Venus Concept Inc., a global medical aesthetic technology leader, announced that it has received a medical device license issued by Health Canada to market Venus Bliss™.
November 19, 2019
TEL: (888) 907-0115
Venus Concept is a leader in the global medical and aesthetic device market, pairing best-in-class technology with the first and only true subscription model in the industry.
Venus Epileve™ is a new, cost-effective, laser hair removal solution designed for the aesthetics market
TORONTO, Nov. 26, 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 medical device license issued by Health Canada and CE Mark from DEKRA Certification B.V. to market Venus Epileve™. It is intended as a treatment for hirsutism, permanent hair reduction and pseudofolliculitis barbae in Europe, and for hair removal, permanent hair reduction, and the treatment of pseudofolliculitis barbae in Canada.
Venus Epileve™ represents a new product introduction that expands the Company’s diode laser hair removal offering beyond the Venus Velocity™ which was introduced to the medical aesthetics market in 2017. The Venus Epileve™ is cost-effective, fast, comfortable, and can be used on all skin types (Fitzpatrick skin types I-VI), including tanned skin. The Venus Epileve™ is a portable and versatile tabletop device that offers two modes of operation (SLIDE and PULSE) and a real-time cooling system aimed at ensuring patient safety and comfort. The Venus Epileve™ is integrated with Internet of Things (IoT) technology that collects technical information to help providers enhance business operations and improve treatment efficiency.
“The receipt of CE Mark and Health Canada Authorization for our new laser hair removal solution, the Venus Epileve™, represents another example of Venus Concept’s ability to introduce new and innovative solutions designed specifically for the non-traditional aesthetics market,” said Domenic Serafino, Chief Executive Officer and Director of Venus Concept Inc. “Building on the success of the Venus Velocity™, we designed the Venus Epileve™ as a cost-effective laser hair removal solution for customers outside of the medical aesthetics market. We are preparing for a limited launch of the Venus Epileve™ in Europe and Canada beginning in the second quarter of 2020 with the full launch targeted for the second half of 2020. We look forward to the commercial expansion of Venus Epileve™ in these markets contributing to our solid growth profile next year and we expect our expanded portfolio of laser hair removal solutions will help us further penetrate the $1.4 billion global hair removal market1 in the years to come.”
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.
Original article featured on globenewswire.com.
For more information call: (888) 907-0115 // info@venusconcept.com // 235 Yorkland Blvd., Suite 900, Toronto, ON, M2J 4Y8 Canada
REGULATORY CLEARANCES [ More ]
Venus Bliss™ is cleared by the FDA and licensed by Health Canada for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less, with the diode laser applicators. The (MP)2 applicator is cleared by the FDA for temporary reduction in the appearance of cellulite, and licensed by Health Canada for temporary increase of skin tightening, temporary circumferential reduction, and temporary cellulite reduction. Venus Bliss™ has CE Mark as a non-invasive medical aesthetic device enabling a comprehensive approach leading to body contouring, addressing fat reduction, skin tightening, circumference reduction, and cellulite reduction.
Venus Versa™ is cleared by the FDA, licensed by Health Canada, and has CE Mark as a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 applicators are cleared by the FDA, licensed by Health Canada, and have CE Mark for the treatment of benign pigmented epidermal and cutaneous lesions and treatment of benign cutaneous vascular lesions. The HR650/HR650XL and HR690/HR690XL applicators are cleared by the FDA, licensed by Health Canada, and have CE Mark for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for Fitzpatrick skin types I-IV. The AC Dual applicator is cleared by the FDA, licensed by Health Canada, and has CE Mark for the treatment of acne vulgaris. The DiamondPolar™ and OctiPolar™ applicators on the Venus Versa™ system are cleared by the FDA for non-invasive treatment of moderate to severe facial wrinkles and rhytides on females with Fitzpatrick skin types I-IV. The DiamondPolar™ applicator is licensed by Health Canada and has CE Mark for non-invasive treatment of moderate to severe facial wrinkles and rhytides on females with Fitzpatrick skin types I-IV. The OctiPolar™ applicator on the Venus Versa™ system is licensed by Health Canada and has CE Mark for temporary body contouring via skin tightening, circumferential reduction, and cellulite reduction. The NanoFractional RF™ (Viva) applicator is cleared by the FDA, licensed by Health Canada, and has CE Mark for dermatological procedures requiring ablation and resurfacing of the skin.
