Proof of Concept Trial Reveal Significant Reduction in Cellulite with No Bruising, No Swelling and No Downtime after single 20-Minute non-invasive Procedure; Justifies proceeding with Pivotal Trial.
May 29, 2019 – Houston, TX – Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced its decision to move forward with a pivotal trial in cellulite after positive data from its proof of concept clinical trial for the reduction of cellulite (the “POC Trial”) confirmed.
The Pivotal cellulite study is being designed to take place at multiple clinical sites across the country with between 45 and 60 patients to be treated in the study. We hope to begin the study within the next three months.
Cellulite affects up to 90% of women and over a billion dollars per year is spent on treatment in the U.S. Now, results from this Trial suggest the potential for a totally new approach to treating cellulite. In a single 20-minute, non-invasive treatment, the Rapid Acoustic Pulse (RAP) device was applied to the surface of the patients’ skin. The treatments required no anesthesia, caused no bruising, swelling or bleeding, and were evaluated as relatively painless by the trial participants, none of whom experienced any post-treatment discomfort or downtime. The data was originally presented at the SCALE (Symposium for Cosmetic Advances and Laser Education) conference in Nashville, Tennessee, by Dr. Elizabeth Tanzi on May 11, 2019.
The POC Trial involved a study of five patients with moderate to severe cellulite, each treated on their thighs, with a new higher-powered version of Soliton’s RAP device. While the Company’s RAP device intended to assist in tattoo removal was recently cleared by the FDA, this higher-powered version will require a new application for clearance for the cellulite indication. In the POC Trial, approximately 97% of treatments were rated 0 on a 0 to 10-point pain scale (with 0 being no pain). At the end of the 12-week POC Trial, in a blinded review by doctors of before and after photos, 100 percent correctly identified which photo was the “after.” The three blinded reviewers, who are trained in the use of the cellulite severity scoring system, scored the before and after photos using the 5-point system. 100% of the patients showed clinical improvement. The range of improvement in cellulite severity score was 20% to 47% and the average improvement for all patients was nearly a 30% improvement (1.24 reduction on the 0 to 5-point cellulite severity scale). As a point of reference, the only FDA approved method for long-term reduction of cellulite is an invasive treatment called Cellfina that produced an average improvement on the same scale of about 2 points. However, this is a procedure requiring topical anesthesia, penetration of the skin and involves potential bleeding, bruising and significant post-treatment discomfort and downtime. We believe Soliton RAP involves none of these potential negatives.
“The market for non-invasive cellulite treatments is about $1 billion in the U.S., so it is clear that many women who are affected by the condition are interested in finding ways to reduce or eliminate it,” said Walter Klemp, co-founder and Executive Chairman of Soliton. “The very encouraging results of the POC Trial are driving our decision to launch the pivotal trial as quickly as possible and suggest we may be able to significantly improve the appearance of cellulite with a single completely non-invasive procedure. The procedure requires no recovery time and avoids the risks that go with even minimally invasive surgery.”
How the Soliton Device Treats Cellulite
Although cellulite has many contributing factors, a primary cause of the deep dimples and ridges associated with cellulite is the presence of sclerotic septa connecting the dermis to the body’s fascia through the layer of subcutaneous fat. Septa normally provide structure and uniformity to the skin, but over time they can lose uniformity and become stiff and less resilient with larger pockets of subcutaneous fat in-between. As the presence of subcutaneous fat increases, it can push up against the dermis causing it to bulge between these septa, leaving dimples and ridges where the septa refuse to yield.
Superficial therapies are largely ineffective at changing this condition and severing the offending septa is the most effective therapy. Currently, the only method cleared by the FDA for long-term reduction of cellulite is called Cellfina and involves the insertion of a blade or lance into the skin below the dermis. The blade is then moved from side to side in a sweeping motion to cut any septa in its path.
