BioPorto (BIOPOR) Status Update summary

Product and Market Overview

• Early detection of acute kidney injury (AKI) is a growing area, with NGAL positioned as a sensitive and specific biomarker enabling intervention much earlier than traditional serum creatinine, providing actionable results within 2 hours.

• The AKI diagnostics market is expanding at over 5% annually, with a total addressable market for NGAL indications estimated at $3 billion.

• NGAL assays are compatible with major clinical chemistry instruments, allowing broad adoption without new capital investment.

• NGAL, KIM-1, and IL-18 are emerging as key biomarkers for AKI detection.

• NGAL test is implemented as a lab-developed test in 7 top US children's hospitals, with 2 more in the process of implementation.

Commercial Platform Development and Strategy

• The commercial strategy focuses on phased market entry: initial targeting of pediatric and young adult ICUs, then expanding to adult and international markets.

• Direct sales teams and medical science liaisons (MSLs) are deployed to engage clinicians and drive adoption.

• Partnerships with instrument vendors (Roche, Abbott, Siemens, Beckman) and geographic distributors are key to scaling market access.

• Revenue targets include $6m in 2024 (EBITDA negative), $15-25m by 2026 (EBITDA neutral), and $100m+ by 2029 (increasing profitability).

• ROW strategy leverages distributors and local demand generation, targeting high-volume centers and expanding to adult indications.

Customer Engagement and Adoption Process

• Engagement focuses on building clinical coalitions within hospitals, starting with a champion clinician and expanding across departments.

• Success stories in both the U.S. and internationally highlight the importance of clinician advocacy and institutional validation.

• The company tracks 325 U.S. hospitals with pediatric ICU beds, prioritizing 133 for initial outreach based on size and complexity.

• Nine of the top ten U.S. News & World Report children's hospitals are customers or implementing the technology.

• Over 20 US hospitals use NGAL for research and clinical purposes, with monthly test volumes ranging from a few to hundreds.