VANCOUVER, British Columbia--(BUSINESS WIRE)--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.

不列颠哥伦比亚省温哥华——（商业新闻短讯）——Sonic Incytes Medical Corp是即时超声波的领导者，它骄傲地宣布，美国食品和药物管理局（FDA）已批准其Velacur®测定脂肪分数（VDFF）的510（k）许可证。这种创新的测量工具集成到Velacur®设备软件中，结合了超声波衰减和反向散射的定量测量。

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-PDFF1,2, a definition for the presence of hepatic steatosis..

VDFF的强相关系数为0.85，可估计MRI质子密度脂肪分数（MRI-PDFF）1，这是基于医院的肝脏脂肪测量金标准。。。

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

VDFF在护理方面提供了与MRI-PDFF相似的临床实用性，改变了肝脏脂肪变性的管理。

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..

代谢功能障碍相关脂肪肝（MASLD）仅在美国就影响了近一亿人，估计有20%的人发展为代谢功能障碍相关脂肪性肝炎（MASH），这是一种导致癌症和死亡的晚期慢性疾病。由于现有非侵入性方法的局限性，MASH和MASLD仍然难以有效诊断，尤其是在护理点可用的方法。。

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..

VDFF正处于关键时刻，最近FDA批准了第一种MASH治疗剂。此外，AASLD最近发布的临床指南建议将肝脏超声作为血液检查的二级筛查，同时指出，“CAP[…]不能准确量化或监测肝脏fat3的变化”，指的是FibroScan设备中使用的受控衰减参数（CAP）。。

“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..

“Rezdiffra（Madrigal Pharmaceuticals）的批准对患者来说是一个巨大的胜利，但它也凸显了对可靠的非侵入性检测（NITs）的迫切需求。VDFF是一种很有前景的新工具，它将为提供者提供我们在护理点管理和监测患者所需的数据”，亚利桑那州菲尼克斯市亚利桑那州肝脏健康（ALH）首席医学官（CMO）、移植肝病学主任兼脂肪肝项目主任Naim Alkhouri博士说。。

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

VDFF测量得到了世界医学和生物学超声联合会发表的临床研究的支持1。

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.

Sonic Incytes计划在未来几周通过软件更新向美国所有新的和现有的Velacur®用户发布VDFF功能。

About Sonic Incytes

关于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.

Sonic Incytes致力于通过创新的诊断解决方案加强患者护理。该公司的旗舰产品Velacur™为医生配备了先进的肝脏成像工具，以帮助管理日益流行的脂肪肝疾病。Velacur提供实时，AI指导的脂肪肝疾病关键标志物定量：肝脏僵硬，衰减和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..

VELACUR 可提供实时结果、较低的前期成本和人工智能指导，使肝脏成像在医疗点变得经济实惠且易于获得。