BIOLASE Inc. Wins FDA Clearance of New Waterlase Express All-Tissue Laser System

IRVINE, Calif.--(BUSINESS WIRE)--BIOLASE, Inc., (NASDAQ: BIOL) the global leader in dental lasers, announced today that its new, fifth-generation Waterlase Express™ all-tissue laser system, having received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA), is available for immediate sale to dentists in the U.S. as well as select international markets in Europe, the Middle East and Asia.

Waterlase Express represents the newest addition to the Company’s best-selling Waterlase® portfolio of Er,Cr:YSGG all-tissue lasers, and is the fifth generation of the world’s most widely used all-tissue dental laser wavelength. Waterlase Express will first be exhibited at the upcoming Chicago Dental Society’s Mid-Winter meeting on February 23-25, and then be unveiled internationally in Cologne, Germany at the International Dental Show (IDS), which is the world’s leading trade show for the dental industry.

With extensive qualitative and quantitative research from a team of dentists around the world guiding the design of the system, Waterlase Express represents the new foundation of the Company’s strategy to greatly expand all-tissue laser use in dentistry.

“We are excited to launch the Waterlase Express, our next-generation Waterlase system designed for easy and intuitive operation, integrated learning, and portability. We believe the Express user interface is to legacy laser user interfaces what the Apple iPhone was to the flip phone,” said Harold C. Flynn, Jr. President and CEO of BIOLASE, Inc. “Express will enable significantly higher penetration and adoption of all-tissue laser dentistry worldwide. With all the value of Waterlase technology at nearly one-quarter the size, one-third the weight, and nearly half the U.S. retail price of our market-leading Waterlase iPlus system, we believe Express is the dental laser that is finally ready for the vast majority of dentists around the world, many of whom have waited to integrate our all-tissue laser solutions into their practices.

“These clinicians can now join our current customers who report improved patient-reported outcomes after integrating the laser into their treatment plans, including greatly simplifying perio disease management with REPAIR Perio™, implant management with REPAIR Implant™, pediatric and restorative procedures.”

BIOLASE Chief Technology Officer Dmitri Boutoussov, PhD, said, “When we began this project, our goal was to create a new version of Waterlase that would be a much smaller, simpler, more reliable and cost-effective system, while still carrying all the benefits of powerful Waterlase laser technology. We designed Express so that every dentist, whether completely new to lasers, or a pro, can easily learn Waterlase Express and start using it, with integrated support by BIOLASE and its network of educators and peer practitioners.”

Waterlase Express offers several breakthroughs to help dentists new to all-tissue lasers integrate powerful Waterlase technology with simple, elegant user controls and learning tools. Key features to support ease of learning and ownership for new dentists include:

Game Changing Features and Technology

Easy to learn and use:

• Familiar tablet-based interface makes it easy for new laser dentists to learn quickly
• HD quality clinical animations for every procedure on-board guiding proper laser techniques
• Easy to use procedure presets, with a simple, one-slider cutting adjustment control
• Simplified and intuitive clinical workflows for expansive library of over 80 clinical procedures
• Step-by-step protocols for guiding laser perio and implant procedures
• Full suite of pediatric and deciduous tooth procedures

Easy to own and get support:

• One-touch access to BIOLASE Customer Care™ from the laser control screen when a customer needs assistance (available to U.S. customers only at launch; international availability to follow)
• BIOLASE Connect™ system to link Express owners to a network of support resources
• Resource Center with Patient marketing support resources to enhance integration
• Video tutorials for easy maintenance and care
• Multiple financing options to enable positive cash flow and a great return on investment

Technology advancements:

• System uses compact, miniaturized version of patented Waterlase Er,Cr:YSGG laser engine, with more than 11,500 lasers installed worldwide and used to perform more than an estimated 20 million procedures
• Patented comfortable, contra-angle handpiece design for improved clinical intraoral access
• Cloud-based software, learning, and support content delivery and remote diagnostics
• New side-firing tips to follow soon for implant thread debridement

Dr. Samuel Low, Chief Dental Officer and Vice President of Dental Affairs, was a member of a team of 11 laser dentists from around the world who collaborated with BIOLASE R&D to develop the Waterlase Express experience. “Every setting, every frame of every animation was meticulously crafted by this team of clinical advisors and very talented artists to create a very high-quality learning tool for new laser dentists,” said Dr. Low. “With learning styles more variable than ever, the Waterlase Express offers an appropriate level of simplicity and access to deeper knowledge when needed,” he added.

To learn more about the Waterlase Express system, and other innovations designed to simplify laser dentistry, visit www.biolase.com/waterlaseexpress.

About BIOLASE, Inc.
BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine and also markets, sells, and distributes dental imaging equipment, including digital x-rays and CAD/CAM scanners. BIOLASE’s products are focused on technologies that advance the practice of dentistry to both dentists and their patients. BIOLASE’s proprietary laser products incorporate approximately 255 patented and 90 patent-pending technologies designed to provide biologically clinically superior performance with less pain and faster recovery times. Its innovative products provide cutting-edge technology at competitive prices to deliver the best results for dentists and patients. BIOLASE’s principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications, and a full line of dental imaging equipment. BIOLASE has sold approximately 32,800 laser systems to date in over 90 countries around the world. Laser products under development address BIOLASE’s core dental market and other adjacent medical and consumer markets.

For updates and information on Waterlase® iPlus™ and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, LinkedIn at www.linkedin.com/company/biolase, Instagram at www.instagram.com/biolaseinc, and YouTube at www.youtube.com/biolasevideos.

BIOLASE® and Waterlase® are registered trademarks of BIOLASE, Inc.

Apple is a trademark of Apple.

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Statements contained in this press release that refer to BIOLASE’s estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements in this press release concerning prospects related to BIOLASE’s strategic initiatives and anticipated financial performance. Forward-looking statements can also be identified through the use of words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “may,” “will,” and variations of these words or similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE’s current expectations regarding existing trends, and its strategic initiatives, and speak only as of the date of this release. Actual results may differ materially from BIOLASE’s current expectations depending upon a number of factors affecting BIOLASE’s business. These factors include, among others, adverse changes in general economic and market conditions, competitive factors including but not limited to pricing pressures and new product introductions, uncertainty of customer acceptance of new product offerings and market changes, risks associated with managing the growth of the business, and those other risks and uncertainties that may be detailed, from time-to-time, in BIOLASE’s reports filed with the SEC. BIOLASE does not undertake any responsibility to revise or update any forward-looking statements contained herein.