Ravi M.'s questions to Integra Lifesciences Holdings Corp (IART) leadership • Q1 2025
Question
Ravi from Truist Securities, on behalf of Richard Newitter, sought clarity on the remediation timeline, asking if the compliance master plan work would conclude by the time the Braintree facility is operational, potentially resolving the FDA warning letter. He also inquired about the company's perspective on the delayed implementation of Medicare LCDs for skin substitutes.
Answer
CEO Mojdeh Poul detailed that site assessments will finish by Q3, with remediation planning in Q4. While most remediations are targeted for completion by year-end 2025, some may extend into 2026. She affirmed they are working diligently to resolve the warning letter issues before the Braintree facility goes live. Regarding the LCDs, Poul stated that since Integra's business is primarily inpatient, the direct impact is limited, but viewed the focus on products with proven clinical evidence as a positive development.