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

CARLSBAD, Calif. (BUSINESS WIRE) June 4, 2024

Nalu Medical Inc. (“Nalu”) revealed significant findings from a landmark clinical trial evaluating the Nalu Peripheral Nerve Stimulation (PNS) System utilizing their proprietary micro-implantable pulse generator (micro-IPG™) to treat chronic pain patients.

The Nalu COMFORT study is a post-market, multicenter, randomized, controlled trial (RCT) evaluating pain reduction and functional outcomes across a variety of peripheral pain targets. The primary endpoint was met, showing Nalu PNS outperformed conventional care alone (p < 0.001). Results were published in Regional Anesthesia & Pain Medicine highlighting sustained therapeutic efficacy and safety.¹

88% of patients using Nalu PNS achieved ≥50% pain relief at 6 months (n=46)

• Patients using Nalu PNS showed a 70% average pain reduction.
• Outcomes were consistent across all anatomical areas in the study, including shoulder, low-back, knee, and foot/ankle pain.
• Devices utilized Nalu advanced programming.

Nalu PNS delivered clinically meaningful functional outcome benefits in addition to significant pain relief 

• 98% reported overall improvement.
• 70% reported quality of life improvement.
• 80% reported reduction in depression.
• 72% reported reduction in disability.

“For the first time, interventional pain management clinicians can confidently provide SCS-level outcomes with a PNS system that is proven with RCT data,” said Dr. John Hatheway, lead author of the study and interventional pain medicine physician at Northwest Pain Care in Spokane, WA. “In addition to significant pain reduction, the COMFORT study demonstrated meaningful improvements in quality of life, mood, and functionality.”

There were no reports of pocket pain, a common concern with traditional implanted neurostimulation devices.² There were also no serious device-related adverse effects and the vast majority of patients found the external components comfortable to wear.

Nalu Medical is leading the charge in developing Level-1 evidence for PNS

The ongoing COMFORT RCT study will monitor patients over a three-year period. Another study, COMFORT 2, is currently enrolling patients with anticipated completion of enrollment in 2024. Together, COMFORT and COMFORT 2 are designed to enroll the largest cohort to date of randomized controlled trial subjects comparing the responder rate of Nalu PNS combined with conventional care to the responder rate of conventional care alone.

“Our dedication to rigorous research cements our leadership in the field,” stated Tom West, CEO and President of Nalu. “The clinical outcomes unveiled by the COMFORT RCT study demonstrate that our technology yields unparalleled benefits for chronic pain patients, setting a new standard of care for PNS.”

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.

Media Contact

Nalu Medical, Inc.

Jon Ruais

jon@nalumed.com

1. Hatheway J, Hersel A, Song J, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3- and 6-month results from the COMFORT randomized controlled trial. Reg Anesth Pain Med. 2024.
2. Burke L, Desai MJ. Pocket pain following spinal cord stimulator generator implantation: A narrative review of this under-reported risk. Pain Pract. Apr 2024;24(4):659-669. doi:10.1111/papr.13336.

• B Capital invests incremental $20M; previously raised $65M led by Novo Holdings with participation from existing investors

• Equity investment to advance treatment for chronic neuropathic pain, accelerate commercial growth, and expand clinical and health-economic evidence for the innovative Nalu Neurostimulation System

CARLSBAD, Calif (BUSINESS WIRE) March 5, 2024

Nalu Medical, Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-pharmacologic solutions for chronic neuropathic pain, announced today the closing of an incremental $20M in equity financing from new investor B Capital, bringing the total Series E round of equity investment to $85M. Series E was led by Novo Holdings (Novo) with $65M of the total closing in late-December 2023. Also participating in the round were all existing significant investors: Gilde Healthcare, MVM Partners, Endeavour Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners.

