BIOLASE and EdgeEndo Announce Plans to Develop New EdgePRO Laser-Assisted

Posted on April 20, 2021

BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, and EdgeEndo, a global leader in commercializing endodontic products, announced in association with the American Association of Endodontists (AAE) Annual Meeting beginning on April 21, 2021, the co-development of EdgePRO, a next-generation Laser-Assisted Microfluidic Irrigation device for endodontists. This new Microfluidic Irrigation device is being developed to offer a solution for endodontists seeking more from their current cleaning and disinfection techniques, such as sodium hypochlorite, ethylenediaminetetraacetic acid, chlorhexidine or 2-in-1 or 3-in-1 irrigation solutions. BIOLASE anticipates submitting a premarket notification (510(k)) to the Food and Drug Administration for the co-developed device in the second quarter of 2021. The device is not currently available for sale in the United States.

The EdgePRO Laser-Assisted Microfluidic Irrigation device will build upon BIOLASE’s patented and proven platform that has been shown to significantly improve debridement1, cleaning and disinfection up to 99%2-4, and removes smear layer 5-9 and biofilms10,11 using the most advanced laser light sound technology with traditional irrigation solutions.

“We had been researching advanced Microfluidic Irrigation technologies in the high-tech endodontic irrigation market for several years and concluded that BIOLASE would be an ideal business partner for EdgeEndo,” said Dr. Charles Goodis, DDS, EdgeEndo founder and CEO. “Their proprietary Waterlase Er,Cr:YSGG technology has proven to be clinically effective in endodontics over the last 20 years. This is reinforced by the publication of more than 75 research papers and the technology’s use by thousands of dentists around the world to enhance clinical outcomes. Partnering with BIOLASE will provide us with access to an endodontic-specific, minimally invasive technology, with proprietary and patented radial firing tip technology to incorporate into our EdgePRO product. We are excited about this collaboration and in the near term look forward to developing a technology for endodontists that has the potential to improve patient experiences and clinical outcomes.”

BIOLASE President and CEO, John Beaver adds, “We are very pleased with the efforts thus far on the design and performance of the EdgePRO as our first OEM laser product. Approximately 75% of all endodontists routinely use EdgeEndo endodontic files, burs, and bioceramics, providing reach and relationships with the endodontists that will further our goal of making Waterlase technology the standard of care in endodontics. This allows BIOLASE to focus its commercial channels on other specialties, such as periodontics and pediatrics, in addition to the approximately 200,000 general dentists in the United States. We look forward to a long and beneficial relationship with EdgeEndo.”

Supporting the needs of endodontists is part of BIOLASE's continued effort to help improve patient experiences and outcomes, while also educating providers on the benefits of dental lasers. This announcement comes on the heels of the recently developed Waterlase Endo Academy, open to all Waterlase endodontists. Learn more about the benefits of laser dentistry in endodontics at biolase.com/betterendo.

About BIOLASE, Inc.

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE's products advance the practice of dentistry and medicine for patients and healthcare professionals. BIOLASE's proprietary laser products incorporate approximately 271 patented and 40 patent-pending technologies designed to provide biologically and clinically superior performance with less pain and faster recovery times.

BIOLASE's innovative products provide cutting-edge technology at competitive prices to deliver superior 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. BIOLASE has sold over 41,200 laser systems to date in over 80 countries around the world. Laser products under development address BIOLASE's core dental market and other adjacent medical and consumer applications.

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

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

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