Hoodin (HOODIN) Status Update summary

Regulatory changes in 2026

• New regulations in life sciences from 2026 require continuous, real-time compliance rather than periodic updates, making manual processes unsustainable.

• Regulatory requirements differ by country and are frequently updated, increasing complexity and risk for non-compliance, including fines, product recalls, and delayed launches.

• Gradual implementation of MDR and IVDR regulations is underway, affecting over a million products, with deadlines in 2026-2028 for legacy products.

AI-driven compliance solution

• Launching Hoodin Compliance Studio, an AI-powered platform designed for regulatory affairs in life sciences, enabling easy transition from current workflows.

• The platform manages applicable regulations, guidance, and standards per product and market, with AI agents trained to interpret and assess regulatory changes.

• AI agents provide tailored support, leveraging user and product data, and are validated specifically for life sciences, unlike generic AI tools.

• The system is built on a unique dataset of 20,000 validated regulatory documents, ensuring accurate, compliant reporting and export capabilities.

Market opportunity and business model

• Target market includes 45,000–50,000 companies with complex regulatory needs, representing a large addressable market.

• Subscription-based pricing model with value-based pricing, averaging €1,129 per month per customer, offers high value and strong margins.

• Over 2,000 signups have completed training, with tens of thousands of companies needing to transition in the coming years.