Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System

POMPANO BEACH, Fla., July 09, 2024 (GLOBE NEWSWIRE) — Curonix LLC, a medical technology company dedicated to relieving chronic pain without the use of opioids, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to expand the labeled indications for its minimally-invasive Freedom Peripheral Nerve Stimulator (PNS) System to include the craniofacial region. This makes Freedom PNS the first and only system cleared for full-body permanent PNS for the treatment of chronic, intractable pain of peripheral nerve origin.

Curonix estimates that over 740,000 chronic knee, shoulder and foot & ankle pain patients in the United States are potential candidates for the permanent Freedom PNS system each year.¹ Craniofacial pain is also one of the most common chronic debilitating pain conditions.² In addition to causing patients physical discomfort, craniofacial pain can bring social impairment, reduced quality of life, and increased financial burdens.³ The expanded indication for craniofacial pain opens the door for more patients to receive the benefits of long-lasting pain relief with the innovative Freedom PNS System.

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 receiver that are surgically connected, is anchored within two separate incisions, including creation of a subcutaneous pocket. The stimulation program is adjusted as needed to provide pain relief for the patient.

In support of the 510(k) clearance process, an investigational device exemption (IDE) was used to conduct a multi-center randomized controlled (RCT) clinical trial with 60 patients, who received a Freedom PNS implant and then were randomized into two groups (activated or deactivated). Patients were followed at 3, 6, and 12 months. The study focused on demonstrating significant long-term pain reduction. The study demonstrated that the HF-EMC powered, permanent Freedom PNS System is a safe and effective therapy for treating craniofacial pain of peripheral nerve origin.

“At Curonix, we are committed to collaborating with leading physicians and their teams to redefine the boundaries of chronic pain management by addressing underserved areas like craniofacial pain,” stated Aure Bruneau, Chief Executive Officer of Curonix. “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, providing them potential relief from chronic pain through our innovative, long-term Freedom PNS System.”

Over 380 Freedom PNS pain patients have now been involved in various long term clinical studies for craniofacial, knee, shoulder, foot & ankle, and other pain conditions. Curonix now plans to work with leading physicians to publish these additional groundbreaking results, which will significantly add to the broad body of published clinical evidence for the Freedom PNS System. This market-leading body of evidence will now be utilized to establish broad patient access for the Freedom PNS System.

To learn more about the Freedom PNS System, visit us at curonix.com.

References:

1. Internal data on file at Curonix.
2. Chichorro JG, Porreca F, Sessle B. Mechanisms of craniofacial pain. Cephalalgia. 2017;37(7):613-626. doi:10.1177/0333102417704187
3. Finnern MT, D’Souza RS, Jin MY, Abd-Elsayed AA. Cervical Spinal Cord Stimulation for the Treatment of Headache Disorders: A Systematic Review. Neuromodulation: Technology at the Neural Interface. Published online December 10, 2022. doi:10.1016/j.neurom.2022.10.060.

About Curonix
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 receiver that are surgically connected, is anchored within two separate incisions, including 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 Information:
Ashley Brown
Director of Marketing Communications, Curonix
Ashley.Brown@Curonix.com
512-791-4743