Biotech Brief: Report Reveals Growing Global Demand for Non-Invasive Cellulite Treatment Options

PALM BEACH, Florida, April 15, 2019 /PRNewswire/ -- 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. Consumers are also now, more inclined, to try modern technical solutions as technology has increased the available alternatives. The report, from Future Market Insights, a provider of market intelligence, says: "Cellulite treatment is a rapidly growing industry that has marked its presence with the rising obese population. The issue is more prevalent in women, due to their body structure and different areas where fat or wax easily gets deposited. Mainly, the treatment market is categorized into non-invasive, minimally invasive and topical treatment. 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), Amarin Corporation plc (NASDAQ: AMRN), Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), Pfizer Inc. (NYSE: PFE), Medtronic plc (NYSE: MDT).

The market for non-invasive treatment is expected to reach a value of over US$ 1,900 Millon 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."

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 Dr. Elizabeth Tanzi of Capital Laser and Skin Care will present preliminary data from its completed cellulite clinical trial at the SCALE (Symposium for Cosmetic Advances and Laser Education) conference in Nashville, Tennessee to be held May 9-11, 2019.

The proof of concept study, conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr. Tanzi, was designed to evaluate the safety and efficacy of Soliton's acoustic pulse device for the reduction of cellulite. The data presented will reflect results from a single acoustic pulse treatment, operating at a higher power level than the Company's RAP device intended for tattoo removal, at the 12-week timepoint. Dr. Tanzi will also review preclinical data that appears to support what the Company believes may be a new method for treating cellulite.

"There has been a lot of anticipation surrounding the potential for our technology as a stand-alone treatment for cellulite," commented Dr. Chris Capelli, President and CEO of Soliton, "especially considering the preclinical data suggesting that our unique acoustic pulses may be capable of achieving results only thought possible with invasive therapies. Considering that our technology is non-invasive and has been well tolerated by our trial participants, our goal has been to deliver clinically significant results without patient discomfort or downtime. We believe the upcoming presentation by Dr. Tanzi will be an important indicator of our progress and potential."  Read this and more news for SOLY at:  https://www.financialnewsmedia.com/news-soly/   

Other recent developments in the healthcare, biotech industries:

Amarin Corporation plc (NASDAQ: AMRN) a pharmaceutical company focused on improving cardiovascular health, recently announced that its licensee in Canada, HLS Therapeutics Inc. (TSX:HLS), has received formal confirmation from Health Canada that the Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission ("NDS") for Vascepa® (icosapent ethyl) capsules.  HLS Therapeutics anticipates filing the NDS in April 2019 seeking approval to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors.

Priority review status may be granted to regulatory filings in Canada for new treatments that potentially address serious, life-threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment. Under priority review the performance target for the screening and review of the original submission is 215 calendar days versus 355 days for a standard review. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product is ultimately approved by Health Canada.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biotechnology company focused on advancing innovative therapies for neurological and neuropsychiatric diseases, recently announced that it enrolled the first patient in a Phase 2/3, double-blind, randomized, placebo-controlled, dose-ranging trial of intranasally administered BHV-3500 for the acute treatment of migraine. BHV-3500 is a novel, structurally distinct, third-generation calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Biohaven.

In the trial, three doses of BHV-3500 (5, 10 and 20 mg) are being compared to placebo in the treatment of a migraine attack. With a planned enrollment of approximately 400 randomized subjects per treatment arm, the trial is powered to provide proof of efficacy on the regulatory endpoints of pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours post-dose. The trial is also designed to detect early onset of other clinical measures that are of great importance to patients, including pain relief and ability to return to normal functioning.

Vlad Coric, M.D., CEO of Biohaven, commented, "This is the first late-stage clinical trial designed to assess the efficacy of an intranasally administered CGRP receptor antagonist in the acute treatment of migraine.

Pfizer Inc. (NYSE: PFE) recently announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for IBRANCE^®(palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database.

Medtronic plc (NYSE: MDT) recently announced data showing promising economic outcomes for the Medtronic HeartWare(TM) HVAD(TM) System after analyzing multiple clinical studies. The economic analyses of the HVAD System - a left ventricular assist device (LVAD) that helps a failing heart pump and increases the amount of blood that circulates through the body - were presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions.

The first analysis showed that heart failure patients who received the HVAD System through a less-invasive thoracotomy procedure in the LATERAL study incurred lower hospitalization and medical supply costs than patients who received a ventricular assist device (VAD) through the traditional sternotomy implant procedure. The average total cost per patient in the thoracotomy (LATERAL) study was $204,107 compared to $260,492 for (non-study) traditional median sternotomy VAD cases (p<0.001).

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