Saluda Medical Secures Debt Financing From Medtronic, Business News

PUBLISHED ONJune 27, 2019 8:00 AM

Proceeds to Fund Continued Development of Evoke® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System

Evoke Trial Validates Level I Evidence Achieved Through First Double-Blind Randomized U.S. Pivotal Study in SCS

ARTARMON, Australia, June 27, 2019 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical") today announced that it has secured a four-year term loan agreement with Medtronic, to fund continued development of its Evoke^® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System for the treatment of chronic intractable pain of the trunk and limbs. Additional terms of the loan agreement were not disclosed.

Medtronic is one of the world's leading medical device manufacturers and founding innovators in spinal cord stimulation, and is an existing shareholder of Saluda Medical, having participated in two previous financing rounds.

"We are pleased to once again partner with Medtronic in this financing," said John Parker, CEO of Saluda Medical. "This funding provides us with the financial flexibility to accelerate further development of our novel closed-loop SCS system and prepare for commercialization. Unlike cardiac pacing technology, where measurement and response technology has driven breakthroughs in clinical outcomes and patient management, technology in the field of SCS is still in its infancy. Energy is still being delivered into the spinal cord without measuring the actual physiologic response to stimulation. Using objective physiologic response data, the Evoke System has been developed to realize substantial improvements in pain, function, sleep, and quality of life. We are passionate about bringing ECAP-controlled, closed-loop technology to the field of pain management to develop mechanistic-based therapies for patients."

The financing follows multiple presentations of the Evoke SCS System by leading pain specialists during the International Neuromodulation Society (INS) 14^th World Congress in Sydney. Evoke is designed to be the first SCS system that measures the spinal cord's response to stimulation via ECAPs, or evoked compound action potentials. It adjusts on every pulse to maintain activation within the patient's therapeutic window.

About Saluda Medical
Saluda Medical is a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry with a platform of closed-loop technologies based on the evoked compound action potential (ECAP). Saluda's first device, Evoke^®, is designed to be the first ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System. Evoke measures the spinal cord's response to stimulation (ECAP), adjusts on every pulse to optimize activation within the patient's therapeutic window, and is designed to maintain long-term results through ECAP control. It is currently under investigation through the first double-blinded, randomized, controlled U.S. pivotal study in SCS. Saluda is pursuing approval to market the Evoke System.

Saluda Medical is a privately-held company with headquarters in Artarmon, New South Wales, Australia and offices in Bloomington, MN, USA and Harrogate, UK. To learn more, visit http://www.saludamedical.com and connect with us on LinkedIn at http://www.linkedin.com/company/saluda-medical/.

Note: The Evoke® Spinal Cord Stimulation System is an investigational device in the United States and is limited by U.S. Federal law to investigational use only.

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