FDA Clears Phase 2 MagSense Trial
Based Imagion Biosystems has successfully secured $3.75 million in capital after receiving FDA clearance for its Phase 2 clinical trial. This trial focuses on using MagSense technology to detect HER2+ breast cancer.
CPS Capital Group Pty Ltd led the capital raise through a two-tranche placement. Tranche 1 involves issuing 49.3 million new shares at $0.012 each, resulting in $592,000. Tranche 2, which aims to raise the remaining $3.2 million, awaits shareholder approval.
Robert Proulx, Executive Chairman, expressed satisfaction with investor demand, stating, “We are very pleased with the strong demand we saw from investors following our milestone achievement of receiving clearance from the FDA for our MagSense imaging to proceed with the clinical trial.”
MagSense Technology Explained
Targeted nanoparticles used by MagSense enhance imaging specificity, enabling clinicians to better differentiate between benign and malignant tumours. This technology promises advancements for a range of cancers, including prostate and ovarian.
Trial activation has commenced, and patient recruitment is anticipated to start later this year. The successful IND application submission marks a significant technical and organizational achievement for Imagion Biosystems.
A clinical-stage company, Imagion Biosystems is pioneering new MRI technology categories. Their goal is to enhance diagnostic certainty across multiple applications using non-radioactive, bio-safe magnetic nanoparticles.
Conventional MRI identifies regions of interest based on anatomical features, lacking molecular specificity, which hampers reliable differentiation between tumour types. MagSense addresses this by improving imaging specificity.
Beyond breast cancer, Imagion has conducted pre-clinical studies on additional imaging agents targeting prostate and ovarian cancers, showcasing the broad potential of their technology.
Continuing to advance their MagSense molecular imaging technology, the company aims to transform cancer detection, facilitating earlier diagnosis and improved treatment efficacy.
Last updated: 29 June 2026, 11:46 am
