Latest Clinical Validation News

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

Nexsen Limited has initiated clinical trials for its StrepSure® GBS Rapid Sensor, a next-generation diagnostic device aimed at improving maternal health outcomes. The trial's success could pave the way for regulatory approval and early market penetration by the second half of 2026.

Immutep Limited’s Phase II trial of eftilagimod alfa combined with radiotherapy and KEYTRUDA in soft tissue sarcoma patients has exceeded its primary endpoint, showing a 51.5% median tumor hyalinization rate, more than triple the historical standard. These promising results, presented at ESMO 2025, suggest a potential breakthrough in a challenging cancer indication.

PainChek Limited has appointed Sasha Grant as Head of Growth for its AI-powered Infant App, aiming to scale its presence in a $15 billion global market. Early Australian adoption shows promising conversion rates as the company prepares for international expansion.

Aroa Biosurgery delivered a robust September quarter with strong cash flow and record sales of its Myriad product, while reaffirming its FY26 revenue and EBITDA guidance. The company also highlighted a promising US Medicare reimbursement proposal for its Symphony product.

Proteomics International has expanded its partnership with the University of Melbourne and Royal Women’s Hospital to further validate and develop its PromarkerEndo blood test, aiming to revolutionize endometriosis diagnosis.

Pacific Edge reports a 9% decline in Cxbladder test volumes amid Medicare coverage loss but gains momentum with new clinical validation and a CMS pricing boost.

INOVIQ Limited has launched an A$11.5 million capital raise to fast-track clinical validation and commercialization of its ovarian cancer screening test and advance its CAR-exosome therapeutic program targeting solid tumors.

INOVIQ Limited has raised $11.5 million through a $9.5 million placement and a $2 million share purchase plan to accelerate the development and commercialisation of its EXO-OC ovarian cancer test and exosome therapeutic program.

PYC Therapeutics has reported encouraging pre-clinical results for its RNA therapy candidate PYC-002 targeting Phelan-McDermid Syndrome, supporting plans to enter human trials in 2026. The data demonstrate safety, brain distribution, and gene expression restoration in key disease regions.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

dorsaVi reports a striking 15-fold increase in US Physical Therapy clinic subscriptions for its ViMove+ product, driven by strong surgeon endorsements and a successful face-to-face training rollout.