POMPANO BEACH, Fla., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Curonix LLC, a leading medical technology company dedicated to relieving chronic pain, today announced the publication of a milestone study, Peripheral Nerve Stimulation for Intractable Chronic Pain: Real-World Clinical Outcomes, Utilization, and Economic Impact (PNS IMPACT Study), in Pain Physician. The study evaluated the clinical outcomes and broader economic impact of the Freedom® Peripheral Nerve Stimulator (PNS) System across a large patient cohort, providing comprehensive insights into its value for patients, providers, and the healthcare system.
Curonix Announces Published PNS IMPACT Clinical Study Showing Freedom® Peripheral Nerve Stimulator (PNS) System is Associated with Reductions in Pain Scores, Opioid Use and Overall Patient Burden
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pain managementCuronixPeripheral Nerve StimulationIntractable Chronic PainIMPACT StudyFreedom Peripheral Nerve Stimulator
The hybrid study by Moghim et al. combined a single-center retrospective review of 175 Freedom PNS implanted patients with a national claims analysis of 953 patients. This landmark study confirms that the benefits observed in previously published randomized controlled trials, such as the Level 1 double-blinded (Billet et al.) and FDA IDE Pathway (Hayek et al.), can be replicated in real-world clinical practice. The findings highlight the PNS therapy’s ability to lessen overall patient burden significantly through sustained pain relief, reduced long-term reliance on high-risk opioid medication, and decreased healthcare resource utilization.
Study results have shown:
Clinical Effectiveness and Opioid Medication Reduction
At 24 months, subjects reported a pain reduction of 80% from baseline, and this reduction remained durable through 36 months.
No serious adverse events (SAEs) were reported.
Opioid reductions observed demonstrated a favorable downward trend, suggesting reduced long-term reliance on high-risk opioids.
Minimizing Patient Burden
Sustained reductions in healthcare utilization suggest improved long-term clinical outcomes, benefiting patients through fewer healthcare encounters, reduced treatment burden, lower healthcare expenditures, and improved functional independence.
At 24 months, office visits and pain management interventions were reduced by 58.9% and 90%, respectively, and HOPD and ASC were reduced by 35.1% and 58.8%, respectively.
“This study was designed to evaluate whether the positive outcomes demonstrated in randomized controlled trials would translate into real-world clinical practice,” said primary author Dr. Robert Moghim, an interventional spine and pain specialist and founder of Colorado Pain Care. “By independently analyzing long-term outcomes reported by patients in my practice, we found results consistent with those observed in controlled clinical studies. These findings provide meaningful real-world evidence and add to the growing body of clinical data evaluating peripheral nerve stimulation as a treatment option for chronic pain.”
“Delivering consistent, long-term pain relief and improving quality of life for those suffering from debilitating chronic pain is our foremost responsibility,” said co-author Dr. Hemant Kalia, Interventional Pain Management Physician and founder and medical director of Savya Neuroscience Institute. “Studying and publishing real-world data quantifying the reduction in burden for both patients and the healthcare system is paramount.”
Curonix is committed to building trust through product research, data, and a continued focus on improving the lives of patients living with chronic pain.
“This publication reinforces Freedom PNS as a clinically supported treatment option, giving physicians greater confidence and patients added reassurance in a therapy supported by Level 1 clinical evidence, consistent safety and efficacy data, and meaningful outcomes replicated in real-world settings,” said Aure Bruneau, CEO of Curonix. “We thank Dr. Moghim, Dr. Kalia and the entire team for leading this most important study.”
For more information about the Freedom PNS System, visit curonix.com.
Drs. Robert Moghim and Hemant Kalia are paid consultants for Curonix.
About Curonix LLC
Curonix LLC is a Delaware medical technology company dedicated to developing and commercializing innovative therapies to help relieve chronic pain. The proprietary Freedom PNS System is a non-integrated, minimally invasive implant that does not include an implanted battery. The Freedom PNS System is powered by HF-EMC (High-Frequency Electromagnetic Coupling) and is comprised of a two-component implantable neurostimulator, an externally worn transmitter, and software used to set patient-specific stimulation programs. The two-component neurostimulator, comprised of an electrode array and a separate surgically connected receiver, is anchored within two separate incisions, including the creation of a subcutaneous pocket. The stimulation program is adjusted as needed to provide pain relief for the patient. The Freedom PNS System is the first and only permanent PNS system in the United States that is MR Conditional with the ability to scan throughout the body and over the implanted device at both 1.5T and 3T.**
Results may vary and depend on individual patient factors. The Freedom® PNS System is indicated for treatment of chronic, intractable pain of peripheral nerve origin. Rx only. Curonix LLC is a manufacturer of medical devices and does not practice medicine. Only a physician can determine what treatment is appropriate. For more information on indications, contraindications, risks, warnings, and possible adverse side effects refer to the Instructions for Use provided with the device or available on curonix.com.
**See full MR conditions in the Instructions for Use at curonix.com.
Contact:
Ashley Brown
Sr. Director, Marketing & Communications
Ashley.brown@curonix.com
512-791-4743
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Curonix's published PNS IMPACT study provides crucial real-world evidence, validating the Freedom® Peripheral Nerve Stimulator (PNS) System's economic value and clinical effectiveness. Demonstrating significant reductions in healthcare utilization and opioid reliance, this study strengthens Curonix's market position. It enhances physician confidence and supports broader adoption and potential reimbursement strategies by replicating randomized controlled trial benefits in practice, addressing overall patient burden.
- Healthcare utilization decreased significantly: 58.9% fewer office visits, 90% fewer pain management interventions, 35.1% fewer HOPD, and 58.8% fewer ASC visits at 24 months.
- The real-world evidence reinforces the Freedom PNS System as a clinically supported option, boosting physician confidence and patient reassurance for market adoption.
PhD Lens: Clinical and outcomes impact
The PNS IMPACT study, a hybrid analysis, confirmed the Freedom® Peripheral Nerve Stimulator (PNS) System's clinical efficacy and safety in real-world settings, replicating prior randomized controlled trial benefits. Patients experienced an 80% pain reduction from baseline at 24 months, sustained through 36 months, with no serious adverse events. The study also noted a favorable downward trend in opioid use, lessening overall patient burden.
- Clinical outcomes showed an 80% pain reduction from baseline at 24 months, durable through 36 months, with no serious adverse events reported.
- The hybrid study combined a single-center retrospective review (175 patients) with a national claims analysis (953 patients) to evaluate real-world outcomes.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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