Surf Therapeutics Announces Early Feasibility Study (EFS) To Advance Non-Invasive Approach to Neuromodulation for Rheumatoid Arthritis

AUSTIN, Texas--(BUSINESS WIRE)--Surf Therapeutics, a clinical-stage neuro-immunomodulation company developing non-invasive ultrasound therapy for chronic inflammatory diseases, is announcing the start of an Early Feasibility Study evaluating its investigational ultrasound device in people living with rheumatoid arthritis. The study is designed to assess a non-invasive approach to activate a neural pathway that triggers a robust anti-inflammatory response, without the need for drugs, surgery, or an implanted device. Information about the study, including eligibility criteria and site locations, is available at ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07293871

“The launch of our EFS trial represents an important step in building a rigorous clinical foundation for our ultrasound neuromodulation platform,” said Dr. Alex Sackeim, Co-founder and Chief Medical Officer of Surf Therapeutics. “People living with rheumatoid arthritis continue to face safety and accessibility issues with existing therapies. Our goal is to deliver a non-invasive solution that is intended to explore an alternative approach to existing and emerging therapeutic modalities, while prioritizing patient safety and accessibility.”

The clinical trial is expected to enroll up to 40 patients in two stages: an initial open-label pilot (10 patients) followed by a randomized, double-blinded, sham-controlled trial (30 patients). Insights from this EFS are expected to inform Surf’s future clinical development, including preparation for a pivotal study.

In addition, Surf Therapeutics announced the addition of two independent board members, further strengthening the company’s governance and clinical translation expertise:

• Jason Witherington, Ph.D., brings extensive experience in translational medicine and clinical development across immunology and inflammatory diseases. He previously held leadership roles at Johnson & Johnson, GSK, and Galvani Bioelectronics.
• Shri Raghunathan, Ph.D., Founder & CEO of Noctrix Health, the company that pioneered the first non-invasive neuromodulation therapy for Restless Legs Syndrome (RLS). Shri brings significant experience in building and scaling companies from founding through commercialization, with deep expertise across at-home neuromodulation delivery, regulatory affairs, and reimbursement strategy.

“I’m honored to join Surf as they pursue a pragmatic revolution of ultrasound neuromodulation for inflammation,” Witherington said. “Surf’s technology holds the potential to be a disruptive, non-invasive solution for millions of patients living with chronic immune-mediated diseases.”

“Non-invasive platforms have the potential to reshape both access and economics in neuroimmunology as standalone or adjunct therapy,” said Shri. “Surf is approaching this opportunity with a clear understanding of the clinical, regulatory, and reimbursement realities required to succeed, and I look forward to the tremendous patient impact realized by commercializing this technology.”

For more information about Surf Therapeutics’ upcoming clinical trial, please visit https://clinicaltrials.gov/study/NCT07293871.

Surf Therapeutics’ investigational device is currently under clinical evaluation and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication. Statements in this press release regarding development plans, potential benefits, future studies, or commercialization are forward-looking and subject to risks and uncertainties, and actual results may differ materially. Participation in clinical studies may not provide direct medical benefit.

About Surf Therapeutics

Surf Therapeutics, Inc. is a clinical-stage company pioneering the development of non-invasive ultrasound neuromodulation technologies to modulate immune-related pathways. Its SUSTAIN™ platform is designed to engage the body’s natural anti-inflammatory pathway without surgery or implanted hardware, enabling safe, at-home use and scalable access to therapy. Surf Therapeutics is headquartered in Austin, Texas. For more information, visit www.surftherapeutics.com.