Emperor — FDA meeting
2026
During the remainder of 2026, we expect to submit an application for FDA Breakthrough Device designation.Source filing
PMI biotech catalysts & pipeline
PICARD MEDICAL INC · Data as of 2026-09-08
Upcoming catalysts
lower-cost driver — NDA/BLA submission
late 2027
We intend to continue reducing per-unit costs, scaling manufacturing capacity toward 3,000 units per year, and advancing a next-generation lower-cost driver targeted for FDA submission in late 2027.Source filing
Emperor — NDA/BLA submission
2028
Next Generation, driver - less STAH; may seek FDA approval in 2028Source filing
Emperor platform — IND submission
in 2028
Development milestones for this initial configuration include pursuit of FDA Breakthrough Device designation, continued preclinical studies, a planned Investigational Device Exemption submission in 2028, and an intent to begin clinical study activities in 2029, the scope and design of which will be determined in consultation with FDA.Source filing
Emperor Total Artificial Heart (TAH) — Regulatory decision
2028
Subject to successful non-clinical testing and regulatory review, we may seek approval as early as 2028, although the regulatory process is inherently unpredictable, and there can be no assurance regarding timing or approval outcomes.Source filing
SynCardia Total Artificial Heart — Regulatory decision
2028
Next Generation, driver - less STAH; may seek FDA approval in 2028Source filing