Venus Concept Submits FDA 510(k) Related to the Use of its Aime™ Next Generation Robotic Technology for Tissue Excision and Skin Resurfacing
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TORONTO, March 31, 2022 (World NEWSWIRE) — Venus Thought Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a worldwide health care aesthetic technological know-how chief, currently introduced it has submitted a 510(k) premarket notification (“510(k)”) to the U.S. Foods and Drug Administration (“Fda”), which is intended to attain a general scientific sign relevant to the use of its Aime™ future technology robotic technologies for tissue excision and skin resurfacing. Aime is a robotic system built to deliver micro-coring for professional medical aesthetic apps.
“We are energized to start the system of obtaining the initially Fda regulatory clearance for our non-surgical robotic technologies platform, Aime,” mentioned Domenic Serafino, Chief Government Officer of Venus Thought. “Aime has the probable to deliver legitimate innovation to the professional medical aesthetics market by switching the way techniques are done and bringing a new stage of consistency and predictability. The submission of this 510(k) provides us 1 step nearer to our intention of commercializing Aime in the U.S., and we look forward to beginning a confined release in the fourth quarter of 2022.”
About Venus Notion
Venus Idea is an revolutionary worldwide health care aesthetic technological know-how chief with a broad solution portfolio of minimally invasive and non-invasive health-related aesthetic and hair restoration systems and access in more than 60 countries and 18 immediate markets. Venus Notion focuses its merchandise revenue strategy on a subscription-primarily based business model in North The us and in its well-founded immediate world wide markets. Venus Concept’s solution portfolio is composed of aesthetic device platforms, such as Venus Versa, Venus Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Glow, Venus Bliss, Venus BlissMAX, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration units consist of NeoGraft®, an automated hair restoration technique that facilitates the harvesting of follicles during a FUE course of action and the ARTAS® and ARTAS iX® Robotic Hair Restoration programs, which harvest follicular models immediately from the scalp and produce recipient implant web pages employing proprietary algorithms. Venus Thought has been backed by leading healthcare business development equity traders such as EW Healthcare Associates (formerly Essex Woodlands), HealthQuest Cash, Longitude Funds Administration, Aperture Enterprise Partners, and Masters Exclusive Predicaments.
Cautionary Statement Regarding Ahead-On the lookout Statements
This interaction incorporates includes “forward-looking” statements in just the which means of Part 27A of the Securities Act of 1933, as amended and Area 21E of the Securities Exchange Act of 1934, as amended. Any statements contained herein that are not of historical information may perhaps be deemed to be ahead-seeking statements. In some cases, you can determine these statements by text such as such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and other equivalent expressions that are predictions of or show long run occasions and long term tendencies. These ahead-hunting statements involve, but are not confined to, statements about our fiscal effectiveness the development in need for our units and other products and solutions and common economic conditions, which include the world financial impact of COVID-19, and contain pitfalls and uncertainties that may induce results to vary materially from those set forth in the statements. These ahead-wanting statements are primarily based on present-day anticipations, estimates, forecasts, and projections about our business enterprise and the sector in which the Organization operates and management’s beliefs and assumptions and are not guarantees of foreseeable future general performance or developments and entail acknowledged and unidentified threats, uncertainties, and other things that are in some scenarios further than our manage. As a final result, any or all of our ahead-wanting statements in this interaction may well turn out to be inaccurate. Variables that could materially influence our organization functions and money overall performance and situation consist of, but are not confined to, those people hazards and uncertainties described beneath Aspect II Item 1A—“Risk Factors” in our Quarterly Reviews on Variety 10-Q and Aspect I Merchandise 1A—“Risk Factors” in our Yearly Report on Kind 10-K for the fiscal yr ended December 31, 2021. You are urged to take into consideration these variables meticulously in analyzing the ahead-looking statements and are cautioned not to area undue reliance on the forward-looking statements. The forward-on the lookout statements are dependent on info available to us as of the date of this interaction. Except if essential by regulation, the Company does not intend to publicly update or revise any ahead-searching statements to reflect new details or long run situations or in any other case.
Get in touch with: Investor Relations Make contact with: ICR Westwicke on behalf of Venus Principle: Mike Piccinino, CFA [email protected]
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