Nervonik, a medical device startup, has announced the successful completion of its first-in-human clinical trial of a peripheral nerve stimulation (PNS) device designed for the treatment of chronic pain. The feasibility study, conducted at Punta Pacifica Hospital in Panama City, Panama, marks a significant step forward in the development of novel neurostimulation therapies.
The trial enrolled patients suffering from chronic shoulder or knee pain. The procedure involved the surgical implantation of small leads, guided by fluoroscopy and ultrasound, to target multiple nerves. These leads were then connected to miniaturized implantable pulse generators (IPGs), wirelessly powered by a programmable, wearable device. Stimulation parameters were individually tailored for each patient using a dedicated app to optimize therapeutic effectiveness.
Device Details and Mechanism
The Nervonik PNS device employs proprietary technology, initially developed at the University of California, Los Angeles (UCLA), to enhance the outcomes of PNS therapy. Peripheral nerve stimulation involves the application of precisely controlled electrical currents to nerves, modulating pain signals and providing relief. This approach aims to address the underlying neuroscience of chronic pain, potentially offering a more effective and personalized treatment experience.
Expert Commentary
Dr. Aydin Babakhani, founder and CEO of Nervonik, stated, "This clinical study marks a tremendous step forward for Nervonik to test our groundbreaking approach to treat chronic pain." Dr. Timothy Deer, President and CEO of The Spine and Nerve Centers of the Virginias, who participated in the study, added, "This work not only verified the preliminary safety and device performance of a new neurotechnology-based therapy but also extended hope to patients with chronic pain."
Future Plans
The data collected from this first-in-human study are currently being compiled, and the results are slated for presentation in early 2025. Further studies will be needed to fully evaluate the long-term efficacy and safety of the Nervonik PNS device.
