Ulthera device clears FDA for décolleté on heels of Merz acquisition plans

Ulthera's ultrasound skin-tightening device--Courtesy of Ulthera

Merz already committed to buying Ulthera for up to $600 million in cash and milestones. Now it will get another FDA-cleared indication as part of the bargain. The company's system has cleared the FDA to improve the lines and wrinkles of the décolleté.

The system had already been cleared by the FDA for lifting the neck, eyebrows and under the chin. The system stimulates the formation of collagen and elastin in the skin by using focused ultrasound energy on the deep skin tissues through a handpiece placed upon the skin. The procedure takes about 30 minutes with results after only one application, the company said.

At the start of the third quarter, the company said more than 1,500 U.S. physicians had the system. It is available in more than 40 countries and was first introduced in 2012.

"At my practice, there is high patient demand for a safe and effective solution to treat the chest, but the only options available involved needles, multiple treatments, recovery time, and/or required restricted sun exposure," principal investigator Dr. Sabrina Fabi, a dermatologist at Cosmetic Laser Dermatology in San Diego, CA, said in a statement.

On June 26, Merz and Ulthera agreed to merge. Merz will pay up to $600 million in cash and milestone payments. The specific milestones were undisclosed. Ulthera expects sales of more than $100 million in 2014. The acquisition is the largest in Merz's history. It's expected to close this quarter.

- here is the press release

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