Browsing Tag
Therapeutic Goods Administration
12 posts
EBR Systems seeks Australian approval for WiSE wireless heart pacing device after US launch
EBR Systems has submitted its WiSE cardiac pacing system for Australian regulatory inclusion following an earlier priority review determination, potentially opening a second commercial market while the company's United States implant rollout continues at a slower pace than previously anticipated.
Cryosite (ASX: CTE) revenue rises 17% as TGA review advances second Sydney clinical trial facility
Cryosite has delivered record first-quarter revenue, stronger operating margins and higher cash flow while advancing a proposed expansion of its Therapeutic Goods Administration licence to cover a second clinical trial and biological storage facility.
Avecho Biotechnology (ASX: AVE) secures Japanese patent for CBD capsule as global licensing strategy expands
Avecho Biotechnology’s Japanese patent adds another major jurisdiction to the intellectual property estate surrounding its TPM-enhanced cannabidiol capsule. The grant strengthens the company’s negotiating position, but clinical completion, regulatory approval and regional licensing remain the decisive commercial tests.
4DMedical (ASX: 4DX) jumps 13% as SimonMed rollout nears
4DMedical has record scans and A$278m cash, but its A$2.2bn value now depends on turning SimonMed’s US network into paid CT:VQ revenue.
CMP-002 trial clearance unlocks $50m as CAMP4 enters first-in-human stage
CAMP4 unlocks up to $50 million after Australian clearance for its CMP-002 trial, strengthening runway while creating major dilution.
4DMedical wins Australian CT:VQ approval as ASX:4DX faces Medicare reimbursement test
4DMedical has gained regulatory access to its home market for CT:VQ, but the commercial value of Australia’s large CT scanner network will depend on hospital implementation, clinical confidence and Medicare reimbursement.
Avecho Biotechnology clears Phase III insomnia interim review as ASX:AVE surges 40%
Avecho Biotechnology’s CBD insomnia trial will continue with its original 519-patient design after an independent monitoring board found that predefined efficacy and safety requirements had been satisfied.
OncoSil Medical (OSL:ASX) has pancreatic cancer data momentum, but investors now need adoption proof
OSL has TRIPP-FFX data, TGA approval and FDA pathway momentum. The bigger test is whether OncoSil can turn evidence into adoption.
Archer Materials (AXE) advances Biochip to beta prototype as silicon-first strategy targets clinical validation
Archer Materials (ASX: AXE) advances its Biochip medical diagnostic to beta prototype, targeting clinical trials via silicon-first strategy and Stage 2 imec partnership. Read the full analysis.
Vaxxas’ TGA licence unlocks GMP production for HD-MAP vaccines: What this means for clinical trials and global delivery strategy
Vaxxas Pty Ltd wins TGA manufacturing licence for needle‑free HD‑MAP vaccines, enhancing clinical scale and delivery potential. Find out what this means next.