MRI Interventions' ClearPoint® Neuro Navigation Technology Highlighted in Voyager Therapeutics, Inc. Interim Parkinson’s Disease Gene Therapy Study Results
The use of real-time, intra-operative MRI-guided delivery allowed the surgical teams to visualize the delivery of VY-AADC01, administer higher infusion volumes, and achieve greater coverage of the putamen
IRVINE, Calif., June 23, 2016 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain, today announced that real-time MRI imaging enabled by the ClearPoint® Neuro Navigation System, was featured in a poster presentation of interim results from an ongoing Phase 1b study of VY-AADC01, Voyager Therapeutics’ gene therapy program for advanced Parkinson’s disease.
The interim results were presented yesterday at the 20th International Congress of Parkinson’s Disease and Movement Disorders (ICPDMD) in Berlin, Germany. The study design included the use of both the ClearPoint Neuro Navigation System and the SmartFlow® Ventricular Cannula which together enabled real-time, intra-operative MRI-guided delivery of VY-AADC01. The surgical teams utilized the ClearPoint System to precisely target and place the cannula into the putamen, visualize the delivery of VY-AADC01, administer higher infusion volumes and achieve greater coverage of the putamen, the brain region that is being targeted with VY-AADC01. The study showed VY-AADC01 continues to demonstrate safety with increasing coverage of targeted regions of the brain. Obtaining sufficient coverage of the putamen with VY-AADC01 is a key step towards potentially improving patients’ response to levodopa, the standard of care treatment for Parkinson’s disease.
Due to the presence of the blood brain barrier, which is formed by the brain capillary endothelium and excludes from the brain ~100% of large-molecule neurotherapeutics and more than 98% of all small-molecule drugs, delivery of therapeutic agents to cells in the brain is challenging. In the emerging field of Convection Enhanced Delivery (CED - direct injection of therapeutic agents into the brain, using continuous, low-positive pressure flow), accurate, real-time targeting and infusion monitoring is crucial to obtaining optimum target coverage. With the intra-operative MRI imaging capability provided by the ClearPoint System, the ability to monitor and adjust the infusion during CED is achieved. As a result, the surgeon can make cannula depth adjustments during the procedure to ensure the infusate is convecting within the target volume, and not escaping via other routes. Currently, seven clinical and pre-clinical studies are utilizing the ClearPoint Neuro Navigation System for delivery of a therapeutic agent directly into the brain.
“We are pleased to be part of this groundbreaking study that utilized the strengths of the ClearPoint Neuro Navigation System and SmartFlow Cannula,” stated Frank Grillo, Chief Executive Officer for MRI Interventions. “We believe that real-time monitoring of the infusion of therapeutic agents in an MRI environment allows surgeons to accurately deliver these investigative treatments, and to make adjustments to the delivery trajectories in real-time for more precise therapeutic coverage. We are excited to see these results, and we look forward to participating in the continued progress in this exciting field.”
The ClearPoint System allows surgeons to plan, target, and adjust trajectories of electrodes, catheters and needles under real time MRI-guided visualization without attaching a large, metal stereotactic headframe to the patient. Real-time MRI imaging provides the surgeon with current views of the patient’s brain anatomy at the time of surgical planning, device alignment, and navigation of the device to target, resulting in improved accuracy and reduced risk of brain shift associated with standard imaging techniques.
About MRI Interventions, Inc.
Building on the imaging power of MRI, MRI Interventions is creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain. The ClearPoint 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.
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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: customer demand and market acceptance of the Company’s products; its ability to successfully expand, and achieve full productivity from, its sales, clinical support and marketing capabilities; its ability to achieve the full benefits from cost reduction efforts that have been implemented or are pending; the sufficiency of its cash resources to maintain planned commercialization efforts; and future actions of the U.S. Food and Drug Administration or any other regulatory body that could impact its commercialization efforts. 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 Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission.
Contact: Wendelin Maners, VP, Marketing MRI Interventions, Inc. 949-900-6833
Released June 23, 2016