Their approach is based on the MagSense device (seen below left) and PrecisionMRX nanoparticles. Unlike X-rays or CT scanners, MagSense technology does not use ionising radiation and, unlike MRI, it does not require radioactive tracers or strong magnetic fields. The PrecisionMRX nanoparticles (seen below right), which are significantly smaller than a single blood cell, are coated with antibodies that are specific to breast cancer and are injected into the patient’s bloodstream. The nanoparticles then bind to the cancer cells and a brief magnetic pulse from MagSense activates the particles, enabling the tumour to be precisely located.
In July 2019, the MagSense technology was designated as a breakthrough device by the FDA. To qualify, a product must have the potential “to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.” Bob Proulx, CEO of Imagion, was understandably upbeat and commented: “Qualifying as a breakthrough device will allow us to expedite our dialogue with the agency and validates that our MagSense technology is not just another medical device but, indeed, represents a transformative opportunity for healthcare and could improve the standard of care for staging HER2 breast cancer.”
Since 20% of primary breast cancers are HER2-positive, Imagion is focusing its first clinical application on these patients. By diagnosing whether malignant cancer cells have metastasised to the sentinel lymph nodes or not, the removal of nodes can potentially be avoided. In preparation for a clinical trial with the University of New Mexico, the company has completed a basic science study in which they demonstrated their nanoparticles are safe and specific for in vivo detection of HER2+ breast tumours.
Since mid-2017, Imagion Biosystems has been listed on the Australian Securities Exchange with a current market capitalisation of AUD 114 million (ASX:IBX). Yesterday, the company requested a halt on trading until Monday, 23 November 2020, pending the release of an important announcement regarding the planning and execution of a capital raise. Hopefully this will enable Imagion to realise its potential as a medical imaging breakthrough.