Candela Announces FDA clearance of Vbeam^® Prima

The new Vbeam Prima takes Candela’s “gold standard” 595 nm Pulsed Dye Laser (PDL) platform to the next level.

WAYLAND, MASSACHUSETTS, JULY 17, 2018 – Candela Corporation, a leading global aesthetic device company, announces the U.S. Food and Drug Administration (FDA) clearance of its Vbeam^® Prima, an advanced 595 nm pulsed dye laser (PDL). With the addition of a 1064 nm wavelength and a number of other new features, the Vbeam Prima will be able to effectively treat a broad range of skin conditions, including: rosacea, port wine stains, acne, facial, leg and spider veins, scars, benign pigmented lesions and wrinkles, warts, stretch marks and photo aging.

“Building on the strong heritage of Vbeam, which has provided life changing aesthetic and dermatologic benefits for millions of patients for more than 20 years, the FDA clearance of the Vbeam Prima represents a step forward in the treatment of vascular and pigmented skin conditions. This important milestone exemplifies Candela’s mission of continuous innovation based on scientifically proven technologies, consistent clinical results and a trusted partnership with both patients and our medical practitioners. Under new ownership and new management, we are recommitting to scientific leadership, real-world clinical results and long term partnerships with our customers,” states Geoffrey Crouse, Chief Executive Officer of Candela.

The Vbeam is a highly efficient PDL used by healthcare providers all over the world to treat a variety of indications for both face and body with high patient tolerability and a low incidence of side effects. The Vbeam has been long considered a “gold standard” for the device based treatment of rosacea, and has also been successfully used for the treatment of port wine stains and vascular anomalies in infants, as well as adults. The Vbeam is currently used in nearly 700 universities and hospitals worldwide, and has been included in hundreds of medical publications. The new Vbeam Prima builds on that legacy of success by offering advanced features that will help physicians and their patients achieve better results, along with an improved treatment experience.

“In a clinical study using Vbeam Prima, facial redness and rosacea symptoms were dramatically reduced after 4 treatments,” said Dr. Eric Bernstein, MD, M.S.E., Director of Laser Surgery & Cosmetic Dermatology at the Main Line Center for Laser Surgery in Ardmore, PA, an investigational site for the device. “I’ve worked with the Vbeam platform for years, and I am extremely excited about advancements with the Prima, especially the 50% greater power enabling a 15 mm spot size, both contact and spray cooling, once-a-day calibration and extended dye life thanks to a completely re-designed system,” he added.

For more information about the Vbeam Prima, please visit https://candelamedical.com

About Candela

Candela Corporation is a leading global medical aesthetic device company with an extensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical aesthetic applications including hair removal; wrinkle reduction; tattoo removal; women's health treatments; facial resurfacing; traumatic and surgical scar treatments; body contouring; improving the skin's appearance through the treatment of benign vascular and pigmented lesions; and the treatment of acne, leg veins, and cellulite. Candela has a wide portfolio of trusted, leading products, including the Vbeam^®, Gentle^® Family, CO₂RE^®, CO₂RE Intima^®, Exceed™, Nordlys™, Frax Pro™, Profound^®, PicoWay^®, and VelaShape^®, as well as other energy-based platforms. Acquired by Apax Partners in July 2017, the Company markets, services and supports its products in over 100+ countries. It has offices in the United States, Australia, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Portugal, Spain and the United Kingdom, and many international distributors.

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