Key Developments: BIOLASE Inc (BIOL.PH)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
BIOLASE Inc Announces NewTom BIOLASE VG3 Panoramic Oral X-Ray System Receives FDA Clearance
BIOLASE Inc announced that the U.S. Food and Drug Administration (the FDA) has cleared the NewTom BIOLASE VG3 (VG3) digital panoramic, cephalometric, and tomographic extra-oral X-ray system which BIOLASE will market and distribute in the U.S. for $50,000 to $120,000. BIOLASE is the exclusive distributor of NewTom digital imaging products for the dental market in the U.S. and Canada. The VG3 is a significant complement to the ultra-high performance full field of view (FOV) provided by the NewTom VGi, which is currently distributed by BIOLASE. The new VG3 is a truly modular hybrid 2D/3D system that can start as a digital 2D panoramic X-ray system, which replaces traditional film-based panoramic units, that can be upgraded at any time to add either a cephalometric sensor and software, necessary for orthodontics and diagnosing head, jaw, and facial pain, and/or 3D cone-beam-computed-tomography (CBCT) with an 11" x 8" FOV, used for implants, endodontics, gum disease, sinus problems, and oral and maxillofacial surgery. The VG3 comes equipped with NewTom's NNT 4.0 imaging analysis software and incorporates NewTom's patented Safebeam technology which emits the lowest possible dosage of radiation. Safebeam technology automatically adjusts the radiation dosage and continuously monitors systems operations thereby eliminating the possibility of unnecessary exposures making it the safest available for patients and staff. Full Article
BIOLASE Inc Reaffirms FY 2013 Revenue Guidance
BIOLASE Inc announced that for fiscal 2013, reiterating its revenue expectation of approximately $68 million to $72 million. The midpoint of $70 million represents a 22% increase over 2012 net revenue and would also represent record revenue for the Company. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $69 million for fiscal 2013. Full Article
BIOLASE Inc Secures New Patent For Non-Contact Handpiece For Tissue Cutting
BIOLASE Inc announced that the U.S. Patent and Trademark Office has issued BIOLASE a new patent for non-contact handpiece for cutting both hard and soft tissue with revolutionary line of WaterLase all-tissue lasers. Full Article
BIOLASE Inc Receives FDA Clearance For EPIC 10S Soft Tissue Diode Laser For Broad Spectrum Of Medical Procedures
BIOLASE Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the EPIC 10S soft tissue diode laser for use as a surgical instrument for over 80 different indications in 19 medical markets including: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, orthopedics, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery (see Exhibit A for a detailed listing of medical markets and indications). The EPIC 10S is the surgical model of the recently released, dental EPIC 10. BIOLASE's diode lasers are currently used in dentistry for a wide variety of surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel, or electrosurge. The 940nm laser wavelength of the EPIC 10 platform is better absorbed by hemoglobin (Hb) and oxyhemoglobin (HbO2) than other diode laser wavelengths, so it cuts efficiently at low power and with considerably less heat and discomfort, making it an excellent alternative to conventional surgical devices. BIOLASE's EPIC 10 940nm wavelength diode laser uses disposable tips which help reduce the risk of infection and cross contamination and is also FDA cleared for tooth whitening and temporary pain relief. Full Article
BIOLASE Inc Issues Q1 2013 Revenue Guidance In Line With Analysts' Estimates; Issues FY 2013 Revenue Guidance Above Analysts' Estimates
BIOLASE Inc announced that for the first quarter of 2013, it expects net revenue of approximately $14.0 million to $15.0 million. For fiscal 2013, it expects net revenue of approximately $68 million to $72 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $14.4 million for the first quarter of 2013 and revenue of $67 million for fiscal 2013. Full Article
BIOLASE Inc Declares Stock Dividend
BIOLASE Inc announced that the Board of Directors has declared a 1.5% stock dividend payable on March 29, 2013, to stockholders of record on March 15, 2013. In addition, the Board adopted a 2% annual stock dividend policy for 2013. Full Article
BIOLASE Inc Raises Q4 2012 Revenue Guidance
BIOLASE Inc announced that for the fourth quarter of 2012, it expects to exceed its previous guidance and report net revenue in excess of $18 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $18 million for the fourth quarter of 2012. Full Article
BIOLASE Inc Declares Stock Dividend For 2012 Fourth Quarter
BIOLASE Inc announced that Board of Directors has declared a 1.5% stock dividend payable on December 28, 2012, to stockholders of record on December 14, 2012. Full Article
BIOLASE Inc Issues Q4 2012 Revenue Guidance In Line With Analysts' Estimates; Comments On Q4 2012 Net Income Guidance; Issues FY 2012 Revenue Guidance In Line With Analysts' Estimates
BIOLASE Inc announced that for the fourth quarter of 2012, it expects net revenue to be approximately $16.5-$17.5 million and expects to generate non-GAAP net income positive. For fiscal 2012, it expects non-GAAP adjusted gross revenue of $55-$58 million which excludes the $1.1 million reduction in net revenue from the inventory re-purchase from Schein during the second quarter of 2012. Therefore, the Company's GAAP revenue guidance, which includes the $1.1 million reduction in net revenue from the inventory re-purchase from Schein during the second quarter of 2012, is effectively $53.9-$56.9 million for fiscal 2012. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $17.9 million and net income of $(0.17) for the fourth quarter of 2012 and revenues of $56.9 million for fiscal 2012. Full Article
BIOLASE Inc Receives FDA Clearance And CE Mark For EPIC 10 Diode Soft Tissue Laser
BIOLASE Inc announced that it has received 510 clearance from the U.S. Food and Drug Administration (FDA) and Conformite Europeene (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. Full Article
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