Latest Clinical Validation News

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

Artrya Limited has signed a significant five-year commercial agreement with Cone Health, marking its third U.S. customer and solidifying its foothold in the American healthcare market with its AI-powered Salix platform.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

TrivarX has received $3.5 million in second-tranche placement funding, enabling advancement of its innovative Stabl-Im technology for early, non-invasive brain tumour detection. The funding supports manufacturing scale-up and regulatory preparations ahead of a planned Phase 1 clinical trial in 2026.

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

INOVIQ Limited has reported compelling preclinical results for its CAR-NK-exosome therapy targeting triple-negative breast cancer, showing significant tumor reduction and perfect survival in treated mice.

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.

4DMedical secures Cleveland Clinic as the third major US academic medical centre to adopt its CT – VQ™ respiratory imaging technology, marking rapid commercial traction post-FDA clearance.

Orthocell has reached a significant milestone with 100 units of its nerve repair product Remplir™ sold in the US, signaling accelerating adoption in a $1.6 billion market. The company’s strategic medical education and distributor network are driving momentum ahead of further hospital approvals.

Proteomics International has secured a US patent for its PromarkerEso blood test, a pioneering diagnostic tool for early detection of esophageal adenocarcinoma, marking a critical step toward commercialisation in the world’s largest healthcare market.

Emyria has secured its first Empax clinic in Victoria, marking a significant step in its multi-state expansion and validating its scalable, reimbursed national mental health platform.

Biome Australia has initiated its first human clinical trial for the proprietary probiotic strain Lactobacillus plantarum BMB18, aiming to validate its benefits for digestive and mood-related symptoms.