Eckert & Ziegler’s SagiNova® afterloader receives FDA market clearance
2015-04-23 / Eckert & Ziegler has received market clearance from the U.S. Food and Drug Administration (FDA) for its new SagiNova® afterloader. The receipt of approval marks yet another milestone in the company’s expansion in the U.S. brachytherapy market. North America is the largest homogeneous market for brachytherapy, a form of radiation therapy that applies radiation directly on the tumor location. Almost 40 % of all tumor irradiation equipment installed worldwide is located at the 2,400 radiation therapy centers in the U.S. Temporary brachytherapy is especially widely used for gynecological applications. However, its wide range of potential applications also allows it to be used on other forms of cancer.
“Eckert & Ziegler BEBIG and Mick Radio-Nuclear Instruments, a U.S. company that we acquired in 2013, have decades of experience in the field of HDR technology. We estimate the annual market volume for tumor irradiation systems in the U.S. to be almost € 50 million, and we’re happy to play an increasingly important role in this market,” says Dr. Edgar Löffler, Member of the Executive Board of Eckert & Ziegler AG in charge of the Radiation Therapy segment.
SagiNova® is the only brachytherapy afterloader available with both a Co-60 and an Ir-192 source with 510(k) approval.
HDR brachytherapy involves placing a miniaturized radiation source in the tumor site for a short period of time and is an integral part of cancer treatment. Patients often receive HDR brachytherapy as a stand-alone treatment or in combination with external radiation therapy or chemotherapy. Based on the age-standardized number of new cases per 100,000 inhabitants, 25 % more people develop cancer in the U.S. than in Europe.
SagiNova® will be unveiled to the public at ESTRO Forum, the annual conference of the European Society for Radiotherapy & Oncology, in Barcelona (April 24–28, 2015).
SagiNova® was awarded a CE mark in late 2014.
About Eckert & Ziegler
With around 700 employees, Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700) is one of the world’s largest providers of isotope technology components for radiation therapy and nuclear medicine.
Contributing to saving lives
For enquiries, please contact:
Eckert & Ziegler AG, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany