SoftWave Tissue Regeneration Technologies announces its plan to embark on a 60-patient study for the treatment of cellulite.
SoftWave TRT has been issued a patent for the use of shockwaves to treat cellulite and numerous other aesthetic conditions. The lead investigator will be Dr John Mullins MD, a plastic surgeon and Chief of Surgery at Piedmont Hospital in Atlanta.
The study will evaluate the safety and efficacy of SoftWave’s DermaGold device for the temporary improvement in the appearance of cellulite. 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 will be some of the inclusion criteria.
Cellulite is different from generalized obesity in that it is a localized alteration in the contour of the skin that has been reported in over 90% of post-pubertal females and affects women of all races and ethnicities. Weight gain can make cellulite more noticeable, but cellulite may be present even in thinner subjects. Clinically, cellulite presents on the buttocks, thighs, lower abdomen and arms. The presence of cellulite is associated with changes in dermal thickness and in fat cells and connective tissue below the skin. The protrusions of the subcutaneous fat create dimpling characteristics in the skin.
Unfocused Extracorporeal Shock Wave Therapy or “Softwaves” have been used for a variety of clinical conditions. Internationally, uESWT has been used since 2005. Dr Karsten Knobloh and Dr Robert Kraemer evaluated 11 clinical trials and found uESWT was able to improve the degree of cellulite both in terms of appearance as well as in terms of ultrasound improvement of the subcutaneous fat. These studies reported very few side effects.
Physical and Biological Response
Unfocused Extracorporeal Shock Wave Therapy guarantees both a physical and biological response, and the mechanism of action is believed to be the disruption of fat components and septae to reduce cellulite. 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 (ADSM). 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.
SoftWave Tissue Regeneration Technologies plans to begin this trial in 2020 and will be filing for a 510K clearance for the treatment of cellulite in the first quarter of 2021. This procedure lasts around 20 minutes, is non-invasive and virtually pain-free and will compete with other all invasive and non-invasive surgical procedures that require anesthesia and are more costly and have potential side effects. It is estimated that women spend over $1 billion for the treatment of cellulite and SoftWave TRT believes it can be a significant player in this market after regulatory clearance.
[Source(s): SoftWave Tissue Regeneration Technologies, Newswire.com]
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