Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Nalu Medical, Inc., a privately held medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic pain. 

Boston Scientific has been a strategic investor in Nalu Medical since 2017. The transaction consists of an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific.*

The Nalu Neurostimulation System is designed to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin, including areas such as the shoulder, lower back and knee, through peripheral nerve stimulation (PNS). The therapy uses mild electrical impulses to interrupt pain signals before they reach the brain. The system features a miniaturized, battery-free implantable pulse generator, powered wirelessly by a small externally worn therapy disc and controlled via a smartphone app. 

Nalu Medical received U.S. Food and Drug Administration 510(k) clearance for the Nalu system in 2019. In the COMFORT and COMFORT 2 randomized controlled trials, evaluating the safety and efficacy of PNS, the system demonstrated significant and sustained pain relief for patients. In COMFORT, 87% of participants reported more than a 50% reduction in pain at 12 months, while in COMFORT 2, 79% of the patients reached an average pain relief of 64% at six months. Real-world data from more than 2,000 individuals reinforced these findings, with 94% of patients achieving clinically meaningful improvement across a broad range of chronic peripheral nerve pain conditions.

“Peripheral nerve stimulation is an exciting field with significant unmet patient need,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “Adding the highly differentiated Nalu Medical technology complements our existing therapies—including spinal cord stimulation, basivertebral nerve ablation and radiofrequency ablation—enabling us to deliver advanced pain relief options to a wider variety of patient populations.”

*On a 100% basis before consideration of Boston Scientific’s current equity ownership in Nalu Medical Inc. and other closing adjustments, the transaction price consists of an upfront cash payment of $600 million.

CONTACTS: 

For Nalu Medical

Sean Patrick, Chief Marketing Officer

spatrick@nalumed.com

<sub>1. Hatheway, J., Hersel, A., Engle, M., Gutierrez, G., Khemlani, V., Kapural, L., Moore, G., Ajakwe, R., Trainor, D., Hah, J., Staats, P., Makous, J., Heit, G., Kottalgi, S., & Desai, M. J. (2024). 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. Advance online publication. https://doi.org/10.1136/rapm-2024-106099
2. Engle M, Gutierrez G, Hersel A, Netzel C, Khemlani V, Kapural L, Cubillo E, Hatheway J, Moore G, Valimahomed A, Khan K, Shuayto M, Majjhoo A, Sayed D, Latif U, Trainor D, Ajakwe R, Staats P, Makous J, Martin P*, Kottalgi S, Desai MJ; COMFORT 2 Study Group. A Confirmatory Randomized Controlled Trial Evaluating a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain: 3- and 6-Month Results from the COMFORT 2 Study. Chronic Pain & Management. 2025; 9: 171. DOI: 10.29011/2576-957X.1000171
3. Hatheway, J. A., Ratino, T., Swain, A. R., Ratino, T., Latif, U., Arulkumar, S., & Desai, M. J. (2025). Long-term pain relief delivered by micro-implantable pulse generator: Findings from a large-scale, real-world data peripheral nerve stimulation patient registry. Chronic Pain & Management, 9, 169. https://doi.org/10.29011/2576-957X.100069</sub>

CARLSBAD, Calif. (BUSINESS WIRE) August 21, 2025 — Nalu Medical Inc., announced the release of a next-generation Therapy Disc—a significantly smaller, lighter and more comfortable version of the external wearable that powers the Nalu micro-IPG^TM. With a 39% reduction¹ in volume from its previous generation, the new Therapy Disc enhances the overall patient experience, while preserving the system’s unique advantages. With this advancement, the Nalu Neurostimulation System may be an option for more individuals seeking relief from chronic pain to be treated using peripheral nerve stimulation (PNS).

This design improvement builds on the Nalu commitment to delivering a more patient-friendly approach to PNS. The unique design of the Nalu System, featuring a small, implanted pulse generator powered wirelessly by an external wearable disc, offers several advantages over traditional, fully implanted systems. By keeping the battery outside the body, the Nalu System enables a less invasive implant procedure, avoids the need for future battery replacement surgeries, and provides greater comfort, especially for patients targeting nerves in more sensitive or mobile areas of the body.

“This launch strengthens our ongoing mission to expand access and make peripheral nerve stimulation therapy a therapeutic option for a broader patient population,” said Tom West, CEO and President of Nalu Medical. “With our next generation Therapy Disc, more individuals seeking relief from chronic pain have options to be candidates for this clinically proven PNS therapy.”

Physicians are already seeing the impact of this next-generation design in clinical settings. Dr. Eric G. Cornidez, MD, MBA, Managing Partner & Chief Medical Officer, Pain Institute of Southern Arizona, who has been using the new Therapy Disc during its limited release, emphasized the significance of this product offering: “The Nalu System has consistently shown strong patient acceptance in our practice. With the reduced size of the next-generation Therapy Disc, we’re now able to expand its use to more nerve targets, particularly in the upper and lower extremities. In our experience, the new design has improved both comfort and overall patient satisfaction, providing the opportunity to enhance patient care.”

The Nalu System is supported by what we believe to be one of the largest real-world clinical data sets in PNS including both randomized control trials, real-world clinical evidence and health-economic data. The introduction of the next-generation Therapy Disc establishes Nalu as a leader in wearable neurostimulation and underscores a commitment to improving chronic pain therapy through meaningful, insight-driven innovation.

