Soliton is planning to file an additional FDA 510(k) application for the use of RAP technology to improve the appearance of cellulite
Image: Soliton’s RAP device appears to deliver increased disruption of the fibrotic septa, implying a dose response to the therapy. Photo: Courtesy of PRNewsfoto/Soliton, Inc.
US-based medical device company Soliton has announced the positive results of preclinical studies of its Rapid Acoustic Pulse (RAP) device.
The medical devices manufacturer said that the results showed an increased disruption of the fibrotic septa that contribute to the appearance of cellulite with increased treatment time, indicating a dose response to the therapy.
Soliton is engaged in developing a unique platform technology licensed from the University of Texas on behalf of the MD Anderson Cancer Centre.
Soliton president and CEO Chris Capelli said: “We are excited to have demonstrated that an increase in treatment time does indeed appear to result in heightened acoustic subcision. Dose ranging has long been seen in the scientific community as an indication that a technology or drug is responsible for the effect observed.
“It also increases our optimism regarding the results we will see in our recently started pivotal clinical trial for the treatment of cellulite.”
The RAP device for the treatment of cellulite is investigational and is not available for sale in the US.
Soliton’s acoustic subcision
Soliton said that the new discovery ‘acoustic subcision’ is expected to compliment the recent proof-of-concept (POC) trial of the RAP device, whose results showed a 20-47% improvement in the cellulite severity score.
In certain cases, where fibrous septa connecting the dermis to the muscle layers through the layer of subcutaneous fat, and become inflexible, the subcutaneous fat pushes up, and the sclerotic fibrous septa hold the skin down to cause the appearance of cellulite with deep dimples.
To remove the dimples, severing the fibrotic septa is currently the only viable means. Subcision is a surgical procedure for severing the fibrotic septa using a special hypodermic needle, punctured through the skin, to bring the dimpled skin associated with cellulite to a flatter, smoother state.
The painful invasive procedure requires anaesthesia and may result in bleeding, bruising and significant post-treatment discomfort and downtime.
The name ‘acoustic subcision’ indicates the capability of RAP technology to perform the procedure without breaking the skin, anaesthesia, bruising, bleeding or post-treatment discomfort or downtime.
Soliton is planning to file an additional 510(k) application for the use of RAP technology to improve the appearance of cellulite.