Ulthera’s ultrasound platform device gets FDA approval

8 July 2014 (Last Updated July 8th, 2014 18:30)

Ulthera has received US Food and Drug Administration (FDA) clearance for its ultrasound platform device to non-invasively treat the chest to improve decolletage lines and wrinkles.

Ulthera has received US Food and Drug Administration (FDA) clearance for its ultrasound platform device to non-invasively treat the chest to improve decolletage lines and wrinkles.

Using the Ulthera System's imaging and micro-focused ultrasound therapy capabilities, the Ultherapy decolletage treatment stimulates the natural formation of collagen and elastin in the skin's foundation to gradually smooth chest wrinkles.

The treatment takes roughly 30 minutes to and results are visible after about three months.

Ulthera said that meaningful results are achieved in just one treatment with the FDA-cleared Ultherapy procedure for lifting the neck, eyebrow and under the chin, and there's no downtime or post-treatment care requirements.

"The Ultherapy treatment addresses four total treatment areas, from the brow to the chest."

Ulthera president and CEO Matthew Likens said: "Our goal is to reward Ultherapy practices by bringing more value to the Ulthera System during each year of ownership.

"Now, the Ultherapy treatment addresses four total treatment areas, from the brow to the chest."

At present, the Ultherapy decolletage treatment is approved in over 40 countries worldwide and has been selectively available since 2012.

The company said that the treatment will be available in over 1,500 physician practices across the US beginning third quarter of 2014.

Ulthera is focused on developing and commercialising technologies for aesthetic and medical applications.

As of 26 June, Merz Pharma and Ulthera have entered a definitive merger agreement, pursuant to which Merz will acquire Ulthera, in a transaction valued at up to $600m in upfront cash and milestone payments.

The merger agreement has been approved by the boards of both companies and is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The transaction is expected to be completed in the third quarter of 2014.