releases - Nalu Medical

Nalu PNS System Significantly Reduces Healthcare-Related Costs in Chronic Pain Patients

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:

“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

Nalu 1-Year PNS Data Show Durable Pain Relief and Significant Functional Improvement

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:

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:

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

About the Nalu Neurostimulation System

Indications for Use

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

Nalu PNS System achieves significant and durable pain reduction, meeting the primary endpoint of the COMFORT RCT study

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)

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

“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

About the Nalu Neurostimulation System

Indications for Use

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

Nalu Medical, Inc. Closes $85 Million Series E Round

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

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

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