- Approved for use throughout EU for treatment of brain tumors
- "Historic moment after more than 20 years of development"
- European market launch to commence
Frankfurt / Berlin, June 28, 2010 – Following more than 20 years of research and development efforts, MagForce Nanotechnologies AG (Frankfurt Stock Exchange: MF6), a majority-owned subsidiary of Nanostart AG, has received regulatory approval for medical use of its Nano-Cancer® therapy throughout the European Union. This momentous event marks the world’s first nanoparticle-based cancer treatment to come to market.
Approval was granted for the treatment of brain tumors.
This novel therapy involves the instillation directly into the tumor of a fluid containing special iron oxide nanoparticles. These magnetic nanoparticles are then subjected to a controlled magnetic field so that they oscillate and generate heat. The elevated temperature within the tumor causes the cancer cells to be damaged or destroyed.
This approval follows successful completion of the conformity evaluation procedure of the company’s NanoTherm® magnetic fluid by Medcert GmbH and of its NanoActivator® magnetic field applicator by Berlin Cert GmbH. Both of these medical certification and testing companies are officially authorized centers for the conformity evaluation of medical devices.
“With regulatory approval now received, our company has entered a new phase. MagForce is transforming itself from a medical R&D company to a commercial provider of medical technology,” said Dr. Peter Heinrich, CEO of MagForce Nanotechnologies.
MagForce founder and CSO Dr. Andreas Jordan added, “After research and development efforts spanning more than 20 years, we now have regulatory approval in hand. This is a historic moment for us.”
This regulatory approval gives the green light for the company to proceed with its planned market launch of Nano-Cancer® therapy, which will commence in the coming weeks.
Nanostart CEO Marco Beckmann underscored that “regulatory approval was granted not just for glioblastoma but for the treatment of all brain tumors, thus opening enormous market potential for the new therapy. We congratulate the management team and entire staff at MagForce on this tremendous success.”
The regulatory approval was received based on the results of a clinical study in patients suffering from recurrent glioblastoma, a particularly aggressive and deadly form of brain tumor. In these clinical trials, the new therapy was able to demonstrate its remarkable effectiveness, with median patient survival time increased from 6.2 months using conventional therapies to 13.4 months using Nano-Cancer® therapy in combination with radiotherapy. Median patient survival following diagnosis of the recurrence was thus more than doubled. Furthermore, compared to existing conventional treatments, the side effects and patient discomfort associated with the new therapy are minimal.
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 a world-leading company in the area of nanotechnology-based cancer treatment. The proprietary procedure which it has developed, Nano-Cancer® therapy, enables the targeted treatment of solid tumors through the intratumoral release of heat from magnetic nanoparticles. Its products used in the therapy, NanoTherm® and NanoActivator®, have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. For further information, 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.
Media contact:
Nanostart AG
Public Relations
Dr. Hans Joachim Dürr
Goethestrasse 26-28
D-60313 Frankfurt
Germany
phone: +49 (0)69-21 93 96 111
fax: +49 (0)69-21 93 96 122
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