The facility at 200 Ballardvale Street features an ISO Class 7 clean room specifically designed for the assembly, inspection, and testing of the eShunt System. This technology offers a percutaneous, transvenous-transdural alternative to traditional shunt surgery for patients suffering from communicating hydrocephalus—a condition frequently associated with gait instability and cognitive decline. By moving into this dedicated space, the company is preparing for a future Premarket Approval submission to the U.S. Food and Drug Administration.
Support for the expansion comes in part from the Massachusetts Life Sciences Center, which provided tax incentives tied to local job creation. CEO Dan Levangie noted that the facility serves as a long-term investment, reinforcing the company's commitment to the Greater Boston innovation cluster. State officials, including Secretary of Economic Development Eric Paley, highlighted the move as evidence of the regional ecosystem's ability to retain companies as they transition from R&D to full-scale manufacturing.
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