ZELTIQ® is pleased to announce that we have received FDA Clearance for Lower Temperature Procedures Enabling Shorter Treatment Times and the Launch of a New Applicator, CoolSmooth PROTM that takes advantage of this new clearance.
New Treatment Parameters Provide Significant Time Savings For You And Your Patient With The Same Great Patient Outcomes
ZELTIQ® announced today that it has received Food and Drug Administration (FDA) clearance to perform the CoolSculpting procedure at lower temperatures which will enable shorter treatment times. In conjunction with this clearance, ZELTIQ will be introducing a brand new applicator, CoolSmooth PROTM, which is a 2nd generation surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges, such as the outer thighs area.
“This FDA clearance will enable healthcare professionals to perform the CoolSmooth procedure in nearly half the time with the same outcomes, which will significantly enhance the efficiency and profitability for the practice while also improving the patient experience,” said Mark Foley, President and Chief Executive Officer of ZELTIQ. “Through an ongoing investment in R&D and technological innovation, we are pleased to continue to provide our CoolSculpting partners with differentiated solutions that enhance their treatment options. And, we look forward to applying this technological advancement to our other CoolSculpting applicators in the future.”
The FDA clearance is based on clinical study data demonstrating that optimized temperatures enable shorter treatment times with equivalent benefits, safety, efficacy, and customer satisfaction when compared to current CoolSculpting procedures.
The new treatment parameters will initially be offered with the CoolSmooth PRO applicator, which is uniquely designed to safely control treatments at colder temperatures. The CoolSmooth PRO applicator also includes an enhanced strapping system that provides increased conformity at the treatment site, while also improving ease of use and patient comfort.
The CoolSmooth PRO will be available in Q2 of this year and ZELTIQ plans to offer current CoolSmooth customers an exchange program at a minimal cost to facilitate access to the new technology.
Provisions are in place to facilitate an easy upgrade of all existing CoolSmooth applicators in practices around the world to ensure that all practices can take advantage of the new features available on CoolSmooth PRO. Additionally, ZELTIQ has also established a program to allow for the return and replacement of all unused CoolSmooth cycles with an equivalent number of CoolSmooth PRO cycles.
Your Practice Development Managers will be able to address your individual questions and needs over the next few weeks. Please reach out to them should you have specific questions that this communication has not directly addressed for you and your practice.
Keith J. Sullivan Mark Foley
Chief Commercial Officer President and CEO