Nalu Medical Submits IPO Prospectus Highlighting 67% Pain Reduction at 24 Months in COMFORT Trial
Nalu Medical
Medical Device Developer
Nalu MedicalIn the journal "Journal Chronic Pain & Management 》Neurostimulators for the Treatment of Chronic Pain---NaluofClinicalResearch Data (COMFORT），DisplayRegardless of the body part being treated or the efficacy assessment metrics used, useNaluTreatment can provide durable, consistent, and statistically significant improvements in chronic refractory pain.
Specific Study Data (24 Months Post-Operation)
85% of subjects in the active treatment group and crossover treatment group were classified as responders (pain reduction ≥50%), with an average pain reduction of
67%, consistent with previously reported data.
28%subjects were high responders (pain reduction ≥80%).
According to the Oswestry Disability Index report,74%of subjects achieved clinically meaningful functional improvement (p<0.001).
72%of subjects reported a clinically meaningful improvement in quality of life (p<0.001).
96%of subjects were satisfied with the treatment.
PI Evaluation
"The 24-month results of the COMFORT RCT confirm what we have observed clinically — peripheral nerve stimulation therapy using the Nalu Neurostimulation System provides clinically meaningful improvements in patient symptoms, quality of life, and overall health. These robust results reinforce the efficacy and safety of the Nalu Neurostimulation System, demonstrating sustained pain relief across multiple anatomical targets at all time points from 3 months to 24 months."
---Mitch Engle
Executive Evaluation
"The 24-month results further demonstrate that Nalu can provide clinically meaningful and sustained relief for patients with chronic refractory neuropathic pain. The consistency of outcomes over the past 24 months, along with reproducible efficacy across a range of neural targets, reinforces confidence that Nalu is an effective PNS solution for localized pain."
---Tom West Nalu MedicalChief Executive Officer and President
Nalu MedicalBy virtue ofNaluExcellent clinical data garnered favor from Boston Scientific last year. In October of last year, Boston Scientific announcedTo be acquired for $600 millionNalu Medical。AlthoughNeuromodulation is Boston Scientific’s smallest business segment, but the company believesPeripheral nerve stimulation is an exciting field with significant unmet patient needs.Nalu MedicalSales data also validates Boston Scientific’s market forecast, since 2019NaluApprovedSince its listing, it has achieved high double-digit growth annually. 2025Nalu’s sales are expected to exceed $60 million, with year-over-year growth surpassing 25% this year. If normal delivery can be achieved this yearresection, leveraging Boston Scientific's strong commercialization capabilities will enableNaluSales increased significantly, which will also benefit Boston Scientific.Dominance in the Field of Neuromodulation.
Nalu
NaluByIt consists of a fully functional, battery-free, miniature implantable pulse generator (IPG), lead wires, a therapy disc, and a remotely controllable app.Micro-implantablePulse GeneratorImplantable Pulse Generator (IPG)By externalThe wearable treatment tray is wirelessly powered, and throughAPPPerform remote control.
Smaller, Less Invasive Implant: 27 Times Smaller Than the Largest Commercially Available Implantable Pulse Generator (IPG). Battery-Free Miniature IPG: Powered externally via a replaceable, wearable therapy disc, eliminating the need for an implanted battery and battery replacement surgery. Upgrade Without Surgery: The software can be upgraded wirelessly without surgery.
Long-term Use: Expected service life of 18 years, indicated for the long-term treatment of chronic intractable pain
Nalu Demo
