Submitted by kBLASTER Team on
By Stacy Lawrence for Fierce Medical Devices
The FDA has given aesthetic medical device player Ulthera, a subsidiary of Merz, a 510(k) clearance for its Cellfina System that it said is the longest that the agency has bestowed for a cellulite treatment. It is cleared to improve the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to two years.
Merz acquired Ulthera a year ago for up to $600 million in cash and milestones. Ulthera expected 2014 sales of about $100 million and says it has been profitable since 2012. The company also has the Ulthera System, which is FDA-cleared to noninvasively lift skin on the neck, under the chin and on the eyebrow as well as to improve lines and wrinkles of the décolleté.
"When Merz acquired Ulthera in June 2014, we recognized that our organizations have a shared mission: to bring innovations to market that meet the needs of physicians and improve the well-being of patients," said President and CEO of Merz North America Bill Humphries in a statement. "This shared long-term vision has enabled the seamless integration of Ulthera into Merz's business operations over the past year and provides us with a solid foundation to launch additional innovative technologies such as the Cellfina System."
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