Sonex Health’s UltraGuideCTR Gains ‘Favorable’ ECRI Rating

ECRI has issued a “favorable” Evidence Bar rating for Sonex Health Inc.’s UltraGuideCTR, concluding the solution is safe and effective for treating carpal tunnel syndrome (CTS).

The rating was based on a Clinical Evidence Assessment ECRI completed of Sonex Health’s UltraGuideCTR. The ECRI Evidence Bar is a visualization of the organization’s judgment about the balance of benefits and harms of technology after assessing the available published clinical evidence in light of key outcomes and comparisons of interest. ECRI’s Clinical Evidence Assessment concluded that UltraGuideCTR is safe and improves functional status and symptom severity in CTS patients based on consistent findings from one randomized controlled trial and eight before-and-after studies reported in 11 publications.   

“The ECRI Evidence Bar Favorable rating is a significant milestone supporting the safety and effectiveness of UltraGuideCTR,” Sonex Health CEO Bob Paulson said. “This report provides payers and healthcare providers with access to a valuable summary of the breadth and depth of the UltraGuideCTR clinical outcomes data.” 

More than 31,000 carpal tunnel release with ultrasound guidance (CTR-US) procedures have been performed by over 200 physicians in 41 states, with another 52 physicians actively training to perform these procedures. In addition, more than 800 hand surgeons have participated in a variety of educational program opportunities sponsored by Sonex Health and The Institute of Advanced Ultrasound Guided Procedures, including a first-of-its-kind MSK Ultrasound Forum that brought together over 100 hand surgeons for hands-on training and peer-to-peer conversations.

The consistent clinical safety and effectiveness data for CTR-ultrasound procedures with the UltraGuideCTR device further support its use among physicians. Sixteen peer-reviewed publications have reported clinical results on more than 1,300 patients and 1,700 wrists, including a high percentage of simultaneous bilateral procedures. Patients consistently return to normal activities and work in three to five days as compared to weeks or months reported following traditional surgical CTR procedures.

“Applying ultrasound to perform carpal tunnel release procedures improves the clinical diagnostic and treatment pathway for both patients suffering from CTS and their physicians,” said Dr. Kevin Chung, professor of plastic surgery and chief of hand surgery at the University of Michigan. “The clinical and economic value of this proven, innovative ultrasound-guided technology benefits patients, their physicians, and the healthcare system.”

Sonex Health Inc. develops ultrasound-guided therapies to treat common orthopedic conditions affecting the extremities, including entrapment neuropathies and tendinopathies. The company’s proprietary devices allow surgeons to use real-time ultrasound guidance to visualize critical anatomy throughout procedures, thereby reducing both invasiveness and the cost of care, and enabling patients to return to their normal activities sooner. The company’s first commercial device, UltraGuideCTR, was designed to treat carpal tunnel syndrome and received U.S. Food and Drug Administration clearance in 2019. The company’s second commercial device, UltraGuideTFR was designed to treat trigger finger, also known as stenosing tenosynovitis, and was released in 2022.

Founded in 2018 to support the Sonex Health mission and clinical excellence, the Institute of Advanced Ultrasound Guided Procedures is focused on innovation supported by robust clinical research and world-class professional education and training that transforms the treatment experience for patients, providers, and payers. 

ECRI is an independent, nonprofit organization focused on improving the safety, quality, and cost effectiveness of care across all healthcare settings. ECRI’s Clinical Evidence Assessment reports are utilized by third-party payers and healthcare providers to help inform objective, evidence-based decisions. ECRI’s reports, ratings and conclusions do not constitute a recommendation or endorsement of any product.