Sonex Health Announces First Patient Enrolled In U.S. Clinical Study To Treat Carpal Tunnel Syndrome With Ultrasound Guidance

SONEX HEALTH ANNOUNCES FIRST PATIENT ENROLLED IN U.S. CLINICAL STUDY TO TREAT CARPAL TUNNEL SYNDROME WITH ULTRASOUND GUIDANCE

U.S. clinical study will compare efficacy and safety of traditional mini-open carpal tunnel release and carpal tunnel release using UltraGuideCTR and real-time ultrasound guidance

Eagan, Minn., August 9, 2022 — Sonex Health and The Institute of Advanced Ultrasound Guided Procedures today announced enrollment of the first patient in the Trial of Ultrasound Guided Carpal Tunnel Release (CTR) Versus Traditional Open Release (TUTOR) – the first multicenter randomized controlled trial in the United States to compare the efficacy and safety of traditional mini-open carpal tunnel release (mOCTR) and carpal tunnel release using the FDA-cleared UltraGuideCTR and real-time ultrasound guidance.

Dr. James F. Watt, an orthopaedic hand surgeon with Orthopaedic Associates in Destin, Fla. enrolled the first patient in the post-market TUTOR study. “I am honored to be an investigator in the TUTOR study and provide UltraGuideCTR and real-time ultrasound guidance as a safe and proven option to treat my patients suffering from debilitating carpal tunnel syndrome,” said Dr. Watt. “I believe this technique is the biggest game changer in how carpal tunnel will be treated. I look forward to using this minimally invasive approach to help patients recover faster and return to enjoying the activities they couldn’t do prior to being treated.”

“Both surgeons and patients prefer the smallest incisions possible so patients can quickly get back to doing the things they love,” said Dr. Kyle R. Eberlin, associate professor of surgery at Harvard Medical School, a plastic and reconstructive surgeon at Massachusetts General Hospital and the study’s principal investigator.

“The TUTOR study gives the investigators the opportunity to undertake a disciplined comparative assessment of an approach to treat CTS that requires only a very small incision while using ultrasound guidance to maintain visualization of the anatomy throughout the procedure.”

Traditional mOCTR procedures are performed by making an incision in the base of the palm and then dividing the transverse carpal ligament to relieve pressure on the median nerve to treat the pain and discomfort of carpal tunnel syndrome (CTS). Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing CTR through a small wrist incision (rather than a palmar incision), enabling most patients to resume normal activities within days versus weeks or months often experienced following mOCTR surgeries.

TUTOR investigators and sites include:

• The study’s principal investigator: Kyle R. Eberlin, MD – Massachusetts General Hospital, Boston, Mass.
• Christopher J. Dy, MD, MPH, FACS – Washington University Physicians, St. Louis, Mo.
• Mark D. Fischer, MD – Twin Cities Orthopedics, Minneapolis, Minn.
• James L. Gluck, MD – Kansas Orthopaedic Center, Wichita, Kan.
• F. Thomas D. Kaplan, MD, FAAOS – Indiana Hand to Shoulder. Indianapolis, Ind.
• Thomas J. McDonald, MD – Sierra Orthopedic Institute, Sonora, Calif.
• Alexander Palmer, DO – Sano Orthopedics, Kansas City, Mo.
• Marc E. Walker, MD – University of Mississippi Medical Center, Jackson, Miss.
• James F. Watt, DO – Orthopedic Associates, Destin, Fla.

Data Safety Monitoring Board members include:

• The study’s DSMB chair and independent medical reviewer:  Kevin C. Chung, MD, MS, professor of surgery, plastic surgery and orthopaedic surgery – University of Michigan Medical School, Ann Arbor, Mich.
• Julie E. Adams, MD, professor of orthopedic surgery – University of Tennessee College of Medicine – Chattanooga, Tenn.
• Warren C. Hammert, MD, DDS, professor of orthopaedic surgery – Duke University School of Medicine, Durham, N.C.

“We are very grateful for the impressive depth and breadth of clinical hand surgery knowledge and experience that each of the TUTOR investigators and members of the Data Safety Monitoring Board bring to this study – which is the first CTR randomized controlled trial in the United States,” said Sonex Health CEO Bob Paulson. “We sincerely appreciate the commitment of the TUTOR investigators to independently evaluate the clinical and health economics benefits of using UltraGuideCTR and real-time ultrasound guidance to treat the painful and debilitating effects of carpal tunnel syndrome.”

UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health – Dr. Darryl Barnes and Dr. Jay Smith – both of whom previously practiced at the Mayo Clinic in Rochester, MN and founded the Institute of Advanced Ultrasound Guided Procedures, which focuses on product innovation, clinical research, and educating physicians on how to hone their musculoskeletal ultrasound skills. UltraGuideCTR is indicated for the treatment of carpal tunnel syndrome.

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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 Dr. Darryl E. Barnes and Dr. Jay Smith 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.

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