BIOLASE and EdgeEndo Announce Plans to Develop New EdgePRO Laser-Assisted Microfluidic Irrigation Device for Endodontists

Rhea-AI Summary

BIOLASE (NASDAQ: BIOL) and EdgeEndo announced a partnership to develop the EdgePRO Laser-Assisted Microfluidic Irrigation device. This device aims to enhance endodontic cleaning and disinfection techniques, building upon BIOLASE's established technology that improves debridement and biofilm removal. A premarket notification to the FDA is anticipated in Q2 2021, with the device currently unavailable for sale in the U.S. The collaboration leverages both companies' strengths, aiming to improve patient outcomes and facilitate broader usage of laser technology in dentistry.

Positive

• Collaboration with EdgeEndo to develop innovative EdgePRO device.
• Establishment of advanced cleaning technology with proven efficacy.
• Expected submission for FDA premarket notification by Q2 2021.

Negative

• The EdgePRO device is not yet available for sale in the U.S.
• Potential reliance on FDA approval timeline for market entry.

FOOTHILL RANCH, Calif., April 20, 2021 /PRNewswire/ -- 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 biofilms^10,11 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.

1. Montero-Miralles P, Torres-Lagares D, Segura-Egea J-J, Serrera-Figallo M-A, Gutierrez-Perez J-L, Castillo-Dali G. Comparative study of debris and smear layer removal with EDTA and Er,Cr:YSGG laser. Journal of Clinical and Experimental Dentistry. 2018;10(6):598-602. doi:10.4317/jced.54936
2. Juric IB, Plecko V, Anic I. Antimicrobial Efficacy of Er,Cr:YSGG Laser-Activated Irrigation Compared with Passive Ultrasonic Irrigation and RinsEndo((R)) Against Intracanal Enterococcus faecalis. Photomedicine and Laser Surgery. 2014;32(11):600-605. doi:10.1089/pho.2014.3767
3. Betancourt, Sierra, Camps-Font, Arnabat-Domínguez, Viñas. Er,Cr:YSGG Laser-Activation Enhances Antimicrobial and Antibiofilm Action of Low Concentrations of Sodium Hypochlorite in Root Canals. Antibiotics. 2019;8(4):232. doi:10.3390/antibiotics8040232
4. Gordon W, Atabakhsh VA, Meza F, et al. The antimicrobial efficacy of the Er,Cr:YSGG laser with radial emitting tips on root canal dentin walls infected with E faecalis. JADA. 2007;138(July):992-1002. doi:10.14219/jada.archive.2007.0297
5. Silva, Anna Cristina Biella et al. "Analysis of Permeability and Morphology of Root Canal Dentin After Er,Cr:YSGG Laser Irradiation." Photomedicine and Laser Surgery 28.1 (2010): 103–108. Print.
6. Madhusudhana, Koppolu et al. "Effect of Endoactivator and Er,Cr:YSGG Laser Irradiation in Removing the Smear Layer after Root Canal Instrumentation: An in Vitro Study." Journal of Dr. NTR University of Health Sciences 5.1 (2016): 24. Web.
7. Soares, Flavio et al. "Impact of Er,Cr:YSGG Laser Therapy on the Cleanliness of the Root Canal Walls of Primary Teeth." Journal of endodontics 34.4 (2008): 474–7. Web. 25 Jan. 2012.
8. Ishizaki, Nelson Tatsunari et al. "Thermographical and Morphological Studies of Er,Cr:YSGG Laser Irradiation on Root Canal Walls." Photomedicine and laser surgery 22.4 (2004): 291–7. Web.
9. Peeters, Harry Huiz, and Ketut Suardita. "Efficacy of Smear Layer Removal at the Root Tip by Using Ethylenediaminetetraacetic Acid and Erbium, Chromium: Yttrium, Scandium, Gallium Garnet Laser." Journal of Endodontics 37.11 (2011): 1585–1589. Web.
10. Schoop, U et al. "The impact of an erbium, chromium:yttrium-scandium-gallium-garnet laser with radial-firing tips on endodontic treatment." Lasers in medical science 24.1 (2009): 59–65. Web. 5 Dec. 2011.
11. Arnabat, Josep et al. "Bactericidal Activity of Erbium, Chromium: Yttrium–scandium–gallium–garnet Laser in Root Canals." Lasers Medical Science 25 (2010): 805–810. Web.

 

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SOURCE BIOLASE, Inc.

FAQ

What is the EdgePRO Laser-Assisted Microfluidic Irrigation device?

The EdgePRO device is a new product being co-developed by BIOLASE and EdgeEndo to enhance cleaning and disinfection in endodontics.

When will the EdgePRO device be submitted for FDA approval?

BIOLASE anticipates submitting a premarket notification for the EdgePRO device in the second quarter of 2021.

Is the EdgePRO device currently available for purchase?

No, the EdgePRO device is not currently available for sale in the United States.

What technology does the EdgePRO device utilize?

The EdgePRO utilizes BIOLASE's patented Waterlase Er,Cr:YSGG technology for improved cleaning and disinfecting in endodontics.

How does the collaboration with EdgeEndo benefit BIOLASE?

This partnership enhances BIOLASE's product offerings and positions its laser technology as the standard of care in endodontics.