Integra LifeSciences
(Nasdaq: IART)
announced today that it plans to restart the manufacturing of two products at a new facility in Massachusetts.
The company plans to resume manufacturing for PriMatrix and SurgiMend at its new Braintree, Massachusetts, facility. Princeton, New Jersey-based Integra expects to operationalize the plant in the first half of 2026.
Integra’s shift comes following an audit of its Boston facility, as the company reassessed its plans and timeline to resume production of these products. A recall that included PriMatrix and SurgiMend led to a plant shutdown in Boston last summer and an FDA warning letter. Analysts also speculated that issues stemming from the Boston plant shutdown may have contributed to the recent termination of a registry looking at nerve repair technology.
While evaluating Boston, the company also furthered its plans to complete and operationalize the new, state-of-the-art Braintree plant.
Based on its assessments, Integra no longer plans to restart manufacturing in Boston as previously suggested. It plans to temporarily utilize the Boston site and equipment to support product and process development, ensuring a smooth transition.
“Given the advantages of the Braintree facility and the challenges of the Boston facility, the decision to consolidate our efforts at our new Braintree location enables us to focus our resources in one location,” said Robert T. Davis Jr., EVP and president of Integra’s Tissue Technologies unit.” This represents a minimal difference in timing compared to restarting in our existing Boston facility, while limiting execution risk.”
Davis said the new facility offers the flexibility to implement more effective quality systems and efficient process flows, plus more capacity. The plant sits just 10 miles from the company’s current Boston location.
“We remain fully committed to bringing PriMatrix and SurgiMend back to the market and to achieving pre-market approval for SurgiMend PRS in implant-based breast reconstruction,” Davis added. “We believe that focusing our efforts to operationalize the new Braintree facility is the right path to meet these commitments.”
