Edap TMS SA was incorporated on December 3, 1979 as a Societe Anonyme organized under the laws of the Republic of France for 60 years from the date of incorporation. It is a holding Company and is responsible for providing common services to its subsidiaries, including preparation and consolidation of the financial statements for the group, complying with the requirements of various regulatory agencies and maintaining the listing of its publicly held securities. Its activity is organized in two divisions: HIFU and UDS. Through these two divisions, the Company develops, produces and markets minimally invasive medical devices, mainly for urological diseases. It's HIFU and UDS divisions operate in Europe, the Americas, Asia and the rest of the world. The HIFU division is engaged in the development, manufacturing and marketing of medical devices based on HIFU technology for the minimally invasive treatment of urological and other clinical indications. Its HIFU business is quite seasonal and generally linked to lengthy hospital decision and investment processes. In addition to developing, manufacturing and marketing HIFU devices, the HIFU division also generates revenues from leasing equipment, as well as from the sale of disposables, spare parts and maintenance services. Currently, the only commercial product of the Company utilizing HIFU technology is the Ablatherm, an ultrasound guided HIFU device for the treatment of organ-confined prostate cancer. As of December 31, 2013, the HIFU division's patent portfolio contained 36 patents consisting of 16 in the United States, 18 in the European Union and Japan and 2 in Israel and the rest of the world. The Company belongs to 18 groups of patents covering key technologies related to therapeutic ultrasound principles, systems and associated software. The UDS division's main business is producing and marketing devices, known as lithotripters, for the treatment of urinary tract stones by means of ESWL technology. In addition to its manufacturing and selling of lithotripters, the UDS division also generates revenues from the leasing of lithotripters, as well as from the sale of disposables, spare parts and maintenance services. The UDS division offers the Sonolith i-move to small and mid-size hospitals, while the Sonolith i-sys is offered to large hospitals that can afford a fully dedicated and integrated lithotripter. Ablatherm-HIFU device competes with all current treatments for localized tumors, which include surgery, brachytherapy, radiotherapy, cryotherapy and hormonotherapy. The Company and its products are regulated in the United States by the FDA under a number of statutes including the Federal Food, Drug and Cosmetic Act.
Benzinga is a fast-growing, dynamic and innovative financial media outlet that empowers investors with high-quality, unique content.