MRI Interventions Recognizes FDA Clearance of Voyager’s Investigational New Drug Application for VY-AADC Allowing its Pivotal Program to Begin for Advanced Parkinson’s Disease
IRVINE, Calif., Jan. 24, 2018 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCQB:MRIC) today commented on Voyager Therapeutics’ announcement of FDA clearance of its Investigational New Drug (IND) application for VY-AADC, Voyager’s gene therapy program targeting advanced Parkinson’s disease. Clearance of the IND allows Voyager to formally initiate clinical trial sites and begin screening patients for its pivotal Phase 2-3 program.
“We are excited that FDA cleared this IND, allowing commencement of Voyager’s gene therapy pivotal program for advanced Parkinson’s disease,” said Wendelin Maners, Vice President of Marketing and Clinical Operations at MRI Interventions. “This represents an important milestone in our own pipeline of gene therapy and drug delivery trials utilizing the ClearPoint® Neuro Navigation system and SmartFlow® drug delivery cannulas as the premier targeting platform for direct deployment of biologics to precise regions within the brain.”
Subsequent to the successful Phase 1b trial involving Voyager’s VY-AADC in which MRI’s ClearPoint Neuro Navigation System was utilized to provide precise positioning of the delivery cannula and monitor, in real-time, the infusion of VY-AADC for optimal coverage of the putamen, Voyager and MRI Interventions worked together to develop an additional posterior approach designed to further optimize the intracranial delivery of VY-AADC. Voyager continues to monitor patients from both Phase I trials and recently reported encouraging safety and efficacy data with the program. Voyager is enrolling additional patients in the Phase 1 posterior trajectory trial ahead of the anticipated dosing of the first patient in the Phase 2-3 trial in the second quarter of 2018.
“Our participation in innovative drug delivery and gene therapy trials is an important aspect of our Company’s five-year growth strategy,” commented Joe Burnett, President and CEO of MRI Interventions. “While our primary focus today is building our presence in functional neurosurgery applications such as lead placement for deep-brain stimulation, laser catheter placement for neuro-surgical ablations and precise targeting for tumor biopsy in the brain, the success of our drug delivery partners in advancing through the U.S. approval process is a key aspect of our long-term growth strategy. We are gratified that the team at Voyager recognizes the value of ClearPoint in enabling pin-point targeting for the delivery of its gene therapy program and real-time image guidance to provide the desired coverage of that specific target in the brain. We look forward to continuing our support of Voyager’s program as outlined in our drug delivery pipeline.”
About MRI Interventions, Inc.
Building on the imaging power of magnetic resonance imaging (“MRI”), MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain. The ClearPoint Neuro Navigation System, which has received 510(k) clearance and is CE marked, utilizes a hospital’s existing diagnostic or intraoperative MRI suite to enable a range of minimally invasive procedures in the brain. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements
Statements herein concerning MRI Interventions, Inc. (the “Company”) 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: 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, 2016, and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, both of which have been filed with the Securities and Exchange Commission.
Contact:
Wendelin Maners
MRI Interventions, Inc.
949-900-6833
Matt Kreps, Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
Released January 24, 2018