SoftWave Tissue Regeneration Technologies plans to start a 60-patient study to evaluate the safety and efficacy of the DermaGold device for the temporary improvement in the appearance of cellulite.
The company has a patent for the use of shockwaves to treat cellulite and numerous other aesthetic conditions. The company will be filing for a 510K clearance for the treatment of cellulite in the first quarter of 2021. The study seeks to recruit women between the ages of 25-65, having at least one dimple with a depth of 5mm, a Cellulite Severity Score of greater than 4 and Body Mass Index (BMI) of less than 30.
Unfocused extracorporeal shock wave therapy (uESWT) provides both a physical and biological response. The applicator releases unfocused SoftWave® energy to the treated tissue. The mechanism of action is believed to be the disruption of fat components and septae to reduce cellulite. This procedure lasts around 20 minutes, is non-invasive and virtually pain-free.
Another physical response is the reduction of lymphedema from the uESWT application. Recently, it has been proposed that the influence of uESWT activating pathways is in adipose-derived stem cells. Clinically diseased skin appears to normalize following uESWT such as in progressive systemic sclerosis with up-regulation of endothelial progenitor cells and circulating endothelial cells, the company states.