The original press release can be accessed here: https://ir.venusconcept.com/news-releases/news-release-details/venus-concept-announces-health-canada-authorization-and-ce-mark
TORONTO, July 20, 2021 (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 to market the Venus Fiore Feminine Health System in Canada. This follows the receipt of CE Mark for the Venus Fiore Feminine Health System in March 2020. The Company intends to begin a limited launch of the Venus Fiore in Canada and the European Union in the third quarter of 2021.
Venus Fiore is the only system that offers three treatment areas in one platform to address both medical and aesthetic concerns without surgery or hormone-based therapies. Venus Fiore can effectively address some of the most common feminine health conditions and concerns with the physical appearance of the vaginal area.
In Canada, the Venus Fiore system is intended for women who are post-menopausal, or have undergone surgically induced menopause, to improve their sexual quality of life. The Venus Fiore VG applicator is intended to treat the vaginal canal to improve symptoms of vaginal laxity and for increased sexual function. Two additional applicators, the Venus Fiore MP applicator and the LA applicator, are intended for dermatological procedures requiring skin tightening/improvement in skin laxity of the Mons Pubis (MP) anatomy and the Labia Majora (LA) anatomy and to improve blood flow.
In the European Union, the Venus Fiore system is intended for improvement of symptoms of vaginal laxity and vaginal atrophy and for dermatological procedures requiring increasing of skin tightening improvement in skin laxity of the Mons Pubis (MP) area and for skin tightening improvement in skin laxity of the Labia Majora (LA) area.
Venus Fiore offers three treatments: internal vaginal treatment which can address vaginal atrophy and laxity, labia skin tightening, and mons pubis skin tightening. Each treatment utilizes a single-use disposable tip for improved safety and hygiene. The vaginal applicator has a unique multi-electrode design that simultaneously and safely delivers (MP)2 (Radio Frequency and Pulsed Electro Magnetic Field) energy. The combined energy is uniformly and circumferentially applied throughout the entire vaginal canal for a 3D controlled deep heating. This innovative design enables Venus Fiore to deliver safe, fast, and comfortable treatments with consistent results. In addition to the vaginal applicator, Venus Fiore utilizes external labia and mons pubis applicators. The proven multi-polar electrode configuration is also incorporated into each of these applicators to enable homogeneous, even, and rapid distribution of heat, resulting in fast and effective treatments, while optimizing patient comfort.
“We look forward to the commercial introduction of our unique, multi-treatment system for women in Canada and the European Union,” said Domenic Serafino, Chief Executive Officer and Director of Venus Concept Inc. “Venus Fiore is the first and only true stationary positioning solution in the market, designed to effectively address some of the most common feminine health conditions and concerns with the physical appearance of the vaginal area. Typically, these procedures require three, 15-minute treatments, approximately one month apart to optimize results. With affordable pricing, cutting-edge technology for all skin types, and hygienic single-use tips, combined with Venus Concept's industry-unique business model, Venus Fiore is designed to be an attractive system for medical and aesthetic customers around the world.”
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 and hair restoration technologies and reach in over 60 countries and 20 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, Venus Glow, Venus Bliss, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration systems 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, as amended (the “1933 Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “1934 Act”). Any statements contained herein that are not of historical facts may be deemed to be forward-looking statements. In some cases, you can identify these statements by words such as such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements include, but are not limited to, statements about our financial performance; the growth in demand for our systems and other products; and general economic conditions, including the global economic impact of COVID-19, and involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business and the industry in which the Company operates and management's beliefs and assumptions and are not guarantees of future performance or developments and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this communication may turn out to be inaccurate. Factors that could materially affect our business operations and financial performance and condition include, but are not limited to, those risks and uncertainties described under Part I Item 1A - “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, Part II Item 1 A - “Risk Factors” in our Form 10 Q for the quarter ended March 31 2021 and in other documents the Company may file with the SEC. You are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are based on information available to us as of the date of this communication. Unless required by law, the Company does not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise.