Mobius Medical Pty Ltd
Founder-led contract research organisation (CRO) focused on clinical development and regulatory pathways for medical devices and combination products. Core services include clinical trial strategy and execution, regulatory submissions and quality systems (ISO 9001, ICH‑GCP/ISO 14155 alignment), data management and biostatistics, pre-clinical coordination, site activation across Australia, New Zealand and the USA, and post-market support including market access and reimbursement planning. The organisation has documented experience running early-phase pilot studies, pivotal multicentre interventional trials (including randomized controlled device trials), and AI-enabled diagnostic studies that supported De Novo and 510(k)/IDE regulatory pathways.
Industries
Nr. of Employees
small (1-50)
Mobius Medical Pty Ltd
North Sydney, New South Wales, Australia, Oceania
Products
Clinical Trial
A clinical trial rescue CRO service that helps sponsors recover studies that are not progressing as expected by reviewing recruitment, site activation, monitoring, data quality, vendor performance, safety processes, documentation, and sponsor oversight to create a practical recovery plan.
Mobius Clinical Trial Services
End-to-end clinical trial delivery across Australia, New Zealand and the USA, managing feasibility, site activation, patient recruitment, and data integrity to ensure compliant, efficient studies aligned with your goals.
Clinical Trial Notification (CTN) pathway support
Support for Australian clinical trials conducted under the Clinical Trial Notification pathway, including ethics review, site governance, study documents, investigator responsibilities, safety reporting, and governance timelines.
Tendyne TMVR solution
A repositionable transcatheter mitral valve replacement system developed to improve heart function and quality of life for patients unsuitable for surgery. It underwent early feasibility trials in Australia and a global pivotal study, demonstrating durable valve function, improved survival, and quality of life.
Clinical Trials
End-to-end clinical trial delivery across Australia, New Zealand and the USA, managing feasibility, site activation, patient recruitment and data integrity to ensure compliant, efficient studies aligned with your goals.
Medical Device CRO Australia
Mobius Medical Pty Ltd offers specialized clinical research organization services focused on medical device trials in Australia, supporting global evidence goals with local delivery for clinical trial planning, site engagement, monitoring, data management, and close-out.
Clinical Trial
A clinical trial rescue CRO service that helps sponsors recover studies that are not progressing as expected by reviewing recruitment, site activation, monitoring, data quality, vendor performance, safety processes, documentation, and sponsor oversight to create a practical recovery plan.
Mobius Clinical Trial Services
End-to-end clinical trial delivery across Australia, New Zealand and the USA, managing feasibility, site activation, patient recruitment, and data integrity to ensure compliant, efficient studies aligned with your goals.
Clinical Trial Notification (CTN) pathway support
Support for Australian clinical trials conducted under the Clinical Trial Notification pathway, including ethics review, site governance, study documents, investigator responsibilities, safety reporting, and governance timelines.
Tendyne TMVR solution
A repositionable transcatheter mitral valve replacement system developed to improve heart function and quality of life for patients unsuitable for surgery. It underwent early feasibility trials in Australia and a global pivotal study, demonstrating durable valve function, improved survival, and quality of life.
Clinical Trials
End-to-end clinical trial delivery across Australia, New Zealand and the USA, managing feasibility, site activation, patient recruitment and data integrity to ensure compliant, efficient studies aligned with your goals.
Medical Device CRO Australia
Mobius Medical Pty Ltd offers specialized clinical research organization services focused on medical device trials in Australia, supporting global evidence goals with local delivery for clinical trial planning, site engagement, monitoring, data management, and close-out.
Services
Concept and feasibility analysis, clinical planning, synopsis and regulatory package preparation, IEC/IRB approvals and KOL collaboration.
End-to-end operational management including site selection, monitoring, validated EDC, eTMF, safety monitoring, biostatistics and clinical investigation reports.
Regulatory pathway assessment, submission support, local sponsor services, QMS implementation and independent quality assurance oversight.
Coordination of bench and lab testing, small and large animal studies and cadaver labs to generate pre-clinical evidence.
Reimbursement strategy, payer research, coding and billing support, health economics and go-to-market partnerships.
Concept and feasibility analysis, clinical planning, synopsis and regulatory package preparation, IEC/IRB approvals and KOL collaboration.
End-to-end operational management including site selection, monitoring, validated EDC, eTMF, safety monitoring, biostatistics and clinical investigation reports.
Regulatory pathway assessment, submission support, local sponsor services, QMS implementation and independent quality assurance oversight.
Coordination of bench and lab testing, small and large animal studies and cadaver labs to generate pre-clinical evidence.
Reimbursement strategy, payer research, coding and billing support, health economics and go-to-market partnerships.
Expertise Areas
- Clinical trial management for medical devices
- Randomized multicentre interventional device trials
- Pivotal trials and long-term follow-up for implantable devices
- Regulatory strategy and submissions (FDA, EMA, TGA, De Novo, 510(k), IDE)
Key Technologies
- Electronic data capture (EDC) systems
- Clinical trial management systems (CTMS) and eTMF
- AI and machine learning for diagnostic classification
- Elastic scattering spectroscopy (ESS)
News & Updates
Active presence at MedTech industry events and partnering forums to engage sponsors and partners.
Guidance and insights describing how Australia-first trial design can support FDA submissions.
Provided clinical trial design and execution support for an AI-enabled handheld spectroscopy diagnostic that achieved ~96% sensitivity in pivotal studies, halved missed cancers in real-world use, and received FDA De Novo clearance and CE Mark.
Managed a prospective, randomized, multicentre interventional trial comparing aspiration thrombectomy devices (~250 patients, 31 sites) that demonstrated high delivery success and superior first-pass revascularisation, supporting FDA 510(k) clearance.
Designed and managed a multicentre pivotal study showing >80% patient improvement and 82% opioid reduction, supporting CE Mark and subsequent FDA regulatory steps.
Completed a 35‑couple pilot evaluating a hydrogel condom material, demonstrating safety, efficacy and consumer preference and preparing the program for pivotal evaluation and scalable manufacturing collaborations.
Active presence at MedTech industry events and partnering forums to engage sponsors and partners.
Guidance and insights describing how Australia-first trial design can support FDA submissions.
Provided clinical trial design and execution support for an AI-enabled handheld spectroscopy diagnostic that achieved ~96% sensitivity in pivotal studies, halved missed cancers in real-world use, and received FDA De Novo clearance and CE Mark.
Managed a prospective, randomized, multicentre interventional trial comparing aspiration thrombectomy devices (~250 patients, 31 sites) that demonstrated high delivery success and superior first-pass revascularisation, supporting FDA 510(k) clearance.
Designed and managed a multicentre pivotal study showing >80% patient improvement and 82% opioid reduction, supporting CE Mark and subsequent FDA regulatory steps.
Completed a 35‑couple pilot evaluating a hydrogel condom material, demonstrating safety, efficacy and consumer preference and preparing the program for pivotal evaluation and scalable manufacturing collaborations.