��������

WASHINGTON, D.C. -- November 14, 2024 – (BUSINESS WIRE) -- ��������, a leader in medical imaging quantification techniques, today announced that it has been awarded a 2024 U.S. Food and Drug Administration Drug Development Tool (DDT) Research Grant to evaluate a novel biomarker aimed at addressing the unmet needs of patients with rare diseases. This award highlights ��������’s steadfast commitment to supporting targeted therapies that improve patient care and quality of life.

The nearly $250,000 research grant will fund ��������’s research in partnership with the (CALiD) to investigate the efficacy of a novel biomarker which shows promise in preliminary research. CALiD is one of the largest U.S. databases for primary sclerosing cholangitis (PSC), a disease which affects just over 36,000 in the U.S. Although rare, PSC is the fourth leading cause of liver transplant. This biomarker could revolutionize the way rare diseases, including PSC, are monitored and treated, offering new hope to patients who currently have limited therapeutic options.

Professor Christopher Bowlus, chief of the Division of Gastroenterology and Hepatology at UC Davis Health and Chair of the Consortium for Autoimmune Liver Diseases (CALiD) commented,

“With support from the FDA, we aim to explore the potential of quantitative MRCP as a monitoring biomarker in PSC. Leveraging the CALiD database—one of the largest PSC patient databases in North America—we plan to study at least 150 patients with serial MRCP+ reports, linking changes in MRCP+ to clinical outcomes. If successful, this could lay the foundation for a non-invasive, reliable biomarker recognized within the FDA Biomarker Qualification Program, improving patient care and serving as an essential tool in clinical trials to bridge the current gap in drug development.”

PSC is a chronic and rare progressive cholestatic liver disease. Currently liver transplant is the only lifesaving intervention because there are no effective pharmacotherapies approved for use by the FDA. Accurately characterizing this disease and its progression is critical to developing new and effective patient treatments. Yet, pharmaceutical companies currently lack access to reliable, non-invasive biomarkers to track the effects of novel treatments in a timely manner.

�������� is already a part of the FDA’s to develop biomarkers as drug development tools. This year �������� was pleased to be awarded a DDT grant to further this work. “�������� is dedicated to pushing the boundaries of health care technology to effect positive impacts on patient health using its advanced MRI quantification techniques,” said �������� CEO, Rajarshi Banerjee, MD, PhD. “The FDA’s grant supports the company as it gathers evidence to determine if the biomarker can be used to assess therapeutic changes. This funding is pivotal in our mission to see a new generation of biomarkers that can transform the landscape of rare disease treatment.”

About MRCP+:
MRCP+ provides enhanced visualization and quantitative assessment of the biliary tree and pancreatic duct, based on newly acquired or historic non-contrast Magnetic Resonance Cholangiopancreatography (MRCP) images. This enables physicians to better evaluate and report on hepatobiliary structures for more accurate diagnosis, staging, and monitoring of disease. MRCP+ is available clinically with FDA 510(k) clearance and CE marking.

About the Grant:
�������� Inc. has been awarded $245,356, 100% of which is funded by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS).

About ��������:
��������, a global medical technology company, with offices in the U.K. and the U.S., delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic disease, multi-organ diseases, and cancer. With a strong focus on precision medicine using advanced imaging, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, monitoring, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers, and technologists, �������� offers a way to manage complex health problems at scale.

For further information, please contact:
Nellie Wild
SVP of Corporate Affairs
nellie.wild@perspectum.com