Genesis Innovation Group’s cultivate(MD) Capital Fund II LP, a fund focused on investments into early-stage healthcare companies with new technologies, announces that one of its portfolio companies, SpinTech, has received U.S. FDA 510(k) clearance for its STAGE MRI software. SpinTech is a privately held company at the frontlines of brain imaging and MRI technology, which has developed a software platform for improving the diagnosis and treatment of a wide range of neurological conditions.

Radiologists face the challenge of accurately detecting the biomarkers critical for proper diagnosis and treatment of brain disorders in a meaningful timeframe and within clinical workflows. STAGE, however, is a multi-contrast imaging method that allows scanning the entire brain in roughly five minutes.

STAGE provides 16 different types of image contrasts, six of which are the critically important quantitative data. Effective quantitative data helps improve diagnostic accuracy and will show changes in a patient’s situation between an initial scan and subsequent examinations. 

STAGE also collects other conventional images, with enhanced contrast, automatically delivering clinical image data back into the radiologists’ workstations. On top of this data, SpinTech has developed a suite of automated diagnostic reports, which continues to grow as improved data and clinical research drive the discovery of new biomarkers, new diagnoses, and better conclusions.

Ward Detweiler, president and CEO of SpinTech says, “STAGE’s novel acquisition technique and post-processing software, which grew from the world’s top MRI research groups, is designed to enhance visualization of biomarkers that couldn’t be seen in the brain before while improving throughput and accuracy, making it a significant advancement in imaging. The FDA clearance allows us to utilize STAGE to help patients in real clinical environments.”

Matt Ahearn, managing director, cultivate(MD) Capital Funds adds, “[The] FDA clearance of STAGE sets the foundation for SpinTech’s initial commercialization and scale. STAGE software is an MRI operating system with specialized scanning sequences. STAGE normalizes data from all MRI manufacturers and Tesla levels and will provide neuroradiologist’s an unparalleled platform for diagnostics and reporting.”

Moreover, the company has also developed a suite of automated biomarker detection tools, including reports for Parkinson’s disease and cerebral microbleed detection and is exploring utilization of the technology in other parts of the anatomy.

“Providing research support is in our DNA,” Detweiler adds. “Now, looking at practical applications, we will show how to tap the full potential of this product to help radiologists unlock new information from the brain.”