Saluda Medical Announces New 3-Month, 12-Month and 18-Month Data Featuring Evoke® ECAP-Controlled, Closed-Loop SCS System to be Presented at 14th INS World Congress

11 Presentations – Including 4 Plenary Presentations – to Feature the Evoke System

ARTARMON, Australia, May 20, 2019 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical") today announced that new data from multiple studies evaluating the company's Evoke^® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System will be featured in 11 separate presentations – including a pre-congress presentation, four plenary presentations, five oral poster presentations, and a Top 5 Best Abstract presentation – during the upcoming International Neuromodulation Society (INS) 14^th World Congress, being held May 25-30, 2019 in Sydney, Australia. Evoke measures the spinal cord's response to stimulation (evoked compound action potential, or 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.

Oral presentations by leading pain specialists will feature new 3-month data from the Evoke U.S. pivotal study, which marks the first double-blinded, randomized, controlled U.S. pivotal study in SCS; additional results from the Avalon multicenter chronic study at 12 months, selected as a Top 5 Best Poster; and long-term results at 18-months from the Avalon study, the first chronic implant study of ECAP-Controlled, Closed-Loop SCS conducted in Australia. Additional presentations will focus on medication titration during treatment with SCS, variability in energy delivery to the spinal cord and its implications, neurophysiological measurements, neuromonitoring, and potential causes for SCS failures.

John Parker, CEO of Saluda Medical, commented, "INS offers the opportunity to demonstrate new scientific evidence supporting our Evoke ECAP-Controlled, Closed-Loop SCS system for the treatment of chronic pain. With a multitude of oral presentations from top-ranking leaders in the field of pain medicine and neuromodulation, we look forward to sharing the latest short- and long-term clinical results of our Evoke system at such a high-caliber meeting."

Details of the presentations include: 

Oral Presentations

• Pre-congress Event: Innovations in Neuromodulation.
  Disruptive Innovation: The Driving Force of Progress in Neuromodulation
• How to Repurpose your Disruption into Other Potential Fields and Applications
• Presenter: John Parker, PhD, Founder & CEO of Saluda Medical
• Time: Sunday, May 26^th; 12:10 - 12:30 AEST      
• Location: Parkside Ballroom
• Opening Plenary Session
• Closed Loop Spinal Cord Stimulation: Evoke Study Results
• Time: Monday, May 27^th; 9:40 - 10:00 AEST      
• Location: Pyrmont Theatre
• Oral Presentations Five Best Abstracts
• Long-Term Results from the Avalon Study – Feedback-Controlled SCS Using Evoked Compound Action Potentials
• Presenter: Charles Brooker, MBChB MRCP (UK) FANZCA                                         
  FFPMANZCA
• Time: Monday, May 27^th; 11:30 - 11:40 AEST      
• Location: Pyrmont Theatre
• Plenary Breakout: Under the Hood – Mechanisms of Action Aspects
• Role of ECAPs in Understanding Spinal Cord Stimulation Action
• Time: Wednesday, May 29^th; 15:00 - 15:15 AEST      
• Location: Meeting Room C4.5 
• Plenary Breakout: Neuromodulation for Pain - Sensing and Feedback
• Feedback Stimulation of the Dorsal Column
• Time: Wednesday, May 29^th; 15:15 - 15:30 AEST      
• Location: Pyrmont Theatre 
• Long-Term Outcomes from the Avalon Study: A Prospective Multicentre Study Evaluating Closed-Loop SCS in the Treatment of Chronic Back and Leg Pain
• Time: Wednesday, May 29^th; 15:30 - 15:45 AEST   
• Location: Pyrmont Theatre

Oral Posters

• Session: Neuromodulation for Chronic Pain
• Evoked Compound Action Potential Recording to Further Understand Effect of Titrating Medication with Spinal Cord Stimulation
• Presenter: Steven Rosen, MD
• Time: Monday, May 27^th; 16:30 - 16:40 AEST      
• Location: Pyrmont Theatre
• Controlling Spinal Cord Activation During Delivery of SCS Therapy in Patients with High Degree of Movement in the Spinal Canal
• Presenter: Jeffrey E. Arle, MD, PhD
• Time: Monday, May 27^th; 16:50 - 17:00 AEST      
• Location: Pyrmont Theatre
• Automated, Routine Monitoring of Neurophysiological Parameters in Spinal Cord Stimulation
• Presenter: Nathan Taylor, BSc(Med) MBBS FANZCA FFPMANZCA
• Time: Monday, May 27^th; 17:20 - 17:30 AEST      
• Location: Pyrmont Theatre
• Session: Neuromodulation Mechanisms of Action and Basic Science
• Spinal Cord Stimulation Failures: Underlying Mechanisms and Clinical Outcomes
• Time: Wednesday, May 29^th; 16:30 - 16:40 AEST      
• Location: Meeting Room C4.5
• Evoked Compound Action Potentials to Guide Lead Placement: A Neuromonitoring Technique - Case Series
• Presenter: Steven M. Falowski, MD
• Time: Wednesday, May 29^th; 17:10 – 17:20 AEST      
• Location: Meeting Room C4.5

For more information, please visit the Saluda Medical Booth #19 at INS 2019. 

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 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 CE Mark, TGA approval, and FDA approval of Evoke.

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 www.saludamedical.com and connect with us on LinkedIn at 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.  These products are not yet approved for marketing or for sale in any geography.

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