First-in-Class Biology. Regulatory Validation. A Clear Path Forward.
EmstoPA is a preclinical-stage biopharmaceutical company developing the world’s first specific reversal agent for tPA-induced haemorrhage. Our programme addresses a critical gap in the management of bleeding in cardiac surgery and major trauma, where elevated tPA levels drive haemorrhage that existing therapies cannot adequately control.
The programme is protected by IP licensed exclusively from the University of Tennessee with exclusivity to 2039, has received formal regulatory endorsement from both the FDA and MHRA, and has attracted engagement from Roche/Genentech as an early indicator of commercial validation.
Regulatory and Programme Recognition
FDA Scientific Advice received — accelerated development pathway endorsed
MHRA Scientific Advice received — accelerated development pathway endorsed
Recommended for the UK ILAP Accelerated Access Programme
Pharma engagement confirming scientific and commercial interest