Tendon Entrapment

Evidence Bar "Favorable" rating from ECRI report indicates UltraGuideCTR is safe and improves functional status in patients with carpal tunnel syndrome EAGAN, Minn., June 7, 2024 /PRNewswire/ -- Sonex Health, Inc. and The Institute of Advanced Ultrasound Guided Procedures announced today that ECRI completed a Clinical Evidence Assessment of its UltraGuideCTR™, with an Evidence Bar rating of "Favorable." 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 patients with carpal tunnel syndrome (CTS), based on consistent findings from one randomized controlled trial and eight before-and-after studies reported in 11 publications. The full report is available to ECRI members. "The ECRI Evidence Bar Favorable rating is a significant milestone supporting the safety and effectiveness of UltraGuideCTR," said Sonex Health CEO Bob Paulson. "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 compelling and consistent clinical safety and effectiveness data for CTR-US procedures with the UltraGuideCTR device further supports its widespread 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." ABOUT SONEX HEALTH Sonex Health, Inc. is a leader in innovative 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 FDA 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. For information about Sonex Health, UltraGuideCTR, and UltraGuideTFR visit . 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. For more information about the Institute visit . ABOUT ECRI 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. Contact: Shelli Lissick [email protected] 651-276-6922 SOURCE Sonex Health

First patient enrolled by North Texas Hand Center in landmark US multi-center clinical study EAGAN, Minn., March 6, 2024 /PRNewswire/ -- Sonex Health, Inc. and The Institute of Advanced Ultrasound Guided Procedures today announced enrollment of the first patient in the Post- Market Reg IStry of the Patient Experience when u Sing UltraGu IdeCTR f Or Carpal Tu Nnel Release (MISSION) registry. Dr. Stuart Hilliard, with North Texas Hand Center, was the first investigator to enroll a patient into the study. MISSION is designed to be the largest multi-center clinical study in the United States assessing the treatment of patients suffering from carpal tunnel syndrome. This landmark study will collect real-world, long-term data on patients suffering from carpal tunnel syndrome (CTS) who are treated with a carpal tunnel release (CTR) procedure using Sonex Health's commercially available device, UltraGuideCTR™ using real-time ultrasound guidance (CTR-US). "Participating in this important study is in direct alignment with how I practice medicine," said Dr. Hilliard. "I firmly believe in ensuring my patients are both knowledgeable about their condition and fully informed of the surgical and nonsurgical options to better involve them in their own care. Studies like MISSION are crucial to being able to give patients the most up-to-date and useful information about their CTS treatment options." The study's principal investigator is Dr. Victor Marwin with Bluegrass Orthopaedics in Lexington, Ky. The MISSION registry is the largest CTR study ever conducted in the U.S., with enrollment objectives targeting at least 2,000 patients at numerous investigational sites across the country. For patients suffering from CTS, the MISSION investigators will determine if a CTR procedure is indicated, and if so, the patients will be screened to determine if they are eligible for enrollment. If patients qualify and consent to participate in the MISSION registry, they will receive a CTR-US procedure, and then periodically provide post-procedure follow-up information over a period of two years. "Clinical research is fundamental to Sonex Health's mission to provide physicians with innovative therapies that reduce invasiveness, improve safety, and reduce the cost of care," said Sonex CEO Bob Paulson. "This formative database of valuable clinical outcomes information about the health and long-term effectiveness of CTR-US procedures with the UltraGuideCTR device is an important element of continuing to deliver on our mission." Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing a CTR-US procedure through a small wrist incision. Performed using only local anesthesia, CTR-US procedures with the UltraGuideCTR device are appropriate for an office-based setting, freeing up surgical suites in hospitals and ambulatory surgery centers (ASCs) for more complex procedures, and lowering the cost of care for treating CTS. UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health, Inc. – Dr. Darryl Barnes and Dr. Jay Smith. Drs. Barnes and Smith previously practiced at the Mayo Clinic in Rochester, Minn., 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. For more information about the MISSION clinical registry, visit: . Physicians interested in participating as investigators in this study can visit or reach out to [email protected]. ABOUT SONEX HEALTH Sonex Health, Inc. is a leader in innovative 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 FDA 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. For information about Sonex Health, UltraGuideCTR, and UltraGuideTFR visit . 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. For more information about the Institute visit . Contact: Shelli Lissick [email protected] 651-276-6922 SOURCE Sonex Health

Oct. 3 Forum precedes American Society for Surgery of the Hand 2023 Annual Meeting in Toronto EAGAN, Minn., Sept. 26, 2023 /PRNewswire/ -- Sonex Health and the Institute of Advanced Ultrasound Guided Procedures have announced they are hosting the first annual Musculoskeletal (MSK) Ultrasound Forum, bringing surgeons together to exchange ideas, engage in hands-on learning activities, and shape the future of MSK ultrasound in hand surgery. This first-ever forum on Oct. 3 from 4 to 10 p.m. at the Westin Harbour Castle precedes the American Society for Surgery of the Hand (ASSH) 2023 Annual Meeting in Toronto Oct. 5-7. "We're excited to bring together thought leaders to educate, discuss and explore the future of MSK ultrasound in this first event of its kind," said Dr. John R. Fowler, MSK Ultrasound Forum event chair, associate professor and assistant dean for medical student research, University of Pittsburgh's Department of Orthopaedic Surgery. "Partnering with Sonex Health and a renowned executive committee of physicians, this annual meeting focuses on innovation, and we welcome surgeons to join us in physician-led discussions, education and exchange of ideas in shaping the future of MSK ultrasound." The forum brings together more than 75 hand surgeons to advance MSK ultrasound through innovation, education and training. Topics include patient care, procedural techniques, technology, expanded indications and the care pathway. During the forum, surgeons can participate in a cadaver lab to learn MSK ultrasound fundamentals and advanced diagnostic techniques, engage with leading manufacturers in ultrasound technology for a first look at future innovations, and join a hand surgeon-led panel discussion of "A Practical Approach for Integrating MSK Ultrasound into Your Hand Surgery Practice." As a physician-led forum, the executive planning committee includes event chair Dr. Fowler; Dr. Mark S. Rekant, Philadelphia Hand to Shoulder Center and associate professor in the Department of Orthopaedic Surgery at Thomas Jefferson University in Philadelphia; Dr. Johnny T. Nelson, The Bone and Joint Surgery Clinic in Raleigh, N.C.; Dr. Jay Smith, chief medical officer and co-founder of Sonex Health and co-inventor of UltraGuideCTR™; and Dr. Darryl Barnes, chief technology officer and co-founder of Sonex Health and co-inventor of UltraGuideCTR. Additional sponsors include ultrasound companies Konica Minolta, GE HealthCare, Clarius, Alpinion, and Sonosite. For more information or to register, visit . ABOUT SONEX HEALTH Sonex Health, Inc. is a leader in innovative 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 FDA 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. For information about Sonex Health, UltraGuideCTR, and UltraGuideTFR visit . 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. For more information about the Institute visit . Media Contact: Shelli Lissick Bellmont Partners [email protected] 651-276-6922 SOURCE Sonex Health