Tendon Entrapment

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

Improvement of patient-reported pain and functionality warrants future research. The homologous-use application validated by Dr. Parker sets a precedent for non-surgical allograft application. PENSACOLA, Fla., Nov. 7, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case report demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Achilles tendon defects. Board-certified in foot and ankle surgery and lower extremity nerve specialist, Dr. Robert Parker of Parker Foot and Ankle in Texas, has presented for publication a novel case study of Wharton's Jelly, an umbilical cord connective tissue, applied to the structural tissue defect of the Achilles tendon in tandem with shock wave and laser therapy. The homologous use application validated by Dr. Parker sets a precedent for non-surgical allograft application. "As practitioners, we all share the knowledge that long-acting steroids, the acetates, are not only detrimental to tendons, they are in my opinion, contraindicated. This is especially true around larger tendons such as the Achilles. We also know the effect of short-acting steroids, the phosphates, though not as destructive, may give some pain relief but do absolutely nothing to help tissues heal themselves. I am very encouraged and optimistic about utilizing umbilical cord connective tissue as a structural allograft which helps my patient's own tissues heal themself even at multiple sites besides the Achille's tendon," shared Dr. Parker. The patient represented in this case report suffered with chronic Achilles tendinosis from chronic enthesopathy at the Achilles tendon insertion with a retrocalcaneal exostosis for three years and has failed standard-of-care practices for over two years. After application of Wharton's Jelly allografts, such as those provided by Regenative, in addition to extracorporeal pulsed-activated therapy (EPAT) and class IV laser therapy treatments, the patient's pain had improved from a 10/10 VAS to a 0/10 VAS in 13 weeks. While Achilles tendonitis and related tendon damage, also known as enthesopathies, is rampant among athletes, it does not exclusively affect athletes. Approximately 65 percent of Achilles injuries diagnosed in general practice are not sport related. Standard care practices for Achilles tendinosis vary from over-the-counter anti-inflammatories or corticosteroid injections with functional rehabilitation therapy to surgical intervention in severe cases. These costs can range upwards of $15k for a surgical repair and do not guarantee complete pain relief. The rising annual number of surgeries is enough to implement conservative protocols alternative to invasive surgical repair of the Achilles tendon. To advance the necessary research and fill the need for non-surgical alternatives, Regenative has been tracking data in its comprehensive retrospective data repository in which physicians across specialties submit patient data as they track patient outcomes up to 120 days after the patient receives an application of Regenative's products, like its Wharton's Jelly allografts. Regenative has collected data from clinics nationwide on Wharton's Jelly applications for Achilles tendon defects and is excited to highlight Dr. Parker's unique procedures in the first of many publications on regenerative podiatric medicine. "Given the high incidence rate and few effective treatment options for defects in the Achilles tendon, this study aims to provide a new, promising alternative intervention for patients who have failed all other standard-of-care treatments. This is just one of many homologous-use applications in regenerative medicine to improve patient outcomes," shared Regenative Labs CEO Tyler Barrett. Barrett is committed to providing patients with alternative options and, through what may be revealed in these studies, offers proven protocols to better address the root cause of their pain. Barrett and his team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine. "We're doing the research at Regenative, and the results are very promising. We are calling on all physicians across the country to engage with us and advance the field of regenerative medicine," Barrett concluded. Contact Regenative to get your practice involved today. About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: About Dr. Robert Parker: Dr. Robert G. Parker is a native Houstonian practicing in Houston, Texas. He graduated from the Ohio College of Podiatric Medicine (currently Kent State University) and was the first board-certified podiatric surgeon recognized by the American Board of Foot and Ankle Surgery in Houston. Dr. Parker is a faculty instructor of the advanced and fundamental Didactic and Cadaver courses for the Association of Extremity Nerve Surgeons. Additionally, he is a Founding Member and fellow of the Association of Extremity of Nerve Surgeons and served as the organization's president in 2013. Dr. Parker served on the American Board of Podiatric Medicine as an examiner for over a decade and was one of two cofounders of The Harris County Podiatric Residency program. He was also the President of the SW division of the American College of Foot Surgeons and has received numerous awards spanning his decades-long career. Learn more at Parker Foot and Ankle's website: SOURCE Regenative Labs

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