SyMRI 3D by SyntheticMR Set for Early 2024 Commercial Launch Post Obtaining CE-Marking

SyntheticMR announced today that their next-generation imaging solution with isotropic 3D resolution, SyMRI 3D, has obtained approval in the EU and is now CE-Marked. With preparations in place, SyntheticMR eagerly anticipates the commercial launch of SyMRI 3D at the start of 2024.

"We are delighted to see our 3D solution CE-marked and available on the European market,” says Ulrik Harrysson, CEO at SyntheticMR AB. “SyMRI 3D represents the next generation of quantitative MRI, offering unprecedented resolution and accuracy in brain imaging, revolutionizing the landscape of medical diagnostics."

SyntheticMR’s new 3D release is a next-generation imaging solution that is poised to revolutionize the field of medical imaging by introducing a myriad of innovative applications within SyMRI's post-processing solution. This advanced SyMRI sequence introduces 3D resolution to quantitative values and tissue segmentations, ensuring the same level of precision in quantification as achieved with SyMRI's 2D imaging.

SyMRI 3D enables precise volumetric estimations of brain regions, a technique commonly referred to as parcellation, which empowers clinicians to gain deeper insights into brain structure and function. Furthermore, the exceptional resolution provided by SyMRI 3D facilitates comprehensive lesion analysis, ensuring a more accurate and in-depth assessment of medical conditions.

“This advanced sequence extends 3D resolution to quantitative values and tissue segmentations, matching the precision achieved in SyMRI's 2D imaging. The CE-marking for SyMRI 3D paves the way for physicians to make more informed decisions through quantitative imaging.” says Kyle Frye, CCO & President of SyntheticMR Inc. “Receiving approval for SyMRI 3D will allow us to enable physicians to make better, more informed decisions using quantitative imaging.”

The CE mark qualification for SyMRI 3D signifies a monumental stride for SyntheticMR, reaffirming its commitment to transforming medical imaging.

This disclosure contains information that SyntheticMR AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 18-12-2023 10:00 CET.

For additional information, please contact Ulrik Harrysson, CEO, SyntheticMR AB, +46 70 529 29 87 ulrik.harrysson@syntheticmr.com or Kyle Frye, President SyntheticMR Inc. at +1 (859) 512-9496 or kyle.frye@syntheticmr.com.

SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB has developed SyMRI®, delivering multiple, adjustable contrast images and quantitative data from a single 5-minute scan. The SyMRI product is available in different packages. SyMRI NEURO delivers multiple contrast images, tissue segmentations and quantitative data on the brain. SyMRI MSK provides multiple contrast images and quantitative data for knee and spine anatomies. SyMRI NEURO is CE-marked, and FDA 510(k) cleared and SyMRI MSK is CE-marked. SyMRI 3D is 510(k)-pending and CE-marked. SyMRI is a registered trademark in Europe and the USA. SyntheticMR is listed on the Spotlight Stock Market Exchange in Stockholm, Sweden. For more information, www.syntheticmr.com.