Frankfurt/Berlin – January 8, 2008 – MagForce Nanotechnologies AG, an investment holding of Nanostart AG, has achieved a further milestone on the road to commercialization of its proprietary NanoCancer® therapy. It has received certification according to the ISO 13485:2003 quality management standard.

Medcert GmbH, the medical certification and testing company, conducted an audit of the quality management system at MagForce in the areas of manufacturing, final inspection and distribution of its NanoTherm® nanoparticle solution and found that all the requirements of the ISO standard were properly fulfilled. The certification is a prerequisite to receive European regulatory approval of the company’s NanoCancer® therapy following completion of the efficacy studies which are now pending. It is also of decisive importance for the introduction of medical products around the world.

Under the EU’s Medical Device Directive (MDD), companies who wish to manufacture and distribute medical devices in Europe are required to establish and maintain an effective quality management system (QMS) for the manufacture of their products. Prior to product introduction, every manufacturer must undergo an audit of its QMS by the designated certification and testing agency. The governing standard for all medical devices is ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes”.

“The certification we have received is a further milestone on the road to regulatory approval of our cancer therapy. We have proved that we are able to translate our research results into final products while fully complying with all quality standards,” remarked Dr. Uwe Maschek, CEO of MagForce Nanotechnologies AG.

Marco Beckmann, CEO of Nanostart AG, added, “We are extremely pleased about the certification of NanoTherm® nanoparticle fluid. MagForce is on the right course to set new standards for cancer therapy once regulatory approval is achieved.”

Media contact:
Nanostart AG
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Dr. Hans Joachim Dürr
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