About Nalu Medical, Inc.

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 Neurostimulation 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 advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years. The Nalu Neurostimulation 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] Data on file, Nalu Medical, Inc. 2025.}

CARLSBAD, Calif. (BUSINESS WIRE) August 6, 2025 — Nalu Medical, Inc., a leader in miniaturized neuromodulation therapies for chronic neuropathic pain, is pleased to announce that CareFirst BCBS has issued an updated medical coverage policy designating the Nalu Neurostimulation System as medically necessary in treatment of chronic pain of peripheral origin. This change, effective August 4th, 2025, follows CareFirst’s review of Nalu’s clinical data, inclusive of the recently published COMFORT 2 confirmatory randomized control trial, and marks an important milestone in Nalu’s mission to expand patient and physician access to safe, innovative, drug-free alternatives for chronic pain relief.

This policy shift moves Nalu from its prior classification of “Investigational/Experimental” to “Medically Necessary” for eligible patients—opening access to more than 3.5 million additional covered lives in the Washington DC, Maryland and Northern Virginia area.

“CareFirst BCBS recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,” said Tom West, President and Chief Executive Officer of Nalu Medical. “We’ve built a robust body of published clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain.  These strong clinical results are further supported by health economic data that demonstrates that use of Nalu PNS results in significant cost savings. We’re proud to see a leading payer like CareFirst acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.”

Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.

About the Nalu Neurostimulation System

The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG)¹ 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 advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years. The Nalu Neurostimulation 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.

About Nalu Medical, Inc.

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 Neurostimulation 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.

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] Data on file, Nalu Medical, Inc. 2025.}

CARLSBAD, Calif. (BUSINESS WIRE) Aug 5, 2025 –– The results of COMFORT 2, the second Nalu Medical Peripheral Nerve Stimulation (PNS) RCT, were published on July 30^th, 2025, in the peer-reviewed journal Chronic Pain & Management and are available here. These results confirm the positive clinical outcomes from the COMFORT trial, the first Nalu PNS RCT, and provide the first Level-1 confirmatory evidence for a permanently implanted PNS device for treating chronic pain.

COMFORT 2 results showed improved net health outcomes with statistically significant gains across all efficacy metrics:

• At 3 months, in the COMFORT 2 Active Arm, there was an 80% responder rate where responders achieved at least 50% pain relief, and there was an average pain reduction of 66% (p<0.001) compared to a 4% responder rate and 3% pain reduction for the Control Arm. At 6 months, the responder rate held at 79% with an average pain relief of 64%.

• 75% of COMFORT 2 Active Arm subjects had clinically significant improvement in functionality (p<0.001) as measured by the Oswestry Disability Index.

• 73% of COMFORT 2 Active Arm patients reported a clinically meaningful improvement in quality of life (p<0.001).

• At 6 months, the pooled data from both COMFORT and COMFORT 2 showed an 82% responder rate with an average pain reduction of 66% (p<0.001) in the Active Arm compared to 4% in the Control Arm.

• 97% of the pooled Active Arm subjects were responders as reported in the Patient Global Impression of Change (p<0.001).

“The outcomes from COMFORT 2 confirm what we have seen clinically — that PNS therapy with the Nalu PNS System results in clinically significant improvement in patient symptoms, quality of life, and general well-being,” said Mitch Engle, MD, PhD, lead author of the paper. “The fact that the results of COMFORT 2 are consistent with those from COMFORT further reinforces the clinical value of this important therapy in helping patients return to a satisfying life.”

Tom West, Nalu CEO and President stated, “This Level-1 confirmatory evidence provides further proof that the Nalu PNS System provides clinically meaningful improvement in the patient’s condition. The consistent and reproducible outcomes across a range of nerve targets give confidence that the use of Nalu PNS therapy, regardless of the area of the body treated, will result in significant relief in patients with chronic intractable 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, robust software 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 https://www.nalumed.com.

Indications for Use

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.

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.

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

Nalu Medical Achieves National Payer Milestone with Aetna Coverage for PNS Therapy
Leading-edge peripheral nerve stimulation therapy now available to more than 22 million Aetna members nationwide

CARLSBAD, Calif., July 15, 2025 – Nalu Medical, Inc., a leader in miniaturized neuromodulation therapies, is pleased to announce that Aetna Inc. has issued an updated medical policy designating the Nalu Neurostimulation System as medically necessary for the treatment of chronic pain of peripheral nerve origin. This change, effective July 31, 2025, marks a critical milestone in Nalu’s mission to expand access to safe, innovative, drug-free alternatives for chronic pain relief.

This policy shift moves Nalu from its prior classification of “Investigational/Experimental” to “Medically Necessary” for eligible patients—opening access to more than 22 million additional covered lives across the U.S.

“Aetna’s recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,” said Tom West, Chief Executive Officer of Nalu Medical. “We’ve built a robust body of clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain, as well as healthcare economic data that demonstrates use of Nalu PNS results in significant cost savings. We’re proud to see a leading payer like Aetna acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.”

Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.

About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG)1 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 advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu Neurostimulation 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.

About Nalu Medical, Inc.
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 Neurostimulation 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.

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