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Biotechnology

Latest news, analysis, and insights from ASX biotechnology companies

EBR Systems Resets US Sales Strategy after WiSE Implant Slowdown
Lead storyBiotechnology

EBR Systems Resets US Sales Strategy after WiSE Implant Slowdown

EBR Systems resets its US sales strategy after WiSE implants fell to 40 in the September quarter, as Medicare reimbursement rates rise by up to 93%.

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Optiscan Imaging Moves Closer to Regulatory Clearance of Real-Time Surgical Imaging Platform
Biotechnology

Optiscan Imaging Moves Closer to Regulatory Clearance of Real-Time Surgical Imaging Platform

Optiscan Imaging submits InVue for FDA 510(k) review, moving its real-time surgical imaging platform closer to US clearance and commercialisation.

Dimerix Achieves First Patient Completion Milestone for DMX-200 Clinical Program
Biotechnology

Dimerix Achieves First Patient Completion Milestone for DMX-200 Clinical Program

Dimerix’s DMX-200 program reaches a milestone as its first patient completes two years in the extension study, with 93% of eligible patients continuing.

Artrya Wins Five-Year US Commercial Deal with Huntsville Hospital Health System
Biotechnology

Artrya Wins Five-Year US Commercial Deal with Huntsville Hospital Health System

Artrya lands five-year US deal with Huntsville Hospital Health System; minimum US$0.5m for Salix Coronary Anatomy SaaS, expanding its US footprint.

Syntara Expands Safety and Tolerability Study of SNT-9465 Topical Scar Treatment
Biotechnology

Syntara Expands Safety and Tolerability Study of SNT-9465 Topical Scar Treatment

Syntara expands Phase 1b trial for SNT-9465, adding 10 participants, new blinded design and Sydney site; top-line data due Q1 2027 to back an IND.

LTR Pharma Final Phase II Report Confirms Fast Absorption for Spontan Intranasal Spray in Treating ED
Biotechnology

LTR Pharma Final Phase II Report Confirms Fast Absorption for Spontan Intranasal Spray in Treating ED

LTR Pharma's Spontan intranasal ED spray peaks in 10 minutes, six-fold faster than oral vardenafil; Phase II data complete, paving US licensing talks.

Vitrafy Life Sciences Expands Platelet Cryopreservation Program With Versiti Blood Health
Biotechnology

Vitrafy Life Sciences Expands Platelet Cryopreservation Program With Versiti Blood Health

Vitrafy Life Sciences expands platelet cryopreservation with Versiti; 94.4% post-thaw recovery from USAISR, two free units, US device listing aimed FY2027.

INOVIQ Defines EXO-OC Commercialisation Path after Independent Review
Biotechnology

INOVIQ Defines EXO-OC Commercialisation Path after Independent Review

INOVIQ maps a 12–18 month path to US LDT for EXO-OC after independent review; aims for H1 2028 lab validation amid sample-handling variability.

Singular Health Group Signs Deal for Florida’s First State-Funded Medical Imaging Repository
Biotechnology

Singular Health Group Signs Deal for Florida’s First State-Funded Medical Imaging Repository

Singular Health inks Florida deal for state-funded 3DICOM imaging repository with FIU, signalling first infrastructure revenue and potential Medicaid blueprint.