Zeltiq Aesthetics

ZeltiqCompany type| Subsidiary

|

Industry| Cryolipolysis
Founded| 2005
Founder| Mitchell Levinson
Headquarters|

Pleasanton, California

United States

Key people

| Mark J. Foley, president and chief executive officer
Products| CoolSculpting Procedure
Parent| Allergan plc
Website| zeltiq.com

Zeltiq Aesthetics is a subsidiary of AbbVie based in Pleasanton, California that markets and licenses devices used for cryolipolysis procedures. The company was founded in 2005 and raised $75 million in funding before going public in 2011. It was acquired by Allergan in February 2017 for $2.48 billion.[1][2][3] Which was then acquired by AbbVie in 2020 for $63 billion.[4]

## History

[edit]

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.[5][6] The company changed its name to Zeltiq in July 2007.[7]

The company developed a medical device to remove fat using a process called cryolipolysis, which it branded as "CoolSculpting".[8] 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.[9] For the clinics that use it, there is a high capital investment, and a room is tied up for a relatively long time.[9] 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.[10]

Cryolipolysis was invented by Rox Anderson and colleagues[11] and Juniper Medical exclusively licensed patent filings on the invention from Massachusetts General Hospital when Juniper was founded.[6] An early prototype was created to test the method on pigs,[12] and preliminary results from a clinical trial were reported in 2009.[11]

In 2009 Gordie Nye was appointed CEO, replacing Levinson, who remained on the board.[13][14]

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.[15][16] 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".[17][18]

The company made money from selling the machines, and also charged doctors for each procedure they did with the machine.[5] Because the procedure was elective surgery, people paid out of pocket for it.[17] By the end of 2010, the company had raised $75 million in financing over four rounds of funding.[19]

The device received FDA clearance to be marketed for removing love handle fat from people's sides in September 2010[20] and from the stomach in 2012.[20] It has also been approved by Health Canada and the European Union.[21] By late 2010 CoolSculpting had been introduced as a body-sculpting procedure in Europe, Asia and Canada.[22] By 2011, Zeltiq was approved to market the procedure in 46 countries.[23]

CoolSculpting became popular in the United States around 2011.[20] 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.[5][23] Zeltiq filed for an initial public offering later that year.[5][23] The IPO raised $91 million.[24]

By January 2012, there had been 150,000 CoolSculpting treatments.[25] 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.[26][27]

As of 2014 the company's device led the market for cryolipolysis.[28][9][29][30]

In February 2017 Zeltiq was purchased by Allergan for $2.48 billion.[2][3]

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.[31]

## CoolSculpting side effects

[edit]

Linda Evangelista claims 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.[32] Other studies, however, indicate that side effects are common on a per-patient basis, since a typical patient receives multiple treatments. [33]

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.[34]

## References

[edit]

