Zeltiq Aesthetics is a subsidiary of

AbbVie AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories. History On October 19, 2011, Abbott Laboratories announced its plan to separate into two publicly traded compan ...

based in

Pleasanton, California Pleasanton is a city in Alameda County, California, United States. Located in the Amador Valley, it is a suburb in the East Bay region of the San Francisco Bay Area. The population was 79,871 at the 2020 United States Census, 2020 census. In 200 ...

that markets and licenses devices used for

cryolipolysis Fat removal procedures are used mostly in Plastic surgery#Cosmetic surgery procedures, cosmetic surgery with the intention of removing unwanted adipose tissue. The procedure may be invasive, as with liposuction, or noninvasive using laser therapy, ...

procedures. The company was founded in 2005 and raised $75 million in funding before going public in 2011. It was acquired by

Allergan Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. ...

in February 2017 for $2.48 billion. Which was then acquired by AbbVie in 2020 for $63 billion.

History

Zeltiq was founded in 2005 as Juniper Medical, Inc., by Mitch Levinson, who had previously led Thermage, a company that sold devices for radio frequency skin tightening. The company changed its name to Zeltiq in July 2007. The company developed a

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

to remove fat using a process called

, which it branded as "CoolSculpting". The device works by pulling a piece of flesh between two paddles, which cool it to below freezing and hold the temperature there for a half hour or so. Afterwards the flesh is frozen and numb; the numbness persists for two to three months. For the clinics that use it, there is a high capital investment, and a room is tied up for a relatively long time. It is intended for body contouring and not general weight loss. As of 2013, clinical trials have found that Cryolipolysis is moderately effective and has mostly mild and temporary side effects. Cryolipolysis was invented by Rox Anderson and colleagues and Juniper Medical exclusively licensed patent filings on the invention from

Massachusetts General Hospital Massachusetts General Hospital (Mass General or MGH) is the original and largest teaching hospital of Harvard Medical School located in the West End neighborhood of Boston, Massachusetts. It is the third oldest general hospital in the United Stat ...

when Juniper was founded. An early prototype was created to test the method on pigs, and preliminary results from a clinical trial were reported in 2009. In 2009 Gordie Nye was appointed

CEO A chief executive officer (CEO), also known as a central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especially ...

, replacing Levinson, who remained on the board. Zeltiq brought the device to market first for use in numbing the skin prior to dermatology procedures being done; Zeltiq received FDA clearance to market it for this purpose under the de novo pathway in 2010. While the company did not market its device for removing fat at that time, doctors on its scientific board were talking about that use at scientific meetings and on TV news, and doctors started using it off-label for "body-sculpting". The company made money from selling the machines, and also charged doctors for each procedure they did with the machine. Because the procedure was

elective surgery Elective surgery or elective procedure (from the la, eligere, meaning to choose) is surgery that is scheduled in advance because it does not involve a medical emergency. Semi-elective surgery is a surgery that must be done to preserve the patien ...

, people paid out of pocket for it. By the end of 2010, the company had raised $75 million in financing over four rounds of funding. The device received FDA clearance to be marketed for removing love handle fat from people's sides in September 2010 and from the stomach in 2012. It has also been approved by

Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...

and the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...

. By late 2010 CoolSculpting had been introduced as a body-sculpting procedure in

Europe Europe is a large peninsula conventionally considered a continent in its own right because of its great physical size and the weight of its history and traditions. Europe is also considered a Continent#Subcontinents, subcontinent of Eurasia ...

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and

Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...

. By 2011, Zeltiq was approved to market the procedure in 46 countries. CoolSculpting became popular in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

around 2011. In the first half of that year, Zeltiq's revenues grew four-fold to $31.6 million, though it was still operating at a small loss. Zeltiq filed for an

initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investment ...

later that year. The IPO raised $91 million. By January 2012, there had been 150,000 CoolSculpting treatments. In 2014, Zeltiq introduced a new model of the CoolSculpting device obviating the suction cup and was cleared by the FDA for use on thighs. As of 2014 the company's device led the market for cryolipolysis. In February 2017 Zeltiq was purchased by

for $2.48 billion. As of June 2020, CoolSculpting has been cleared to treat the abdomen, love handles (flanks) upper arm, back fat, bra fat, banana roll, submental area, and thighs.

CoolSculpting side effects

Linda Evangelista Linda Evangelista (; born May 10, 1965) is a Canadian fashion model. She is regarded as one of the most accomplished and influential models of all time, and has been featured on over 700 magazine covers. Evangelista is primarily known for being ...

claims Claim may refer to: * Claim (legal) * Claim of Right Act 1689 * Claims-based identity * Claim (philosophy) * Land claim * A ''main contention'', see conclusion of law * Patent claim * The assertion of a proposition; see Douglas N. Walton * A righ ...

CoolSculpting procedure she underwent resulted in an uncommon side effect paradoxical adipose hyperplasia, experienced by under 1% of the patients, and causing fatty tissue to thicken and expand, the outcome contrary to the expected from the procedure. Other studies, however, indicate that side effects are common on a per-patient basis, since a typical patient receives multiple treatments. Side effects under 1% (1 on 100) are called: "uncommon" by EMA, while they need to be under 1 on 1,000, to be called: "rare" and under 1 on 10,000, to be called: "very rare". If the side effect equals 1%, EMA scale calls it a "common" side effect.

References

{{reflist, 2 Medical technology companies of the United States American companies established in 2005 Companies formerly listed on the Nasdaq Companies based in Pleasanton, California Technology companies established in 2005