Palm Beach, FL – August 14, 2019 – People with cellulite are not as happy as those without cellulite. That may seem to be self-evident, but now it is supported by studies. One such report, a study published by Surgical and Cosmetic Dermatology, found that regarding the psychology of patients with cellulite, nearly 50% of the study population reported dissatisfaction regarding their appearance while nearly 78% reported the need to seek treatment. Women are more susceptible to suffer from cellulite than men. Cellulite is mostly noticeable on the thighs and buttocks, affecting more than 90% of post-adolescent women, although men also can get cellulite. Another report in the Asian Hospital & Healthcare Management (AHH), projected that the Global Cellulite Treatment market revenue is expected to expand at impressive CAGR of 7.7% over the forecast period to reach value of US$ 5,227.7 million by 2028. There are several factors related to cellulite, the major ones include hormonal factors, genetics, diet, sedentary lifestyle, medications, and certain health conditions. At present, according to Grandview Research, the market is segmented into minimally invasive, non-invasive, and topical procedures. The non-invasive segment dominated the market in 2018 and is projected to expand further at the highest CAGR over the forecast through 2026. Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), Amarin Corporation plc (NASDAQ: AMRN), Eli Lilly and Company (NYSE: LLY), Gilead Sciences, Inc. (NASDAQ: GILD).
The AAH article continued adding the following markets observations: “In terms of revenue, Non-invasive treatment procedure segment is projected to remain the dominant it is expected to gain traction due to high demand from specialized dermatology clinics and hospitals. Soft cellulite segment is expected to gain significant market share over the forecast period due to high number of obesity population. Among all end users, Specialized dermatology clinics dominated the global market by 50.1% share in 2018. North America is considered to be a lucrative marketplace for the global cellulite treatment market and estimated to retain over 39.8% (2018) of the global market share during 2018–2028.”
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 that the company has treated the first patients in its pivotal cellulite trial.
Dr. Chris Capelli, President, CEO and co-founder of Soliton, commented, “Patient treatments have now begun at the Chicago site.” He continued, “It is incredibly exciting to have arrived at this point of the study. A tremendous amount of work goes into preparing for a study of this magnitude and treating the first patients is quite rewarding.”
Cellulite affects up to 90% of women and over a billion dollars per year is spent on treatment in the U.S. Results from our initial proof of concept clinical trial suggest the potential for a new approach to treating cellulite. In the proof of concept trial, the Soliton Rapid Acoustic Pulse (“RAP”) device was applied to the surface of the patients’ skin for a single 20-minute, non-invasive treatment. The treatments required no anesthesia, caused no bruising, swelling or infection, and were evaluated by the trial participants as a “0” on a pain scale of 0-10 in 97% of the treatments. None of the patients experienced any post-treatment downtime. The Soliton device used in this trial has not been reviewed or cleared by the FDA for marketing and, accordingly, none of the information in this press release is intended to promote the sale or use of the device. The device is investigational and is not available for sale in the United States. Read this and more news for SOLY at: https://financialnewsmedia.com/news-soly/
Recent developments in the healthcare, biotech industries:
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) recently reported updated data from its ongoing Phase 1 clinical study of ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with second-line through fourth-line plus gastrointestinal stromal tumors (GIST).
In a separate press release issued today, Deciphera announced positive top-line results from its INVICTUS pivotal Phase 3 clinical study supporting a potential new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib. In addition to the INVICTUS data, Deciphera will also be submitting in its NDA supportive data from the ongoing Phase 1 clinical study, which will include the updated data from GIST patients at doses of >100mg of ripretinib.
Amarin Corporation plc (NASDAQ: AMRN) recently announced that it received notice today from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study. Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due to scheduling constraints for such a meeting.
“We look forward to the planned advisory committee meeting as an opportunity to highlight the landmark REDUCE-IT data and the important role we expect Vascepa should play in the treatment of cardiovascular disease in appropriate patients,” stated John Thero, president and chief executive officer of Amarin. “We plan to continue to work collaboratively with the FDA on the pending REDUCE-IT sNDA while we prepare for a robust launch of REDUCE-IT data assuming approval of Vascepa before the end of 2019 for a cardiovascular risk reduction indication based on REDUCE-IT.”
Eli Lilly and Company (NYSE: LLY) recently announced Taltz® met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus TREMFYA® (guselkumab) in people living with moderate to severe plaque psoriasis (PsO). The IXORA-R trial is the first completed head-to-head (H2H) trial between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint.
At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100. In addition, Taltz met all major secondary endpoints up to week 12, which include superiority over TREMFYA in the proportion of patients achieving PASI 75 at Week 2, PASI 90 at Weeks 4 and 8, PASI 100 at Weeks 4 and 8, static Physician’s Global Assessment (sPGA) 0 at Week 12 and PASI 50 at Week 1. Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the China National Medical Products Administration (NMPA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone and is the smallest INSTI-based triple-therapy STR available. In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
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