Soliton, Inc.’s Rapid Acoustic Pulse ("RAP") device may selectively disrupt of the fibrotic septa that contribute to the appearance of cellulite, according to preclinical studies.
The device is cleated for use in tattoo removal, however, technology for the treatment of cellulite is investigational and not available for sale in the United States. Soliton will file an additional 510(k) application for the use of RAP technology to improve the appearance of cellulite.
The new discovery, referred to as "acoustic subcision," helps explain the recent proof-of-concept trial results showing an improvement in the appearance of cellulite following use of the RAP device. The device has also been shown to stimulate new collagen production in animal models, the Company states.
“Acoustic subcision' describes the apparent ability of the RAP technology to sever the fibrotic septa without ever breaking the skin. What's more, the procedure should require no anesthesia and importantly and there should be no bruising, bleeding or post-treatment discomfort or downtime, the Company states.
The higher-powered prototype RAP device may promote collagen production through the body's repair of the mechanically disrupted septa.
"We believe the ability to promote production of new collagen is a major finding and critical to the ability of this new technology to potentially improve the appearance of cellulite," says Dr. Chris Capelli, Soliton's President, CEO and co-founder, in a news release. "An important message here is to understand the potential value of the combined effects – the nearly immediate effect of acoustic subcision to mechanically disrupt sclerotic septa leading to the improvement in the appearance of cellulite dimples and ridges and the longer-term effect of increased collagen production which has the potential to improve the overall smoothness of the skin. More clinical testing is planned to validate these early results."