Clinical Trial Completed for Nervonik’s Chronic Pain Treatment Tech

Medical device startup Nervonik has completed the first-in-human clinical study that assesses its peripheral nerve stimulation (PNS) solution for treating chronic pain without opioids.

The Nervonik PNS device uses proprietary technology, originally developed in Dr. Aydin Babakhani’s laboratory at the University of California, Los Angeles, to enhance therapy outcomes. “This clinical study marks a tremendous step forward for Nervonik to test our approach to treat chronic pain. This was a real team effort to engineer the system and then translate it to the clinic with physicians and scientists,” stated Dr. Babakhani, Nervonik’s founder and CEO.

The study was conducted in Panama City, Panama, at the Punta Pacifica Hospital, affiliated with Johns Hopkins. Patients with chronic shoulder or knee pain were enrolled in the feasibility study. Small wires, called leads, were surgically implanted by Dr. Timothy Deer, utilizing fluoroscopy and ultrasound to target multiple nerves. The leads were then connected to miniaturized implantable pulse generators, which are wirelessly powered by a small, programmable, wearable device. The stimulation parameters were customized for each patient via a dedicated app to achieve optimal effectiveness.

Peripheral nerve stimulation is a therapy that involves applying highly controlled electrical currents to the body’s nerves, which modulate pain signals and provide pain relief. Dr. Timothy Deer, president/CEO of The Spine and Nerve Centers of the Virginias who was involved in the study, commented, “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.” 

Nervonik Chief Scientific Officer Jeff Kramer, Ph.D., who boasts more than 20 years of neurotechnology-based therapy development, added, “The approach that we are taking to the treatment of chronic pain is founded in an understanding of how PNS affects the underlying neuroscience of chronic pain and helps us to better address approaches that can enhance the patient experience.”

“We are thrilled to have been a part of this study with Nervonik to advance chronic pain therapies for patients around the world. It was very satisfying to see our patients doing well with this new PNS device,” principal study investigator Dr. Ricardo Bermudez stated.

Study results are being compiled and will be presented later this year.

Nervonik is a medical technology company developing improved alternatives to dangerous opioid prescription and complex spinal-cord stimulators in treating chronic neuropathy. The California-based medical technology company is developing the smallest, most advanced, and most power-efficient neuromodulation implants on the market. Its implants rely on next-gen, neural-sensing integrated circuits to deliver an optimized therapy with minimal therapeutic resistance.