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releases

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:

  • 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

January 8, 2025 0 comments
releases

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:

  • 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

December 3, 2024 0 comments
releases

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)

  • 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.

June 4, 2024 0 comments
releases

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

  • 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

March 5, 2024 0 comments
releases

Nalu Medical, Inc. Presents Long-term and Holistic Outcomes from the COMFORT RCT for PNS at NANS 2024

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.

January 23, 2024 0 comments
releases

Nalu Medical, Inc. Announces $65 Million Equity Financing to Advance Treatment for Chronic Neuropathic Pain

  • 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

January 3, 2024 0 comments
releases

Nalu Medical, Inc., Announces Positive Results of US Spinal Cord Stimulation Clinical Study in Pain Physician Journal

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

November 29, 2023 0 comments
releases

Nalu Medical, Inc. Ranked Number 19 Fastest Growing Company in North America in the 2023 Deloitte Technology Fast 500™

Attributes 9,623% Revenue Growth to the exceptional clinical performance and unique technology of the Nalu Neurostimulation System in treating unmet needs in chronic intractable neuropathic pain.

CARLSBAD, Calif (BUSINESS WIRE) November 9, 2023

Nalu Medical today announced that it ranked number 19 in the 2023 Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 29th year. Within the life sciences category, the company ranked number 7. Nalu Medical revenue grew 9,623% during the period from 2019 to 2022.

Nalu chief executive officer, Tom West, credits the exceptional clinical performance and unique technology of the Nalu Neurostimulation System for the company’s 9,623% revenue growth rate. He said, “We are proud to be in the company of so many life sciences leaders. We are also deeply gratified that our unique technology has been able to relieve the chronic pain of patients for whom traditional medical management and more conventional interventions would not be appropriate. Our use of advanced microelectronics has allowed us to develop an advanced and small implantable pulse generator (micro-IPG™) with an external battery that allows Nalu to uniquely and effectively treat neuropathic pain peripherally at the site of pain (PNS) and centrally in the spinal column (SCS). In addition, with Nalu, unlike conventional neurostimulators for pain, patients do not need to have a lithium battery implanted beneath the skin. A growing body of clinical data has clearly demonstrated the efficacy and lifestyle benefits for chronic pain patients of the Nalu System.”

Overall, 2023 Technology Fast 500 companies achieved revenue growth ranging from 201% to 222,189% over the three-year time frame from 2019 to 2022, with an average growth rate of 1,934% and median growth rate of 497%.

 

About the 2023 Deloitte Technology Fast 500

Now in its 29th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2019 to 2022.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

 

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.

 

About Deloitte

Deloitte provides industry-leading audit, consulting, tax, and advisory services to many of the world’s most admired brands, including nearly 90% of the Fortune 500® and more than 8,500 U.S.-based private companies. At Deloitte, we strive to live our purpose of making an impact that matters by creating trust and confidence in a more equitable society. We leverage our unique blend of business acumen, command of technology, and strategic technology alliances to advise our clients across industries as they build their future. Deloitte is proud to be part of the largest global professional services network serving our clients in the markets that are most important to them. Bringing more than 175 years of service, our network of member firms spans more than 150 countries and territories. Learn how Deloitte’s approximately 457,000 people worldwide connect for impact at www.deloitte.com.

Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms.

 

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

November 9, 2023 0 comments
releases

Nalu Medical, Inc. Presents Important New Clinical Data for PNS and SCS at ASPN 2023

CARLSBAD, Calif. (BUSINESS WIRE) July 20, 2023

Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based neurostimulation company that has miniaturized neurostimulation implants for the management of chronic intractable pain for both Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS) indications, presented significant new data from several studies at the 2023 American Society of Pain and Neuroscience (ASPN) Conference in Miami Beach, Florida.

Interim analysis of 6-month outcomes from the COMFORT PNS RCT1

The COMFORT RCT interim 6-month data show a 100% responder rate (≥50% reduction in pain) for subjects suffering from chronic peripheral neuralgia treated with the Nalu Peripheral Nerve Stimulation System (n=15). Additional highlights from the presentation include the following:

  • 78% mean pain relief from baseline.
  • 65% mean Oswestry Disability Index (ODI) score improvement.
  • 100% improvement measured by Patient Global Impression of Change (PGIC) reported by patients.

The lead author, Dr. Mitchell Engle, noted, “Interim results show that the Nalu PNS System can provide sustained pain relief and functional improvement for patients with peripheral neuralgia. These results are best-in-class for this type of treatment. I am anticipating the final analysis of this study, which will provide pain management physicians with the clinical evidence they need to recommend the Nalu PNS System to their patients.”

Exploring composite endpoints from the SCS nPower™ US study2

This study explored how multiple endpoints may be an indication of valid clinical benefit. In addition to 86% of subjects implanted with the Nalu SCS System reporting significant pain relief in back and leg(s), the vast majority (97%) of patients achieved a minimal clinically important difference (MCID) in one functional metric or more. Additional highlights from the presentation include the following:

  • 88% reported improved Patient Global Impression of Change (PGIC).
  • 94% reported improved Activities of Daily Living (ADL).
  • 77% reported improved Quality of Life (QoL).

