Latest Clinical Validation News

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.

Optiscan Imaging Limited reported a 17.6% revenue decline and a 4.1% increase in net loss for FY25, driven by lower orders and higher R&D spending. The company unveiled two new medical imaging devices as it ramps up commercial efforts.

Zelira Therapeutics reported a significantly reduced loss of AUD 3.85 million for FY25, driven by clinical progress and strategic funding for its HOPE® cannabinoid medicines. The company also expanded its patent portfolio and commercial footprint across key markets.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

ECS Botanics reports a 5% revenue dip to $19.5 million in FY25 but sees strong B2C growth and record harvest volumes, offset by non-cash impairments.

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

BCAL Diagnostics has launched its first commercial breast cancer diagnostic test, BREASTESTplus™, in Australia, marking a key milestone despite a $7.24 million loss for FY2025. The company is also advancing its US operations with a new subsidiary and clinical trials underway.

Immutep Limited reported a widened loss of A$61.4 million for FY2025, driven by increased R&D and clinical trial expenses, while progressing its lead immunotherapy candidate into a pivotal Phase III lung cancer trial. The company maintains a robust cash position supporting operations through 2026.

Next Science reports a 42% improvement in adjusted EBITDA loss for 1H FY25 despite a 7% dip in product sales, while shareholders approve a major asset sale to OSARTIS GmbH.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

Memphasys Limited reported a net loss of AUD 4.94 million for FY25 while accelerating commercial efforts for its Felix System and advancing its RoXsta diagnostics platform.