The Basics: Tattoos & Macrophages

The most common method of tattooing uses an electric tattoo machine which rapidly injects ink into the skin.  The body’s immune system attacks the invading ink pigment with macrophages to capture, consume and remove the ink from your system.  Some macrophages over-consume and become so full that they can’t move, remaining where they are, and the agglomeration of ink they have consumed is visible through the skin as a tattoo.

Today’s Common Treatments

The most common method of tattoo removal uses a short-pulse laser to target tattoo macrophages and break down the agglomerations of ink into smaller particles that can be carried away by the body’s immune system.

This process is highly inefficient because of two key problems.  The first is what we call “particle shielding.”  Because lasers are “line of sight,” meaning they can only hit what they can see, the particles at the top of the agglomerations shield the particles below. 

If that were the only problem, as these upper particles are destroyed, an additional pass with the laser during the same treatment session would reach the next layer of particles and eventually, enough additional laser passes could reach most of the ink. 

However, the second problem results from the intense heat generated when the laser interacts with the ink.  This creates an instant explosion of steam vacuoles, both at the surface of the skin (visible as blisters) as well as below the surface just above the macrophages.  These vacuoles act as an additional shield, preventing the laser energy from reaching any more ink.  Although the surface vacuoles will dissipate within an hour or more, the deeper vacuoles below the skin’s surface will persist for days, so additional laser passes in the same treatment session have no significant effect. 

Therefore, patients typically must wait 6-8 weeks for the vacuoles to dissipate naturally and for their skin to recover.

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.   

8 patents and provisionals filed

60601 Electrical Safety certified; 2 MOPP/MOOP

IRB “non-significant risk” established

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.

Soliton’s Future

Although tattoo removal is currently the lead use for our technology, several additional aesthetic indications appear feasible. As a team we’re dedicated to coming up with new ideas, rigorously testing them, and bringing them to market with a comprehensive understanding of both patients’ needs and clinician practices.

Our shockwave technology is capable of inducing mechanical stress in cells called “fibroblasts,” which in turn leads to new collagen growth.  Stimulating sufficient new collagen has the potential to reduce skin laxity and the appearance of cellulite by creating firmer, smoother skin.  We know there is a tremendous unmet need for a painless, non-invasive treatment to reduce cellulite.  Extensive preclinical testing suggests there is potential for our acoustic shockwave technology, and we’re excited to explore additional applications.

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