Latest Clinical Validation News

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

Zelira Therapeutics has secured a fourth funding tranche of US$681,000, advancing its HOPE® Autism Spectrum Disorder FDA trial process and bringing total funding to US$3.25 million. The company is progressing clinical validation and product development, including the transformation of Zenivol® into a capsule formulation.

OncoSil Medical has secured new distribution agreements across key international markets and achieved critical regulatory milestones, while raising $8 million to fuel its growth in pancreatic cancer treatment.

Biome Australia Limited has announced encouraging results from functional studies on its probiotic strain BMB18, highlighting its potential to modulate immune responses, reduce inflammation, and support intestinal health. These findings pave the way for targeted clinical research and product innovation.

Artrya Limited reports solid progress on its FDA 510(k) application and secures a A$5 million capital raise, positioning itself for imminent commercial rollout in the US healthcare sector.

Aroa Biosurgery has reported its first quarter of positive operating cash flow since listing on the ASX in 2020, alongside robust revenue growth projections and new regulatory approvals across key international markets.

Rhythm Biosciences reported a strong December quarter, securing a $3.2 million R&D tax incentive and completing a strategic acquisition of Genetype assets, positioning the company for commercial expansion in cancer diagnostics.

Emyria Limited announces key leadership shifts with Greg Hutchinson stepping up as Executive Chairman and Dr. Michael Winlo transitioning to Chief Scientific Officer, aiming to scale innovative mental health therapies amid growing demand.

Invex Therapeutics reports encouraging results from its collaboration with Tessara Therapeutics, showing Exenatide’s potential to improve neuronal survival in a 3D human brain model of Alzheimer's disease. The company maintains a stable cash position while exploring new neurological partnerships.

Pacific Edge faces a significant Medicare reimbursement setback as Novitas finalizes a non-coverage decision for its Cxbladder tests, prompting the company to activate legal challenges and operational restructuring.