1. ^ "Allergan Will Buy Zeltiq for $2.48 Billion". Fortune. Retrieved 2023-12-14.
2. ^ a b "Allergan to Acquire ZELTIQ, Best-in-Class Company in Fast-Growing Body Contouring Segment, for $2.47 Billion". Retrieved 2017-11-01.
3. ^ a b "Meet one of the most important medical entrepreneurs you've never heard of". BostonGlobe.com. Retrieved 2017-11-01.
4. ^ "Three factors that drove the transformational integration of AbbVie, Allergan". abbvie.com. November 30, 2022. Retrieved December 14, 2023.
5. ^ a b c d Avalos, George (July 13, 2014). "Pleasanton-based Zeltiq files for $115 million IPO". San Jose Mercury News. Archived from the original on March 4, 2016.
6. ^ a b "Zeltiq Amendment No. 8 to Form S-1". Zeltiq via SEC Edgar. 18 October 2011.
7. ^ ZELTIQ Aesthetics, Inc.; Yahoo Profile, Yahoo, retrieved January 28, 2015
8. ^ "CoolSculpting". February 4, 2021.
9. ^ a b c Kabir Sarbana; Vijay K. Garg (July 1, 2014). Lasers in Dermatological Practice. JP Medical Ltd. p. 356\. ISBN 978-93-5152-300-0.
10. ^ H. Ray Jalian & Mathew M. Avram (March 2013). "Cryolipolysis: a historical perspective and current clinical practice". Seminars in Cutaneous Medicine and Surgery. 32 (1): 31–34\. PMID 24049927.
11. ^ a b Jancin, Bruce (April 2009). "Cryolipolysis on Track to Become First Cool Way to Remove Cellulite". Skin & Allergy News. Vol. 40\. p. 11.
12. ^ Mathew Avram (March 9, 2015). Fat Removal: Invasive and Non-invasive Body Contouring. John Wiley & Sons. pp. 102ff. ISBN 978-1-4443-3428-9.
13. ^ Brown, Steven (September 29, 2009). "Zeltiq Aesthetics changes CEOs". San Francisco Business Times. Retrieved January 28, 2015.
14. ^ "Diary:Movers and Shakers". Chemistry & Industry. November 9, 2009.
15. ^ "DEN090002, K080521: Device Classification under Section 513(f)(2)(de novo)". FDA. August 24, 2010. Archived from the original on January 18, 2020. Retrieved 9 June 2018.
16. ^ Weintraub, Karen (March 29, 2010). "Who might be a candidate?". The Boston Globe.
17. ^ a b Louis, Catherine (February 4, 2010). "Zap or Chill? Targeting Fat Without Surgery". The New York Times. p. E.1. Retrieved January 28, 2015.
18. ^ Louis, Catherine (June 30, 2010). "Beauty Spots". The New York Times. Retrieved January 28, 2015.
19. ^ Martino, Maureen (June 3, 2010). "Zeltiq raises $25M for fat-reduction tech". FierceMedicalDevices. Retrieved September 28, 2014.
20. ^ a b c Stevens, W. G.; Pietrzak, L. K.; Spring, M. A. (2013). "Broad Overview of a Clinical and Commercial Experience With CoolSculpting". Aesthetic Surgery Journal. 33 (6): 835–846\. doi:10.1177/1090820X13494757. ISSN 1090-820X. PMID 23858510.
21. ^ Boey, Gerald E.; Wasilenchuk, Jennifer L. (2014). "Enhanced clinical outcome with manual massage following cryolipolysis treatment: A 4-month study of safety and efficacy". Lasers in Surgery and Medicine. 46 (1): 20–26\. doi:10.1002/lsm.22209. ISSN 0196-8092. PMC 4265298. PMID 24338439.
22. ^ Lee, Jenny (August 23, 2010). "Lose those love handles". The Vancouver Sun. Retrieved September 28, 2014.
23. ^ a b c Cowan, Lynn (October 10, 2011). "Zeltiq Is Next Week's IPO". Wall Street Journal. Retrieved January 28, 2015.
24. ^ Spears, Lee (October 19, 2011). "Zeltiq Aesthetics Raises $91 Million in Initial Public Offering". Bloomberg. Retrieved September 28, 2014.
25. ^ Uken, Cindy (January 11, 2012). "Non-invasive procedure popular method to get rid of unwanted 'love handles'". The Billings Gazette. pp. C1. Retrieved September 28, 2014.
26. ^ Stahl, Stephanie (May 27, 2014). "Health: Procedure Now Approved To Melt Fat Off Thighs". CBS News. Retrieved October 11, 2014.
27. ^ Leuty, Ron (April 14, 2014). "Hot on 'cool' thighs, Zeltiq wins FDA clearance for fat-chilling procedure". BizJournals. Retrieved October 7, 2014.
28. ^ Coppola, Gabrielle (September 29, 2014). "Manhattan Analysts Lose Belly Fat". Bloomberg. Retrieved September 28, 2014.
29. ^ Fulmer, Melinda (August 16, 2013). "With cosmetic treatments, more men enlist in battle of the bulges". Los Angeles Times. Archived from the original on October 12, 2014. Retrieved October 11, 2014.
30. ^ Woolston, Chris (November 8, 2010). "Freezing fat might shrink it". Los Angeles Times. Retrieved September 26, 2014.
31. ^ "Department of Health & Human Services" (PDF). November 16, 2016. Archived from the original (PDF) on April 12, 2019.
32. ^ "Why Linda Evangelista Waited to Tell Son About Fat-Freezing Trauma: 'He Shouldn't Have to Support Me'". People. February 17, 2022.
33. ^ "A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement". New York Times. April 16, 2023.
34. ^ "How are the words 'rare' and 'common' defined for side effects? | Q and A | HIV i-Base". i-base.info. Retrieved 2022-08-19.