Zeltiq Aesthetics Submits IPO Prospectus Following FDA, CE, and NMPA Certifications and Acquisitions by Allergan and AbbVie

# Medical Aesthetic Liposuction Originated from Surgical ProceduresIn 1928, a French surgeon used a uterine curette, originally designed for gynecological dilation and curettage (D&C), to scrape away subcutaneous fat from a patient’s legs. This procedure resulted in significant tissue trauma, ultimately necessitating the amputation of both of the patient’s legs.

Modern liposuction, in the true sense of the term, emerged in 1976, when an American father-and-son duo invented a blunt-tipped, hollow cannula that could be connected to a suction device to aspirate excised fat. As this technique involved no infusion of fluids into the patient’s body prior to fat removal, it was termed “dry liposuction.”Disadvantages of Dry LiposuctionThe drawbacks of dry liposuction are evident, as it involves significant blood loss during the procedure. For every 1,000 mL of fat aspirated, blood loss can reach 30%. Therefore, the volume of fat removed in a single session should not exceed 2,000 mL.. Calculated at a fat density of 0.9 g/mL, 1,000 mL of fat weighs approximately 900 grams, or 1.8 jin.

By the 1980s, liposuction underwent a revolutionary change. Two American dermatologists introduced the injection of tumescent fluid—diluted lidocaine (a local anesthetic) combined with epinephrine—during the procedure.This improvement reduced blood loss from the original 30% to less than 1%.。

With continuous technological advancements, fat reduction technologies have gradually transitioned from the invasive era, represented by liposuction surgery, to a new era of non-invasive lipolysis, characterized by energy-based devices such as cryolipolysis, ultrasound, radiofrequency, and laser. Driven by the booming “beauty economy,” liposuction has evolved from mere “weight loss” to comprehensive “body contouring.” In response to the growing and increasingly refined market demand, numerous companies have entered the field.

As an active cryolipolysis manufacturer in China, Zeltiq Aesthetics (hereinafter referred to as “Zeltiq”), founded in 2005, launched its CoolSculpting fat-reduction device more than a decade ago.CoolSculpting is currently the only cryolipolysis device worldwide to have received triple certification from the U.S. FDA, China's NMPA, and the EU CE.。

Adipocytes in the human subcutaneous tissue are rich in triglycerides and particularly sensitive to low temperatures. At specific low temperatures (0–10°C), adipocytes become inactive, while adjacent tissue cells, being less sensitive to cold, remain unaffected.Cryolipolysis leverages the cold sensitivity of adipocytes by employing a non-invasive cryo-energy delivery device to administer precisely controlled cooling to targeted areas, thereby selectively eliminating fat cells in those specific regions.。

Such is the principle behind the CoolSculpting cryolipolysis device. The CoolSculpting equipment widely used in China consists of a main unit, one handpiece, three vacuum applicators (commonly referred to as treatment heads or probes), and other accessories.

The treatment applicator contacts the treatment area, draws tissue into the suction cup, and delivers cooling energy to the target site. Meanwhile, temperature sensors embedded within the cooling plates on both sides of the applicator monitor the temperature of the treatment area in real time via a patented safety protection system, adjusting the degree of cooling to maintain the targeted tissue at a specific constant temperature (4°C). Additionally, a thermally conductive gel pad is placed between the applicator and the skin to provide isolation and serve as a secondary safety measure.

CoolSculpting features three distinct applicators—Cool Core, Cool Curve, and Cool Max—designed for different body areas.

(1) Cool Core is applied to the periumbilical region, targeting small fat deposits in the upper and lower abdomen. Typically, four treatment points are administered around the umbilicus to eliminate stubborn subcutaneous fat in the lower abdominal area.

(2) Cool Curve™ is designed for waist contouring and can be used to address stubborn fat deposits in the flanks and along the bra line.

(3) Cool Max has the largest treatment area, which is 2.5 times that of the other two treatment probes. It is used for the upper or lower abdomen, such as male beer bellies and female postpartum lower abdominal bulges.

CoolSculpting features short treatment times, is painless and non-invasive, requires minimal downtime, and prevents rebound. It is indicated for reducing subcutaneous fat in the abdomen and flanks where the fat layer exceeds 1 cm in thickness and can accommodate negative pressure suction. As a medical-grade device, studies indicate that CoolSculpting is not suitable for individuals with muscular body types, severe skin laxity, poor health conditions, or visceral obesity.

According to the official research report by Zeltiq,CoolSculpting can reduce up to 27% of fat in the treated area per session.。

Building on CoolSculpting, Zeltiq improved the treatment temperature and shape of the cooling panels to develop a new generation of applicators, CoolAdvantage, featuring three-dimensional (3D) cooling surfaces. The system includes seven 3D vacuum applicators in various shapes and sizes, designed to treat visible fat bulges in nine areas, including the thighs, subgluteal region, and abdomen. Additionally, the device is equipped with two handpieces that can simultaneously treat two areas. The C-shaped 3D cooling surface design ensures better adhesion and conformity to the skin, effectively reducing skin tension caused by vacuum suction during treatment.

