Integra Lifesciences terminates post-market nerve repair registry
“We’ll be the first to admit, it’s difficult to draw conclusions just on this alone but given the challenges that IART has faced over the last 18 months, it makes us wonder about the status of the NeuraGen 3D product, the state of the nerve repair business, and whether this signals a shift in strategy in some parts of IART’s business,” Zimmerman and Iseult McMahon wrote today.
Those challenges include a plant shutdown in Boston last summer, followed by another shutdown and layoffs in Indiana this year. In August 2023, Integra received an FDA warning letter related to that Boston facility. The letter listed four violations by the company, labeling the company’s response for all four as “inadequate.” CEO Jan De Witte elected to retire in February as well, with a successor still yet to be named.
“We’ll be the first to admit, it’s difficult to draw conclusions just on this alone but given the challenges that IART has faced over the last 18 months, it makes us wonder about the status of the NeuraGen 3D product, the state of the nerve repair business, and whether this signals a shift in strategy in some parts of IART’s business,” Zimmerman and Iseult McMahon wrote today.
Those challenges include a plant shutdown in Boston last summer, followed by another shutdown and layoffs in Indiana this year. In August 2023, Integra received an FDA warning letter related to that Boston facility. The letter listed four violations by the company, labeling the company’s response for all four as “inadequate.” CEO Jan De Witte elected to retire in February as well, with a successor still yet to be named.