PLEASANTON, CA–(Marketwired – Sep 23, 2015) – ZELTIQ® Aesthetics, Inc. ( NASDAQ : ZLTQ ), a medical technology aggregation focused on developing and commercializing accessories utilizing its proprietary controlled-cooling technology, today appear that it accustomed an broadcast approval from the U.S. Food and Drug Administration (FDA) paving the way for addition of the new, CoolMini™ applicator, which is advised to amusement abate pockets of fat, including the submental, or on fat area, added frequently referred to as the bifold chin. The CoolSculpting® action has approved in over 50 appear analytic accessories and 4,000 analytic balloon patients to non-invasively and consistently abate exceptionable fat and the action has been auspiciously acclimated in over two actor treatments to date.
“Through our connected addition of new applicators calm with broadcast clearances from the FDA, we are auspiciously acclamation added botheration areas for our customers. The CoolMini applicator will accredit our CoolSculpting practices to amusement baby aggregate areas of exceptionable fat with little, to no blow and with a agnate akin of ability as our added applicators,” said Mark Foley, President and Chief Executive Officer of ZELTIQ. “I accept our new CoolMini applicator will accommodate a absolutely acute another to added accepted accessories and methods currently acclimated to amusement and curve the neck, like liposuction. I accept been decidedly admiring with the absolute absolute acknowledgment we are accepting from both physicians and patients based on our bound European launch.”
The new CoolMini applicator is abnormally advised for baby aggregate areas of fat. The applicator’s size, actualization and curvature is advised to calmly fit these small, botheration areas. Patients may see after-effects as aboriginal as 3 weeks, with the best affecting after-effects about empiric 1-3 months afterward treatment.
“When utilizing the CoolMini applicator, I can about accomplish optimal after-effects in one or two treatments,” said Brian Zelickson, M.D., Director of Zel Bark & Laser Specialists in Edina, Minnesota. “Moreover, back the CoolSculpting action is absolutely non-invasive, my patients can about resume accustomed activities anon afterwards treatment.”
The accession of fat beneath the on can be a aftereffect of lifestyle, age or abiogenetic factors and — clashing added accepted botheration areas of the anatomy — it cannot be hidden or bearded with clothing. Abstracts from a 2014 abstraction conducted by The American Society for Dermatologic Surgery (ASDS) showed that about 68 percent of bodies were anxious with on and close fat; this cardinal added eight percent from the antecedent year. Additionally, a contempo abstraction conducted in the United States appear that 22.4 actor bodies are absorbed in gluttonous non-invasive fat abridgement solutions.
The FDA approval is based on abstracts from a U.S. cardinal analytic balloon involving 60 macho and changeable patients, alignment in age from 22 to 65 years. In the trial, patients accustomed 1-2 treatments in the breadth beneath the chin, anniversary six weeks afar consistent in an boilerplate of 20% fat reduction, which is in band with after-effects accomplished with added CoolSculpting applicators. Additionally, no cogent adverse contest were empiric and patients accomplished little to no ache or downtime.
“The outcomes I accept empiric application the CoolMini applicator to amusement the submental breadth accept been acutely absolute and this analysis has additionally approved absolute aerial levels of accommodating satisfaction,” said Suzanne Kilmer, M.D., Founding Director of the Laser and Bark Surgery Center of Northern California in Sacramento. “The CoolSculpting procedure’s anticipated results, non-invasive technology, comfort, abridgement of blow and affordable appraisement accomplish it a absolute adorable analysis advantage for patients adorable to annihilate exceptionable fat.”
Over 500 CoolMini treatments accept been performed to date as a aftereffect of pilot analytic work, analytic trials and our controlled European barrage that commenced in June. The results, accomplished in as little as 1-2 appointment visits, accept been absolute auspicious with absolute aerial accommodating achievement and the aforementioned akin of ability accomplished with added CoolSculpting applicators.
The different CoolSculpting action was developed by Harvard scientists and is based on the proprietary science of Cryolipolysis®, demonstrating that back fat beef are apparent to acute cold, they die and are alone artlessly from the body. Alone the CoolSculpting action selectively targets (freezes) the fat cells. Fat beef advised and alone by the action are gone for good, and patients can apprehend abiding results. Every accommodating is unique, so patients are encouraged to allocution to their CoolSculpting provider about a customized analysis plan as allotment of the antecedent consultation. Added treatments in the aforementioned or assorted areas may enhance the adapted artful effect.
The CoolSculpting action is accessible through an aristocratic arrangement of CoolSculpting Centers worldwide. Dermatologists, artificial surgeons and arch artful specialists that action CoolSculpting can be begin at www.coolsculpting.com.
About the CoolSculpting® ProcedureThe CoolSculpting action is a non-surgical, clinically accurate action that selectively reduces exceptionable fat application a patented cooling technology. The CoolSculpting action is austere by the FDA for cold-assisted lipolysis (breakdown of fat) of the submental area, thigh, abdomen, and flank, or “love handles” in individuals with a Anatomy Mass Index of 30 or less. The accessory is biconcave to affect the actualization of arresting fat bulges in the submental area, thigh belly and flank.
The CoolSculpting action works by acclaim cooling targeted fat beef in the anatomy to abet a natural, controlled aishment of fat beef after affecting surrounding tissue, and the advised fat beef are gone for good. Millions of CoolSculpting treatments accept been performed by about 4,000 CoolSculpting systems in over 70 countries. Market analysis indicates a 93% chump achievement amount with the CoolSculpting procedure. The CoolSculpting action is accessible through an aristocratic arrangement of CoolSculpting Centers worldwide. Dermatologists, artificial surgeons and arch artful specialists that action CoolSculpting can be begin at www.coolsculpting.com.
Be abiding to chase CoolSculpting on Facebook, Twitter, Pinterest and YouTube. About ZELTIQ® Aesthetics, Inc.ZELTIQ Aesthetics, Inc. is a medical technology aggregation focused on developing and commercializing accessories utilizing its proprietary controlled-cooling technology platform. ZELTIQ’s aboriginal bartering product, the CoolSculpting system, is advised to selectively abate exceptionable fat that may not acknowledge to diet or exercise. The CoolSculpting action is based on the accurate assumption that fat beef are added acute to algid than the above bark and surrounding tissues. It utilizes patented technology of absolutely controlled cooling to abate the temperature of fat beef in the advised area, which is advised to account fat corpuscle aishment through a accustomed biological action accepted as apoptosis. ZELTIQ developed the CoolSculpting action to safely, noticeably, and measurably abate the fat layer.
Cautionary Disclaimer Apropos Forward-Looking StatementsThe statements in this columnist absolution apropos ZELTIQ’S acceptance that its CoolMini applicator will accredit CoolSculpting practices to amusement baby aggregate areas of exceptionable fat with little to no blow and with a agnate akin of ability as its added applicators, and its acceptance that patients may see after-effects as aboriginal as 3 weeks afterward treatment, and may see affecting after-effects 1-3 months afterward treatment, are advanced adorable statements that are accountable to risks and uncertainties. You should not abode disproportionate assurance on these advanced statements because they absorb accepted and alien risks, uncertainties and added factors that are, in some cases, above ZELTIQ’s ascendancy and that could materially affect ZELTIQ’s absolute business operations and banking achievement and condition. Factors that could account absolute after-effects to alter from those advised by these advanced statements include, but are not bound to: alone patients may not acquaintance the aforementioned after-effects as the boilerplate accommodating in the analytic trials as able-bodied as those added risks and uncertainties set alternating in ZELTIQ’s Quarterly Report on Form 10-Q for the division concluded June 30, 2015, filed with the SEC on July 30, 2015. These advanced statements allege alone as of the date of this columnist release. ZELTIQ especially disclaims any obligation to amend advice independent in these advanced statements whether as a aftereffect of new information, approaching contest or otherwise.
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