DALLAS, TX, Feb. 16, 2026 (GLOBE NEWSWIRE) — Spark Biomedical, Inc., a leader in wearable neurostimulation, announced today that the Trauma Research and Combat Casualty Care Collaborative has awarded a Clinical Research Award grant of $500,000 for a novel clinical trial evaluating transcutaneous auricular neurostimulation™ (tAN) as a non-invasive treatment for chronic subdural hematomas (cSDH).
The study—“Transcutaneous Auricular Neurostimulation for Treatment of Non-Surgical Chronic Subdural Hematoma”—will be led by Principal Investigator Dr. Alex Valadka, Professor of Neurological Surgery at UT Southwestern Medical Center, with co-investigators Dr. Ryan Chiu (UTSW) and Dr. Peter Kan (UTMB). The clinical trial will use Sparrow Link™, Spark Biomedical’s advanced neurostimulation platform designed to target vagal and trigeminal pathways implicated in inflammation and hemostasis.
A New Direction for Treating One of the Most Common Neurosurgical Conditions
Chronic subdural hematomas account for over 90,000 hospitalizations annually and are projected to become the most common neurosurgical condition by 2030. Current interventions—including surgery and middle meningeal artery (MMA) embolization—are invasive, carry risk, and are not always effective in preventing recurrence.
If successful, this first-of-its-kind trial has the potential to:
- Reduce hematoma growth in non-surgical patients
- Decrease the need for invasive rescue operations
- Introduce the first non-invasive therapeutic approach for cSDH
- Improve patient outcomes while reducing procedural risk
Expanding tAN Into Neurotrauma Care
Spark Biomedical’s Sparrow Link system delivers transcutaneous auricular neurostimulation™ (tAN) through wearable ear-based electrodes that stimulate both vagal and trigeminal nerve branches. Prior clinical and preclinical research with tAN has demonstrated modulation of inflammatory biomarkers, platelet activation pathways, and clot physiology—mechanisms highly relevant to the pathogenesis of cSDH.
Spark Biomedical is proud to highlight its Fellowship Program with UT Southwestern Neurosurgery, which offers emerging clinician-innovators hands-on experience at the intersection of medicine and neurotechnology. As part of this collaboration, Dr. Ryan Chiu, a fifth-year neurosurgery resident at UTSW, has been working closely with Spark to gain real-world training in entrepreneurship, clinical trial design, non-invasive neuromodulation, engineering, grant writing, and patent development.
“Spark Biomedical was founded on the belief that neurostimulation can address critical unmet needs in medicine through safe, targeted, wearable technology,” said Michael Darrow, PhD, Director of Research Innovations at Spark Biomedical. “We are deeply honored that our platform will support this groundbreaking research. This TRC4 grant award highlights the value of Spark’s Fellowship Program with the UTSW Neurosurgery department, and it demonstrates the hard work of Dr. Ryan Chiu to identify a large unmet need and design a study to test tAN’s potential to reduce neuroinflammation and bleeding risk in a population with limited options.”
About the Study
The randomized, double-blind, sham-controlled pilot study will enroll 20 adults diagnosed with cSDH who are deemed candidates for non-operative management. Participants will self-administer daily 30-minute tAN sessions for one month using Sparrow Link.
Outcomes include:
- Primary: Need for rescue surgical intervention (craniotomy, burr hole, or MMA embolization)
- Secondary: Changes in hematoma volume, midline shift, and thickness on imaging
- Biomarker Analysis: Effects on CRP, cortisol, IL-6, and other inflammatory markers
About Spark Biomedical
Spark Biomedical, Inc. is a U.S.-based wearable medical device innovator dedicated to advancing the field of bioelectronic medicine. The company develops novel wearable neurostimulation therapies across neurological health, women’s health, and hemostasis, leveraging deep neuroscience and engineering expertise to create evidence-based solutions for complex clinical challenges that exceed the capabilities of existing treatments.
Spark’s work is supported by funding from federal agencies—including the NIH and Department of Defense—and strengthened through collaborations with leading private and academic research partners.
Spark Biomedical is committed to shaping the future of patient care by delivering safer, smarter, and more accessible neurotechnology solutions. For more information, visit www.sparkbiomedical.com.
Spark Biomedical, Inc. research@sparkbiomedical.com
