The Situation Today
The global growth in tattoo incidence is without dispute, as is the growth in tattoo removal. While laser removal therapy holds the largest share of this removal market, patient concerns growing from dissatisfaction with the therapy due to the unexpected, and often unpredictable, number of treatments, the resulting cost and months/years to achieve successful removal, patient discomfort, and post-treatment complications have hampered growth in the removal market.
The Patient Experience
In a proprietary research study conducted in 2014, only 10% of those beginning tattoo removal procedures completed all the recommended treatment sessions. Recent innovations in laser devices, notably the introduction of picosecond technology, represent opportunities for improvement but come with a significant price tag. Fundamentally, the greatest growth opportunity rests in the ability to provide safe, predictable, effective, fast tattoo removal therapies for the lowest incremental cost, both to the clinician as well as the patient.
Soliton’s RAP (Rapid Acoustic Pulse) Device works in partnership with a short pulse laser to achieve superior results in tattoo removal.
With Soliton’s RAP device, this all changes. After the initial laser pass is made and the vacuoles have formed, the RAP Device is applied immediately afterward. Within seconds, the RAP’s acoustic waves remove the vacuoles as well as further dispersing the ink pigment from the macrophages.
Another laser pass is now immediately possible and may be followed by another RAP Device pass and still another laser pass. With this new approach, Soliton’s RAP Device enables multiple passes in a single treatment session, something that would take months to complete without Soliton’s RAP.
Trial Data
In a pivotal blinded clinical study of 32 tattoos comparing the Soliton Multi-Pass treatment to Laser-Only treatment (the current standard of care), the Soliton combination treatment outperformed Laser-Only in 94% of cases. Furthermore, with just a single treatment session, 41% of the tattoos treated with the Soliton Multi-Pass method had an “excellent or complete response” (≥50% fading) compared to 12% of the tattoos treated with Laser-Only. Finally, 19% of the tattoos treated with the Soliton Multi-Pass method had a “complete response” (76% to 100% fading) compared to 3% of the tattoos treated with Laser-Only, again in just a single treatment session. In a Matched Pair T-Test, these results were considered statistically significant at P<.00001.
In a second blinded clinical trial, 11 unique patients received 2 to 3 treatment sessions, again comparing the Soliton Multi-Pass treatment to Laser-Only treatment. 100% of the tattoos treated with the Soliton Multi-Pass method had a complete response (76 to 100% fading). In comparison, only 17% of the tattoos treated with Laser-Only had a complete response.