Latest Clinical Evidence News

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.

Firebrick Pharma has published its pivotal Phase 3 trial results for Nasodine nasal spray, confirming its effectiveness and safety in treating the common cold, especially when used early.

Pacific Edge has successfully raised NZ$16 million through an upsized equity placement, surpassing its initial target and setting the stage for a planned NZ$5 million Share Purchase Plan. The funds aim to accelerate clinical and commercial milestones, including regaining Medicare coverage for its cancer diagnostic tests.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Pacific Edge Limited reported a resilient FY25 performance despite losing Medicare coverage for its Cxbladder tests in the US, announcing a $20 million equity raise to support commercialization and growth.

Aroa Biosurgery has reported FY25 results that exceed revenue guidance and deliver a positive normalised EBITDA, setting the stage for ambitious growth and reimbursement expansion in FY26.

AVITA Medical reported a strong first quarter with revenues up 67% to $18.5 million, driven by expanded commercial sales and new product introductions. Despite a narrower net loss, the company faces ongoing challenges from revenue covenants and macroeconomic pressures.

HeraMED reports strong Q1 FY25 progress with 4,282 registered users on its HeraCARE platform, a new collaboration with Garmin Health, and advancing commercial deals in the US and Europe. Early clinical data suggests improved maternal outcomes and operational efficiencies.

Tissue Repair Limited reports progress in its Phase 3 clinical trials for TR987® despite enrollment delays caused by US regulatory disruptions, while TR Pro+® sales hit record highs and manufacturing scale-up advances.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

Aroa Biosurgery reports a second consecutive quarter of positive operating cash flow and record sales for its Myriad product line, while maintaining full-year FY25 revenue and EBITDA guidance.