Amplifi Vascular Gains FDA Breakthrough Device Status & CMS Category B

A Breakthrough in Dialysis Access

ST. LOUIS, Jan. 13, 2026 /PRNewswire/ -- Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi Vein Dilation System. This significant recognition highlights the company's innovative advancements in medical technology, marking a pivotal step in its mission to address critical healthcare needs.

"This coveted Breakthrough Device Designation reflects the innovative work already completed at Amplifi Vascular, inclusive of a robust first-in-human data from nineteen patients, and also strategically positions us for accelerated development and patient access," said Sean Morris, CEO. "The ability to engage frequently and efficiently with the FDA, coupled with the Category B assignment from CMS, will significantly streamline our path to market, ultimately benefiting patients in need of life-sustaining dialysis access. With an eye towards market access, we have taken important early steps towards establishing a relationship with CMS and have included important healthcare economics in the context of our clinical study design."

The Breakthrough Device Designation is a distinction reserved for technologies that offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This esteemed status is not easily attained; it is granted exclusively to companies whose innovations meet stringent criteria, reflecting a substantial leap forward in medical science. Amplifi Vascular's comprehensive data set, which included compelling first-in-human results from nineteen patients, was a key factor in securing this designation.

This designation provides Amplifi Vascular with opportunities for more frequent and efficient interactions with the U.S. Food and Drug Administration (FDA). Such enhanced collaboration can streamline the development and review processes, potentially accelerating the availability of important new therapies to those who need them most. The concurrent Category B assignment from CMS further acknowledges the potential impact of the company's advancements on future patient access and coverage.

This recognition underscores several key aspects of Amplifi Vascular's commitment to innovation:

• Rigorous Selection: The Breakthrough Device Designation is exclusively awarded to companies demonstrating innovations that address unmet medical needs for serious conditions, signifying a high level of scientific merit.
• Clinical Validation: The designation was supported by a robust and complete data set, featuring initial human study results from nineteen individuals, providing a solid foundation for its potential.
• Streamlined Development: This recognition facilitates closer and more productive engagement with the FDA, potentially speeding up regulatory pathways and bringing solutions to patients sooner.
• CMS Recognition: The accompanying Category B assignment from CMS highlights the potential for future coverage and patient access, indicating a broader understanding of the technology's value.

This achievement reflects Amplifi Vascular's dedication to developing impactful medical technologies and its potential to significantly improve patient outcomes for those in need of durable, life-sustaining dialysis access.

Amplifi Vascular is a medical device company developing innovative solutions to improve outcomes in hemodialysis vascular access. The Amplifi™ Vein Dilation System is designed to dramatically enhance vein size and quality prior to AVF creation, enabling more durable, reliable dialysis access and supporting the shift toward earlier, safer cannulation. For more information, visit www.amplifivascular.com.

SOURCE Amplifi Vascular, Inc