Dental devices maker Biolase (NSDQ:BIOL) touted FDA clearance for its EPIC 10S soft tissue diode laser, which the company can now market for more than 80 indications spanning 19 medical markets.
The EPIC 10S system got the green light for indications in plastic surgery, aesthetics, neurosurgery, orthopedics and more, according to a press release.
"We are extremely pleased to receive clearance for such a broad number of indications and procedures for our EPIC platform," Biolase chairman & CEO Federico Pignatelli said in prepared remarks. "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," Pignatelli added.
The regulatory win was based on a February 2013 win for an older Diolase laser, according to a press release. Biolase claims the next-generation 10S cuts efficiently at low power, and generates less heat and causes less discomfort compared to its peers.
The company also announced today that it has retained the services of Michael Porter of Porter, LeVay & Rose, Inc. to head its investor relations, replacing In-Site Communications Inc. Porter had worked previously with Biolase in the early 2000s, Pignatelli noted.
The full list of Biolase’s EPIC 10S indications is as follows:
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
