T2 Biosystems (TTOO) Sidoti Micro-Cap Virtual Conference summary

Diagnostic platform and market overview

• Offers a patented, FDA-cleared direct-from-blood sepsis test, targeting a $2B+ market and selling in 45 countries.

• Products are reimbursed in the U.S. and used by top hospitals globally.

• Sepsis is a leading cause of death and cost in U.S. hospitals, with current care standards failing many patients.

• Standard blood culture methods are slow (2–5 days) and have poor sensitivity, while recent supply shortages create further challenges.

• The platform detects pathogens directly from blood in 3–5 hours, bypassing the need for blood culture.

Product portfolio and clinical impact

• Three main panels: T2Candida (fungal), T2Bacteria (bacterial), and T2Resistance (antibiotic resistance), all with high sensitivity and specificity.

• T2Resistance Panel has FDA Breakthrough Device Designation; FDA submission planned for Q4.

• Meta-analysis of 14 studies shows 77 hours faster pathogen ID, 42 hours faster targeted therapy, and 5 days shorter hospital stays.

• CMS granted New Technology Add-on Payment for T2Bacteria Panel, covering about two-thirds of the cost.

• T2Biothreat Panel detects six high-priority biothreat agents with high accuracy.

Commercial strategy and operations

• About 200 instruments installed, split between U.S. (direct sales) and international (distributors).

• Negotiating a strategic U.S. partnership with a large healthcare company to expand reach.

• Focus on expanding within current customers, adding new accounts, and accelerating implementation.

• Razor-blade business model: instrument placement drives recurring test sales.

• Underlying test contribution margins are 70–80%, with margins expected to improve as volume scales.