About SoftWave Therapies

Tissue Regeneration Technologies, LLC (hereinafter referred to as “TRT”) is a limited liability company based in Woodstock, Georgia. It was founded in 2004 as SoftWave Technical Service, LLC, and amended its name to its current form in 2006. TRT is a medical technology company that develops, manufactures, and sells SoftWave 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 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:

• Patented, unfocused SoftWaves for soft tissue indications (e.g., wounds)
• Focused SoftWave for lithotripsy and bone 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 SoftWave 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:

• treatments do not require anesthesia
• larger surfaces, such as wounds, can be treated faster and easier than with competing shockwave devices
• SoftWave devices can be manufactured to be smaller and less expensive than competing shockwave devices, alleviating the need for a costly field service organization.

Product Lines TRT currently has product lines developed for the treatment of five distinct areas of care:

• CardiologyCardioGold – Cardiac and vascular indications
• LithoGold – Lithotripsy and urology indications
• OrthoGold – Orthopedic indications
• UroGold – Urology indications
• VetGold – Veterinary indications
• DermaGold – Wound care indications

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.