ULF Neuromodulation May Impact SCS Pain Market

by James Cavuoto, editor, and Jeremy Koff, senior consulting editor

August 2021 issue

The market for spinal cord stimulation systems for treating chronic back pain has undergone a number of transformations in recent years. In an effort to improve pain relief and expand market access, a cascade of vendors have offered paradigm shifts away from the original SCS therapy, which used tonic stimulation of the dorsal column. These have included high-frequency stimulation, DRG stimulation, burst stimulation, closed loop stimulation, and differential target multiplexed stimulation.

The most recent alternative to these treatment strategies is now ultra-low frequency stimulation. Presidio Medical, Inc., the San Francisco Bay Area startup, earlier this month unveiled the company’s ULF neuromodulation therapy in Science Translational Medicine. The publication describes a collaborative effort from investigators in the U.S., U.K., and Australia to use ULF neuromodulation to inhibit pain signals in pre-clinical animal models, computational models, and in a clinical trial. The global effort included scientists and physicians at King’s College London, University of Michigan, Hunter Pain Specialists in Australia, and Presidio Medical, Inc.

“The ability of ULF neuromodulation to inhibit pain neurons in a controlled and reversible manner is incredibly exciting,” said Stephen McMahon, the Sherrington Professor of Physiology at King’s College London. “The mechanism of action of this novel technology has been studied from bench to bedside and we now understand that ULF neuromodulation can elicit both an immediate and slowly developing neural inhibition through sodium channel inactivation, which can be particularly useful in persistent pain states.”

In the clinical study, 95 percent of patients were responders (greater than 50 percent pain relief) and 90 percent of patients were profound responders (greater than 80 percent pain relief) with ULF neuromodulation therapy. “This novel technology elicits a unique mechanism of pain inhibition in the nervous system, which translates to improved efficacy for a wide variety of chronic pain patients,” said Marc Russo, a pain medicine physician and director-at-large of the Neuromodulation Society of Australia and New Zealand. “Because ULF neuromodulation works differently and appears to be more efficacious than current SCS technologies, we have the opportunity to explore existing and new applications to improve even more patients’ lives.”

Presidio Medical’s technology is designed to provide pain relief across a broad spectrum of pain types where conventional treatment has failed. The company is also researching the application of its novel technology for additional indications across several therapeutic areas with significant unmet medical needs.

In June, Presidio announced the appointment of former Boston Scientific Neuromodulation president Michael Onuscheck as chairman and CEO, replacing founder and outgoing CEO Michael Ackermann. Ackermann will continue to serve on the board of directors and remain close with the company. Most recently, Onuscheck served as an executive committee member of Alcon and president, global businesses and innovation.

“This is an exciting day for Presidio” said Ackerman. “Michael Onuscheck is the Lebron James of neuromodulation and one of the world’s premier leaders in medical technology. We have a platform technology that has been proven clinically, and there is no one better than Michael to lead this business into the next phase and beyond.”


©2019 Neurotech Reports. All rights reserved.