SAN JOSE, Calif., Aug. 15, 2019 (GLOBE NEWSWIRE) -- Restoration Robotics, Inc. (HAIR), announced today that it received CE Mark approval for the sale of the ARTAS iX™ System with implantation functionality in Europe. The CE Mark approval follows the Company’s receipt of ISO 13485:2016 Certification for ARTAS iX in January 2019.
Ryan Rhodes, President and Chief Executive Officer of Restoration Robotics, states, “We are very pleased to announce our receipt of CE mark approval, which further expands our addressable market for ARTAS iX. With this approval ARTAS users in Europe will have the ability to leverage our new platform which includes novel implantation functionality, optimizes clinical outcomes, and further improves hair restoration process workflow. In these geographies, we will continue to sell through our international sales team and our distributor partners, as we maintain our focus on expanding our commercial presence globally.”
The ARTAS® Robotic Hair Restoration System is the first and only hair restoration system in the world combining robotic and artificial intelligence technology designed to assist surgeons through the most significant and tedious stages of the hair restoration process. It allows for precise, efficient, and repeatable hair restoration and automates the most significant aspects of hair transplantation procedures: graft harvesting, recipient site making, and now, implantation. ARTAS iX™ features an advanced stereoscopic machine vision system with improved 44-micron resolution and a 7-axis robot arm to deliver unmatched procedural analysis, precision, repeatability, and clinical workflow efficiency.
For more information on the ARTAS® iX system, please visit https://artas.com
About Restoration Robotics
Restoration Robotics, Inc. is a medical device company developing and commercializing the ARTAS® and ARTAS iX™ Robotic Hair Restoration Systems. The ARTAS iX System is the first and only physician-assisted system to dissect and assist in the harvesting of follicular units directly from the scalp, create recipient implant sites using proprietary algorithms and implant the hair follicles into the designated sites. The Company has unique expertise in machine vision, image guidance, visual servoing and robotics, as well as developing intuitive interfaces to manage these technologies. ARTAS iX is currently approved in Europe and the United States.
Statements made in this press release that are not statements of historical fact are forward-looking statements. Forward-looking statements are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are commonly identified by words such as “would,” “may,” “expects,” “believes,” “plans,” “intends,” “projects” and other terms with similar meaning. Investors are cautioned that the forward-looking statements in this document are based on current beliefs, assumptions and expectations, speak only as of the date of this document and involve risks and uncertainties that could cause actual results to differ materially from current expectations. Such statements, including our expectations and plans for expanding our presence in Europe and globally generally, are subject to certain known and unknown risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results and other future events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Material factors that could cause actual results to differ materially from current expectations include, without limitation, the following: the progress of our commercialization, marketing and manufacturing capabilities; and the timing or likelihood of regulatory filings and approvals for ARTAS for use in transplanting of hair. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on August 14, 2019, as well as any reports that we may file with the SEC in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.