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.
Products
Clinical Trial Management
Service managing the planning, execution, and monitoring of clinical trials to ensure data integrity and regulatory compliance.
Electronic Data Capture (EDC) Services
Provision of electronic systems to collect, manage, and store clinical trial data digitally for improved accuracy and accessibility.
Clinical Trial Management
Service managing the planning, execution, and monitoring of clinical trials to ensure data integrity and regulatory compliance.
Electronic Data Capture (EDC) Services
Provision of electronic systems to collect, manage, and store clinical trial data digitally for improved accuracy and accessibility.
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.