SoftWave Tissue Regeneration Technologies (SoftWave TRT) has secured the US Food and Drugs Administration (FDA) approval for the treatment of superficial, partial-thickness, second-degree burns.
The bio-medical device company SoftWave TRT has previously received FDA approval for the treatment of Diabetic Foot Ulcers (DFU’s), and is the only Extracorporeal Shock Wave Therapy (ESWT) provider to receive regulatory approvals for both acute (burns) and chronic wounds (DFU’s).
SoftWave TRT said that its treatment technology leverages unfocused extracorporeal shock wave technology (uESWT) to generate both physical and biological responses to enhance the wound healing.
The therapy is expected to provide physicians, treating patients with burn wounds, with additional option for healing burn wounds, said the company.
SoftWave TRT has more than thirty patents for stem cell, heart, and wound healing indications
The company said that most of the superficial wounds heal within two weeks. However, patients with severe burns would experience severe physical and psychological pain during the treatment phase.
A randomised clinical trial conducted by Dr. Christian Ottomann, patients who had undergone uESWT, experienced accelerated epithelialisation, and reduction in the time needed for healing, compared to patients who did not undergo uESWT.
The company said that the SoftWave biological response for wound healing is related to neovascularisation, and an elevated oxygenation and perfusion, resulting in angiogenesis.
SoftWave TRT has secured first regulatory approval in 2018, for OrthoGold to activate connective tissue and registered for pain reduction and increased blood flow, followed by a second approval in 2019, for the treatment of Diabetic Foot Ulcers.
The company holds more than thirty patents, addressing different of indications, including stem cell activation, cellulite reduction, numerous indications involving the heart, and wound healing.
