BIOLASE To Collaborate With St. Barnabas Medical Center In Study Of New Laser, Code Named DRAGON&#0153

Published: Feb 04, 2014

IRVINE, CA--(Marketwired - February 04, 2014) -

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BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, including the Company's proprietary WaterLase, and a pioneer in laser surgery in other medical specialties, as well as a distributor of digital radiography and Galaxy CAD/CAM systems for dentistry, today announced that it has agreed to collaborate with the St. Barnabas Medical Center in New York City to conduct specified research with its recently developed and patent-pending, revolutionary new surgical laser, code named the DRAGON™.

Dr. Dara Rosenberg of St. Barnabas Hospital said, "I am delighted to work with BIOLASE on developing a wound-healing protocol for their new dual wavelength laser. Once Institutional Review Board approval is obtained, I believe a subsequent wound healing study using this protocol has the potential to significantly enhance our current wound healing therapies."

With the DRAGON laser, BIOLASE has recently successfully combined its proprietary WaterLase technology with a diode laser to deliver simultaneous and intertwined laser energy in the same delivery system. The result of two years of research and development, DRAGON differs from BIOLASE's current laser products in that the user may power two or more different wavelengths of laser energy, with the same hand piece, simultaneously. This creates interesting clinical capabilities that could potentially apply to a variety of medical applications. The Company has recently built its tenth fully-functioning prototype, six of which are already involved in pre-clinical testing by key opinion leaders and physicians.

"The DRAGON elevates BIOLASE's patented WaterLase technology to new levels," said Professor and Doctor Norbert Gutknecht of the Aachen Center for Laser Dentistry (the "AALZ") in Germany, the world's largest university-based laser education institute. "The effects of combining two different laser energies emitting through a single fiber is not only remarkable from a technological point of view, but it will revolutionize the biophysical interaction with hard and soft tissue. After undertaking in depth preclinical research with this new extraordinary technology, I am very impressed by the histological results. DRAGON technology offers a radical new hard and soft tissue cutting efficiency combined with a strong pain reduction effects and has the potential to set new landmarks in treating infected tissues due to its high bactericidal effect. One of the preclinical advantages that I have most observed is a notable decrease of the post-op recovery period. We have generated a tremendous amount of positive preclinical data in a very short period of time which will be integrated in a number of new treatment clinical protocols."

Dr. Yosef Krespi, M.D., F.A.C.S, an otolaryngologist at the New York Head & Neck Institute, a part of the North Shore Long Island Jewish hospital system, where he also chairs the Sleep Disorders Center, stated, "I have had the opportunity to test the DRAGON in my laboratory, and this new laser has superior qualities and outstanding performance that should allow surgeons to perform a wide range of minimally invasive hard- and soft-tissue procedures. The DRAGON, with its two unique wavelengths, has the potential to revolutionize laser surgery and become the standard of care in ENT. In addition to its conventional laser tissue effects of precise ablation, coagulation, and char-free cutting, it has the potential to offer a number of unique characteristics such as bio-stimulation, anti-inflammatory, microbial reduction, and biofilm disruption."

Federico Pignatelli, Chairman and CEO, stated, "BIOLASE has historically been categorized as a dental laser company. This innovative new multiple-wavelength laser, code named the DRAGON, has the potential to provide practitioners, across several additional medical specialties, with better treatments and outcomes for their patients. Pending required market clearance by the U.S. Food and Drug Administration, we look forward to introducing this product into the marketplace."

The DRAGON is currently targeted toward several new medical markets for BIOLASE including:

1. Wound healing for burns and trauma: approximately 70,000 people suffer severe large body surface area full-thickness burns each year in the U.S. and we believe that wound debridement is integral during the painful healing phase to optimize clinical outcomes.
2. Wound healing for chronic wounds: some 2.2 million patients in the U.S. and 12.5 million patients worldwide suffer from chronic non-healing wounds which can include venous stasis ulcers, decubitus ulcers, and diabetic foot ulcers. Laser therapy could excise the dead (necrotic) tissue of these difficult-to-treat wounds, leaving the clean, healthy tissue and a fresh wound bed.
3. Otolaryngology ("ENT") surgery: this includes solutions for nasal turbinate reductions, sleep apnea interventions, and the surgical treatment of chronic rhino sinusitis, or CRS. There are approximately 700,000 CRS procedures treated surgically each year in the U.S., and up to 30% of these cases need surgical revisions because of poor healing outcomes.
4. Ophthalmology: treating presbyopia requires precisely cutting the ciliary muscles of the lens, thereby restoring visual accommodation. Keratoconjunctivitis sicca, or "dry eye syndrome," is another target area. BIOLASE has previously addressed this area through a variety of filed and pending U.S. and international patents.

President and COO Alexander K. Arrow, MD, said, "Our next step is to inquire with the Food and Drug Administration regarding acceptable clinical protocols to generate data to support a 510(k) application for the use of the DRAGON as a surgical tool in multiple medical fields. Once the clinical trial design is set, the data generated could be used to support a CE Mark which will allow BIOLASE to provide this technology to clinicians in Europe."

About BIOLASE, Inc.
BIOLASE, Inc. is a biomedical company that develops, manufactures, and markets innovative lasers in dentistry and medicine and also markets and distributes high-end 2D and 3D digital imaging equipment and CAD/CAM intraoral scanners and in-office milling machines; products that are focused on technologies that advance the practice of dentistry and medicine. The Company's proprietary laser products incorporate approximately 300 patented and 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 more than 24,800 lasers. Other laser products under development address ophthalmology and other medical and consumer markets.

For updates and information on WaterLase and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, Pinterest at www.pinterest.com/biolase, LinkedIn at www.linkedin.com/company/biolase, Google+ at www.google.com/+BIOLASEIrvine, Instagram at www.instagram.com/biolaseinc and YouTube at www.youtube.com/biolasevideos.

BIOLASE®, WaterLase®, and DRAGON™ are registered trademarks or trademarks of BIOLASE, Inc.