ACCESS-2 study provides additional clinical experience with X9's investigational technology for vascular access in hemodialysis
WALLINGFORD, Conn., Oct. 26, 2026 (GLOBE NEWSWIRE) -- X9, Inc., a privately held medical technology company dedicated to elevating vascular access, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the X9 Ultrasound System with Power-Assisted Needle Insertion. X9 also announced the completion of ACCESS-2, the company's second clinical study evaluating its investigational technology in patients undergoing hemodialysis.
FDA granted Breakthrough Device Designation to the X9 System for its proposed use in providing healthcare professionals with imaging and guidance to identify validated vascular access sites and assist with guided needle insertion for hemodialysis cannulation of vascular accesses.
“Reliable vascular access is essential to hemodialysis treatment, yet needle insertion remains a demanding procedure. Breakthrough Device Designation marks an important milestone for X9 as we work to address the significant unmet need in vascular access,” said Eb Bright, CEO of X9. “Together with the results of our second clinical study, this designation marks important progress in the development of technology with the potential to make vascular access more consistent and reproducible. We look forward to advancing the X9 System through continued clinical development.”
“At DaVita, we see firsthand how even routine parts of the healthcare experience can create discomfort for patients. X9 has the potential to change that, not just in kidney care, but across healthcare,” said Steve Phillips, chief strategy officer for DaVita. “We're energized to support X9 as an investor, and this milestone is an important step toward bringing that innovation to more patients and clinicians.”
ACCESS-2 Clinical Study
ACCESS-2 was a prospective, single-center study evaluating the feasibility and safety of the investigational X9 System in patients undergoing hemodialysis through an arteriovenous fistula. Ten patients were enrolled in the study, which included multiple dialysis sessions using investigational-device-assisted cannulation.
ACCESS-2 demonstrated successful needle placement with the X9 System and subsequent initiation of dialysis, while achieving the study's primary safety objective. No serious device-related adverse events or other device-related adverse events were reported.
“ACCESS-2 builds on our initial first-in-human experience and provides important additional clinical evidence as we advance the X9 System,” said Bright. “Our objective is to develop technology designed to address longstanding challenges associated with reliable vascular access while integrating into the demanding clinical workflow of hemodialysis care.”
About FDA Breakthrough Device Designation
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and healthcare providers with more timely access to medical devices by expediting their development, assessment, and review.
Breakthrough Device Designation does not constitute FDA clearance or approval of the X9 System and does not guarantee future marketing authorization.
About X9, Inc.
Launched from the ExploraMed incubator, X9, Inc. is a privately held medical technology company developing technologies intended to advance vascular access and patient care in dialysis and other critical therapies. X9 focuses on using imaging, intelligent guidance and device-assisted approaches to address longstanding vascular access challenges.
The X9 Ultrasound System with Power-Assisted Needle Insertion is an investigational device. It has not been cleared or approved by the U.S. Food and Drug Administration and is not available for commercial sale in the United States.
For more information, visit www.x9med.com or contact Eb Bright at ebright@x9med.com.
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