Presidio Medical has obtained Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a pivotal, global randomised controlled trial named the FULFILL Study in the US and Australia.
The trial will use Ultra Low Frequency (ULF) neuromodulation, delivered through leads implanted in the epidural space, a method known as Spinal Cord Stimulation (SCS).
Presidio Medical aims to address chronic nociceptive low back pain by developing a novel ULF neuromodulation platform.
This platform is designed to target and reduce neuronal responses to localised pain, potentially offering relief to patients who currently have no approved SCS treatment options, said the clinical-stage medical device company.
The market for treating nociceptive back pain is estimated to be worth $20bn, highlighting the significant opportunity for Presidio’s technology.
Presidio Medical CEO Michael Onuscheck said: “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.”
The company has also announced the appointment of Dimas Jiménez as its new CFO. With over 40 years of experience in finance, Jiménez will focus on enhancing the financial infrastructure of Presidio Medical. His role will include supporting the commercialisation of the ULF neuromodulation system and strengthening relationships with investors.
Onuscheck added: “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-commercialisation start-up organisations is invaluable as we continue to grow and evolve as a company.”
