An Evidence-Based
Path to Clinical Integration
Innovation requires rigor. We are committed to a transparent and robust clinical research pathway to validate the efficacy of Aura of Intelligence and ensure its safe, effective integration into the Australian healthcare system.
Phased Clinical Trial Protocol
Our research is structured in three distinct phases, designed to systematically build evidence from usability and feasibility to definitive clinical effectiveness.
Phase 1: Feasibility & Usability
Objective: Refine the prototype and confirm user acceptability.
In this initial phase, we work with a small cohort of individuals with mild dementia and their carers. Through qualitative interviews and usability testing, we ensure the Aura system is intuitive, engaging, and genuinely helpful before wider deployment. This crucial step provides the human factors evidence required for regulatory submission.
Phase 2: Single-Site Pilot Study
Objective: Gather preliminary efficacy data and test trial procedures.
A controlled pilot study will provide the first quantitative data on clinical outcomes. We will measure the impact of Aura on key metrics such as the reduction of BPSD, caregiver burden, and quality of life using validated clinical scales. The results will power the design of our large-scale efficacy trial.
Phase 3: Multi-Site Efficacy Trial (RCT)
Objective: Definitively prove effectiveness and cost-effectiveness.
A large-scale, multi-site Randomised Controlled Trial (RCT) across diverse Queensland locations will provide the highest level (Level 1) of clinical evidence. This pivotal trial is designed to generate the definitive proof required for TGA approval, inclusion in government funding programs, and publication in high-impact medical journals.
Regulatory Approval & Pathway to Care
Our goal is to make Aura of Intelligence an accessible, government-supported tool within the Australian care ecosystem.
Ethical & Regulatory Approval
We are navigating the comprehensive approval processes required in Australia. This includes submitting our clinical trial protocols to a Human Research Ethics Committee (HREC) for rigorous review, with a special focus on protecting vulnerable participants. Concurrently, we are preparing a full technical file for the Therapeutic Goods Administration (TGA) to classify Aura as a Software as a Medical Device (SaMD), ensuring it meets the highest standards for safety and performance.
NDIS & My Aged Care Integration
The evidence generated from our clinical trials is designed to position Aura as a fundable Assistive Technology (AT) under the National Disability Insurance Scheme (NDIS) for younger-onset dementia, and within My Aged Care programs like Home Care Packages. Our go-to-market strategy is a 'prescription' model, empowering clinicians and assessors with the evidence they need to justify funding for their clients, making Aura an integral part of modern, subsidized dementia care.