Restoration Robotics® Secures ISO 13485:2016 Certification
Announces Shipment of first ARTAS iX™ Systems to Europe
SAN JOSE, Calif., Jan. 02, 2019 (GLOBE NEWSWIRE) -- Restoration Robotics, Inc. (HAIR), announced today that it has successfully completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale of the ARTAS iX™ System with implantation in Europe. The Company shipped the first ARTAS iX Systems to customers in Europe in December 2018.
Ryan Rhodes, President and Chief Executive Officer of Restoration Robotics, added, “This certification and our first shipments of the ARTAS iX System to customers in Europe further validate our technology and represent two critical milestones ahead of final CE Mark approval. We look forward to further expanding access to our cutting-edge robotic hair restoration technology with implantation functionality while driving system sales globally.”
The International Organization of Standards (ISO) is a non-government entity comprised of academic and industry professionals that certifies that companies are compliant with industry-standard best practices in their production and operations. Specifically, ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.
About Restoration Robotics
Restoration Robotics, Inc. is a medical device company developing and commercializing the ARTAS® and ARTAS iX™ Robotic Hair Restoration System. 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.
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 as to our expectations for the receipt of CE mark, including the timing thereof, 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 March 5, 2018, as well as any reports that we may file with the SEC in the future, including our Quarterly Report for the nine months ended September 30, 2018 filed on November 5, 2018, 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.
Director of Marketing
Restoration Robotics, Inc.