Restoration Robotics® Receives European CE Mark Approval for the ARTAS iX™ Robotic Hair Restoration System
15 Agosto 2019 - 7:00AM
Restoration Robotics, Inc. (NASDAQ: 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 RoboticsRestoration 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.
Forward-Looking Statements
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.
Media Contact Lisa Markle Director of
Marketing Restoration Robotics, Inc. +1 650-787-0574
lisam@restorationrobotics.com
Investor Contact The Ruth Group Carol
Ruth/Kaitlyn Brosco+1 (646) 536-7000 ir@restorationrobotics.com
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