Curonix Secures FDA Clearance for Freedom® PNS System, Including Craniofacial Pain Indication

Wednesday, July 10, 2024

Curonix LLC, a medical technology company specializing in non-opioid chronic pain relief, has announced that it has received U.S. Food and Drug Administration (FDA) clearance to expand the indications for its minimally-invasive Freedom Peripheral Nerve Stimulator (PNS) System to include the craniofacial region.

This makes Freedom PNS the first system cleared for full-body permanent PNS to treat chronic, intractable pain of peripheral nerve origin.

Curonix estimates that over 740,000 patients in the United States suffering from chronic knee, shoulder, and foot & ankle pain could benefit from the Freedom PNS system each year.

Craniofacial pain, a prevalent and debilitating condition, can lead to physical discomfort, social impairment, reduced quality of life, and increased financial burdens.

The new indication for craniofacial pain allows more patients to experience the benefits of long-lasting pain relief through the Freedom PNS System.

The Freedom PNS System is a non-integrated, minimally-invasive implant that does not require an implanted battery.

It is powered by High Frequency Electromagnetic Coupling (HF-EMC) and consists of an implantable neurostimulator with two components, an externally worn transmitter, and software for customizing stimulation programs.

The neurostimulator, which includes an electrode array and a separate receiver, is anchored through two incisions, including the creation of a subcutaneous pocket. The stimulation program can be adjusted as needed to alleviate pain.

To support the 510(k) clearance process, a multi-center randomized controlled trial with 60 patients was conducted under an investigational device exemption (IDE).

Patients who received a Freedom PNS implant were randomized into two groups (activated or deactivated) and followed at 3, 6, and 12 months.

The trial demonstrated significant long-term pain reduction, confirming that the HF-EMC powered, permanent Freedom PNS System is a safe and effective therapy for craniofacial pain of peripheral nerve origin.

"At Curonix, we aim to collaborate with top physicians and their teams to push the boundaries of chronic pain management, particularly in underserved areas like craniofacial pain."

"With this new full-body PNS indication and long-term clinical evidence, we're expanding access for more patients who previously had limited treatment options, offering them potential relief from chronic pain through our innovative, long-term Freedom PNS System."

To date, over 380 patients have participated in long-term clinical studies for various pain conditions, including craniofacial, knee, shoulder, foot & ankle pain, using the Freedom PNS system.

Curonix plans to collaborate with leading physicians to publish these findings, further expanding the extensive body of clinical evidence supporting the Freedom PNS System. This comprehensive evidence will be leveraged to enhance patient access to the Freedom PNS System.






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