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MULTICENTER OBSERVATIONAL STUDY CONFIRMS IMPROVEMENTS IN RECOVERY TIMES AND OTHER BENEFITS FOR PATIENTS UNDERGOING CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR™ WITH REAL-TIME ULTRASOUND GUIDANCE

Mar 25th, 2022

Eagan, Minn., March 25, 2022 — Sonex Health and the Institute of Advanced Ultrasound Guided Procedures announced the publication of the results of a multicenter study reporting that carpal tunnel release (CTR) using UltraGuideCTR with real-time ultrasound guidance demonstrated clinically meaningful improvements in symptoms and function, rapid return to normal activities, and minimal work absenteeism in real-world clinical practice.

The peer-reviewed article, “Multicenter pragmatic study of carpal tunnel release with ultrasound guidance,” was published in the March issue of Expert Review of Medical Devices. The study reported the results of a heterogenous group of 373 carpal tunnel syndrome (CTS) patients (427 hands, mean age 55 years, 71% female) who underwent CTR using UltraGuideCTR with real-time ultrasound guidance at 24 clinics in the United States. Nearly 90 percent of procedures were performed using only local anesthesia.

Data were collected from a real-world registry, Assessment of the Patient Experience – Carpal Tunnel Release (APEX-CTR), established by the Institute of Advanced Ultrasound Guided Procedures and Sonex Health in 2019 following the commercial launch of Sonex Health’s UltraGuideCTR device (formerly SX-One MicroKnife®).

Study authors, John Fowler, MD of the University of Pittsburgh Medical Center, Kevin Chung, MD of the University of Michigan Comprehensive Hand Center, and Larry Miller, PhD of the Department of Biostatistics at Miller Scientific, analyzed patient-reported outcomes daily for up to two weeks and, also one, three and six months post-CTR, using the validated CTS symptom and functional assessment instruments Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH or QDASH) and Boston Carpal Tunnel Questionnaire (BCTQ), as well as return to normal activities, return to work, and patient satisfaction.

Highlights of the study results:

  • The median time to return to activities was three days and return to work five days, suggesting a favorable time to return to normal activities and work when compared to the published results of open/mini-open CTR procedures
  • Compared to baseline, there were significant decreases in QDASH, BCTQ-SSS (Symptom Severity Scale) and BCTQ-FSS (Functional Status Scale) scores at two weeks, three and six months (all p<0.001)
  • Nearly 15% of procedures were simultaneous bilateral CTRs, shortening the overall episode of care for patients with significant bilateral disease and suggesting the potential for cost savings to the healthcare system
  • No major neurovascular complications were reported

“My patients treated with CTR-US reported clinically meaningful improvements in symptoms and function,” said Paul Paterson, MD orthopedic hand and upper extremity surgeon in Buffalo, N.Y.

“This is the largest study published on CTR using ultrasound guidance to report return-to-activity and return-to-work data.”

Matthew Kirsch, MD orthopedic surgeon in Rochester, Minn. adds, “This study confirms that a patient undergoing this type of procedure can more quickly return to their activities, which can have a significant positive effect on their overall satisfaction and quality of life.”

More data to come

This recent multicenter study is the eighth peer-reviewed publication reporting the clinical results on CTR-US utilizing the UltraGuideCTR device with ultrasound guidance, totaling 521 patients and 651 wrists at up to 2.5 years post-CTR.

This year, the Institute of Advanced Ultrasound Guided Procedures plans to initiate two prospective clinical studies to further explore the benefits of CTR-US:

  • A multicenter, prospective randomized controlled trial (RCT) comparing CTR-US using real-time ultrasound guidance to traditional OCTR/mOCTR – the first RCT for CTR-US in the United States
  • A multicenter, prospective study to examine recovery time, effectiveness, and safety in subjects suffering from CTS who are treated with CTR-US using real-time ultrasound guidance in a procedure room

“Our published data, and the upcoming clinical studies we plan to execute over the next several months, exemplify our commitment to continue building a robust and compelling outcomes dataset to further demonstrate the safety and efficacy of UltraGuideCTR,” said Sonex Health CEO, Bob Paulson. “We look forward to sharing the findings.”

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ABOUT SONEX HEALTH

Founded in 2014, Sonex Health’s mission is to be the world leader in ultrasound guided surgery by delivering physicians innovative therapies that reduce invasiveness, improve safety, and reduce the cost of care. With a strong focus on entrapment neuropathy, Sonex Health’s first proprietary technology — developed by Darryl E. Barnes, MD and Jay Smith, MD at the world-renowned Mayo Clinic — is UltraGuideCTR (formerly referred to as SX-One Micro-Knife), which may be utilized with or without ultrasound guidance to perform carpal tunnel release. Sonex Health’s second proprietary technology is UltraGuideTFR, for the treatment of trigger finger, also known as stenosis tenosynovitis.

For information about Sonex Health, UltraGuideCTR, and UltraGuideTFR please visit www.sonexhealth.com.

ABOUT THE INSTITUTE OF ADVANCED ULTRASOUND GUIDED PROCEDURES

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, as well as world-class professional education and training that transforms the treatment experience for patients, providers and payers.