ARTAS iX™ is cleared by the FDA, licensed by Health Canada and has CE Mark with indication for use for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. ARTAS iX™ is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation; creating recipient sites; and implanting harvested hair follicles.
NeoGraft® is cleared by the FDA, licensed by Health Canada and has CE Mark with indication for use in suction-assisted follicular extraction and re-implantation. NeoGraft® is an auto-graft system and can be used on both male and female patients.
Venus Legacy™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in females with Fitzpatrick skin types I-IV with the OctiPolar™ and DiamondPolar™ applicators, and temporary reduction in the appearance of cellulite with the 4D Body (LB2) and 4D Face (LF2) applicators. It is licensed by Health Canada and has CE Mark for the temporary increase of skin tightening, temporary circumferential reduction, temporary cellulite reduction, and temporary wrinkle reduction.
Venus Velocity™ is cleared by the FDA, licensed by Health Canada and has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types.
Venus Fiore™ received regulatory approval in Israel for aesthetic and functional treatment of the vagina, labia and mons pubis. Venus Fiore™ is available for sale in India, Hong Kong, and other selected Asian countries.
The Venus Viva™ MD is cleared by the FDA, licensed by Health Canada and has CE Mark for the use in dermatological procedures requiring ablation and resurfacing of the skin using the Viva™/Viva™ MD applicator, and the non-invasive treatment, reduction in the appearance of moderate to severe facial wrinkles and rhytides for females in Fitzpatrick skin types I-IV with the DiamondPolar™ applicator.
The Venus Viva™ MD is cleared by the FDA for the use in dermatological procedures requiring ablation and resurfacing of the skin, and the non-invasive treatment of moderate to severe facial wrinkles and rhytides for females in Fitzpatrick skin types I-IV with the DiamondPolar™ applicator.
Venus Epileve™ is cleared by FDA, licensed by Health Canada and has CE Mark for hair removal, permanent hair reduction (defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen), and the treatment of pseudofolliculitis barbae for all Fitzpatrick skin types. Venus Epileve™ is also CE-Marked for hirsutism.
Venus Freeze Plus™ is cleared by the FDA for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in females with Fitzpatrick skin types I-IV. It is licensed by Health Canada for temporary skin tightening, and temporary reduction in the appearance of cellulite on the abdomen and flanks, using the DiamondPolar™ and OctiPolar™ applicators. The DiamondPolar™ applicator on Venus Freeze Plus™ has CE Mark for the non-invasive treatment of moderate to severe facial wrinkles and rhytides, and the increase of skin tightening, temporary circumferential reduction, and cellulite reduction with the OctiPolar™ applicator.
Venus Heal™ is licensed by Health Canada and can be used for the treatment of both acute and chronic disorders of the musculoskeletal system, such as muscle spasms, back pain, and soft tissue injuries, and results in effects such as pain relief, myorelaxation, increase of local blood circulation, and edema reduction. In the U.S., Venus Heal™ is cleared by the FDA for the relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. These indications enable the treatment of certain soft tissue injuries and conditions.
Venus Glow™ is cleared by the FDA as a Class I motorized dermabrasion device. It provides a dermal rejuvenation treatment that works to open up and deep-clean pores. Venus Concept is the exclusive distributor for Venus Glow™.
Venus Skin™ is a skin care line of various lotions and creams intended to improve different aspects of skin appearance, skin serums, and skin nourishment solutions.
Copyright 2023 Venus Concept. All rights reserved.
You are entering our website. For other countries/regions and language options, please click the SELECT A DIFFERENT REGION button below.
SELECT A DIFFERENT REGIONAre you looking to get a treatment? Please visit our patient website to learn more.
Click HereBe aware of schemes involving fraudulent job postings.
Read More