Landmark Study Performed by the Independent McGuire Institute Confirms Positive 12 Month Clinical Outcomes for BIOLASE REPAIR® Perio Protocol

Rhea-AI Summary

BIOLASE, Inc. (NASDAQ: BIOL) announced groundbreaking findings from a 12-month follow-up to a clinical trial at The McGuire Institute™, validating BIOLASE REPAIR® Perio Protocol as a superior alternative for treating intrabony periodontal defects. The study compared BIOLASE's protocol to the traditional minimally invasive surgical technique (MIST) and found similar clinical outcomes, enhanced patient experience, safety, minimal invasiveness, and faster recovery.

Positive

• The study confirms the effectiveness of BIOLASE's Waterlase REPAIR® Perio protocol, providing a safe and patient-friendly alternative to surgical treatment for intrabony periodontal defects.
• Patients who underwent BIOLASE's Waterlase REPAIR® Perio laser treatment reported significantly better patient-reported outcomes (PROs) at six months, indicating a more comfortable and less invasive approach to periodontal care.
• The study found no adverse events associated with BIOLASE's Waterlase REPAIR® Perio laser procedure, highlighting its safety and minimal invasiveness.
• Patients in the BIOLASE Waterlase group reported a quicker reduction in swelling and discomfort, suggesting a faster and more comfortable recovery compared to traditional treatment.

Negative

• None.

Validates BIOLASE REPAIR^® Perio Protocol is a Superior Alternative as it pertains to patient reported outcomes.

LAKE FOREST, Calif., Nov. 8, 2023 /PRNewswire/ -- BIOLASE, Inc.(NASDAQ: BIOL), the global leader in dental lasers, today announced groundbreaking findings from a 12-month follow-up to a clinical trial performed at The McGuire Institute™. The findings will be published in the November 2023 issue of the Journal of Periodontology. The pioneering study was designed to meet the stringent American Association of Periodontology Best Evidence Consensus (BEC) standards, and is the first-of-its-kind study to compare BIOLASE's REPAIR^® Perio protocol to the traditional minimally invasive surgical technique (MIST) treatment of moderate to severe generalized periodontitis.

Key highlights include:

• Clinically Proven and Validated by Scientific Research
  The study confirms that BIOLASE's Waterlase REPAIR^® Perio protocol has similar and sustainable clinical outcomes as compared to traditional MIST in treating intrabony defects over the 12-month study thus reaffirming rigorous scientific research and the laser's clinical efficacy.
  
  
• Enhanced Positive Patient Experience
  Patients who underwent BIOLASE's Waterlase REPAIR^® Perio laser treatment reported significantly better patient-reported outcomes (PROs) at six months. These findings show that patients experienced less pain, reduced bleeding, and minimal discomfort, indicating a patient-friendly approach to periodontal care.
  
  
• Safety and Minimal Invasiveness
  The study found no adverse events associated with BIOLASE's Waterlase REPAIR^® Perio laser procedure, highlighting its safety. Furthermore, it emphasizes that this laser treatment is minimally invasive, ensuring a highly effective and more comfortable experience for patients.
  
  
• Faster Recovery
  Patients in the BIOLASE Waterlase group reported a quicker reduction in swelling and discomfort, suggesting a faster and more comfortable recovery compared to traditional treatment.

"This exciting study provides further strong evidence that our Waterlase laser and REPAIR^® Perio protocol is a safe and effective alternative to surgical treatment for intrabony periodontal defects with lasting results," said Dr. Russell Morrow, the Chief Dental Officer at BIOLASE. "The results ensure patients will not have to compromise on effectiveness, or comfort when choosing a less invasive approach."

BIOLASE's Waterlase laser is a minimally invasive laser that can be used to treat a variety of dental conditions, including intrabony periodontal defects. Intrabony periodontal defects are pockets that form between the tooth and bone and can lead to tooth loss. The Waterlase laser works by vaporizing the diseased tissue and stimulating the body to produce new bone and gum tissue.

"The study provides a firm rationale for an alternative surgical approach in the treatment of intrabony periodontal defects and forges the path for future comparisons using regenerative therapies in conjunction with the REPAIR^® Perio technique," said Rick H. Heard, DDS, MS and Executive Director of Clinical Research and Operations of the McGuire Institute, a network of master clinicians trained and qualified to conduct high level clinical research in a practice based setting and located strategically throughout the United States. "It also supports superiority over a minimally invasive surgical technique with respect to patient reported outcomes."

Additionally, the McGuire study has earned a well-deserved nomination for the 2024 DrBicuspid Dental Excellence Awards, affectionately known as the "Cuspies," a platform to honor the best in dental innovation and excellence. Among the esteemed categories, the "Dental Study of the Year" spotlights research that promises to reshape the future of dental practice.

Winning this prestigious award at the Cuspies would not only be an accolade, but a testament to how the McGuire study could potentially redefine and elevate the standard of care for periodontal patients globally. It is an opportunity to celebrate a study with the power to reshape the landscape of periodontal treatment, setting new benchmarks for excellence in the dental field.

About BIOLASE

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. As of December 31, 2022, BIOLASE's proprietary laser products incorporate approximately 259 patented and 24 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 dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. From 1998 through December 31, 2022, BIOLASE has sold over 45,500 laser systems 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.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements, regarding BIOLASE's expected revenue and revenue growth and beliefs regarding its financial resources. Forward-looking statements can be identified through the use of words such as "may," "might," "will," "intend," "should," "could," "can," "would," "continue," "expect," "believe," "anticipate," "estimate," "predict," "outlook," "potential," "plan," "seek," and similar expressions and variations or the negatives of these terms or other comparable terminology. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE's current expectations 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. These factors include, among others, the coronavirus (COVID-19) and the effects of the outbreak and actions taken in connection therewith, 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 are described in the "Risk Factors" section of BIOLASE's most recent annual report filed on Form 10-K filed with the Securities and Exchange Commission. Except as required by law, BIOLASE does not undertake any responsibility to revise or update any forward-looking statements.

For further information, please contact:

EVC Group LLC
Michael Polyviou / Todd Kehrli
(732) 933-2754
mpolyviou@evcgroup.com / tkehrli@evcgroup.com

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SOURCE BIOLASE, Inc.

FAQ

What are the key highlights of the groundbreaking findings from BIOLASE's clinical trial at The McGuire Institute™?

The study validated BIOLASE REPAIR® Perio Protocol as a superior alternative for treating intrabony periodontal defects, with similar clinical outcomes, enhanced patient experience, safety, minimal invasiveness, and faster recovery compared to traditional treatment.

What are the benefits of BIOLASE's Waterlase REPAIR® Perio protocol?

The protocol provides a safe and patient-friendly alternative to surgical treatment for intrabony periodontal defects, with better patient-reported outcomes, minimal invasiveness, and faster recovery.

What recognition has the McGuire study received?

The McGuire study has earned a nomination for the 2024 DrBicuspid Dental Excellence Awards, particularly for the 'Dental Study of the Year' category, showcasing its potential to reshape the future of dental practice.

How does the McGuire study impact the landscape of periodontal treatment?

The study has the potential to redefine and elevate the standard of care for periodontal patients globally, setting new benchmarks for excellence in the dental field.