The Nalu Team - Nalu Medical
Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc.
Link to Boston Scientific Press Release
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."
CONTACTS:
For Nalu Medical
Sean Patrick, Chief Marketing Officer
spatrick@nalumed.com
- Hatheway, J., Hersel, A., Engle, M., et al. (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. DOI
- Engle M, et al. (2025). 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. DOI
- Hatheway, J., et al. (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. DOI
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. This design improvement builds on the Nalu commitment to delivering a more patient-friendly approach to PNS.
“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.”
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.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) 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 and advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years.
CareFirst BCBS Recognizes Nalu Neurostimulation System as Medically Necessary for Chronic Peripheral Pain
CARLSBAD, Calif. (BUSINESS WIRE) August 6, 2025— Nalu Medical, Inc., 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 opens 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.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app.
Nalu Announces Publication of Results from COMFORT 2 Randomized Control Trial (RCT)
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. COMFORT 2 results showed improved net health outcomes with statistically significant gains across all efficacy metrics:
- 80% responder rate at 3 months where responders achieved at least 50% pain relief, and an average pain reduction of 66% (p<0.001).
- At 6 months, the responder rate held at 79% with an average pain relief of 64%.
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.
Nalu Medical Achieves National Payer Milestone with Aetna Coverage for PNS Therapy
CARLSBAD, Calif., July 15, 2025 – Nalu Medical, Inc., 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 marks a critical milestone in Nalu’s mission to expand access to drug-free pain relief.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focusing on innovative and minimally invasive solutions for chronic neuropathic pain.
Publication of the Largest Long-Term Report of Real-World Data on a Permanent PNS Device
CARLSBAD, Calif. (BUSINESS WIRE) May 8, 2025 —Publication of the Nalu Real-World Data (RWD) findings establishes 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.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on chronic neuropathic pain solutions.
Nalu Medical Appoints Raymond W. Cohen Chairman of its Board of Directors
CARLSBAD, Calif. (BUSINESS WIRE) Apr 3, 2025 — Nalu Medical, Inc. announced today the appointment of Raymond W. Cohen to serve as chairman of its board of directors.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on developing innovative solutions for chronic neuropathic pain.
Nalu Expands MRI-Conditional Labeling for Peripheral Nerve Stimulation
CARLSBAD, Calif. (BUSINESS WIRE) Jan 21, 2025 — Nalu Medical announces the FDA clearance for expanded labeling of its Peripheral Nerve Stimulation (PNS) System, approved for whole-body MRI-conditional use.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on chronic neuropathic pain solutions.
Nalu PNS System Significantly Reduces Healthcare-Related Costs in Chronic Pain Patients
CARLSBAD, Calif. (BUSINESS WIRE) Jan 8, 2025 — Nalu announced publication of a study showing that the use of Nalu PNS therapy in chronic pain patients is associated with lower healthcare resource utilization and significant cost savings.
Key findings:
- 61% reduction in mean total outpatient costs.
- 38% reduction in the amount of additional services costs.
- 31% decrease in the number of patients using opioids.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on chronic neuropathic pain solutions.
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) confirm the consistent performance of Nalu peripheral nerve stimulation (PNS) technology.
Durable Reduction of Pain
Highlights include:
- 87% of patients experienced 50% or more pain relief.
- 69% average pain reduction.
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on chronic neuropathic pain solutions.