Imagion Biosystems Limited announced that the first patient has been enrolled in the MagSense® HER2 breast cancer Phase I first-in-human study. The study, which is expected to enroll approximately 15 patients, is the first clinical investigation of Imagion Biosystems' MagSense® nanoparticle technology. This study investigates the use of a MagSense® imaging agent as a means of aiding in the staging of HER2 positive breast cancer by detecting if the patient's tumor has spread to the lymph nodes. Current standard of care requires biopsy or surgical removal of lymph nodes to confirm metastases. With approximately half of HER2 breast cancer patients having no nodal disease, the MagSense® HER2 test achieved Breakthrough Device designation from the US FDA based on its potential to provide a non-invasive way to eliminate unnecessary surgical biopsy procedures and their resultant morbidities. Each patient in the study receives an injection of the MagSense® nanoparticle imaging agent and undergoes imaging by MRI. Additionally, a sample of the lymph node is also assessed using Imagion's proprietary MagSense® magnetic relaxometry technology. The primary endpoint of the study is to determine the safety and tolerability of the MagSense® imaging agent, but the study will also explore the effectiveness of the nanoparticles for in vivo detection which will inform further development and commercial considerations.