MRI Interventions Announces FDA Clearance of ClearPoint® 2.0 Next-Generation Software Platform
Initial Limited Market Release Shipments to Commence Immediately
IRVINE, Calif., Nov. 06, 2018 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCQB:MRIC) today announced FDA clearance for the company’s latest software platform – ClearPoint® 2.0. The platform’s new features are designed to improve the clinical workflow and user experience of the company’s ClearPoint Neuro Navigation System, including enhanced functionality in areas of image fusion, volume of interest display and measurement, 3D image visualization and multi-trajectory planning.
“ClearPoint 2.0 is a generational upgrade that has been years in the making,” commented Joe Burnett, President and CEO of MRI Interventions. “Its development illustrates the close collaboration between our team and our neurosurgeon customers as we continue to execute on our growth strategy. We believe the features in this new software platform provide our customers with tools designed to reduce procedure time, enabling multiple procedures to be performed in the same MRI scanner in the same day, and enhance the surgical process.”
The company plans to immediately commence shipment and installation of ClearPoint 2.0 under a limited market release and expects it will be made available for purchase by all new and existing ClearPoint customers in the first half of 2019.
About MRI Interventions, Inc.
Building on the 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.
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, which has been filed with the Securities and Exchange Commission, and its Quarterly Report on Form 10-Q for the three months ended September 30, 2018, which the company intends to file with the Securities and Exchange Commission on or before November 14, 2018.
Matt Kreps, Darrow Associates Investor Relations