BIOLASE Receives FDA Clearance for the EPIC 10S Soft Tissue Diode Laser for a Broad Spectrum of Medical Procedures

Download as PDF

Clearance for Over 80 Procedures in 19 Additional Medical Markets

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

Ear, Nose and Throat and Oral Surgery:
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

Arthroscopy:
Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as:

  • Menisectomy
  • Syovectomy
  • Chondromalacia

Gastroenterology:
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

Orthopedics:

  • Dissect and coagulate

General Surgery, Dermatology & Plastic Surgery, and Podiatry:
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

GI/GU:
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

Gynecology:
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

Neurosurgery:
Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as:

  • Hemostasis in conjunction with meningiomas
  • Percutaneous Disc Decompression (PLDD)

Ophthalmology:

  • Dacryocystorhinostomy transcanalicular
  • Open DCR
  • Tumor Excision
  • Blepharoplasty

Pulmonary Surgery:
Hemostasis, vaporization, and excision of tissue, such as:

  • Tracheobronchial malignancy or stricture
  • Benign and malignant pulmonary obstruction

Cardiac Surgery:

  • Coagulation and hemostasis of cardiac tissue

Thoracic Surgery:

  • Thoracotomy
  • Pulmonary resection
  • Hemostasis
  • Pericardiectomy
  • Adhesiolysis
  • Coagulation of blebs and bullae

Urology:
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)

Dermatology/Aesthetics:

  • 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

Vascular Surgery:

  • 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 dental lasers and also distributes and markets dental imaging equipment; products that are focused on technologies that advance the practice of dentistry and medicine. 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 products 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 www.biolase.com, Facebook at www.facebook.com/biolaseinc, Twitter at twitter.com/biolaseinc, and YouTube at www.youtube.com/biolasevideos. 

For further information, please contact:
Michael Porter
Porter, LeVay & Rose, Inc.
212-564-4700

Source: BIOLASE, Inc.

Released April 11, 2013