Presidio Medical announced today that it received FDA investigational device exemption (IDE) for its ultra-low frequency (ULF) neuromodulation platform.
IDE enables the company to commence a global, pivotal, randomized controlled trial — the FULFILL study — in the U.S. and Australia. In the study, investigators intend to deliver ULF neuromodulation via leads implanted in the epidural space (spinal cord stimulation/SCS).
San Mateo, California-based Presidio designed its ULF neuromodulation platform to target localized pain by reducing neuronal responses. Suppression of these signals may reduce suffering for patients who have chronic nociceptive low back pain. The company says no current approved SCS treatment options exist for this type of back pain. It views it as 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,” said Michael Onuscheck, Presidio Medical’s CEO.
Presidio also has a new CFO
In addition to announcing the IDE, the company said it named Dimas Jiménez as its new CFO. Jiménez brings more than four decades of financial experience, including on Wall Street and with large and startup life science organizations.
Responsibilities at Presidio include building out the company’s financial infrastructure and supporting commercialization efforts. Jiménez is also responsible for 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,” said Onuscheck.
Jiménez most recently served as CFO of Spire Health. He previously held the same post at StemoniX and Orphagen Pharmaceuticals. His track record includes managing four company exits and raising $670 million in capital for life science organizations.
“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,” said Jiménez.
