Latest Regulatory Filings News

Linius Technologies has addressed a late filing of a director's interest notice, attributing the delay to an administrative oversight involving a new class of securities. The company has updated its processes and will re-brief directors to ensure future compliance.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

Orthocell has reported a record $3 million revenue for the September quarter, driven by strong sales of its nerve repair product Remplir™ in Australia and Singapore, with early US sales and Canadian market entry poised to accelerate growth.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

Imagion Biosystems has completed the second tranche of its $3.5 million placement, raising $2.85 million to advance its proprietary MagSense® imaging technology targeting breast, prostate, and ovarian cancers.

ReNerve Ltd is rapidly advancing its nerve repair product portfolio, with four ranges expected on the market by the end of 2025 and expanding global distribution. Clinical studies highlight significant patient benefits, supporting the company’s growth in a booming biomaterials market.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

Cobalt Blue Holdings has completed the issuance of over 22 million shares following a placement announced earlier this month, leveraging its ASX capacity. The move marks a key step in the company’s capital strategy without requiring additional disclosure.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Vonex Limited shareholders have overwhelmingly approved Maxo Telecommunications’ acquisition scheme, setting the stage for a court decision that could delist Vonex from the ASX.