Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
EMVision Making Strong Progress with emu and First Responder Brain Scanners
EMVision advances emu brain scanner validation; recruitment milestones hit as ischaemia endpoint eyed to bolster FDA De Novo clearance and value.
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Cyclopharm Secures 11-Site US Technegas Deployment with UH Cleveland
Cyclopharm to roll out Technegas at 11 UH Cleveland sites within weeks, expanding US footprint with immediate, recurring revenue from imaging procedures.
HeraMED Clears First Lee Health Digital Obstetrics Pilot Phase
HeraMED Phase 1 Lee Health digital obstetrics pilot validates HeraCARE; 44 patients, 92% adopt digital path; Phase 2 decision soon.
Neurotech International Granted FDA Clearance for US Paediatric Study of NTI164
Neurotech's NTI164 gets FDA IND clearance for US trial; kicks off PopPK study, paving global regulatory path ahead of potential autism therapy approvals.
OncoSil Medical Completes Manufacturing Validation of Pancreatic Cancer Treatment
OncoSil completes three manufacturing validation cycles for pancreatic cancer brachytherapy device, de-risking scale-up; regulatory review ongoing; H2 prod.
Proteomics International Labs Secures US Patent for PromarkerEndo Blood Test
Proteomics International wins US patent for PromarkerEndo endometriosis blood test, boosting licensing/partnering prospects and extending protection to 2041.
Argent BioPharma Licences CannEpil Globally in US$5.5m Debt-Clearing Transaction
Argent BioPharma inks global CannEpil license with Splash Beverage, US$5.5m upfront debt-clearing, 15% royalty; boosts US growth and potential listing.
Optiscan Imaging Launches First Clinical Device into US Veterinary Market
Optiscan debuts InSpecta as its first US commercial clinical imaging device after FDA CVM submission, unlocking US sales in a $15.9B market.
Compumedics Delivers Record FY26 Revenue as SaaS Growth Accelerates
Compumedics posts FY26 revenue of $60.3m (+18%), SaaS up ~70% led by Somfit/Nexus 360; MEG delays temper guidance, FY27 targets double-digit growth.
Orthocell Appoints MediTime as Thai Distributor for Remplir Nerve Repair
Orthocell names MediTime exclusive Thai distributor for Remplir nerve repair, taps US$84m market; Thai FDA CY25 approval; $48m cash, no debt.
Imricor Medical Systems Gains FDA Paediatric Clearances for NorthStar and Diagnostic Catheter
Imricor gains FDA paediatric clearance for NorthStar and Vision-MR, unlocking radiation-free iMR procedures for children across 250+ US hospitals.
Imugene Adds Second Complete Response in Azer-Cel BTKi Cohort
Imugene logs a second complete response within 24 hours in Azer-cel BTKi cohort, Day-28 CR in MCL after BTKi failure, following FL CR.