Curonix Publishes Results for the First and Only IDE PNS Multi-Center Randomized Clinical Trial Resulting in an FDA 510(k) Expanded Indication for Treating Chronic Craniofacial Pain

POMPANO BEACH, Fla., Oct. 02, 2025 (GLOBE NEWSWIRE) -- Curonix LLC, a leader in non-opioid neuromodulation therapies for the treatment of chronic pain, today announced the publication of its landmark prospective, multi-center, randomized, FDA-approved IDE clinical trial (RCT) for chronic craniofacial pain in Pain Physician.

The study, Hayek et al., evaluated the Freedom^® Peripheral Nerve Stimulator (PNS) System for the treatment of chronic craniofacial pain and provides Level I evidence, further supporting that it is the only full-body permanent PNS system to safely deliver significant and long-term pain reduction.

Study results have shown:

69% of patients receiving active stimulation achieved a ≥50% pain reduction at three months, compared to only 11% of the deactivated control group (p<0.001). Mean pain reduction and improved function were sustained through 12 months.
A 62% mean reduction in Visual Analog Scale (VAS) pain scores were reported by the active stimulation group, while the deactivated control group reported only an 8.5% reduction (p<0.001) in pain scores at three months. A significant mean decrease in pain scores was reported out to 12 months.
Significant improvements were observed in quality of life (SF-36), patient global impression of change (PGIC), and reductions in daily pain interference (BPIF).
No serious adverse events (SAEs) were reported.

“We congratulate all the study centers, physicians, and their teams for leading through this historic clinical trial. This publication represents a significant milestone for thousands of patients suffering from chronic pain, the Freedom PNS System, and the PNS therapy overall,” said Aure Bruneau, CEO of Curonix. “The Freedom PNS system delivers a safe, long-lasting relief alternative to treat chronic craniofacial pain.”

This groundbreaking study contributes to the existing PNS body of evidence through peer reviewed publications that include over 350 study patients implanted with PNS devices. Curonix is committed to utilizing this foundational evidence to facilitate advanced education for providers and work with private insurers, ensuring appropriate chronic pain patients gain access to PNS, a vital long-term permanent alternative to opioids.

For more information about the Freedom PNS System, visit curonix.com.

About Curonix LLC

Curonix LLC is a Delaware medical technology company dedicated to developing and commercializing innovative therapies intended 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. For more information, visit curonix.com.

Contact:
Ashley Brown
Sr. Director of Marketing & Communications, Curonix
Ashley.Brown@curonix.com
512-791-4743

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