CoolAdvantage™ series applicators have received FDA and NMPA clearance.While ensuring treatment safety and efficacy, CoolSculpting 2.0 increases the cryogenic coverage area by 18%, reduces treatment time by 42%, and shortens the per-area treatment duration to as little as 35 minutes.^[1]。

In 2019, Zeltiq also launched CoolTone, a muscle stimulation system that uses magnetic pulses to stimulate the abdomen, buttocks, and thighs for muscle toning. The system has received FDA approval.

Most people prioritize aesthetic enhancements in the order of facial contour, skin quality, and body shape. Similarly, the supply-side development of the medical aesthetics industry has largely followed this trajectory, evolving from plastic surgery to cosmetic dermatology and then to body contouring centers. With the frequent emergence of innovative solutions such as cryolipolysis, thermal lipolysis, and ultrasonic lipolysis, leading companies are expanding their footprint in the fat reduction segment of the medical aesthetics market and initiating acquisition strategies.

Zeltiq is one of the companies that were acquired.In February 2017, two months after Zeltiq’s CoolSculpting received approval from the NMPA, U.S.-based Allergan acquired Zeltiq, then the second-largest player by market share, for $2.48 billion, thereby bringing CoolSculpting into its portfolio.。

Allergan, founded in 1948, is a global healthcare company that initially focused on the field of ophthalmology. After acquiring Botox manufacturer Oculinum in 1991 and entering the medical aesthetics sector, Allergan reaped significant benefits and began to continuously consolidate its medical aesthetics brand through investments and acquisitions. Kythera, Anterios, LifeCell, Envy Medical, and Soliton are among the medical aesthetics companies acquired by Allergan in recent years. In addition to ophthalmology and medical aesthetics, Allergan has also expanded into therapeutic areas such as neurological rehabilitation and gastroenterology.

Surprisingly, although CoolSculpting achieved respectable results following its official launch in China more than a year after the acquisition of Zeltiq, Allergan still failed to reverse its losses, declining stock price, and significant layoffs, ultimately meeting the same fate of being acquired.In June 2019, global biopharmaceutical company AbbVie announced its acquisition of Allergan for $64.084 billion, making Zeltiq part of Allergan Aesthetics, a subsidiary of AbbVie.. Following the acquisition, AbbVie's revenue surged directly from $33.266 billion in 2019 to $45.804 billion in 2020, representing a 38% increase.

Meanwhile, the market for CoolSculpting has remained unaffected by Allergan and has continued to show a growth trend. According to official data from Allergan, in the first half of 2020, CoolSculpting’s sales volume in China increased by more than 100% year-on-year, equipment coverage grew by nearly 50%, and the number of officially partnered medical aesthetic clinics/hospitals rose by nearly 70%. In the first quarter of 2021, CoolSculpting’s sales surpassed the peak level of 2020, representing a 280% year-on-year increase, while the number of officially partnered medical aesthetic clinics or hospitals doubled compared to the same period of the previous year. As of 2022, CoolSculpting had been adopted in 74 countries and regions worldwide, with over 11 million cumulative treatment cases globally.

As the most active market for fat reduction and body contouring globally, the United States accounts for nearly 20% of the global volume of fat reduction and body contouring procedures. Additionally, according to ISAPS data, in 2018, the U.S. accounted for 18.9% of the global number of body contouring treatments, ranking first worldwide. In contrast, in the Chinese market, data from Deloitte shows thatIn 2019, China’s penetration rate was only 0.8 procedures per 1,000 people, less than one-third of the U.S. market’s 2.8 procedures per 1,000 people.。

In the development of fat reduction and body contouring procedures, surgical interventions hold a dominant position in the fat reduction market, accounting for approximately 70%, due to their long clinical history and mature technological development. Meanwhile, non-invasive lipolysis is gaining increasing consumer favor thanks to its advantages of being non-invasive, painless, surgery-free, safe, efficient, and requiring a short recovery period. However, only a few non-surgical body contouring technologies available on the market have obtained certification from the National Medical Products Administration (NMPA). These include imported brands such as the CoolSculpting cryolipolysis device, the VelaShape III optoelectronic radiofrequency treatment system, the UltraShape V3 focused ultrasound lipolysis device, and the SculpSure semiconductor laser lipolysis device. There are very few domestically approved products.

Both in terms of surgical penetration rate and product availability, domestic development lags behind that of foreign markets, indicating substantial room for growth in China’s fat reduction and body contouring sector. According to Deloitte data, the annual growth rate of China’s medical aesthetic body contouring industry has currently exceeded 20%, and its market size is projected to reach RMB 100 billion by 2030.

 References:

1.Suzanne L. Kilmer,Prototype CoolCup Cryolipolysis Applicator With Over 40% Reduced Treatment Time Demonstrates Equivalent Safety and Efficacy With Greater Patient Preference[J]. Lasers in surgery and medicine, 2016, 48(4): 423-423.