Progress with FDA Submission
The company has made significant progress with its FDA product, ReftAssure DX, and is on track to submit a data package to the FDA by the end of the year, aiming for FDA approval in 2026.
Successful Assay and Workflow Design Improvements
Assay and workflow design improvements have been completed and transferred to manufacturing, resulting in positive early feedback and adoption by multiple centers.
Strong Engagement with Transplant Centers
The company has engaged with 20 sites to train on the GraftAssure workflow by the end of the year, with 10 sites already running the research use only assay across several countries.
High Positive Predictive Value Achieved
The company demonstrated a positive predictive value of close to 80% by combining two scores algorithmically, which is a substantial improvement over the typical PPV of 50%.
Solid Financial Position
The company ended the second quarter with $26 million in cash and managed cash burn effectively, with plans to continue investment in their FDA program.