Under the collaboration, Voyager transferred its existing 510(k) clearance for the V-TAG device to MRI Interventions who will manufacture and supply the device as a choice for neurosurgeons, along with MRI’s Clearpoint system, for use in Voyager’s RESTORE-1 Phase 2 trial of its VY-AADC gene therapy program for Parkinson’s disease.

“We continue to evolve and expand our relationship with Voyager with the common goal of delivering gene therapy to specific regions of the brain with accuracy to give our patients the best possible chance at success,” commented Joe Burnett, President and CEO at MRI Interventions. “This endeavor allows both companies to do what they do best.  We at MRI will now take on all commercial and production responsibility for not only our ClearPoint platform, used in the Voyager trials, but also as an additional choice for neurosurgeons, for the V-TAG device, transferred to us from Voyager. Our goal is to be the medical device extension of our biologics and drug delivery partners where we will take on the development, regulatory and commercial responsibility for navigation and delivery of their therapies.”

V-TAG is a 510(k) cleared medical device intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.   Under the terms of the collaboration, MRI Interventions will currently supply the V-TAG device only to trained Voyager clinical sites for use in the RESTORE-1 Phase 2 trial.

Source: Company Press Release