According to the lead author, Dr. Mehul Desai, “These data show that 86% of patients experienced ≥50% pain relief and MCID was achieved across a variety of functional endpoints. This indicates that treatment with the Nalu SCS System provides a robust, holistic treatment response.” Nalu attributes results of this study to advanced engineering and the patented pulse stimulation pattern (PSP) waveform, which leverages multiple mechanisms of action in a single waveform3.

About Nalu Medical

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

About the Nalu Neurostimulation System

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

Indications for Use

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

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

Disclaimers

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

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

1. Engle M, Sayal P, Liu E, et al. A report on the interim analysis of 6-month outcomes for the COMFORT PNS RCT. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.
2. Desai MJ, Raju T, Ung C, et al. Exploring composite endpoints from the US nPower study. Presented at: Fifth Annual American Society of Pain & Neuroscience (ASPN) Conference; July 13-16, 2023; Miami, FL.
3. Desai, Mehul J et al. “A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.” Neuromodulation : journal of the International Neuromodulation Society vol. 26,1 (2023): 182-191. doi:10.1016/j.neurom.2022.10.053

Media Contact

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

July 20, 2023 0 comments
releases

Nalu Medical, Inc. Announces First Enrollment of COMFORT-2 Peripheral Nerve Stimulation Randomized Controlled Trial

CARLSBAD, Calif. (BUSINESS WIRE) May 31, 2023

Nalu Medical, Inc. (“Nalu”) a Carlsbad, California-based company that markets a minimally invasive neurostimulation implant for the management of chronic intractable pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, announces the first patient enrollment in the Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain (COMFORT-2) Peripheral Nerve Stimulation Randomized Controlled Trial.

Together with COMFORT-1, COMFORT-2 is designed to enroll the largest cohort of randomized controlled trial subjects comparing the responder rate of PNS combined with conventional medical management versus the responder rate of conventional medical management alone.

In the United States, up to 8 million people suffer from peripheral neuropathic pain.1 The Nalu Neurostimulation System for PNS (Nalu PNS system) is FDA-cleared for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. It offers long-term pain relief with an FDA-cleared serviceable life of 18 years.

The Nalu PNS system incorporates a battery-free, micro implantable pulse generator (micro-IPG™), powered by an externally worn device (Therapy Disc) housing the battery and controller. The system utilizes mild electrical pulses to create an energy field that acts to modulate the transmission of pain signals to the brain.

Dr. John Hatheway, interventional pain physician at Northwest Pain Care in Spokane, Washington, enrolled the first patient in the COMFORT-2 randomized controlled trial.

“I am thrilled to have enrolled the first patient in this important clinical trial. This is a significant milestone for our team and many clinicians who eagerly await empirical data to guide PNS treatment decisions,” said Dr. Hatheway. “I am confident that this trial will provide valuable insights into the safety and efficacy of this innovative therapy, and I look forward to continuing to work with Nalu Medical to advance this program and build Level 1 clinical evidence in the field of PNS.”

The COMFORT-2 randomized controlled trial will enroll up to 200 patients in up to 20 study centers in the U.S. Subjects who have been diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the low back, shoulder, knee, or foot (including ankle) will be randomized to PNS combined with conventional treatments or conventional treatments alone.

The primary endpoints are responder rate at 3 months and the rate of serious and non-serious adverse events. Secondary endpoints include responder rates and the rate of serious and non-serious adverse events at 6 and 12 months, as well as patient-reported functional outcomes.

“This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin,” says Tom West, Nalu Medical CEO and President. “We are proud to lead the charge in building scientific evidence for PNS while growing our portfolio of Nalu PNS clinical outcomes. We are committed to being the leader in PNS clinical data development.”

This is the second PNS randomized controlled trial sponsored by Nalu Medical. An interim analysis of the COMFORT-1 study was presented at the American Society of Interventional Pain Physicians in March 2023. Preliminary data demonstrated 81% of patients in the treatment arm experienced ≥ 50% pain relief vs. 0% in the control arm.2 Additional COMFORT-1 interim analysis will be presented at the 5th Annual American Society of Pain and Neuroscience conference to be held in Miami, FL, from July 13-16, 2023.

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.

Disclaimers

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

© 2023. All rights reserved. Nalu, micro-IPG, and the Nalu logo are trademarks of Nalu Medical, Inc.

  1. van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. Apr 2014;155(4):654-662. doi: 10.1016/j.pain.2013.11.013.
  2. Huynh, J., Martin, P., Kottalgi, S., Desai, M.J., et al. Early outcomes from a randomized control trial for the treatment of peripheral neuralgia. Presented at: American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, March 16-18, 2023, National Harbor, MD.

Media Contact

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

May 31, 2023 0 comments
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