South Korea’s Ministry of Food & Drug Safety approved the PicoSure Picosecond laser; the device will be sold by Cynosure’s Korean salesforce. The Taiwan Food & Drug Administration also approved the laser, in addition to the company’s Smartlipo Triplex and Apogee+. A 3r- party distributor will be responsible for sales of these 3 devices in Taiwan.
The PicoSure laser is used for tattoo and benign pigmented lesion removal, using a faster-wavelength laser to break down the tattoo ink. The Apogee+ is a laser hair removal system which can also be used to break down benign epidermal pigmented lesions. The Smartlipo Triplex is a laser body sculpting system designed to break down fat cells and tighten tissue. All 3 devices have won 510(k) clearance from the FDA.
“PicoSure is building a loyal worldwide following among physicians and their patients seeking a safe, effective treatment for the removal of tattoos and benign pigmented lesions. We continue to make excellent progress in broadening the product’s reach to key international markets and consumers,” president & CEO Michael Davin said in prepared remarks.
In a note to investors, Leerink Partners analyst Richard Newitter wrote that Cynosure should be able to drive sales "right out of the gate" thanks to its 2011 Conbio acquisition, which gave it a footprint in the BPL and tattoo-removel spaces.
"These territories should open up a large addressable market opportunity for PicoSure, particularly with respect to the device’s application in pigmented lesions, where the demand for this type of procedure is very large (>$1B)," Newitter wrote.
The Westford, Mass.-based medical device company in December won a $10 million settlement to Tria Beauty, closing 2 lawsuits the company inherited from its buyout of Palomar Medical Technologies. Tria will also pay royalties on future sales of its hair removal products, which use 2 sets of patents from Palomar.