To anyone interested in fat reduction via Coolsculpting

We receive numerous inquiries regarding what technology the CoolScultping system uses and how CoolSculpting’s technology differs from technologies that are marketed and promoted as being „just like CoolSculpting,“ including, among others, LipoCryo, KryoKontur, Coolplas, Lipoglaze, Lipo Freeze, Cooltech and CoolContour. These devices go by many similar-sounding names, but they all have one thing in common: each has designed its advertising to mislead health care professionals into believing that their device provides, and to convince patients that they are receiving, treatments indistinguishable from genuine CoolSculpting treatments. This letter explains and clarifies the facts on fat reduction through the proprietary technology known as Cryolipolysis.

Here are the most commonly asserted falsehoods:

All fat freezing devices feature cryolipolyses technology

They do not. Cryolipolysis and CoolSculpting, among otherse, are 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 modality that eliminates fat cells in the body through an entirely natural process known as apoptosis. Only CoolSculpting by ZELTIQ can be said to perform Cryolipolysis treatments , as ZELTIQ is the sole licensee and manufacturer of that specific technology and has branded the treatments as Cryolipolysis. The nearly thirty peer-reviewed clinical articles that attest to the safety, efficacy and high levels of patient satisfaction and acceptance of Cryolipolysis procedures all do so with CoolSculpting technology. To our knowledge, none of the competing „fat freezing“ systems can cite even a single authoritative proof source of their safety or effectiveness.

All fat freezing devices are FDA-approved

They are not. Only CoolSculpting by ZELTIQ is (U.S. Food and Drug Administration 510 (k)-Nr. K090094). Competitive systems claim that because CoolSculpting is FDA-cleared and their devices are based on the CoolSculpting system’s technology, their systems are therefore FDA-cleared. The claim is false. The U.S. Food and Drug Administration does not clear for marketing a technology, it clears for marketing devices. To date, the FDA has cleared only CoolSculpting. In fact, the CoolSculpting system is the only one to have both FDA clearance and a medical CE mark. A device claiming to perform identically to CoolSculpting’s treatments cannot piggy back on ZELTIQ’s FDA clearance without going through the FDA clearance process itself.

Coolsculpting's technology is not protected by patents

It is. The patents upon which the CoolSculpting system’ s technology is based and marketed are issued to Massachusetts General Hospital (MHG), which has licensed them to ZELTIQ, exclusively. In addition ZELTIQ holds a number of patents that cover various aspects of the CoolSculpting technology. ZELTIQ’s patent portfolio provides protection for our technology both in the United States and all over the world. Unscrupulous companies may claim that the CoolSculpting technology is not covered by patents; however , such an assertion is simply untrue. We invite you to review our publicly-filed documents with the U.S. Securities and Exchange Commission (SEC) for more details on our patent portfolio.

Despite ZELTIQ’s strong intellectual property portfolio, numerous competitors that sell imitation devices that have flooded Europe continue to make false claims. But when it comes down to the true facts, the CoolSculpting system rises above the copycats. Here’s why:

  • Imitators cannot claim to have Freeze Detect technology. The CoolSculpting system contains an array of sensors that detect potential adverse events including the freezing of epidermal and dermal tissue. Without Freeze Detect technoloy, skin freezing or other injury is more likely to occur. We have received reports of injuries from imitation devices that in the most serious instances include severe burns that have required surgical excision of the affected skin.
  • The majority of imitators cannot claim to have a CE marked Class IIa medical device.
  • They cannot claim to have sold nearly two thousand systems worldwide.
  • They cannot claim to have provided more than 800,000 patient treatments, and counting.
  • They cannot claim to be a company of almost 300 employees with a market capitalization of over one-half billion dollars.

No, only Zeltiq Aesthetics, the creator of the CoolSculpting System, can make these claims.

Knowledge is power. But it can only be powerful if acted upon. When deciding which fat reduction system to purchase, or which to be treated on, do not accept anything at face value. If told that you are being offered a device with Cryolipolysis technology, ask for proof that it is an authentic ZELTIQ CoolSculpting System. If told that a system is „FDA approved“ ask for proove.
If told that an instrument is backed by clinical research, ask for proof ( and not some white paper that can be easily generated by any company’s in-house marketing departement but peer-reviewed articles that have been published in reputable medical journals). If you do that, the choice will be clear.

CoolSculpting by ZELTIQ – Ask for it by name.

Accept no substitutes.

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

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

*This document is a true copy of the original letter.