X9, Inc. announced positive results from its first-in-human clinical feasibility study evaluating the X9 Ultrasound System with Power-Assisted Needle Insertion, the company’s innovative handheld device for ultrasound-guided, power-assisted needle insertion in arteriovenous fistula (AVF) cannulation for hemodialysis patients.

The clinical study was conducted at the Territorial Medical Association of Yangiyul district, Republic of Uzbekistan, and received Ethics Committee approval. The study enrolled adult hemodialysis patients with upper extremity AVF and assessed the device’s ability to safely perform needle insertion based on machine learning-enabled, real-time ultrasound data analysis.

“The X9 Ultrasound System is designed to address barriers in vascular access, simplifying workflows and reducing reliance on specialized operator training,” said Eb Bright, CEO of X9, Inc. “This successful first-in-human trial is a significant milestone validating our platform’s potential to transform vascular access.”

Key study highlights:

The device consistently enabled precise vessel alignment and accurate needle placement using real-time, machine learning-assisted vessel alignment.

All procedures were performed by a local nephrologist following brief training on the device, supporting the device’s ease-of-use and rapid adoption potential.

The system utilized standard disposable dialysis needles, integrating seamlessly with existing dialysis clinic workflows and cost thresholds.

Traditional cannulation techniques in hemodialysis often depend on operator experience, and miscannulation leads to notable patient and healthcare burdens. Building upon X9’s 510k-cleared Ultrasound-only system, this innovative X9 Ultrasound-Guided, Power-Assisted System offers a single-handed, operator-controlled solution, overcoming the need for ultrasound image interpretation and two-handed needle insertion.