Latest Clinical Evidence News

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.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.

AdAlta Limited is accelerating its 'East to West' cellular immunotherapy strategy, aiming to bridge Asian innovation with Western clinical development and manufacturing to target solid cancers. The company plans to secure three assets by the end of 2025 and initiate clinical trials, positioning itself as a leader in this emerging market.

Alterity Therapeutics has reported positive Phase 2 results for ATH434, showing significant slowing of Multiple System Atrophy progression and a favorable safety profile. The trial demonstrated clinical benefits alongside reductions in brain iron accumulation, a key disease driver.

Paradigm Biopharmaceuticals has secured FDA clearance for its phase 3 knee osteoarthritis trial and raised $16 million to fund its next clinical steps, positioning the company for a pivotal year ahead.