Growing Global Demand for Non-Invasive Cellulite Treatment with FDA Clearance

PALM BEACH, Florida, May 29, 2019 /PRNewswire/ -- Cellulite affects 85% to 90% of all women worldwide and was first described nearly 100 years ago, and has been the bane of women (and men) ever since. But to find a 'cure' or effective 'solution' the cause must be understood. First of all, cellulite is a cosmetic problem, not a disease process. It isn't harmful, but it is a serious cosmetic concern for those people who want to feel better about their appearance. According to dermatology sites, causes may be genetic, hormonal, or vascular in nature and may be related to the septa configuration in the subdermal tissue. Fibrosis at the dermal-subcutaneous junction as well as decreased vascular and lymphatic circulation also may be causative factors. Consumers are also now, more inclined, to try modern technical solutions as technology has increased the available alternatives. Reports suggest that there is growing demand from consumers, especially those with disposable income, to look for non-herbal, non-invasive solutions to combat cellulite. "Non-invasive is a highly lucrative market that leads in terms of market value and growth rate during the forecast period. In non-invasive procedure ultrasound, radiofrequency technology, infrared light etc., are used to destroy the fat." Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Shockwave Medical, Inc. (NASDAQ: SWAV), Pfizer Inc. (NYSE: PFE), Sesen Bio, Inc. (NASDAQ: SESN), Boston Scientific Corporation (NYSE: BSX).

According to an industry publication: "the market for non-invasive treatment is expected to reach a value of over US$ 1,900 Mn by the end of 2028, growing at a robust CAGR of 8.0% during the forecast period. This is followed by minimally invasive treatment which secures the second position in the market, the market for minimally invasive treatment is expected to witness a growth rate of 7.8% during the projection period. Significant rise in the world's middle-class population over the next few years will result in increase in the purchasing power and discretionary spending, which are the key factors responsible for the stability and growth of (the) market worldwide."

Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS: Soliton, 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." Read this and more news for SOLY at: https://www.financialnewsmedia.com/news-soly/   

Other recent developments in the healthcare, biotech industries:

Boston Scientific Corporation (NYSE: BSX) has recently initiated the OPTION trial to compare safety and effectiveness of the next-generation WATCHMAN FLX™ left atrial appendage closure (LAAC) platform to first-line oral anticoagulants (OAC) – including direct oral anticoagulants (DOAC) and warfarin – for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) who undergo a cardiac ablation procedure.

Approximately 33 million patients worldwide have AF, a common heart rhythm disorder. In recent years, the number of U.S. patients who have undergone an in-hospital cardiac ablation procedure to prevent abnormal electrical signals from moving through the heart has grown tenfold. More than 50% of those patients become asymptomatic, making them less likely to adhere to current guidelines recommending the continuation of OAC post-procedure to reduce the risk of stroke. Stroke is five times more likely to occur in patients with AF than in someone with a normal heart rhythm.

Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced this month that the Company has appointed Keith D. Dawkins, M.D. as Chief Medical Officer. 

"Given the challenges associated with treating calcium throughout the cardiovascular system, joining Shockwave and contributing to the development of what will likely become the new standard of care for calcium modification was an attractive opportunity," said Dr. Dawkins. "The Company has made significant progress in the last year in both technology development and the successful application of IVL to a variety of clinical settings; I believe that the future potential of IVL has yet to be fully realized." 

Sesen Bio, Inc. (NASDAQ: SESN) a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, recently announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration (FDA) on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time.

In its Phase 2 and 3 clinical trials, Sesen Bio manufactured Vicinium in its facility in Winnipeg, Manitoba. Based on the Company's assessment of the global demand potential for Vicinium, Sesen Bio sought a commercial manufacturer with outstanding manufacturing quality, a proven track record with regulatory agencies, and the capacity to meet global demand forecasts.

Pfizer Inc. (NYSE: PFE) recently announced that a Phase 3 study to assess the use of LYRICA^® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo. Lyrica is not indicated in any population for the treatment of PGTC seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).

"Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalized tonic-clonic seizures," said Juan Ovalle, M.D., Global Chief Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. "These data contribute to our growing understanding of pediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research."

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