Latest Reimbursement Strategies News

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Proteomics International is pivoting from research to disciplined commercial execution of its proteomics-based diagnostic tests, focusing on distributor partnerships and reimbursement pathways in Australia and the US.

Entropy Neurodynamics has been granted an Australian patent for its novel two-phase IV infusion method administering psilocybin and psilocin, securing exclusive rights through 2042 and strengthening its lead asset TRP-8803’s competitive position.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

Cleo Diagnostics has raised $5 million to support the U.S. commercial launch of its Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test, signaling strong investor confidence in its technology.

Cleo Diagnostics has identified a significantly larger U.S. patient population for its pre-surgical ovarian cancer test, expanding its commercial opportunity ahead of next year’s market entry.

Cleo Diagnostics has secured positive FDA feedback and nearly 1,600 biobank samples, accelerating its ovarian cancer blood test development ahead of a planned 2026 U.S. market entry.

OncoSil Medical reported a $15.1 million loss for FY25 amid strong revenue growth and significant regulatory milestones, supported by over $14 million in capital raises to fuel its global expansion.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.