Venus Concept Inc. Announces CE Mark and Australian Regulatory Approval for NeoGraft 2.0, A Trusted Name in Hair Restoration
Introducing the next generation of NeoGraft, a comprehensive hair restoration solution; Limited commercial launch in Europe and Australia in the fourth quarter of 2019
TORONTO, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received a CE Mark from DEKRA Certification B.V. and Therapeutic Goods Administration (TGA) clearance in Australia to market NeoGraft 2.0 for hair restoration.
NeoGraft 2.0 is intended as an automated hair transplant device using the Follicular Unit Extraction (FUE) method of harvesting and implanting hair follicles. With the introduction of NeoGraft 2.0, Venus Concept has eliminated the inefficiencies of manual extractions and implants and replaced it with advanced technology that provides patients with the benefits of the FUE procedure, while also enabling physicians to benefit from easier transplants that yield superior clinical results. The NeoGraft® 2.0 is a next generation version which offers an extended and double-jointed arm, updated implant and extraction tools, a pneumatic motor, and touchscreen interface, which together offer clinicians a more efficient treatment room and more consistent clinical outcomes. NeoGraft 2.0 procedures are minimally invasive, require less recovery time, and offer natural-looking results for all hair types, males and females alike.
“We launched NeoGraft 2.0 on a limited basis in Europe and Australia in the fourth quarter and look forward to a full commercial launch in these markets in the first quarter of 2020,” said Dom Serafino, Chief Executive Officer and Director of Venus Concept Inc. “Our recent merger with Restoration Robotics allows us to offer an end-to-end portfolio of minimally invasive solutions unique from any competitor in the hair restoration market today with ARTAS iX and NeoGraft 2.0. With more than 600,000 procedures and an estimated $4 billion1 spent annually in global hair restoration, our portfolio of unique technology solutions, combined with our large global selling infrastructure, positions us well to drive growth in an extremely attractive global hair restoration market.”
About Venus Concept
Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic technologies and reach in over 60 countries and 29 direct markets. Venus Concept focuses its product sales strategy on a subscription-based business model in North America and in its well-established direct global markets. Venus Concept’s product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Freeze Plus, and Venus Bliss. Venus Concept’s hair restoration division includes NeoGraft, an automated hair restoration system that facilitates the harvesting of follicles during a FUE process and the ARTAS® and ARTAS iX™ Robotic Hair Restoration Systems, which harvest follicular units directly from the scalp and create recipient implant sites using proprietary algorithms. Venus Concept has been backed by leading healthcare industry growth equity investors including EW Healthcare Partners (formerly Essex Woodlands), HealthQuest Capital, Longitude Capital Management, and Aperture Venture Partners.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, as they relate to Venus Concept, including the expected revenue, operating results and other financial information, involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These statements are based on current plans, estimates and projections, and therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Venus Concept undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the medical device industry, and other legal, regulatory and economic developments. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results could differ materially from the results contemplated by these forward-looking statements. Material factors that could cause actual results to differ materially from current expectations include, without limitation, the following: the progress of the commercialization, marketing and manufacturing capabilities for the combined company’s products; the number of Venus Concept systems that are sold; the success of the commercial launch of Venus Bliss; the timing or likelihood of regulatory filings and approvals for products; the expected synergies from the merger; and the expected revenue for the combined company. Venus Concept cannot give any assurances that the combined company will achieve its expectations. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the business of Venus Concept described in the “Risk Factors” section contained in the Registration Statement on Form S-4 and the prospectus and definitive proxy statement contained therein for the merger of Restoration Robotics and Venus and described in the “Risk Factors” section of Restoration Robotics Annual Report on Form 10-K for the year ended 2018 filed on March 20, 2019 and as amended on April 29, 2019, the Restoration Robotics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed on November 14, 2019, as well as any reports that Venus Concept may filed with the SEC in the future. All forward-looking statements included in this press release are based upon information available to Venus Concept as of the date hereof, and Venus Concept assumes no obligation to update or revise such forward-looking statements to reflect events or circumstances that subsequently occur or of which Venus Concept hereafter becomes aware.
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1 Source: International Society of Hair Restoration Surgery (ISHRS): “2017 Practice Census Results Report”
Investor Relations Contact: Westwicke Partners on behalf of Venus Concept Mike Piccinino, CFA For Further Information: Melissa Kang Phone: (888) 907-0115, ext. 139 Fax: (855) 905-0115 Email:
