Global leader in dental lasers, BIOLASE, Inc. (NASDAQ:BIOL), announces it has received 510(k) clearance for commercial distribution from the USFDA and can now be sold in the U.S.
IRVINE, Calif.–(BUSINESS WIRE)–
BIOLASE, Inc., (BIOL) the global leader in dental lasers, announced today its Epic Pro™ laser system, a new, innovative dental diode laser system that offers higher laser power than most diode lasers in dentistry, has received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA). The Epic Pro laser system, which received marketing authorization in select international markets late last year, can now be sold in the U.S.
The newest addition to the Company’s Epic portfolio of soft-tissue diode lasers, Epic Pro offers important advancements in cutting speed, control, precision and improvements in consistency and predictability.
The Epic Pro is the first commercially available laser system resulting from BIOLASE’s strategic development agreement with IPG Medical Corporation, a subsidiary of IPG Photonics Corporation, reached in 2015.
“The collaboration between IPG Medical and BIOLASE has been exciting,” said IPG Medical President Gregory Altshuler, Ph.D. “The Epic Pro with IPG Medical’s super pulse diode laser offers all new computer-controlled thermal super pulsing capability with real-time tip temperature monitoring and automatic power control designed to assist dentists in performing procedures quickly and with great precision. This new feature is a very significant innovation that we believe will provide the technological basis for other clinical modalities.”
BIOLASE President and CEO Harold C. Flynn, Jr. noted that the Company’s worldwide launch is now underway with systems available for delivery in the U.S. and select international markets.
“We are proud to expand the BIOLASE product portfolio by introducing the Epic Pro as our premium diode laser solution. There is nothing else like it on the market,” Flynn said. “The high end capabilities of this new laser, such as its cutting speed, power and control, allow us to access market segments we have not been able to before, such as the oral and maxillofacial surgeon markets, which previously had not been interested in diode lasers. This advanced new laser system also provides us a platform for the future expansion of our capabilities and indications. Epic Pro represents our ongoing commitment to elevating the standard of care in dentistry, and achieving better patient reported outcomes while enabling clinicians to realize better business returns.”
To learn more about Epic Pro visit www.biolase.com
About BIOLASE, Inc.
BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine and also markets, sells, and distributes dental imaging equipment, including digital x-rays and CAD/CAM scanners. BIOLASE’s products are focused on technologies that advance the practice of dentistry to both dentists and their patients. BIOLASE’s proprietary laser products incorporate approximately 255 patented and 90 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 approximately 32,800 laser systems to date in over 90 countries around the world. Laser products under development address BIOLASE’s core dental market and other adjacent medical and consumer markets.
For updates and information on Waterlase® iPlus™ and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, LinkedIn at www.linkedin.com/company/biolase, Instagram at www.instagram.com/biolaseinc, and YouTube at www.youtube.com/biolasevideos.
BIOLASE® and WaterLase® are registered trademarks and Epic Pro™ is a trademark of BIOLASE, Inc.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Statements contained in this press release that refer to BIOLASE’s estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements in this press release concerning prospects related to BIOLASE’s strategic initiatives and anticipated financial performance. Forward-looking statements can also be identified through the use of words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “may,” “will,” and variations of these words or similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE’s current expectations regarding existing trends, and its strategic initiatives, 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 affecting BIOLASE’s business. These factors include, among others, 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 may be detailed, from time-to-time, in BIOLASE’s reports filed with the SEC. BIOLASE does not undertake any responsibility to revise or update any forward-looking statements contained herein.
BIOLASE, Inc. (NASDAQ:BIOL) shares are trading +14.29% on the news and in the range of $1.56 – 1.84 during the current trading session. When taking a look at which direction the stock might be headed, investors often look to brokerage analysts who cover the stock. Sell-side research firms on Wall Street currently have a consensus one-year price target of $2.00 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call.
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Sell-side analysts are projecting earnings per share of $0.00 for the next fiscal quarter. For the current year, analysts are predicting earnings of $-0.14 per share according to First Call.
In looking at where the stock is trading on a technical level, the stock is trading +3.09% away from its 50-day moving average of $1.63. Based on the most recent available data, the equity is -15.15% off of its 52-week high of $1.98 and +124.00% away from its 52-week low which is $0.75.
Today, the stock opened at $1.75 and the last bid at the time of writing stood at $1.68. During the session thus far, the equity dipped down to $1.56 and touched $1.84 as the high point. BIOLASE, Inc. (NASDAQ:BIOL) has a market cap of $113.51M and has seen an average daily volume of 87,897 over the past three months.
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