Integra LifeSciences Holdings Corp. has begun producing SurgiMend at its Braintree facility and is building inventory for a phased fourth-quarter 2026 relaunch. Management expects no meaningful SurgiMend contribution in 2026, making 2027 the key period for judging share recapture and portfolio recovery. The company anticipates a gradual revenue return, targeting roughly 50% of the product's historical performance of about $40 million. The December 2024 FDA warning letter remains unresolved, but Integra expects all action items implemented by the end of 2026, with premarket approval dependent on a successful pre-approval inspection at Braintree and expected earlier in 2027. SurgiMend would join a Tissue Reconstruction recovery already supported by DuraSorb growth and the PriMatrix relaunch, though second-quarter Tissue Reconstruction revenues declined 2% organically.
Integra LifeSciences HoldingsProduction start and inventory build for SurgiMend relaunch signals supply recovery, though 2026 contribution minimal.
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