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Austria, Czech Republic, France, Germany, Italy, Poland, Spain, Switzerland, Turkey and Great Britain
+ 800 624 367 23
+ 800 MAGFORCE
United States, Canada, Guam, Puerto Rico and US Virgin Islands
+ 1 844 833 9623
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Recent news & events

Series of clinical trials and clinical research

Over the past two decades, our team vision, encouraged by initial positive research results, has lead to the development of a successful alternative therapy for tumour treatment. But our research and development work is by no means complete, pending regulatory approval in certain regions and additional clinical trials for new applications.
We continue to work on improving the individual therapy components so that we can improve the effectiveness of the treatment, while at the same time minimizing possible side effects for patients. With the prostate cancer study in the USA, we aim to obtain approval of the therapy for the focal treatment of prostate cancer.

Patients with prostate cancer

With the ability to completely destroy small prostate tumors, NanoTherm® has a great deal of potential: firstly, to be used as a monotherapy for intermediate risk prostate cancer and secondly, to extend the period in which the patient remains in active observation and thirdly, to retain the function of the organ and thus, good quality of life.
The US regulatory authority, the FDA (“Food and Drug Administration”) has granted our American subsidiary, MagForce USA, Inc., approval to conduct a clinical study (“Investigational Device Exemption”, IDE) with NanoTherm® therapy as a treatment for focal tumor ablation in the case of intermediate prostate cancer.

This approval now allows MagForce to conduct a pivotal clinical evaluation using our innovative NanoTherm® therapy at selected medical centres in the USA. We are looking forward to collaborating with the FDA project team and to advancing the approval process significantly. A success in the US could also mean the breakthrough for this indication in Europe at a later date. In order to conduct the study, MagForce has already installed two NanoActivator® devices, i.e. the magnetic field applicators, in which the NanoTherm® therapy is carried out, at the medical centre at the University of Washington in Seattle and at the Christus Santa Rosa Hospital, Medical Center in San Antonio.
Unlike the devices that are being used in Germany to treat brain tumors using NanoTherm® therapy, these devices can also be used to treat prostate cancer. The registration study on focal thermal ablation (“Focal Thermal Ablation Registration Study”) will recruit up to 120 patients in a single-arm study. The aim is to show that NanoTherm® can destroy carcinogenic lesions in patients whose prostate cancer has reached the intermediate stage and who are under active observation.

Focal ablation of these carcinogenic lesions is intended to allow patients to remain in active surveillance programmes and to avoid non-reversible treatments such as the surgical removal (resection) or radiation treatment of the entire prostate - with the usual side effects.

Potentially 50,000 to 100,000 men in active surveillance programmes could benefit from this focal treatment after approval is received in the USA.
For furhter information on the prostate cancer clinical trial, please contact us via phone +1 833 287 1150 or email: prostatestudy@magforce-usa.com.

Survival benefit of the NanoTherm® therapy

The therapy has partially prolonged the life expectancy of some patients in combination with stereotactic radiotherapy.

NanoTherm® patient examples

Three application examples of NanoTherm® therapy at different stages of a glioblastoma.
Use of NanoTherm® in a patient with recurrent glioblastoma
Use of NanoTherm® patient with progressive glioblastoma
Use of NanoTherm® in a patient with relapsed glioblastoma after resection

Facts concerning NanoTherm® therapy

The cell-damaging effect of hyperthermia has been used therapeutically for a long time. Conventional hyperthermia methods use different energy sources to produce a temperature increase in the tissue: externally irradiated electromagnetic waves (e.g. radio frequency or microwave hyperthermia), ultrasound (externally or interstitially), current flow between two or more electrodes, electrical or magnetic fields between implanted antennas, electrically or magnetically excited thermoseeds, or tubes supplied with hot water. The biggest problem facing the hyperthermia methods used today is achieving a homogeneous heat distribution in the tissue being treated. If this does not succeed, the tumor areas can either be undersupplied, or cause organ damage through excessive temperatures in other sections. NanoTherm® therapy is a special form of local deep thermotherapy. It has the advantage that, for the first time, the heat deposition selectively targets the tumor and thus largely accommodates the requirement for maximum deposition of the heat dose in the target volume with maximum protection of the surrounding healthy tissue.
The treatment method relies on a defined power transfer to biocompatible, superparamagnetic iron oxide nanoparticles in an alternating magnetic field. The resulting heat production is determined by the particle type, the particle concentration in the target volume, the frequency of the radiated alternating magnetic field and the magnetic field strength. Depending on the temperatures reached and the duration of treatment, tumor cells are either irreparably damaged (thermoablation) or become more sensitive to concomitant radiotherapy or chemotherapy (hyperthermia).
The magnetic liquid can be distributed in small quantities of any size and thus, can be continuously distributed in the target volume. By knowing the power consumption, the activity distribution of the nanoparticles can be deducted from the density distribution measured on the CT. This makes a three-dimensional calculation and simulation of the temperature distribution possible. By introducing a defined total quantity into a target volume, a level of controllability can achieved that cannot be achieved by any other interstitial method. Due to the long retention of the particles in the treatment area, repeating treatments and the incorporation in multimodal therapy concepts are possible.
The magnetic liquid is comprised of superparamagnetic nanoscale iron oxide particles in aqueous solution with an iron concentration of 112 mg/ml. The nanoparticles consist of an iron oxide core with a diameter of about 12 nm and an envelope of amino silanes. The particles can be dispersed colloidally in aqueous solution because of this coating. The magnetite core has an intrinsic magnetic momentum, which is activated by the externally applied alternating magnetic field. The particles release heat to the environment through relaxation processes.
In principle, the nanoparticles can be instilled in tumor tissue using any commercially available cannula [min. 19 gauge]. The dosage is 0.3 ml [± 0.1 ml] of magnetic liquid per cubic centimetre of the target volume. The distance between the individual puncture channels should not exceed 8 to 10 mm. The magnetic liquid is distributed by slowly retracting the injection cannula in single doses of 0.3 ml per cm puncture channel. During treatment of brain tumors the first method is the instillation of the particles, either stereotactically or using neuronavigation. The second method is the “nanopaste” and is carried out through an introduction at the resection cavity wall after the tumor resection. In prostate cancer, the instillation is carried out under transrectal ultrasound and X-ray control.
NanoTherm® therapy is performed in an alternating magnetic field applicator (NanoActivator®) that has been specially developed for this therapy. The alternating magnetic field with a frequency of 100 kHz, generates field strengths between 4 and 15 kA/m, and causes the iron oxide nanoparticles in the magnetic liquid, NanoTherm®, to vibrate, thereby achieving therapeutic treatment temperatures in the tumor. The NanoActivator® is universally applicable for tumors in all regions of the body. As a rule, patients receive six treatments lasting one hour each over a period of three weeks (twice a week).