FDA Grants 510(k) Clearance to Sonic Incytes' Velacur® Determined Fat Fraction (VDFF), a breakthrough for patients with MASLD and MASH

FDA Grants 510(k) Clearance to Sonic Incytes' Velacur^® Determined Fat Fraction (VDFF), a breakthrough for patients with MASLD and MASH

Media
Barry Allen
Communications@sonicincytes.com
604-807-6388

Sonic Incytes Medical Corp, a leader in point-of-care ultrasound, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Velacur® Determined Fat Fraction (VDFF). This innovative measurement tool is integrated into the Velacur® device software, combining quantitative measures of ultrasound attenuation and backscatter. With a strong correlation coefficient of 0.85, VDFF estimates MRI proton density fat fraction (MRI-PDFF)¹, the hospital-based gold standard in liver fat measurement. VDFF has an outstanding accuracy (AUC) of 95% as a classifier of patients with more than 5% MRI-PDFF^1,2, a definition for the presence of hepatic steatosis.

VDFF delivers similar clinical utility to MRI-PDFF at the point of care, transforming the management of hepatic steatosis.

Metabolic dysfunction-associated steatotic liver disease (MASLD) affects almost 100 million people in the US alone, with an estimated 20% progressing to metabolic dysfunction associated steatohepatitis (MASH), an advanced chronic disease leading to cancer and death. MASH and MASLD remain challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care.

VDFF is arriving at a critical time, with the recent FDA clearance of the first MASH therapeutic. In addition, recently published clinical guidance by the AASLD recommends liver ultrasound as a secondary screen to blood tests while noting that, ”CAP [...] does not accurately quantify or monitor changes in liver fat³”, referring to the controlled attenuation parameter (CAP) used in FibroScan devices.

“The approval of Rezdiffra (Madrigal Pharmaceuticals) was a big win for patients, but it also highlighted the urgent need for reliable non-invasive tests (NITs). VDFF is a promising new tool that will arm providers with the data we need to manage and monitor patients at the point of care” said Dr. Naim Alkhouri, Chief Medical Officer (CMO), Chief of Transplant Hepatology, and Director of the Steatotic Liver Program at Arizona Liver Health (ALH) in Phoenix, AZ.

The VDFF measurement is supported by clinical research published in the World Federation for Ultrasound in Medicine and Biology¹.

Sonic Incytes plans to release the VDFF feature to all new and existing Velacur® users in the United States through a software update in the coming weeks.

About Sonic Incytes

Sonic Incytes is committed to enhancing patient care through innovative diagnostic solutions. The company's flagship product, Velacur™, equips physicians with an advanced liver imaging tool to help manage the growing epidemic of fatty liver disease. Velacur offers real-time, AI guided quantification of the key markers for fatty liver disease: liver stiffness, attenuation and VDFF. With real-time results, a low up-front cost and AI guidance, VELACUR makes liver imaging at the point of care affordable and accessible.

For more information, visit www.sonicincytes.com.

1: Honarvar, Mohammad & Lobo, Julio & Schneider, Caitlin & Klein, Samuel & Smith, Gordon & Loomba, Rohit & Ramji, Alnoor & Hassanein, Tarek & Yoshida, Eric & Pang, Emily & Curry, Michael & Afdhal, Nezam. (2024). Methods and Validation of Velacur Determined Fat Fraction in patients with MASLD. WFUMB Ultrasound Open. 2. 100061. 10.1016/j.wfumbo.2024.100061.

2: K233977

3: Rinella, Mary E.1; Neuschwander-Tetri, Brent A.2; Siddiqui, Mohammad Shadab3; Abdelmalek, Manal F.4; Caldwell, Stephen5; Barb, Diana6; Kleiner, David E.7; Loomba, Rohit8. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology 77(5):p 1797-1835, May 2023. | DOI: 10.1097/HEP.0000000000000323