“The Nalu Team is committed to addressing the unmet needs of patients suffering from chronic intractable neuropathic pain. We believe that our highly capable technology and uniquely small implant will elevate the standard of care in peripheral nerve stimulation (PNS) while being disruptive to the established spinal cord stimulation (SCS) market,” said Tom West, President and CEO of Nalu. “We are proud that our efforts serve the greater well-being of patients who suffer from chronic pain, and we are grateful for B Capital’s support in fulfilling and accelerating our mission.”

“The unique, clinically proven Nalu Neurostimulation System has the potential to address the unmet needs of millions who suffer from chronic neuropathic pain,” said Dr. Robert Mittendorff, Head of Healthcare and General Partner at B Capital. “We look forward to partnering with Nalu’s talented management team and strong syndicate of investors at a time of high revenue growth and potential for the company.”

The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations. Nalu will continue to invest in building clinical data that provide physicians with clear evidence of its benefits while also serving as the basis for expanded access and payor coverage.

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 micro-IPG are trademarks of Nalu Medical, Inc.

About B Capital

B Capital is a multi-stage global investment firm that partners with extraordinary entrepreneurs to shape the future through technology. With $6+ billion in assets under management across multiple funds, the firm focuses on seed to late-stage venture growth investments, primarily in the enterprise, financial technology, and healthcare sectors. Founded in 2015, B Capital leverages an integrated team across nine locations in the US and Asia, as well as a strategic partnership with BCG, to provide the value-added support entrepreneurs need to scale fast and efficiently, expand into new markets, and build exceptional companies. For more information, visit www.b.capital.

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com

CARLSBAD, Calif (BUSINESS WIRE) January 23, 2024

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, presented interim data from the landmark COMFORT randomized controlled trial (RCT) at the 2024 North American Neuromodulation Society (NANS) Annual Meeting in Las Vegas, Nevada.

The ongoing COMFORT RCT is a randomized, controlled, post-market, open-label, minimal risk, multi-center clinical study focused on evaluating the effectiveness of peripheral nerve stimulation (PNS) therapy with the Nalu Neurostimulation System to treat chronic pain in the shoulder, low back, knee, or ankle/foot. The study is designed to develop 3-year data to demonstrate the sustained pain relief and quality of life improvements achievable with the Nalu PNS system.

Interim 12-month pain relief data¹

• 87% of subjects were responders (≥50% pain relief)
• 73% average pain reduction

Holistic outcomes at 3 months²

According to Dr. John Hatheway, first author and presenter of the oral report, “Clinicians recognize the value of combining pain relief with functional outcomes to provide a more comprehensive assessment of device effectiveness in treating chronic, intractable pain. In the COMFORT RCT, we are measuring variables that present this broader picture. Results show that the Nalu PNS System is truly unique. For the first time, clinicians have access to advanced technology that enables us to offer effective long-term therapy to a broader range of patients.”

Highlights of the presentation include the following:

• 98% of subjects using Nalu PNS experienced ≥ 50% pain relief and/or reported improvement compared to 21% of the subjects who did not use Nalu PNS (p<0.001).
• 93% of subjects using Nalu PNS experienced ≥50% pain relief and/or reduced disability compared to 35% who did not use Nalu PNS (p<0.001).

“We are thrilled to see such promising results from our advanced micro-IPG in a rigorous RCT setting,” said Tom West, Nalu CEO. “The COMFORT RCT is intended to provide reliable evidence of the sustained effectiveness and impact on quality of life provided by Nalu PNS therapy and to expand the use of Nalu PNS to patients for whom physicians have limited options. Our approach to this research underscores our commitment to take a leadership role in generating evidence for continued and extended application of effective PNS therapy for chronic pain sufferers.”

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 micro-IPG are trademarks of Nalu Medical, Inc.

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com
925-667-6329

1. Engel M, Song J, Guttierez G, et al. A report on interim long-term pain outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.
2. Hatheway J, Hersel A, Song J, et al. Composite (combined) outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.

