Katie Valez
Vice President of Global Marketing and Strategy, ANEUVO
Abstract
ANEUVO
Background:
Spinal cord injury (SCI) affects approximately 15 million individuals worldwide, with nearly 500,000 new cases annually. Chronic SCI patients remain an underserved population, as rehabilitation strategies have traditionally focused on compensatory approaches and are limited by resource constraints. Recovery typically plateaus within 12 months post-injury, leaving patients vulnerable to secondary complications that impair physical and psychosocial health.
Objective:
To evaluate the safety and efficacy of transcutaneous spinal cord stimulation (TSS) combined with upper extremity therapy in improving motor function among individuals with chronic, traumatic SCI.
Methods:
The ASPIRE Study was a multicenter, prospective, randomized, double-masked, parallel-group pivotal trial conducted across 14 sites. Participants underwent a 1-week baseline assessment, followed by 8 weeks of therapy and a 4-week follow-up. Subjects were randomized to Active or Sham groups. The Active group received cervical-level stimulation using the ExaStim™ system with ReCure™ electrode pads for 45–60 minutes during therapy sessions, enabling multi-channel, targeted stimulation. The Sham group received minimal stimulation (<10 seconds per activity) to mimic sensation without neuromodulation. The primary endpoint was change in Upper Extremity Motor Score (UEMS) per International Standards for Neurological Classification of SCI. Secondary outcomes included functional use, sensation, quality of life, and safety.
Results:
Of 128 enrolled subjects, 120 completed follow-up. No serious device-related adverse events were reported. The primary endpoint was met in the per-protocol analysis, with secondary analyses demonstrating improvements in functional upper limb use, light touch sensation, and self-reported quality of life. Gains were sustained at follow-up, suggesting potential long-term benefit.
Conclusion:
TSS delivered via the ExaStim™ system, combined with conventional rehabilitation, is a safe and effective intervention for improving upper limb function in chronic SCI. Future research will explore home-based applications to support continued recovery along the care continuum.
Bio
With 22 years of experience in the neuromodulation industry, Katie Velez is a global strategic marketing professional with a passion for developing and commercializing cutting-edge therapies that improve patients’ lives. Before joining ANEUVO in 2022, Ms. Velez worked in consulting, product development and marketing for large strategic organizations, focusing on deep brain stimulation for movement and psychiatric disorders, as well as spinal cord stimulation for chronic pain.
As the Vice President of Global Marketing and Strategy at ANEUVO, Ms. Velez is responsible for creating and executing the global strategic plan for the company’s neuromodulation portfolio, including the launch of ANEUVO’s ExaStim, a novel therapy for spinal cord injury. She works closely with cross-functional teams, key opinion leaders, and external partners to drive market access and expansion, adoption, and differentiation for ANEUVO's products, and to identify and evaluate new opportunities for growth and innovation in this rapidly evolving field.
