ZELTIQ Aesthetics, Inc., a medical technology company, focuses on developing and commercializing products utilizing its proprietary controlled cooling technology platform. CoolSculpting System The company’s primary commercial product, the CoolSculpting system, is designed to selectively reduce stubborn fat bulges. CoolSculpting is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. CoolSculpting utilizes precisely controlled cooling to reduce the temperature of fat cells in the treated area, which is intended to cause fat cell elimination through a natural biological process known as apoptosis, without causing scar tissue or damage to the skin, nerves, or surrounding tissue. The company developed CoolSculpting to reduce the fat layer within a treated fat bulge without requiring the patient to diet or exercise. In its pivotal U.S. clinical trial involving 60 patients, physicians were able to differentiate between pre- and post-treatment photographs in 88% of the patients, while unable to identify aesthetic benefits in the remaining 12%. The company received clearance from the Food and Drug Administration (FDA), in 2010 to market CoolSculpting for the selective reduction of fat around the flanks, an area commonly referred to as the love handles. The company received further FDA clearance in 2012 to use CoolSculpting for the selective reduction of fat around the abdomen area. In 2014, CoolSculpting was cleared by the FDA for treatment of the thigh area, and most recently, in January 2015, CoolSculpting was cleared by the FDA for treatment at lower temperatures which would enable shorter treatment times. The company sells its CoolSculpting system primarily to dermatologists, plastic surgeons, and aesthetic specialists and generates revenue primarily from sales of its CoolSculpting system and from sales of consumables to its customers. Consumables are the CoolSculpting procedure packs the company sells that are needed to perform procedures using its CoolSculpting system. CoolSculpting Control Unit The CoolSculpting control unit is the base of the CoolSculpting system and contains the simple user interface, power management and control functions, and chiller unit that is responsible for the controlled cooling. The company’s CoolSculpting control unit also contains a Health Insurance Portability and Accountability Act of 1996, complaint connectivity and data management tool that locally tracks and collects data about each procedure performed, as well as any error messages that may be generated during the procedure. CoolSculpting Applicators The CoolSculpting applicator delivers vacuum suction and cooling to the fat bulge being treated; can be used to start and stop a CoolSculpting procedure and to turn the vacuum suction on and off; and has a thermoelectric cooling panel with temperature and pressure sensors which provide precise thermal control and monitoring of the fat bulge being treated and will automatically stop the procedure if a problem is detected. With the launch of the company’s CoolSmooth applicator in 2014, the company offers five CoolSculpting applicators for use with its CoolSculpting system. Each CoolSculpting applicator is designed to allow the physician to treat a different size and shape fat bulge. CoolSculpting Procedure Packs The company’s consumable CoolGels are cotton sheets saturated in a solution that protects the skin and ensures proper thermal coupling during a CoolSculpting procedure. Its consumable plastic CoolLiners protect the applicator from gel contact. Strategy The key elements of the company’s strategy include selectively marketing and selling its CoolSculpting system; delivering a focused and efficient marketing strategy; leveraging data and customer insights; increasing utilization of CoolSculpting through its marketing and customer support programs; increasing its international presence; expanding its FDA-cleared indications for CoolSculpting; and leveraging its technology platform. Research and Development For the year ended December 31, 2014, the company’s research and development expenses included $18.2 million. Sales and Marketing In North America, the company utilizes a direct sales force to sell CoolSculpting. In international markets, it sells CoolSculpting primarily through a network of distributors. The company’s product has regulatory approval in 72 countries. Patents and Proprietary Technology As of December 31, 2014, the company’s patent portfolio comprised 117 issued patents and 83 pending patent applications, each of which it either owns directly or for which it is the exclusive licensee. ZELTIQ, CoolSculpting, and the company’s logo are among its registered trademarks in the United States and in certain foreign countries. Seasonal Fluctuations Seasonal fluctuations in the number of patients seeking treatment and the availability of the company’s customers are likely to continue to affect its business. Seasonal fluctuations occur in both system revenue and consumable revenue, as well as by geographic region. Specifically, the company’s customers often take vacation or are on holiday during the summer months and therefore tend to perform fewer procedures, particularly in certain international countries. Government Regulation The design, development, manufacture, testing and sale of the company’s products are subject to regulation by various governmental authorities, principally the FDA, and corresponding state and foreign regulatory agencies. Its operations are impacted by the federal Patient Protection and Affordable Care Act of 2010. History The company was founded in 2005. It was incorporated in Delaware in 2005 as Juniper Medical, Inc. and changed its name to ZELTIQ Aesthetics, Inc. in 2007.
zeltiq aesthetics inc (ZLTQ:NASDAQ GS)
4698 Willow Road
Pleasanton, CA 94588
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