Japanese medical device developer seeks distributors and agents in the EU for their handheld magnetic probe utilized in sentinel lymph node detection and occult lesion localization

Established in 2005, this Japanese SME has developed a handheld magnetic probe designed to detect magnetic fluids injected during sentinel lymph node biopsy (SLNB), as well as magnetic markers inserted during occult lesion localization (MOLL). The company specializes in research & development of medical devices and equipment for diagnosis of cancer metastasis, anti-Tenascin antibody therapy, medical supplies, medical-use cells, pharmaceuticals and diagnostic agents, as well as new technologies for diagnosis and treatment in regenerative medicine. Sentinel lymph node biopsy is the current standard in early breast cancer therapy. It involves the removal of just 2-3 lymph nodes from the underarm area, therewith greatly reducing the risk of lymphedema or morbidity compared to traditional lymph node dissection, which requires the removal of almost all lymph nodes from the patient’s armpit. Supported by prominent Japanese public organisations, this SME’s device – consisting of a permanent magnet and a hall sensor – is the result of a joint collaboration between researchers at a famous Japanese university and a team of renowned surgeons, aiming to create an alternative to conventional radioisotope techniques. The magnetic probe is CE Marking certified. Furthermore, the company has a European Authorized Representation agreement for their product with a German partner since 2018. Clinical trials to prove the magnetic method’s non-inferiority to the conventional radioisotope technique in detecting sentinel lymph nodes was conducted in recent years resulting in an overall successful detection rate of 94.9%. Originally developed for diagnosing breast cancer metastases, clinical trials to investigate the magnetic probe’s effectiveness in other types of cancer are currently in progress. Furthermore, to prevent false negatives when operating a magnetic probe, the SME also designed non-magnetic titanium retractors to be used in conjunction with the device. This addition to the magnetic probe is planned for launch onto the Japanese market in 2021. The company wants to make its market debut in the EU and is seeking partners in the form of distribution services and commercial agency agreements. The Japanese company will provide the partner with technical information on the device in English and German and is also willing to support distribution partners or commercial agents with on-demand assistance and information.