other material
confidence high
sentiment neutral
materiality 0.75
LENSAR holds commercial launch meeting for ALLY System after FDA clearance
LENSAR, Inc.
- LENSAR (LNSR) held commercial launch meeting week of June 27, 2022 for ALLY Adaptive Cataract Treatment System.
- Company expects to place 8 to 12 ALLY Systems in a controlled initial launch starting Q3 2022.
- ALLY launched with phacoemulsification features disabled; second 510(k) delayed due to predicate device withdrawal.
- Supply chain constraints delayed raw material delivery; wider U.S. availability planned for 2023.
- LENSAR plans to file CE Mark application in 2022 to commercialize ALLY in the European Union.