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Proven clinical data from the Nalu System for Peripheral Nerve Stimulation (PNS)

The Nalu System for PNS is backed by a robust portfolio of clinical evidence.

Proven by clinical data. Demonstrated in practice.

Evidence that reinforces lasting impact

2 Randomized Clinical Trials (RCTs) backed by a Real World analysis demonstrate the Nalu System is

Effective

Sustained pain relief and improved functional outcomes over 24 months1

Versatile

Proven to treat 4 anatomical regions: shoulder, low back, knee, and foot/ankle1,2

Reproducible

Consistent pain relief across 2 Level 1 RCTs1,2


2 Randomized Clinical Trials

COMFORT RCT outcomes at 24 months (n=46)1

85%

Responder rate*

74%

Reported improvement in disability**

96%

Patient satisfaction***


COMFORT 2 outcomes at 6 months (n=81)2

79%

Responder rate*

75%

Reported improvement in disability**

92%

Patient satisfactionŦ

* ≥50% pain relief from baseline
** On the Oswestry Disability Index (ODI)
*** Defined as “very much,” “much” or “minimally improved” on the Likert Scale
Ŧ Pooled data from COMFORT and COMFORT 2 at 6 months; defined as “very much,” “much” or “minimally improved” on the Likert Scale


Real-World data

Nalu System registry outcomes at an average of 6.6 months after implant (n=2,273)3

2,273

patients

154

clinical sites

94%

of patients reported improvement¥

¥ “Very much,” “much,” or “minimally improved” on the PGIC scale


Healthcare utilization cost comparison 12 months before and 12 months after implantation (n=122)4

31%

of patients eliminated opioids

61%

reduction in outpatient costs


†Nalu™ Neurostimulation System
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.

References

  1. Engle MP, Hersel A, Gutierrez G, Khemlani V, Kapural L, et al. (2026) Long-Term Clinical Outcomes (24 Months) of Peripheral Nerve Stimulation in the Treatment of Chronic Pain - COMFORT RCT. Chron Pain Manag 10: 179. DOI: 10.29011/2576-957X.100079 (N=46)​
  2. Engle M, Gutierrez G, Hersel A, Netzel C, Khemlani V (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. Chron Pain Manag 9: 171. DOI: 10.29011/2576-957X.1000171 (N=81)
  3. Hatheway JA, Ratino T, Swain AR, Ratino T, Latif U, et al. (2025) Long-Term Pain Relief Delivered by MicroImplantable Pulse Generator: Findings from a Large-Scale, Real-World Data Peripheral Nerve Stimulation Patient Registry. Chron Pain Manag 9: 169. https://doi.org/10.29011/2576-957X.100069 (N= 2,273)​
  4. Kalia H, Thapa B, Staats P, Martin P, Stetter K, Feldman B, Marci C. Real-world healthcare utilization and costs of peripheral nerve stimulation with a micro-IPG system. Pain Manag. 2025 Jan;15(1):27-36. doi: 10.1080/17581869.2025.2449810. Epub 2025 Jan 6. PMID: 39757932; PMCID: PMC11801342. (N=122)