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FDA Investigational Device Exemption (IDE) Approval enables Presidio’s ULF platform technology to be tested in a pivotal clinical trial in the United States, representing a significant step in bringing this transformational technology to patients who suffer from chronic nociceptive low back pain.
SAN MATEO, Calif.--(BUSINESS WIRE)--Presidio Medical, Inc., a global clinical-stage medical device company developing a transformational Ultra Low Frequency (ULF™) neuromodulation platform, received IDE approval from the FDA, enabling the company to commence a global, pivotal, randomized controlled trial, the FULFILL Study, in the United States and Australia. ULF Neuromodulation will be delivered via leads implanted in the epidural space, also known as Spinal Cord Stimulation (SCS).
Presidio is a patient-centric medical technology company developing a novel approach to treating chronic nociceptive low back pain with the goal of providing durable relief to an underserved patient population. 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 $20B 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 Chief Executive Officer.
In addition, the company is pleased to announce Dimas Jiménez has joined as Chief Financial Officer (CFO). Mr. Jiménez brings over four decades of finance experience, spanning roles from Wall Street to both large and start-up life science organizations. He will be responsible for continuing to build the financial infrastructure of Presidio, supporting the commercialization efforts of our 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,” said Onuscheck.
“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.
Mr. Jiménez most recently served as the 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. Mr. Jiménez received a Bachelor of Arts degree from Dartmouth College, a Master of Business Administration from Stanford University and is a Chartered Financial Analyst (CFA).
About Presidio Medical
Presidio Medical was founded in 2017 and is headquartered in San Mateo, CA. This clinical stage privately held medical device company is developing a transformational neuromodulation platform to treat diseases of undesired neural activity, with a first indication in the treatment of chronic pain. Presidio’s investors include Deerfield Management, Invus Opportunities, Action Potential Venture Capital, and ShangBay Capital. For more information, visit: www.presidiomedical.com.
Contacts
Media Contact
Maureen Shay
Presidio Medical, Inc.
[email protected]
650-502-1071
