Quadlytics.Inc.
International Expansion of Wearable Epileptic Seizure Detection Systems

Program name

Deep-Tech Startups Support Program

Research theme

International Expansion of Wearable Epileptic Seizure Detection Systems

Business Plan

Regarding the wearable epilepsy seizure prediction system that our company is developing in Japan to become the world's first medical device, this project will refine and accelerate the international expansion strategy following domestic approval. We will achieve regulatory approval and reimbursement in Australia, which will be a significant milestone for our U.S. expansion. Based on the clinical trial data and health economic research results obtained in Australia, we aim to achieve regulatory approval and insurance reimbursement in the U.S. more smoothly, at lower cost, and with reduced risk.

Research Outline

In this R&D project, we will refine the commercialization roadmap in Australia of our technology by addressing the following issues, aiming for early clinical trials after the completion of the STS phase:
1. Formulating a regulatory strategy through retrospective and prospective clinical studies at Australian medical institutions and pre-submission meetings with the TGA.
2. Developing mass production prototypes in collaboration with local manufacturers.
3. Formulating an insurance strategy through negotiations with insurance agencies and consultants.

International collaborative technology demonstration

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