FDA Grants IDE Approval to Presidio Medical for Ultra Low Frequency Neuromodulation Study

Presidio Medical Inc. has gained U.S. Food and Drug Administration (FDA) IDE approval to begin a clinical study of its Ultra Low Frequency (ULF) neuromodulation platform in the United States and Australia.

Neuromodulation in the pivotal, randomized controlled FULFILL Study will be delivered through leads implanted in the epidural space, also known as spinal cord stimulation (SCS).

Presidio is developing a novel approach to treating chronic nociceptive low back pain. The ULF neuromodulation platform is designed to target localized pain by reducing neuronal responses; suppression of these signals may reduce suffering for patients who have chronic nociceptive low back pain. There are currently no approved SCS treatment options for nociceptive back pain, which presents a $20 billion market opportunity.

“IDE approval from the FDA represents a significant milestone for Presidio and enables the study of ultra low frequency modulation of the nervous system. The results from our first-in-human clinical trial in Australia, which were presented by Dr. Marc Russo at NANS earlier this year, were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform,” Presidio Medical CEO Michael Onuscheck stated.

In addition to its IDE approval announcement, the company also disclosed that it has hired Dimas Jiménez as chief financial officer (CFO). Jiménez has more than four decades of finance experience, spanning roles from Wall Street to both large and startup life science organizations. He will continue to build the financial infrastructure of Presidio, supporting the commercialization efforts of the company’s ULF neuromodulation system, and expanding relationships with current and future investors.

“We are extremely pleased to welcome Dimas to the Presidio team. The breadth and depth of his experience within the life science industry and his expertise in working with pre-commercialization start-up organizations is invaluable as we continue to grow and evolve as a company,” Onuscheck said.

Jiménez most recently worked as CFO of Spire Health and has held prior positions as CFO at StemoniX and Orphagen Pharmaceuticals. He has managed four company exits and has helped raise $670 million in capital for life science organizations. Jiménez earned a bachelor of arts degree from Dartmouth College and an MBA from Stanford University, and is a chartered financial analyst.

“Presidio’s ULF platform has the potential to greatly improve the lives of patients who suffer from debilitating chronic back pain. I’ve spent a significant amount of my career working with companies whose goal is to disrupt the status quo. I couldn’t be more excited to be a part of this mission-driven and patient-centric organization,” Jiménez said.

Presidio Medical was founded in 2017 and is headquartered in San Mateo, Calif. This clinical stage privately held medical device company is developing a neuromodulation platform to treat diseases of undesired neural activity, with a first indication in chronic pain treatment. Presidio’s investors include Deerfield Management, Invus Opportunities, Action Potential Venture Capital, and ShangBay Capital.