MRI Interventions Announces Collaboration with Voyager Therapeutics for the Design, Manufacture and Supply of V-TAG™ Device
IRVINE, Calif., March 11, 2019 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCQB:MRIC) a platform neurosurgery company developing products designed to deliver navigation, ablation, deep brain stimulation, aspiration, biopsy and gene therapy today announced a collaboration with Voyager Therapeutics, Inc. (Nasdaq: VYGR) to design, manufacture and supply the Variable Trajectory Array Guide, or V-TAG, neurosurgical device for Voyager. 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.
About MRI Interventions, Inc.
MRI Interventions is a leading platform company for MRI-guided neurosurgery procedures, including deep-brain stimulation, ablation, aspiration, biopsy, and gene therapy delivery. The ClearPoint Neurosurgery Navigation system is FDA cleared and CE marked, and installed in more than 55 surgical centers in the U.S. To date, close to 3,000 procedures have been performed leveraging the sub-millimetric accuracy of the ClearPoint platform. For more information, please visit www.mriinterventions.com.
Statements herein concerning MRI Interventions, Inc.’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s ability to obtain additional financing; estimates regarding the sufficiency of the Company’s cash resources; future revenues from sales of the company’s ClearPoint Neuro Navigation System products; and the company’s ability to market, commercialize and achieve broader market acceptance for the company’s ClearPoint Neuro Navigation System products. More detailed information on these and additional factors that could affect the company’s actual results are described in the “Risk Factors” section of the company’s Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three months ended June 30, 2018, both of which have been filed with the Securities and Exchange Commission, and its Annual Report on Form 10-K for the year ended December 31, 2018, which the company intends to file with the Securities and Exchange Commission on or before April 1, 2019.
Matt Kreps, Darrow Associates Investor Relations