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Soliton Inc. (SOLY) - Mark Your Calendar For Mar.21

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Aesthetic medical device company Soliton Inc. (SOLY) is all set to report results of a pivotal clinical trial evaluating its Rapid Acoustic Pulse, or RAP, device for the treatment of cellulite on March 21, 2020.

Cellulite is formed by changes in the structure of the skin and in the subcutaneous fat layer, resulting in dimples and ridges that occur most often in the thigh region. Globally, cellulite is said to affect between 80-90% of women and the current standard of care is Cellfina, a surgical procedure.

According to a report by Grand View Research Inc, the global cellulite treatment market size is anticipated to reach $2.81 billion by 2026, registering a CAGR of 11.0%.

In a proof of concept trial in which five patients with moderate to severe cellulite on their thighs were treated with Soliton's RAP device, there was a 20-47% improvement in Cellulite Severity Score.

Based on the proof of concept trial results, the Company initiated a pivotal trial of its Rapid Acoustic Pulse device for the temporary improvement in the appearance of cellulite last July. The trial completed enrolment of all 67 required patients last November, and the results are all set to be reported in another 10 days.

Soliton's Rapid Acoustic Pulse device received FDA clearance for tattoo removal last May. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals.

Earlier this week, the Company entered into a Manufacturing Services Agreement with Sanmina Corporation, under which Sanmina will manufacture Soliton's RAP device and replaceable cartridges. The delivery and sales of the initial RAP devices for tattoo removal are expected in mid-2020.

The tattoo removal market is predicted to reach $4.3 billion by 2023, according to Walter Klemp, Executive Chairman of Soliton.

The RAP device has also produced encouraging results in a proof-of-concept clinical trial involving 10 people with keloid and hypertrophic scar (also known as "fibrotic scars"). According to the results announced last October, there was an average reduction in the volume of over 27% and a reduction in height of almost 17%.

Keloids and hypertrophic scars are caused by cutaneous injury and irritation, including trauma, insect bite, burn, surgery, vaccination, skin piercing, acne, folliculitis, chicken pox, and herpes zoster infection. (Source: Int. J. Mol. Sci. 2017, 18(3), 606).

Grand View Research estimates the global market for keloid and hypertrophic scars may reach $10.2 billion by 2025. The most common treatment for keloid and hypertrophic scars is the direct injection of steroids into the scar, requiring multiple injections and may not be a permanent solution.

Soliton is also seeking FDA clearance for its Generation II Rapid Acoustic Pulse device for the tattoo removal indication, and a 510(k) application was filed with the FDA last month.

The Generation II RAP device delivers the same tattoo-removal therapy as the Generation I device but is slightly modified for improved ease of use in the physician's office.

Cash Position

The Company ended the year 2019 with total cash of $12.1 million.

SOLY has traded in a range of $5.01 to $29.00 in the last 1 year. The stock closed Tuesday's trading at $10.66, up 6.92%.

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