Where available, hemophilia A and B are treated with prophylactic (3 times per week) or on-demand intravenous administration of plasma-derived or recombinant FVIII or FIX products. However, the current products are constrained by several inherent properties including 1) high manufacturing cost resulting from poor recombinant expression, 2) the development of anti-product antibodies (inhibitors) that occur in up to 30% of all severe hemophilia A patients, 3) short half-life that necessitates multi-weekly, life-long infusions to maintain adequate blood clotting activity. FVIII infusion therapy costs $250,000 - $350,000 USD per patient year for prophylaxis. In the context of FVIII inhibitors, product costs can soar to >$1 M USD per patient year during immune tolerance induction therapy (ITI). ITI regimens under investigation involve more frequent (often daily), higher dose (up to 200 International Units per kilogram), FVIII infusions for up to 2 years. Although these strategies appear to effectively eradicate the inhibitors in up to 70% of inhibitor patients, all involve the use of existing FVIII infusion products marketed and priced for routine infusion therapy. ET is developing a recombinant FVIII infusion product, designated ET3i, that demonstrates higher manufacturing yields and significantly lower costs than existing FVIII infusion products. This innovation should enable the commercialization of a more cost-effective product that will lead to a more economical solution for immune tolerance induction (ITI) and likely facilitate the treatment of a larger fraction of the hemophilia A population across the globe.