HOUSTON, Feb. 28, 2019 (GLOBE NEWSWIRE) -- Soliton, Inc., (Nasdaq: SOLY), (“Soliton” or the “Company”), a medical technology company that has developed a new breakthrough acoustic shockwave device, today announced that it believes that what they have discovered in preclinical testing with their Rapid Acoustic Pulse (“RAP”) technology may also give them the ability to reduce cellulite.
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Cellulite is believed to be the result of multiple factors. One of those factors is inadequate collagen structure in the dermis leading to a weakening of the dermal extracellular matrix (ECM). Excess subcutaneous fat can then protrude into the weak pockets within the ECM resulting in a mottled or lumpy appearance to the skin.
The cells in the body that are responsible for synthesizing collagen and helping to maintain a well structured ECM are called “fibroblasts.” Soliton believes its RAP technology is capable of delivering a very compressed, high pressure shockwave at repetition rates of up to 100 per second, providing the necessary mechanical stress to induce fibroblast production of collagen without pain, or patient downtime. In preclinical testing, the Company demonstrated that their RAP device is capable of consistently inducing the production of new collagen within the ECM of the dermis, therefore creating the potential for reducing the appearance of cellulite and skin laxity.
“The discovery that our proprietary rapid acoustic pulse technology has the potential to treat cellulite constitutes a potential game-changer for our company,” commented Dr. Chris Capelli, CEO of Soliton, Inc. “Preclinical research supported conducting a preliminary proof of concept clinical trial for the treatment of cellulite, which we are now close to completing.”
The Company intends to conduct both a proof-of-concept and a full FDA trial targeting the cellulite indication. To learn more about how Soliton RAP works and its potential impact on cellulite, please visit Soliton.com.
About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product will use rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company expects to file for premarket clearance with the U.S. Food and Drug Administration ("FDA") for its’ first device in the first quarter of 2019 and expects to receive clearance to market the device in mid 2019. This initial filing is limited to the Company’s device used in conjunction with the 1064 nm Q-switched laser to enable effective multiple pass laser treatments in a single office session to accelerate removal of black tattoos on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. While the Company believes its’ technology has many potential applications, the Company has initially focused on the removal of tattoos, where both animal and human studies have shown promising results. The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using the Company’s RAP device, in conjunction with a Q-switched laser, has the potential to produce similar results in just 2 to 3 office visits versus the industry average of 10 or more with a stand-alone laser. The Company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods.
For more information about the Company, please visit: http://www.soliton.com
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to reduce cellulite in clinical trials. Clinical trials relatred to the acceleration of existing fat removal technologies and cellulite are in early stages and there is no guarantee that any specific outcome will be achieved. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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