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medestheticsmagazine.com | JULY/AUGUST 2017 59 The fi rst device being developed under this patent, RCI- 02, is designed to inject soft tissue fi llers such as hyaluronic acid. The device is also being developed for the injection of RepliCel's RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the motorized device will be optimized for other injectables such as drugs, biologics, vaccines and fat grafts. The company is aiming to have the product licensed and available in 2018. TA RO PH A R M ACEUTICA LS TO DISTR I BUTE PLI AGLIS Crescita Therapeutics has granted Taro Pharmaceuticals an exclusive license to the rights to sell and distribute Pliaglis (lidocaine 7%/tetracaine7%), a topical anesthetic that sets into a peelable mask, in the U.S. market. The license agree- ment also includes a second-generation, patent-pending enhanced version of Pliaglis. Crescita will retain all rights to the product in Canada and Mexico. "We are delighted to have Taro as our new licens- ing partner for Pliaglis in the U.S.," said Dan Chicoine, executive chairman and interim CEO of Crescita. "Taro is a leading supplier of topical dermatological products in the U.S. We look forward to working with Taro to not only re- introduce Pliaglis to the U.S. market, but also to obtain FDA approval for the patent-pending Enhanced Formulation." N DA ACCEPTED FOR N EW TOPICA L SK TR EATM ENT The U.S. Food & Drug Administration has accepted Aclaris Therapeutics' New Drug Application (NDA) for A-101 40% topical solution, a high-concentration hydrogen per- oxide formulation for the treatment of seborrheic keratosis (SK). The NDA indicates that the company's application is suffi ciently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA's review of the NDA is December 24, 2017. If approved, A-101 40% would be the fi rst FDA-approved topical medication for the treat- ment of SK. "The FDA's acceptance of our NDA for A-101 40% is a signifi cant achievement that brings Aclaris one step closer to providing an innovative treatment option for SK patients and the physicians who treat the condition," said Christopher Powala, chief operating offi cer of Aclaris. "There is a signifi - cant need for a noninvasive, topical SK treatment as it often appears in highly visible locations like the face and neck and can adversely affect patients' emotional well-being." EDGE SYSTEMS NOW TH E H Y DR A FACI A L COM PA N Y Edge Systems, creator of the hydradermabrasion HydraFa- cial system and Perk skincare line, has changed its name to The HydraFacial Company. In conjunction with the name change, the company is introducing a new logo. "Our logo represents our modern approach to turning the expected upside down. The brand visual identity is a celebration of our uniqueness, demonstrating the emotional connec- tion we create by revealing a brighter, more confi dent life through amazing skin," said Rosemarie Holcomb, director of marketing for The HydraFacial Company. "We have set a modern vision for the company to build upon our great product technology," added CEO Clint Carnell. "In the near term, I think you'll see that we take a purposeful approach to growing our brand, with a focus to drive patient awareness, as well as best-in-class physician support, both from a clinical and marketing perspective. We are staking out our space and being very disciplined, thoughtful and assertive in what HydraFacial stands for." M ERZ NORTH A M ER ICA A N NOU NCES N EW CEO A N D CCO Merz Pharma, a global provider of aesthetic products and neurotox- ins, has appointed Bob Rhatigan president and chief executive offi cer (CEO) of Merz North America. Patrick Urban has been appointed chief commercial offi cer. Both Rhatigan and Urban will be based in Raleigh, North Carolina. Prior to joining Merz, Rhatigan served as president and chief operating offi cer at Alphaeon Corporation, a healthcare company focused on the lifestyle medical space, as well as senior vice president of Allergan's Facial Aesthet- ics business. He will join Merz's global management board and will report directly to Philip Burchard, CEO of Merz Pharma Group. "I am honored and excited to lead the Merz North America team to an even higher level of achievement and ensure a successful future for the organization. We have a well-rounded and strong portfolio in which I see clear potential," said Rhatigan. Urban, who most recently served as interim president and CEO for Merz North America and has more than 20 years of commercial experience in the U.S. pharmaceutical and medical device industries, will report directly to Rhati- gan and play a critical role in driving the commercial success of the Merz Aesthetics portfolio. Bob Rhatigan, CEO