Integra LifeSciences (NASDAQ: IART) recently announced that it plans to resume manufacturing in its Boston facility by the end of the fourth quarter.
Just two months before, Integra voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. According to the company, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.
During a July 27 earnings call with analysts, CEO Jan De Witte said the company, over the past months, has strengthened its leadership and project management in Boston, made investments and brought in outside subject matter experts. A third-party auditor is assessing progress and key milestones over the project’s course.
The project plan has Integra Lifesciences resuming manufacturing in Boston by the end of the fourth quarter this year, building inventory to support a commercial launch by Q2 2024, according to De Witte.
“Patient safety is non-negotiable for us, and we apply an abundance of caution in making compensations like the ones we have made over the past few months,” De Witte said.
In addition to resolving manufacturing problems in Boston, Integra has been busy preparing to file with the FDA by the end of August to bring its CereLink system for intracranial pressure (ICP) monitoring back to the market. CereLink was the subject of a Class I-level recall last year.
Integra Lifesciences expects to relaunch CereLink internationally in Q3, with a U.S. launch by Q4.
BTIG analysts kept their Neutral rating on IART shares. Ryan Zimmerman, Sam Durno and Iseult McMahon at BTIG said that “what makes it hard to get constructive is the risk around timelines from the remediation of the Boston facility.”
