Energy-based Approach to Cellulite: The Role for Soliton’s RAP Technology

Soliton Inc.’s Rapid Acoustic Pulse (RAP) technology recently received FDA clearance for the short-term improvement in the appearance of cellulite. Results from clinical trials submitted to the FDA as part of the 510(k) application, show that a single, non-invasive treatment—provided with no anesthesia and causing no unexpected or serious adverse events—produced noticeable improvement in the appearance of cellulite. Treatment was well tolerated, with an average pain score of 2.4 out of 10. The Soliton RAP device, which was cleared in mid-2019 for treatment of tattoos, is launching commercially over the next few months.

A Novel Acoustic Technology

The Soliton device is unique among acoustic technologies currently on the market. Soliton’s RAP device is the first technology of its kind that can generate high intensity shock waves at up to 100 times per second. As these high intensity sound waves pass through the skin, they mechanically disrupt the fibrous septae that we know tether the skin and lead to the puckered appearance of cellulite. This process, known as acoustic subcision, has been well documented histologically. It is exciting to be able to cleave the fibrous septae without having to cut the skin.

In the original clinical study of RAP for cellulite, we saw significant improvement in the vast majority of study subjects with a single treatment. Clinical improvements in cellulite were seen for up to 12 months, and there is ongoing observation to determine if those results are going to last longer. Among my study subjects, there was no downtime and minimal discomfort.

The studies that supported FDA clearance were robust and comprehensive. Nonetheless, I am confident that we will continue to learn more about this technology and its potential applications for aesthetics. There is much more we don’t know in terms of the potentially useful effects of the RAP device when used on the skin. I am eager to learn what else we could be doing with this technology. There is some evidence of biologic effects on the skin, such as anti-inflammatory and collagen stimulation properties. There is ongoing research studies looking into how RAP technology impacts scars.

It is also possible that our use of RAP for cellulite will evolve as we gain clinical experience with the device. In the clinical study we delivered a single treatment with good response. However, it remains to be seen whether additional treatments could provide superior results for cellulite, and if so, what interval is best to deliver those treatments.

Selecting and Educating Patients

Compared to other sound and shock wave devices, the RAP device is unique because of the speed, the high peak power, and repetition rate at which the sound waves are delivered. Patients should be educated that this device is unique and is not to be confused with other acoustic devices on the market.

Patients should also be educated on what to expect during and after treatment. Compared to other technologies currently on the market for the appearance of cellulite, the RAP technology has advantages because of the lack of discomfort and recovery time associated with treatment. Because there is no heat created during treatment and no cavitation of the fat cells, discomfort and recovery are minimized. During the study, treatment areas were barely pink at end-treatment, with no bruising and essentially no downtime. The satisfaction rate was 92 percent among study subjects.

Treatment of the buttocks and posterior thighs will likely take less than 40 minutes. During the trials we treated one thigh and buttock in about 20 minutes; the contralateral side served as a control.

It is important to keep in mind that multiple factors contribute to the appearance of cellulite. Patient assessment and consultation are crucial. While not yet studied, it seems reasonable that patients treated with RAP would additionally receive treatment with injectables or other energy-based devices to address concerns like texture and laxity. The ability to utilize a combination of interventions has been a hallmark of modern aesthetic practice, and this should be no different.

A Practice Fit

Treatment with the RAP device for cellulite is a highly delegatable procedure. It is very straightforward, with a highly favorable side effect profile. As the treatment rolls out, I anticipate a very positive impact on my practice.

The original study subjects that I treated during the trial are calling on a regular basis to find out when I will have the device back in my office. They were happy with the improvement and want more. My initial marketing will include outreach to existing patients who have expressed interest in cellulite treatments that provide long-lasting improvement. From there, a combination of word-of-mouth and external marketing should continue to drive traffic.

As we know from clinical experience and the data, cellulite is not a function of weight; many patients with cellulite are in a healthy BMI. However, there are patients with cellulite who also have excess weight concerns, and it seems likely that we can expand services by offering patients contouring treatments as well as treatments to improve the appearance of cellulite.

Kick-starting a New Age

We are at a great advantage to have multiple new modalities available to improve the appearance of cellulite. The Soliton RAP device answers demand for a patient-friendly, safe, effective treatment that deliver results with no pain and no downtime. It will be up to the expertise of the aesthetic surgeon to utilize and combine the technologies to deliver optimal results.