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.
TISSUE REGENERATION TECHNOLOGIES announces that shockwave (SoftWaves®) technology has been utilized to treat coronavirus patients
The effect of extracorporeal shock wave therapy (ESWT) in acute traumatic complete (AIS A) and incomplete (AIS B‐D) cross-sectional lesions on motor and sensory function within six months after injury
A two‐arm three‐stage adaptive, prospective, multicenter, randomized, double‐blind, placebo‐controlled clinical trial
This is a two‐arm three‐stage adaptive, prospective, multi‐center, randomized, double‐blind, placebo-controlled clinical trial according to the MPG “Medizinproduktegesetz [Medical Devices Act])” which is designed as a two‐arm three‐stage adaptive trial. Fifteen treating hospitals and three rehabilitation centers in Austria and Germany will participate. The allocation of the study groups will occur by means of a block randomization, in order to guarantee the best possible balance between the treatment group, the control group and the treating hospitals. The
study groups are comprised of a treatment group (extracorporeal shock wave therapy by means of electrohydraulic shock wave generation) and a control group (placebo ESWT).
To gain as homogenous groups as possible, a stratified block randomization with a block size of four will be done. The assignment to treatment and placebo group will be made in a ratio of 1:1. For stratification, three different neurological levels of injury will be used:
1. Cervical injuries: C1‐C8
2. Thoracic and lumbar injuries (T1‐L1)
3. Peripheral nervous system injuries (Cauda equina and conus medullaris syndromes; L2‐S5)
Recruitment of patients takes place continually at admission to acute care in one of the 15 participating hospitals (14 in Austria, 1 in Germany). Patients and assessors of study relevant data are blinded to group allocation. The operating room staff and persons involved in the application of the study intervention are not blinded to group allocation and are required to keep it as a secret.
On December 23rd, 2019 the ethical commission of Innsbruck approved this study. This is the first study offering a potential causal therapy to patients with a spinal cord injury worldwide.
On January 8th, 2020 the study got approval from the ethical commission of the AUVA (Workmen´s compensation board of Austria).
On this map you see the participating centers in Austria (pink and pink framed: approved, grey: before approval, green rehabilitation centers).
The first patients to be enrolled are planned for March. The trauma center berlin is also supposed to participate.
Tissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is a Georgia limited liability company with its principal place of business in Woodstock, Georgia. It was founded in 2004 as Shockwave Technical Service, LLC, and amended its name to its current form in 2006. TRT is a medical technology company that develops, manufactures, and sells shockwave devices used to treat a variety of medical conditions. Originally conceived and operated as a research and development company, TRT began marketing and sales operations of certain of its products in 2008. TRT is currently engaged in business throughout the United States, and has a strong international presence through its German affiliate, MTS Europe GmbH (hereinafter referred to as “MTS”).
TRT develops and manufactures its “softwave” devices through its German affiliate, MTS. The technology utilized in the devices can be categorized into two groups: (1) patented, unfocused “SoftWaves” for soft tissue indications (e.g., wounds), and (2) focused shockwaves for lithotripsy and bony indications (e.g., non-healing fractures).
The patented softwave technology uses various lens configurations to produce pressure waves. These waves have a characteristic pressure profile of short rise-times reaching high amplitudes (comparable to a sonic boom). The pressure waves can be shaped through a reflector, which enables the transmission of either highly-focused shockwaves for use on urinary stones or non-union fractures, or soft-focused pressure waves (i.e., SoftWaves) for most soft tissue indications.
TRT’s patented SoftWave technology is distinguished from competitors’ shockwave technology in that TRT uses a patented parabolic (as opposed to an ellipsoid) reflector in the therapy head, which allows delivery of unfocused waves of acoustic energy over a broad target area. TRT’s SoftWave technology generates less pain, has a higher efficacy rate, and has a lower re-treatment rate than competitors’ high-energy, focused shockwave systems. TRT is the first company to discover that “softwaves” have the same or better clinical benefit as high-energy focused shockwaves for most medical conditions. Following this discovery, TRT further developed the idea into a useful format, and secured patents protecting its inventions.
