Tissue Regeneration Technologies: 251 Heritage Walk Woodstock, GA 30188|(404) 402-6844
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.