BIOLASE Receives FDA Clearance and CE Mark for Its "EPIC 10" Diode Soft Tissue Laser

Date Announced: 03 Oct 2012

New product immediately offered for sale in US.

IRVINE, CA--(Marketwire - October 03, 2012) - BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Conformité Européene (CE) Mark approval for its EPIC 10™ diode soft tissue laser.

BIOLASE initiated commercial sales in the final days of the third quarter of 2012 throughout the European Union and in those Asian and Latin American countries that recognize the CE Mark. The Company received notification of clearance from the FDA on October 1, 2012, and immediately began offering the EPIC 10 for sale in the U.S.

Federico Pignatelli, Chairman and Chief Executive Officer, said, "We are extremely pleased to have received FDA clearance and the CE Mark for the EPIC 10, the next generation of our diode laser technology platform. These are very significant milestones for BIOLASE. It also marks the second FDA clearance received since the new management team was put in place under my leadership. With its superior technology and design features, and total suite of treatment offerings, we expect that the EPIC 10 will develop into a substantial revenue driver."

Innovations include the evolution of ComfortPulse™, BIOLASE's proprietary technology that allows dentists to precisely control the level of laser energy that penetrates the target tissue. ComfortPulse keeps patients more comfortable by avoiding pain-inducing heat buildup at the surgical site, which can also cause excessive tissue damage. ComfortPulse can reduce laser pulses to as little as a ten-millionth of a second, with longer periods of "off" time, which results in greater patient comfort.

"While the EPIC 10 became available to sell in a limited number of countries internationally only in the final days of the third quarter of 2012, BIOLASE enjoyed solid year over year and sequential growth in its core Waterlase™ products, enabling the Company to meet its previously stated financial guidance for the quarter. We are very pleased with the backlog we have generated internationally for the EPIC 10, as well as very strong domestic interest. We expect the EPIC 10 to make significant contributions to our revenue in the 2012 fourth quarter and beyond," Pignatelli concluded.

Chief Technology Officer Dmitri Boutoussov, PhD, said, "This next generation diode soft tissue laser allows for cleaner cutting, superior hemostasis, improved patient comfort, and greater versatility. Further, the EPIC 10 features a revolutionary and intuitive applications-based user interface with a high-resolution touch screen pre-programmed with 15 of the most commonly performed soft tissue procedures, including Pain Therapy, which is a highly popular treatment in the dental community for addressing pain in the oral-maxillofacial region."

Source: Biolase

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