The advantages of SoftWave technology include the following benefits: (1) treatments do not require anesthesia; (2) larger surfaces, such as wounds, can be treated faster and easier than with competing shockwave devices.
TRT currently has product lines developed for the treatment of six distinct areas of care:
⦁ LithoGold – Lithotripsy and urology indications
⦁ OrthoGold – Orthopedic indications
⦁ DermaGold – Wound care indications
⦁ CardioGold – Cardiac and vascular indications
⦁ VetGold – Veterinary indications
⦁ UroGold – Urologic indications
The OrthoGold has been FDA cleared for connective tissue activation and registered for increased blood flow and pain relief. The DermaGold has been FDA cleared to treat diabetic ulcers. Each of these devices has successfully undergone CE approval. TRT has the rights to distribute the products throughout North America, and MTS has the rights to distribute in all other locations.
TRT currently has approval to distribute two devices in the United States: the LithoGold and VetGold systems. In Canada, TRT is approved to distribute the LithoGold, DermaGold, and VetGold systems, along with specific products in its OrthoGold line.
Disclaimer: This Executive Summary of Tissue Regeneration Technologies, LLC is for information purposes only, and does not represent an offer or proposal of any transaction, investment or otherwise. None of the information contained herein is to be relied upon for any purpose whatsoever, and Tissue Regeneration Technologies, LLC explicitly disclaims any warranties or representations as to the accuracy or completeness of the information contained herein. Nothing herein is to be construed as binding or obligating Tissue Regeneration Technologies, LLC to perform any action whatsoever.
Cebicci MA1, Sutbeyaz ST2, Goksu SS3, Hocaoglu S2, Oguz A3, Atilabey A2.Author information1
Department of Physical Therapy and Rehabilitation, Kayseri Training and Research Hospital, Kayseri, Turkey. Electronic address: firstname.lastname@example.org.
Department of Physical Therapy and Rehabilitation, Kayseri Training and Research Hospital, Kayseri, Turkey.
Department of Medical Oncology, Kayseri Training and Research Hospital, Kayseri, Turkey.AbstractOBJECTIVE:
To investigate the clinical effect of extracorporeal shock wave therapy (ESWT) in patients with secondary lymphedema after breast cancer treatment.
Prospective clinical pilot study.
Education and research hospital.
Women with a diagnosis of lymphedema secondary to breast cancer (N=11).
Patients were treated for 12 sessions of ESWT with 2500 impulses each. The treatment frequency was 4Hz in multiple shock mode. The energy flow density during treatment was equal to a working pressure of 2 bar.
MAIN OUTCOME MEASURES:
The primary outcome measure was volumetric measurements. The secondary outcome measures were the short version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) and the brief version of the World Health Organization Quality of Life (WHOQOL-BREF). Assessments were conducted by the same investigator at baseline, posttreatment, and at 1, 3, and 6 months after treatment for all patients.
Significant reduction was found in the amount of lymphedema with ESWT treatment in all patients, and this reduction was maintained for 6 months. A statistically significant reduction was observed in volumetric measurements for the follow-up period (P=.001). The mean volume displacement of the affected upper extremity before treatment was 870.45±384.19mL at 6 months, and after the treatment it was 604.54±381.74mL. In addition, improvements were observed in the QuickDASH functional assessment tool and in the physical health domain of the WHOQOL-BREF questionnaire (P=.002 and P=.007, respectively).
ESWT was shown to provide a reduction in the amount of lymphedema in patients with lymphedema secondary to breast cancer. Also, a marked improvement was observed in the functional status and quality of life of study patients. Treatment efficacy was maintained in the long term. As a noninvasive, novel, and effective method, ESWT is a promising treatment modality for the treatment of lymphedema, which is a chronic, progressive, and refractory condition.
Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.