• Proceeds will accelerate commercial growth and expand clinical and health-economic evidence for the innovative Nalu neurostimulation system featuring the revolutionary micro-IPG.™

• Series E round led by Novo Holdings and joined by all existing significant investors.

CARLSBAD, Calif (BUSINESS WIRE) January 3, 2024

Nalu Medical Inc. (Nalu), a private company focused on innovative, minimally invasive, and non-opioid solutions for chronic neuropathic pain, announced today the closing of a $65 million equity financing. The round was led by a new investor, Novo Holdings (Novo). Also participating in the round were all of the Nalu existing significant investors: Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida, and Aperture Venture Partners. The proceeds from this financing will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development, and scale operations.

“The Nalu Team is excited about meaningfully expanding and improving the treatment options in the peripheral nerve pain space by setting a new standard of care while also offering a disruptive, minimally invasive, solution in the established spinal cord stimulation market,” said Tom West, President, and CEO of Nalu. “We continue to invest in building clinical data to expand access for patients who often don’t have other therapeutic options. We are proud that our efforts serve the greater well-being of patients who suffer from chronic pain and benefit those that care for them.”

“The differentiated Nalu neurostimulation product has the potential to benefit millions of patients suffering from chronic neuropathic pain,” said Eric Snyder, partner in the Venture Investments team at Novo Holdings. “We are impressed with their growing body of clinical evidence demonstrating meaningful clinical results in both the emerging market for peripheral nerve stimulation (PNS) and in the established market of spinal cord stimulation (SCS). We are delighted to support the strong management team at Nalu in this period of rapid commercial growth.”

“Nalu has made tremendous strides commercially and clinically in the past two years. Novo’s investment in Nalu reflects that progress and the confidence they share in the strong commercial potential for Nalu,” observed Geoff Pardo of Gilde Healthcare and Chairman of the Nalu Board.

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 micro-IPG are trademarks of Nalu Medical, Inc.

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio, with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. In the U.S. Novo Holdings operates through its wholly owned subsidiary Novo Holdings US, Inc. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development.

www.novoholdings.dk

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com
925-667-6329

CARLSBAD, Calif (BUSINESS WIRE) November 29, 2023

Nalu Medical, Inc (“Nalu”) is a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain across a variety of targets with both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications. Today the company announces publication of the SCS nPower™ US clinical study in the Pain Physician Journal that reports on clinical outcomes related to the use of the Nalu SCS System to treat patients suffering from chronic intractable pain of the of trunk and/or limbs, including unilateral or bilateral pain.

The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 comprehensive pain centers in the US. The Nalu Neurostimulation System was evaluated in 35 subjects with chronic low back and leg pain from baseline to 3 months. Highlights of the results include:

• 86% of subjects were “responders” (≥50% pain relief) in the low back and leg(s).
• 54% of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief).
• 75% average pain reduction in the low back and 76% in the leg(s).
• The wearable Therapy Disc was reported by all patients to be comfortable and easy to use.
• Secondary endpoints regarding sleep, mood, functional disability, and quality of life all demonstrated statistically significant outcomes at 3 months compared with baseline.

According to lead author, Dr. Mehul Desai, “This study demonstrates best-in-class pain outcomes with the added benefit of a battery-free implant and minimally invasive procedure substantiated by a small, 1.5 cm incision. In addition to pain reduction, patients reported holistic improvements that may be attributed to the unique multi-dimensional waveform that potentially addresses up to 6 mechanisms of action simultaneously.”

“Tom West, Nalu CEO, said, “In addition to strong clinical outcomes, the Nalu SCS System offers interventional pain specialists a treatment option that traditional SCS systems do not provide: a micro-IPG™ paired with a wearable battery. The implanted, battery-free micro-IPG is cleared by the FDA to last at least 18 years. Therefore, the risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated. The strong nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our unique neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”

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 micro-IPG 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.

Media Contact

Nalu Medical, Inc.
Jon Ruais
jon@nalumed.com
925-667-6329