BIOLASE Receives FDA Clearance for the EPIC 10S Soft Tissue Diode Laser for a Broad Spectrum of Medical Procedures
Clearance for Over 80 Procedures in 19 Additional Medical Markets
(firmenpresse) - IRVINE, CA -- (Marketwired) -- 04/11/13 -- BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today 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, next-generation dental EPIC 10™.
"We are extremely pleased to receive clearance for such a broad number of indications and procedures for our EPIC platform. The clearance for the EPIC 10S is based on the clearance we received in February 2013 for our older Diolase soft tissue diode laser and, needless to say, we are extremely happy to have received it so quickly," said Federico Pignatelli, Chairman and Chief Executive Officer. "This clearance gives us the ability to leverage our EPIC 10™ modular soft tissue diode laser platform and consumable business across a wide range of multi-billion dollar medical markets with appropriate strategic partners or in a direct mode. With the vast number of procedures now available for the EPIC, the opportunities for this new modular platform are tremendous."
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.
"It is truly remarkable to see how our core technologies can impact so many other medical fields. Our 940nm diode lasers are excellent alternatives to conventional surgical devices and we have already begun performing clinical studies for a variety of these new applications and some of our early results have been extraordinary," said Fred Furry, Chief Operating Officer and Chief Financial Officer. "Our plan remains to focus on growing our core laser business in the dental market but we will also continue to expand the capabilities, applications, and indications for these core technologies in other medical markets, as well."
Exhibit A - Detailed Listing of Medical Markets and Indications for Use
Hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity, such as:
Removal of benign lesions from ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in-situ
Ablation and vaporization of hyperkeratosis
Laryngeal papillectomy
Excision and vaporization of herpes simplex I and II
Neck dissection
Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as:
Menisectomy
Syovectomy
Chondromalacia
Hemostasis, incision, excision, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as:
Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps
Hemostasis of colonoscopy
Hemostasis of esophageal varices
Dissect and coagulate
Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of Keloids
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcer
Hepatobiliary
Mastectomy
Dermabrasion
Vaporization & hemostasis of capillary hemangioma
Excision, vaporization & hemostasis of abdominal tumors
Excision, vaporization & hemostasis of rectal pathology
Pilonidal cystectomy
Herniorraphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystecomy
Thyroidectomy
Resection of organs
Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as:
Hemorrhoidectomy
Excision, vaporization, and hemostasis of rectal pathology
Excision, vaporization, and hemostasis of abdominal tumors
Ablation, excision, hemostasis, and vaporization of tissue, such as:
Excision or vaporization of condylomata acuminata
Vaporization of CIN (cervical intraepithelial neoplasia)
Cervical conization
Menorrhagia
Ovarian cystectomy
Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as:
Hemostasis in conjunction with meningiomas
Percutaneous Disc Decompression (PLDD)
Dacryocystorhinostomy transcanalicular
Open DCR
Tumor Excision
Blepharoplasty
Hemostasis, vaporization, and excision of tissue, such as:
Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
Coagulation and hemostasis of cardiac tissue
Thoracotomy
Pulmonary resection
Hemostasis
Pericardiectomy
Adhesiolysis
Coagulation of blebs and bullae
Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as:
Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia
Circumcision
Vaporization of the prostate to treat benign prostate hyperplasia (BPH)
Photocoagulation of vascular & dermatological lesions of the face and extremities
Photocoagulation of telangiectasia, venulectasia of the legs and face
Treatment of reticular veins and branch varicosities
Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi
Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement
Seborrheic keratosis
Mixoid cyst
Papillary varix
Acne treatment
Photocoagulation of vascular & dermatological lesions of the face and extremities
Photocoagulation of telangiectasia, veinulectasia of the legs and face
Treatment of reticular veins and branch varicosities
About BIOLASE, Inc.
BIOLASE, Inc. is a biomedical company that develops, manufactures and markets and also distributes and markets dental ; products that are focused on technologies that advance the practice of dentistry and . The Company's laser products incorporate over 340 patented and patent-pending technologies designed to provide biologically clinically superior performance with less pain and faster recovery times. Its imaging products provide cutting-edge technology at competitive prices to deliver the best results for dentists and patients. BIOLASE's principal are 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 22,000 lasers. Other products under development address ophthalmology and other medical and consumer markets.
For updates and information on WaterLase and laser dentistry, find BIOLASE online at , Facebook at , Twitter at , and YouTube at .
For further information, please contact:
Michael Porter
Porter, LeVay & Rose, Inc.
212-564-4700
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Datum: 11.04.2013 - 07:00 Uhr
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