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FDA last month cleared Soliton Inc.’s Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite. In clinical trials submitted to the FDA as part of the 510(k) application, results were seen with a single, non-invasive treatment that required no anesthesia and caused no unexpected or serious adverse events. Treatment was well tolerated, with an average pain score of 2.4 out of 10.

The Soliton RAP device was cleared in mid-2019 for treatment of tattoos and is being launched commerically in the near future.

Ahead, Elizabeth Tanzi, MD, lead investigator of the clinical trials for cellulite, discusses RAP technology and its potential role in practice.

What is the Soliton device and how does it treat cellulite?

Elizabeth Tanzi, MD: We have seen other acoustic technologies come to market, but Soliton’s rapid acoustic pulse or RAP technology truly stands apart. 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. When passing through the skin, these high intensity sound waves mechanically disrupt the fibrous septae that tether the skin and lead to the puckered look of cellulite.

Good histologic data demonstrates that these very high intensity sound waves cleave the fibrous septae without the need to cut the skin, a process referred to as acoustic subcision. In the original clinical study, 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.

These findings are based on the clinical studies used for FDA-clearance. I think there is much more we don’t know in terms of the potentially useful effects of the RAP device when used on the skin. It is intriguing technology, because we see the disruption of those bands histologically, but there are also other biologic effects on the skin, including some anti-inflammatory and collagen stimulation properties. There are many possibilities and questions that deserve additional investigation.

Although in the clinical study we delivered a single treatment with the RAP technology with good response, once available in our offices, we need to determine if additional treatments provide superior results for cellulite, and if so, what interval is best to deliver those treatments. But to me, the biggest question is: What else could we be doing with this technology? Is it something that will help with skin laxity? Is it something that will help improve skin crepiness and tone? There are some ongoing research studies looking into how RAP technology impacts scars. The future is bright for this exciting technology.

How will you describe the technology to patients? How will you differentiate it from other devices?

Dr. Tanzi: The RAP technology, as compared to other sound and shock wave devices, is unique because of the speed, the high peak power and repetition rate at which the sound waves are delivered. Although there are other sound wave technologies available, it is really like comparing apples to oranges, because of the specifics of the RAP device.

There is no heat created during treatment and no cavitation of the fat cells, therefore discomfort and recovery are minimized. During the study, treatment areas were barely pink at end-treatment, with no bruising and essentially no downtime. Compared to other technologies currently on the market for the appearance of cellulite, or those that will be released shortly, the RAP technology has advantages because of the lack of discomfort and recovery time associated with treatment.

What is the treatment procedure like? Is it something you could delegate?

Dr. Tanzi: This is a highly delegatable procedure. It is very straightforward with a highly favorable side effect profile. In the clinical study, subjects received a single 20-30 minute treatment to the posterior thigh and buttock with the contralateral leg serving as a control. The satisfaction rate was 92 percent among the study subjects. I will absolutely be delegating this to my staff. I anticipate a very positive impact on my practice.

What are your plans for marketing both internally and externally?

Dr. Tanzi: 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. The first step in marketing will be to reach out to my existing patients who have expressed interest in cellulite treatments that provide long-lasting improvement. There is a lot of interest! Of course, each patient will need a thorough consultation because there are numerous factors that cause what patients perceive as “cellulite,” and patient selection will be critical for success.

Do you see any reason Soliton treatment would preclude treatment with other emerging technologies for cellulite?

Dr. Tanzi: Absolutely not. As the appearance of cellulite can be caused by a number of factors, a variety of good treatment options is essential to be able to meet the needs of our patients. More tools in the toolbox allows us to provide better results. There is no “one size fits all” when it comes to patients and the presentation of their cellulite.

We are at a great advantage to have multiple new modalities available to improve the appearance of cellulite. It will be up to the expertise of the dermatologic surgeon to utilize and combine the technologies to deliver optimal results.

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