While this “invasive subcision” is immediately effective at removing or reducing deep dimples and ridges, it is also quite painful, requiring the subcutaneous injection of anesthesia. It can also cause bleeding and bruising and significant patient downtime due to ongoing soreness as the wounds from these skin penetrations and cutting actions heal. In addition, this method does very little to smooth or tighten the skin to remove the “orange peel” or “cottage cheese” appearance often associated with cellulite.
Soliton has created a new form of acoustic pulses, which was recently awarded “Best in Show” by the American Society for Laser Medicine and Surgery (ASLMS), that it has shown in animal models are capable of selective disruption of sclerotic septa without ever penetrating the skin. The procedure creates no bleeding or bruising and results in no post-treatment discomfort or downtime.
We believe the disrupted septa resulting from the acoustic pulses induces increased collagen production that thickens and tightens the skin over time. More normal and robust septa are rebuilt with the skin in a smoother position.
“We believe this could represent a new approach to reducing cellulite, which could represent a significant change from the currently available invasive and non-invasive treatments, many of which only work with surface dimpling and can’t help the big dimples in the skin that many want to eliminate,” explained Dr. Chris Capelli, President, CEO, and co-founder of Soliton. “This new approach uses very fast, compressed acoustic pulses in the form of shockwaves and our data suggests that the acoustic pulses may be capable of achieving results previously only thought possible with invasive therapies.”
The Trial was conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston in collaboration with Dr. Elizabeth Tanzi of Capital Laser and Skin Care.
Dr. Kaminer stated: “Having led the clinical development of Cellfina, the only treatment with FDA clearance for producing long-term reduction of cellulite, I am particularly aware of the unmet need in the treatment of cellulite. Having a non-invasive alternative treatment could provide a real benefit for patients while also expanding the breadth of services offered by clinicians.”
Drs. Kaminer and Tanzi are members of Soliton’s Scientific Advisory Board.
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 is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. Both products are investigational and are not available for sale in the United States.
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’s acoustic shockwave device to prove safe and effective for reducing cellulite in larger clinical trials and the timing of the commencement of the pivotal clinical trial. 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 “Item 1A. Risk Factors” in the Form 10-K for year ended December 31, 2018 we filed with the SEC and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. 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.
This corporate profile is a paid advertisement and is provided for information purposes only; it should not be used as the basis for any investment decision. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the SEC) or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. The information contained in this corporate profile is not an offer to buy or sell securities. We distribute opinions, comments, and information free of charge exclusively to individuals who wish to receive them. This corporate profile has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any of the companies profiled based solely on information contained in this corporate profile. Individuals should assume that all information in this corporate profile is not trustworthy unless verified by their own independent research. Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some or all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stock broker before investing. As of May 9, 2019, Pre-IPO Buzz and Strikepoint Media have received total compensation of Three-Hundred and twenty-five thousand dollars from Soliton, Inc. for the preparation, publication, and management of this corporate profile as well as other marketing and investor relations services. We anticipate receiving additional compensation up to the amount of five hundred thousand dollars for the duration of the campaign. Pre-IPO Buzz, Strikepoint Media, and its principals currently hold no shares in Soliton, Inc., but may buy or sell such shares at any time without notice. This compensation and position constitute a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurance as to the accuracy or completeness of the information provided, including information regarding a profiled company’s plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company’s operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so.
Information contained in this corporate profile will contain “forward looking statements” as defined under Section 27A of the Securities Act of 1933 and Section 21B of the Securities Exchange Act of 1934. Readers are cautioned not to place undue reliance upon these forward looking statements. These forward looking statements are subject to a number of known and unknown risks and uncertainties outside of our control that could cause actual operations or results to differ materially from those anticipated.
Statistical information, dollar amounts, and market size data was provided by the profiled company and related sources which we believe to be reliable. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided herein, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to, lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information). We encourage you to invest carefully and read investment information available at the websites of the SEC and the Financial Industry Regulatory Authority (“FINRA”).