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Softwave® Tissue Regeneration Technologies Announces Landmark Trial for Acute Traumatic Spinal Cord Injuries
SoftWave® Tissue Regeneration Technologies, a disruptive bio-medical device company, announces the beginning of a trial for “Extracorporeal Shock Wave Therapy in Acute Traumatic Complete and Incomplete Cross – Sectional Lesions.” The trial will be sponsored by the Austrian Workers’ Compensation Board (AUVA). It will be conducted in 13 hospitals in Austria and one in Germany, over the next two years.
In this multi-center, randomized, double-blind, placebo-controlled trial, the primary endpoint is to investigate whether unfocused electro-hydraulic shockwaves (uESWT aka SoftWaves®) can achieve a statistically significant improvement in motor and sensory function (the AIS grade) for acute spinal cord injuries, if applied within the first 72 hours of said injury. Assessments on the ability to walk, quality of life, pain, and everyday independence will be compared over time in each group.
The hypothesized mechanisms of action associated with the improved clinical outcomes include the following: stem cell activation, a reduction in apoptosis, neovascularization, and, most importantly, a reduction in the inflammatory response post-injury. The aforementioned reduction is due to SoftWave’s® known ability to regulate inflammation via the Toll Like Receptor 3 pathway (TLR3).
Medical research shows that swelling after spine trauma may disrupt the remaining viable spinal cord function, even after the injury has been stabilized. Swelling is the enemy of SCI patients in the early hours and days post-trauma. SoftWaves® dramatically reduce swelling, offering hope to SCI patients, if applied early after an injury. Previous in vitro and animal trials suggest that SoftWaves® may reduce the degree of paralysis, if applied within hours of an injury. The treatment dramatically reduces the inflammation and initiates a strong biologic cascade, including stem cell activation and neovascularization.
About Spinal Cord Injuries
Every year, in the United States, there are over 17,700 acute spinal cord injuries resulting in devastating lifelong effects on the health and quality of life for the patient. This trauma leaves astronomical financial burdens on families and on the healthcare system. The most common causes of acute traumatic spine injuries (TSCI) are traffic accidents, high-altitude falls, and sports injuries (accounting for almost 9%). One-third of affected individuals with spinal cord injury suffer from tetraplegia, and approximately 50% of said affected individuals are paraplegics. The extent and severity of motor, sensory, and automatic dysfunction do not only depend on the height of the lesion, but also whether it is a “complete or incomplete” lesion. The AUVA and SoftWave® TRT are dedicated to funding high-level research to find a cure for this devastating condition.
The OrthoGold is cleared by the FDA for activation of connective tissue. The OrthoGold is used worldwide for a variety of spine and orthopedic conditions, wound care, and regenerative medicine. The OrthoGold’s proprietary shockwaves, “SoftWaves,®“ recently demonstrated a cellular response of TLR3 in rats with spinal cord injuries. This study resulted in the significant improvement of motor and sensory function. The OrthoGold has shown, in animals, to regenerate peripheral nerves and to improve function of the musculoskeletal system. The hope for the Austrian study is to duplicate similar positive outcomes using the OrthoGold for humans with SCI.
About SoftWave® Tissue Regeneration Technologies
SoftWave® TRT is a bio-medical device company that has proprietary patented technology using unfocused acoustic waves to treat a variety of conditions. SoftWave® has FDA clearance for activation of connective tissue and for the treatment of diabetic foot ulcers. SoftWave® TRT has over 30 patents for a variety of indications including stem cell activation, cellulite reduction, and wound healing.