New Hope for Facial Pain: Curonix Launches First-of-its-Kind Implant

POMPANO BEACH, Fla. – January 16, 2026 – For the millions of Americans living with the debilitating effects of chronic craniofacial pain, a condition historically marked by limited and often ineffective treatment options, a significant breakthrough has arrived. Medical technology company Curonix LLC today announced the full commercial launch of its Freedom® Peripheral Nerve Stimulator (PNS) System for this indication, making it the first and only permanent, full-body PNS therapy available in the United States specifically cleared for chronic pain in the head and face.

This announcement marks a pivotal moment in pain management, introducing a clinically-proven, long-term solution to a market where both patients and physicians have long sought more durable and effective therapies. The system's availability follows the successful completion of a rigorous, FDA-approved clinical trial that provides top-tier evidence of its effectiveness.

Addressing a Silent Epidemic

Chronic craniofacial pain, which encompasses a range of neuropathic conditions affecting the face and head, is a widespread and often invisible burden. Affecting more than one-fifth of the U.S. population, it can arise from facial trauma, infections like herpes zoster, or other nerve damage. The pain is frequently described as relentless and severe, leading to significant reductions in quality of life, social impairment, and substantial financial strain.

For many, the journey for relief is a frustrating cycle of trial and error. First-line treatments typically involve medications such as anticonvulsants and analgesics. However, a large subset of patients develops refractory pain, meaning their symptoms do not respond adequately to conventional pharmacotherapy, or they suffer from intolerable side effects. These individuals have historically been left with few reliable medical or surgical alternatives, a gap that Curonix aims to fill.

“Having access to the Freedom PNS System allows me to treat patients suffering from chronic craniofacial pain, a condition for which I previously had limited treatment options,” said Richard Weiner, MD, a neurosurgeon from Dallas, Texas, and a paid consultant for Curonix. “As the only peripheral nerve stimulation system designed to treat pain throughout the full body, including craniofacial pain, it enables me to offer a consistent, evidence-based therapy to a broader range of patients, all without compromising clinical confidence.”

A Breakthrough Backed by Level I Evidence

The foundation of Curonix's market entry is not just innovation, but robust scientific validation. The company's claims are supported by a landmark prospective, multi-center, randomized controlled trial (RCT) published in the October 2025 issue of Pain Physician. Conducted under an FDA Investigational Device Exemption (IDE), the study provides what is considered Level I evidence—the highest standard in clinical research.

The trial enrolled 60 participants with refractory craniofacial neuropathic pain across seven U.S. clinical sites. After implantation of the Freedom PNS device targeting the trigeminal or occipital nerves, an astounding 93% of patients reported significant (at least 50%) pain relief within the first week.

Following this initial phase, patients were randomized, with one group continuing active stimulation and a control group having their devices deactivated. The results at three months were stark: 69% of patients in the active group maintained significant pain relief, compared to just 11% in the deactivated control group. The average pain score, measured on a Visual Analog Scale, plummeted by 62% in the active arm, while the control arm saw a negligible reduction. These benefits, which included marked improvements in quality of life and daily function, were sustained through 12 months of follow-up. Importantly, no serious adverse events related to the device were reported throughout the study.

Innovative Technology Drives a New Standard

At the heart of the Freedom PNS System is a unique technological approach that sets it apart from other neurostimulation devices. The system operates using High-Frequency Electromagnetic Coupling (HF-EMC), a technology that powers the implant wirelessly from an external transmitter worn by the patient. This elegantly engineered design eliminates the need for an implanted battery.

For patients, this means the system is a permanent implant without the need for future surgeries to replace a depleted battery—a common requirement for many other neurostimulation systems. The implant itself is minimally invasive, consisting of a small electrode array placed near the target nerve and a separate receiver, which are anchored in two small incisions. The external transmitter not only provides power but also allows physicians to fine-tune patient-specific stimulation programs for optimal pain relief.

Perhaps one of its most critical features in modern healthcare is that the Freedom PNS System is MR Conditional. Patients with the implant can safely undergo full-body MRI scans at both 1.5T and 3T field strengths, even with the scan centered over the device itself. This is a crucial advantage, as many patients with chronic conditions require periodic diagnostic imaging, a procedure often prohibited for those with older or less advanced neurostimulation implants.

Reshaping the Neuromodulation Market

Curonix's claim to be the “first and only” PNS system for this indication appears well-founded. A review of the competitive landscape reveals a clear opening in the market. Other PNS systems, such as SPR Therapeutics' SPRINT, are designed for short-term (60-day) use and specifically exclude the treatment of pain in the craniofacial nerve region. Bioness's StimRouter system is also not indicated for craniofacial pain.

Larger players in the neuromodulation space, like Medtronic and Abbott, have primarily focused on spinal cord stimulation (SCS) or dorsal root ganglion (DRG) stimulation for pain in the trunk and limbs. While case studies have explored off-label uses of various devices, the Freedom PNS System is the first to secure a specific FDA clearance for permanent use in the craniofacial region backed by a dedicated IDE clinical trial.

By targeting an underserved patient population with a technologically advanced and clinically-proven solution, Curonix is not just launching a new product; it is establishing a new standard of care. For countless individuals who have endured chronic facial pain without hope for lasting relief, the commercial availability of the Freedom PNS System represents a long-awaited and transformative development in their therapeutic journey.