FDA market clearance received for HDR brachytherapy afterloader SagiNova®

2015-04-23 Page Views : 931 Author : Admin

Important Notes:

In January 2021, BEBIG Medical GmbH took over the global production and distribution structures of the HDR brachytherapy products of Eckert & Ziegler BEBIG GmbH including Mick Radio-Nuclear Instruments, Inc.

Below news are related to the HDR brachytherapy business and is quoted originally from the website:

Original Content:

Eckert & Ziegler has received market clearance from the U.S. Food and Drug Administration (FDA) for its new SagiNova® afterloader has been recieved. 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, hav decades of experience in the filed of HDR technology. We estimat the annual market volume for tumor irradiation systems in the U.S. to be almost EUR 50 million, and we're happy to play an increasingly important role in this market," says Dr. Edgar Löffler, Member of 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 combination with external radiation therapy or chemotherapy. Based on the aged-standarized 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 Radiothrapy & Oncology, in Barcelona (April 24-28, 2015).

SagiNova® was awarded a CE mark in late 2014.

About BEBIG Medical GmbH:

BEBIG Medical GmbH (“BEBIG Medical”) is a global provider of high quality radiation therapy products for cancer treatment headquartered in Berlin, Germany. Preceded by the high dose brachytherapy business unit of Eckert & Ziegler AG, BEBIG Medical has a heritage of more than 40 years’ experience in brachytherapy field and continues to provide affordable healthcare with proven clinical outcomes via strong and viable technology.BEBIG Medical’s US subsidiary, Mick Radio-Nuclear Instruments, Inc., is also known internationally for its manufacturing expertise in the field of applicators and accessories to advance brachytherapy. With a team of professionals and offices in Europe, United States and Asia, the company is empowered to serve customers in more than 65 countries and regions together with a worldwide distribution network.



Crystal Chen, Chief Commercial Officer:

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