OmniMed Coolsculpting Original device

An open letter from ZELTIQ* - To all those interested in fat reduction with CoolSculpting

We receive numerous inquiries about what technology is used in the CoolSculpting system and how CoolSculpting technology differs from other technologies on the market that claim to be "like CoolSculpting," including LipoCryo, KryoKontur, Coolplas, Lipoglaze, Lipo Freeze, Cooltech and CoolContour. These devices are marketed under many similar-sounding names, but they all have one thing in common: each is marketed under a different marketing campaign designed to convey to physicians that these devices are the equivalent of true CoolSculpting, and to convince patients that they are receiving a treatment that is no different from true CoolSculpting treatments. The purpose of this letter is to explain and clarify the process of fat reduction using the proprietary technology known as Cryolipolysis with some facts.

The most common false statements:

All devices feature the Cryolipolysis procedure for reducing fat cells through cold

This is not true. Cryolipolysis and CoolSculpting are some of the registered trademarks of ZELTIQ Aesthetics, Inc. and refer in part to services related to the proprietary, patented CoolSculpting technology. Cryolipolysis technology is a scientifically based, clinically proven procedure that removes fat cells in the body through a completely natural process called apoptosis. Only CoolSculpting by ZELTIQ can claim to perform cryolipolysis treatments, as ZELTIQ is the sole licensee and manufacturer of this specific technology and has trademarked the treatments under the brand name Cryolipolysis. The nearly thirty clinical peer-reviewed articles demonstrating the safety, efficacy, high patient satisfaction and acceptance of the cryolipolysis procedure all relate to the CoolSculpting technology. As far as we are aware, none of the competing "fat freezing" systems have a single authoritative source to support their safety or efficacy.

Please use our online appointment bookingto make an appointment for a CoolSculpting treatment in Eisenstadt or Klagenfurt. You are also welcome to call the practice directly to make an appointment: +43 676 4777829 (Mon-Fri from 8h-18h)

All fat freezers are approved by the FDA

This is not true. Only CoolSculpting from ZELTIQ is approved (U.S. Food and Drug Administration 510 (k) No. K090094). Competitors' systems claim that because CoolSculpting is FDA approved and their devices are based on the technology of the CoolSculpting system, they are therefore also FDA approved. This claim is false. The U.S. Food & Drug Administration does not approve the marketing authorization of a technology, it approves the marketing authorization of devices. To date, the FDA has only approved CoolSculpting. In fact, the CoolSculpting system is the only system that has both FDA approval and the CE mark for medical devices. All devices that are claimed to work exactly like CoolSculpting treatments cannot claim ZELTIQ FDA approval without going through the FDA approval process themselves.

The CoolSculpting technology is not protected by patents

Yes, it is. The patents on which the CoolSculpting system technology is based and under which it is marketed have been granted to Massachusetts General Hospital (MHG), which has licensed them exclusively to ZELTIQ. In addition, ZELTIQ holds a number of patents covering various aspects of the CoolSculpting technology. ZELTIQ's patent portfolio protects our technology in the U.S. and in countries around the world. Unscrupulous companies may claim that CoolSculpting technology is not protected by patents; however, such a claim is simply untrue. We invite you to review our public filings with the U.S. Securities and Exchange Commission (SEC) for more details about our patent portfolio.

Despite ZELTIQ's strong intellectual property portfolio, many competitors who flood Europe with imitations of our devices continue to make false claims. But when it comes to the real facts, the CoolSculpting system clearly stands out from the copycat products. Here are the reasons why:

  • The copycat products cannot be said to use Freeze Detect technology. The CoolSculpting system is equipped with a series of sensors that detect potential adverse effects, including freezing of the outer (epidermal) and dermal (dermal) layers of tissue. Without the Freeze Detect technology, injuries are more likely to occur. We have received reports of injuries from copycat devices, in the most serious cases causing severe burns that have required surgical removal of the affected areas of skin.
  • The majority of imitation devices cannot be claimed to have a CE marking as a class IIa medical device.
  • You cannot claim that more than 800,000 patient treatments have been carried out with these devices, and the number of treatments is constantly increasing.
  • They cannot claim to have been produced by a company with almost 300 employees and a market capitalization of over half a billion dollars.

Please use our online appointment bookingto make an appointment for a CoolSculpting treatment in Eisenstadt or Klagenfurt . You are also welcome to call the practice directly to make an appointment: +43 676 4777829 (Mon-Fri from 8h-18h)

No, only ZELTIQ Aesthetics, the manufacturer of the CoolSculpting system, can make this statement.

Knowledge is power. But this knowledge only has value if you act accordingly. When deciding which fat reduction system to buy or which one to be treated with, you should not take everything you are told at face value. If you are offered a device with Cryolipolysis technology, ask for proof that it is an authentic ZELTIQ CoolSculpting system. Ask for the appropriate evidence if you are told that the device is "FDA approved". If you are told that the use of a device is supported by clinical studies, ask to see the relevant documents (not just any marketing brochures that may be produced by the company's marketing departments, but peer-reviewed articles published in reputable medical journals). If you do this, the choice is easy.

CoolSculpting from ZELTIQ - ask for it directly.

We welcome the opportunity to set the record straight. If you would like additional information, please do not hesitate to contact us at intlsupport@zeltiq.com.

Keith J. Sullivan, Senior Vice President, Global Sales & Marketing
James P. Bucher, Vice President, Europe, Middle East, Africa

*This is a copy of the original letter.

CoolSculpting at OmniMed

OmniMed has four CoolSculpting systems and is the largest CoolSculpting practice in Austria. We work exclusively with the approved system from the original manufacturer ZELTIQ, which is the only cryolipolysis procedure approved by the US FDA. If you have any further questions about this effective method of fat reduction, please take a look at our Cryolipolysis and CoolSculpting FAQs.

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