Mursla Bio Receives FDA Breakthrough Device Designation for EvoLiver Test

• Reflects the potential of EvoLiver test to improve early liver cancer detection among high-risk patients
• EvoLiver leverages Mursla Bio’s platform based on organ-specific extracellular vesicles circulating in blood
• Breakthrough status provides expedited review and closer collaboration with the FDA, ultimately enabling broader market reach and commercial adoption

CAMBRIDGE, England, & BOSTON--(BUSINESS WIRE)--Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk patients through the power of Dynamic Biopsy technology, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its lead product, EvoLiver™. The designation recognizes the potential of the Company’s Dynamic Biopsy-based blood test, EvoLiver, which is enabled by a novel platform based on organ-specific EVs for the surveillance of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in high-risk cirrhotic patients.

The FDA’s Breakthrough Device Designation is awarded to medical technologies that offer more effective diagnosis of life-threatening or irreversibly debilitating diseases and that represent a breakthrough over existing solutions. The designation enables an accelerated regulatory pathway, including priority review and closer collaboration with the FDA, which ultimately supports broader market reach and commercial adoption.

HCC is the fastest-growing cause of cancer-related deaths. Although clinical guidelines recommend routine surveillance for high-risk individuals, adherence to these programs remains low, and the standard-of-care method, based on ultrasound, has limited sensitivity, particularly for detecting small tumors and in overweight patients. Together, these challenges contribute to late diagnoses, poor patient outcomes, and escalating healthcare costs. The FDA’s Breakthrough Device Designation follows the announcement of the Company’s results from its MEV01 multi-center clinical in which EvoLiver demonstrated 86% early-stage sensitivity at 88% specificity for liver cancer surveillance¹.

Pierre Arsène, Founder and CEO of Mursla Bio, said: “This designation is a powerful validation of both our scientific vision and clinical strategy - EvoLiver is the first liver cancer surveillance test in at least five years to receive FDA Breakthrough status. This is not another iteration on liquid biopsy - it is a leap. We are creating a new diagnostic layer based on organ-specific EV intelligence, allowing us to identify disease in ways previously not possible. EvoLiver has the potential to transform liver cancer surveillance by enabling earlier detection through a more accurate, accessible, and patient-friendly blood test.”

Mursla Bio’s Dynamic Biopsy technology combines the accuracy and disease sub-typing capabilities of tissue biopsies with the ease of liquid biopsy sample collection, providing a non-invasive intervention with comprehensive biological insights. This is made possible by advanced EV science and an innovative extracellular omics approach, supported by Mursla Bio’s technologies. These technologies include organ-specific EV isolation from biofluids for precise targeting, an AI-enabled multi-omics workflow for disease biomarker identification, and a scalable assay platform using optimal biomarkers for clinical use.

Mursla Bio is advancing regulatory compliance for EvoLiver as a Laboratory Developed Test (LDT) in preparation for its upcoming product launch, while also laying the groundwork for future FDA approval through the Premarket Approval (PMA) pathway to enable broader clinical and commercial scale-up.

For further information on Mursla Bio, please visit https://mursla.com/.

1. Press release: Mursla Bio’s EvoLiver surpasses current standards in liver cancer surveillance