BioLase Branches Out Of Dentistry With WaterLase® iPlus® All-Tissue FDA Nod

In short

BIOLASE, Inc. , the world’s leading manufacturer and distributor of dental lasers, announced today that the U.S. FDA has cleared the WaterLase® iPlus® all-tissue laser for use as a surgical instrument for soft-tissue procedures in orthopedic and podiatric surgery.

Background

BIOLASE, Inc. develops, manufactures, and markets lasers in dentistry and medicine and also markets and distributes dental imaging equipment. The Company’s laser products incorporate over 340 patented and patent-pending technologies aimed at optimising performance, minimising pain and shortening recovery time.

The company’s WaterLase iPlus has now been specifically FDA cleared for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including soft and cartilaginous tissue in small and large joints.

Company comments

“We are extremely pleased to receive this first non-dental WaterLase clearance related specifically to our revolutionary iPlus,” said Federico Pignatelli, Chairman and Chief Executive Officer. “This clearance gives us the ability to leverage our flagship iPlus and its related consumables business in the orthopedic and podiatric markets, each with tremendous potential. Just the top ten orthopedic surgical soft-tissue procedures, for example, offer a $2.6 billion market opportunity for our WaterLase technology.”

Amado Carino, MD, Global Clinical Affairs Manager, said, “During the past several years, the use of lasers in orthopedic surgery has become more accepted as a less invasive alternative to conventional surgery and it has become clear that modern lasers will play a significant role in the treatment of musculoskeletal injuries. Procedures can include debridement of both healthy and diseased tissue, soft tissue release, tendon transfer, incision, excision, coagulation and hemostasis, and nerve and vascular repair, both in the upper and lower extremities of the human body. These types of soft-tissue procedures are generally performed in an out-patient setting and with its revolutionary Er,Cr:YSGG laser technology, the WaterLase iPlus will provide an innovative and relevant alternative to orthopedic and podiatric surgeons.”

Source: BioLase, Inc., Marketwired