releases - Nalu Medical

Nalu Announces Publication of Results from COMFORT Randomized Controlled Trial (RCT) Demonstrating Sustained Pain Relief and Functional Improvements Over 24 Months

The 24-month results of the COMFORT Peripheral Nerve Stimulation (PNS) RCT were published on January 23, 2026 in the peer-reviewed journal Chronic Pain & Management. These results demonstrate that treatment with the Nalu Neurostimulation System resulted in durable, consistent and statistically significant improvements for chronic intractable pain, regardless of the area of the body treated and efficacy metric used.

At 24 months,

“The 24-month outcomes of the COMFORT RCT confirm what we have seen clinically — that peripheral nerve stimulation therapy with the Nalu Neurostimulation 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. “These robust results reinforce the efficacy and safety of the Nalu Neurostimulation System with consistent pain relief across multiple anatomical targets at all timepoints, from 3 to 24 months.”

Tom West, Nalu CEO and President stated, “The 24-month outcomes provide further proof that the Nalu Neurostimulation System delivers clinically meaningful and sustained relief in patients with chronic intractable neuropathic pain. The consistency of results over the last 24 months, and the reproducible outcomes across a range of nerve targets give confidence that the Nalu Neurostimulation System is an effective PNS solution for localized pain.”

Consensus Guidelines for the Use of Peripheral Nerve Stimulation in the Treatment of Chronic Pain and Neurological Diseases: A Neuron Project from the American Society of Pain and Neuroscience

Peripheral nerve stimulation (PNS) has evolved substantially over recent decades in terms of hardware and evidence supporting efficacy. Treatment targets continue to expand and address both pain and functional applications. The American Society of Pain and Neuroscience (ASPN) seeks to substantially update and expand upon a review of the evidence supporting PNS as well as provide guidelines for clinical practice. A diverse multidisciplinary panel of experts was selected to provide opinions and guidance based on evidence-graded assessment and clinical knowledge. This document aims to serve as a resource for clinicians and payors in the interest of expanding awareness of the breadth of research in the field of PNS and expanding access to therapy.

Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc.

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.”

Nalu Advances Wearable Neurostimulation with New, 39% Smaller Therapy Disc

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™. With a 39% reduction 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.”

CareFirst BCBS Recognizes Nalu Neurostimulation System as Medically Necessary for Chronic Peripheral Pain, Expanding Access to 3.5 Million Covered Lives

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.”

Nalu Announces Publication of Results from COMFORT 2 Randomized Control Trial (RCT) Making Nalu the First Permanent PNS Device to Demonstrate Level-1 Clinical Evidence

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 30th, 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:

“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.”

Nalu Medical Achieves National Payer Milestone with Aetna Coverage for PNS Therapy

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.”

Nalu Announces Publication of the Largest Long-Term Report of Real-World Data (RWD) on a Permanent PNS Device

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.

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.

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.”

Nalu Medical Appoints Veteran Medtech Executive Raymond W. Cohen Chairman of its Board of Directors

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).

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.”

Nalu Expands MRI-Conditional Labeling for Peripheral Nerve Stimulation with FDA Clearance for Whole-Body MRI

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.”