Frankfurt / Berlin – June 4, 2009 – MagForce Nanotechnologies AG, a majority-owned portfolio company of Nanostart AG, has received an essential certification.
The authorized medical certification company audited the quality management systems of MagForce in the areas of development, manufacturing, final inspection and distribution for the products used for its therapy systems for hyperthermia and thermoablation, including the related treatment planning software, and determined that all requirements of European Norm (EN) ISO 13485:2003 + AC:2007 were properly fulfilled.
With this certification, the company has now fulfilled a key prerequisite for the successful commercialization of its Nano-Cancer® therapy. An application for European regulatory approval should be submitted later this year.
“We are extremely pleased to have received this latest certification, which now also confirms that the development areas for our NanoTherm® and NanoPlan® products, audited for the first time, likewise fulfill the requirements for a rigorous quality management system. This represents another key step on the road toward the European market launch of our novel cancer treatment approach,” said Dr. Uwe Maschek, CEO of MagForce Nanotechnologies.
Marco Beckmann, CEO of Nanostart, added that “Magforce is on a solid path to set new standards in cancer treatment. The ISO certification is an essential part of this in that it ensures the reliability and quality of the processes and products.”
Under the German Medical Devices Act (Medizinproduktegesetz), companies which wish to manufacture and distribute medical devices must establish and maintain an effective quality management system (QMS) for the manufacture of their products. Before being allowed to introduce any product, every manufacturer must have its QMS audited by the responsible certification and testing authority. The standard for all medical devices is European Norm (EN) ISO 13485:2003 + AC:2007 (“Medical devices - Quality management systems - Requirements for regulatory purposes”). The audit at MagForce was conducted by Medcert GmbH, which was the responsible medical certification and testing company.
About Nanostart:
Nanostart AG is the world’s leading nanotechnology investment company. The Frankfurt-based company provides venture capital financing for nanotechnology companies in various growth phases. It also provides the benefits of its experience and expertise to developers of financial instruments and to investors in the nanotechnology sector. For further information about the company, please visit www.nanostart.de.
About MagForce Nanotechnologies:
MagForce Nanotechnologies AG is the world’s leading company in the area of nanotechnology-based cancer treatment. Its patented therapy allows the targeted destruction of tumors using magnetic nanoparticles. MagForce’s nanotechnology represents a revolutionary approach to the future successful treatment of solid tumors. For more information, please visit www.magforce.com.
Disclaimer:
This notice constitutes neither an offer to sell nor a solicitation of offers to purchase or subscribe to securities. There will be no public offering of securities of Nanostart AG in conjunction with the existing listing of its shares in the “Entry Standard” segment of the regulated unofficial market (Freiverkehr) on the Frankfurt Stock Exchange. This notice does not constitute a securities prospectus. Neither this notice nor the information contained within is intended for direct or indirect distribution within the United States of America, Canada, Australia or Japan.
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