Presidio Medical wins FDA IDE approval for neuromodulation trial, names new CFO

Author(s):

Todd Shryock

Fact checked by:

Chris Mazzolini

Key Takeaways

Presidio Medical's ULF neuromodulation platform received FDA IDE approval for a pivotal trial targeting chronic nociceptive low back pain.
The FULFILL Study will evaluate the safety and efficacy of spinal cord stimulation in the U.S. and Australia.
Chronic nociceptive low back pain represents a significant unmet medical need, with a potential market estimated at $20 billion.
Dimas Jiménez, with over 40 years of finance experience, joins Presidio as CFO, strengthening the company's leadership team.

The FDA’s IDE approval allows Presidio to initiate a randomized, controlled trial in the United States and Australia to evaluate the safety and efficacy of its ULF neuromodulation technology

Presidio wins FDA IDE approval for neuromodulation trial: ©Sasin Paraksa - stock.adobe.com

Presidio Medical announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin a pivotal clinical trial of its Ultra Low Frequency (ULF) neuromodulation platform. The company also named industry veteran Dimas Jiménez as its new chief financial officer.

The FDA’s IDE approval allows Presidio to initiate the FULFILL Study, a randomized, controlled trial in the United States and Australia to evaluate the safety and efficacy of its ULF neuromodulation technology for patients with chronic nociceptive low back pain. The treatment uses spinal cord stimulation via leads implanted in the epidural space to reduce pain signals by modulating neuronal activity.

“IDE approval from the FDA represents a significant milestone for Presidio and enables the study of ultra low frequency modulation of the nervous system,” said Michael Onuscheck, Presidio Medical’s CEO. “We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform.”

Chronic nociceptive low back pain is a major unmet medical need, and there are currently no approved SCS therapies for this condition. Presidio estimates the potential market at $20 billion.

Alongside the IDE news, the company also announced the appointment of Dimas Jiménez as CFO. Jiménez brings more than 40 years of finance experience to the role, including executive positions in both startups and large life science organizations. He has managed four company exits and helped raise $670 million in capital.

“Presidio’s ULF platform has the potential to greatly improve the lives of patients who suffer from debilitating chronic back pain,” Jiménez said. “I couldn’t be more excited to be a part of this mission-driven and patient-centric organization.”

Jiménez previously served as CFO at Spire Health and held leadership roles at StemoniX and Orphagen Pharmaceuticals. He holds an MBA from Stanford University and a bachelor’s degree from Dartmouth College, and is a chartered financial analyst.