Following two decades of intensive research and development efforts, MagForce Nanotechnologies AG, a Berlin-based medical technology company founded in 1997, has received European regulatory approval for its Nano-Cancer® therapy.
The official notice of regulatory approval signifies that the authorized testing centers in Germany responsible for conformity evaluation of medical devices have completed their examination of the application submitted for market approval of Nano-Cancer® therapy and that the approved medical devices fulfill all requirements with regard to quality, safety and medical efficacy.
“This is a historic milestone for MagForce,” exclaimed Dr. Peter Heinrich, CEO of MagForce Nanotechnologies AG, on news of the regulatory approval. “Over the past twenty years, the company has worked in close partnership with a number of partners in academia, particularly the Charité University Medical Center in Berlin, to develop this highly innovative therapeutic approach for treating solid tumors. Along this long road, Dr. Andreas Jordan, founder of the company and my colleague on the executive board, always remained true to his vision of an entirely new concept in cancer treatment based on recent advances in nanotechnology. In recognition of his many years of dedication, I am thus particularly delighted that, with regulatory approval received, a revolutionary new product in nanomedicine may now be brought to market.”
The regulatory approval covers the treatment of brain tumors throughout the European Union. With this approval in hand, the company is now accelerating and strengthening its sales and marketing activities to introduce its new therapeutic procedure into the major European markets, starting with Germany, as well as moving its business model into the next stage. A further focus of these activities in preparation for market launch is discussion with medical insurers, such as the German Krankenkassen, regarding coverage for this therapy. In addition, MagForce will in the coming months be defining a development, partnership and commercialization strategy for the North American and Asian markets.
Initial revenues from the commercialization of Nano-Cancer® therapy through the company’s own sales structures should be reflected in its 2011 financial results. With European regulatory approval now received, the company anticipates that its share listing on the Frankfurt Stock Exchange will be changed over the medium term from the Entry Standard segment to Prime Standard.