IQ-AI Regulatory News (IQAI)

Flying Brands Limited

("Flying Brands" or the "Company")

ECOG-ACRIN TO PROCESS CLINICAL TRIAL DATA USING IMAGING BIOMETRICS SOFTWARE

IB Rad Tech will be used to assess brain tumour treatment response in multi-center trial

Imaging Biometrics®, LLC ("IB"), a wholly-owned subsidiary of Flying Brands Limited (LON:FBDU), and the American College of Radiology Imaging Network ("ACRIN") have united efforts in a multi-center Phase II trial sponsored by the Eastern Cooperative Oncology Group (ECOG)-ACRIN Cancer Research Group. The study will use IB Rad Tech™ to post-process datasets acquired from over 20 US sites to determine how well dynamic susceptibility contrast magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with recurrent glioblastoma, and to ultimately correlate changes in rCBV to overall survival (OS) and progression free survival (PFS).

Patients enrolled in the study will undergo a DSC-MRI exam right before beginning treatment with bevacizumab (Genentech, San Francisco). After the baseline exam, follow-up DSC-MRI exams will be scheduled prior to the second dose administration of bevacizumab, typically 2-3 weeks after the initial dose. In total, 165 patients are estimated to participate in the study.

IB Rad Tech, a customizable software interface, acts as a "workflow wizard" to guide users through a series of automated processing steps. The specific workflow used in this study will leverage IB's FDA cleared software modules IB Neuro and IB Delta Suite to easily determine the tumor region of interest (ROI) and compute DSC-MRI-based normalized and standardized rCBV maps. Exclusive to IB, standardization is a machine-learned calibration approach that translates relative MR values to a fixed and consistent scale regardless of scanner vendor, field strength, or patient. The ability to automatically generate quantitative rCBV values consistently, independent of scanner or timepoint, makes it ideal for longitudinal assessment of treatment response.

ACRIN Principal Investigator Jerrold L. Boxerman, MD, PhD, Associate Professor of Diagnostic Imaging at The Warren Alpert Medical School of Brown University and Fellow of the American College of Radiology, said "This study will help determine if rCBV can serve as an early response imaging biomarker to an anti-angiogenic agent (bevacizumab) in patients with recurrent brain cancer. If successful, rCBV will lead the way for the incorporation of more advanced imaging biomarkers into clinical trials, which should help to improve the development efforts for new cancer treatments. IB Rad Tech's ability to quantify how patients are responding to treatment will provide for a more robust study and greatly simplifies the post-processing of the numerous datasets that we will acquire."

Michael Schmainda, CEO of IB said "We are delighted IB Software was chosen for this important multi-center trial. Our quantitative analysis resolves many inconsistencies that have inhibited routine and robust brain tumour assessment, and has the potential to cause a paradigm shift in how tumours are managed and treated. Moreover, IB Rad Tech streamlines the processing in a very consistent and cost-effective manner.".

ABOUT Imaging Biometrics™, LLC

Imaging Biometrics, a subsidiary of Flying Brands Limited (LON:FBDU), develops and provides visualization and analytical solutions that enable clinicians to better diagnose and treat diseases with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform-independent software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB's advanced visualization software seamlessly integrates into routine workflows. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com.

Flying Brands Limited (Ticker:FBDU) is the parent company of StoneChecker® and Imaging Biometrics® focused on advanced and state of the art medical software and services. (www.flyingbrands.co.uk).

The Directors of the Company accept responsibility for the contents of this announcement.

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