 73% of patients reported a reduction in disability.
• 70% of patients reported an improvement in quality of life.

John Hatheway, MD, lead investigator for the COMFORT RCT trial, adds specific details: “This study demonstrated that Nalu PNS therapy provided robust, consistent, and durable statistically significant improvement in pain, disability, quality of life, and mood. This level of long-term improvement from PNS across a spectrum of anatomic areas has not been previously reported. It is also important to note that beyond significant, long-term reduction in pain, patients with the Nalu PNS System are typically able to get back to a more satisfying experience of life.”

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

1. Hatheway J, Hersel A, Engle M, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Regional Anesthesia & Pain Medicine. Published Online First: 20 November 2024. doi: 10.1136/rapm-2024-106099