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Cutera Announces Expansion of FDA Indications for enlighten™ Laser Platform

Cutera Announces Expansion of FDA Indications for enlighten™ Laser Platform

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BRISBANE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) -- CUTERA, INC. (Nasdaq: CUTR) (“Cutera” or the “Company”), a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, today announces the U.S. Food and Drug Administration (FDA) approves clearance of an additional indication, for acne scars, on its premier enlighten® laser platform. The enlighten is also cleared by the U.S. Food and Drug Administration for tattoo removal and the treatment of benign pigmented lesions.

Acne affects approximately 650M people, 40% of whom will have some form of acne scarring.1

enlighten’s new application, PICO Genesis™ FX, improves the appearance of acne scars safely and effectively with minimal patient downtime and side effects on all skin types. In a recent study with more than 100 treatments performed, 97% of patients saw mild to moderate improvement in acne scars as graded by blinded evaluators. In addition, the study revealed statistically significant improvement in skin radiance, smoothness, pigmentation, erythema, and pore size. 1

Dr. Neil Sadick, a world-renowned dermatologist, of Sadick Dermatology, NY, NY stated, “PICO Genesis FX elevates enlighten’s existing skin revitalization capabilities and introduces a fractional approach to treating acne scars, textural concerns and aging skin on all skin types. Its novel Micro Lens Array (MLA) treats the upper layers of the epidermis and dermis which generate collagen stimulation and remodeling of the skin. The expansion of this new fractional treatment means my patients will receive more efficacious results with little-to-no downtime for active lifestyles.”

"The FDA clearance for acne scars represents another achievement for the enlighten platform and showcases Cutera's on-going focus on innovation and clinical advancements in laser and light-based technology,” said James Reinstein, President and CEO of Cutera. "The system's multiple wavelengths, dual pulse durations, and high power are all industry-leading features that offer practitioners a broad range of treatment settings and cleared indications. We will continue to develop technologies that advance the medical aesthetics industry and meet the needs of our customers and their patients.”

The enlighten Laser Platform with PICO Genesis FX will be available Q1 2019.

About Cutera, Inc.

Brisbane, California-based Cutera is a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that enable physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients. For more information, call 1-888-4CUTERA or visit www.cutera.com.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the impact of our products, expected product performance, and the anticipated benefits and market adoption of our products are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause Cutera's actual results to differ materially from the statements contained herein. Potential risks and uncertainties that could affect Cutera's business and cause its financial results to differ materially from those contained in the forward-looking statements include those related to the Company's efforts to improve sales productivity, hire and retain qualified sales representatives, improve revenue growth and profitability through leveraging operating expenses; the Company's ability to successfully develop and launch new products and applications and market them to both its installed base and new customers; the length of the sales cycle process; unforeseen events and circumstances relating to the Company's operations; government regulatory actions; and those other factors described in the section entitled, "Risk Factors" in its most recent Form 10-Q as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Cutera undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

Cutera Announces Expansion of FDA Indications for enlighten™ Laser Platform

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