Amplifi Vascular has achieved significant clinical and regulatory milestones with its innovative Vein Dilation System, reporting positive first-in-human study results that could transform hemodialysis access for patients with end-stage renal disease. The St. Louis-based medical device company announced successful completion of its initial clinical study alongside FDA approval for expanded U.S. trials and completion of $6.9 million in Series A financing.
Clinical Study Demonstrates Efficacy
The Amplifi first-in-human study enrolled 19 patients to evaluate pre-dilation of veins prior to surgical arteriovenous fistula (AVF) creation. The study met its primary objectives, demonstrating rapid post-procedure vein enlargement that supported successful fistula creation and physiological maturation. Patients achieved the critical benchmarks of ≥5mm in diameter and ≥500ml/min flow, with early functional use documented.
"Our first-in-human study not only met its primary objectives but also demonstrated rapid post-procedure vein enlargement, facilitating successful fistula creation, physiological maturation, and early functional use," stated Sean Morris, President and Chief Executive of Amplifi Vascular.
The safety profile proved favorable, with no significant device-related adverse events reported during the study period. These results support the system's potential to address fundamental challenges in AVF creation that have historically led to extended maturation times and high failure rates.
Addressing Critical Unmet Need
The Amplifi Vein Dilation System represents a first-of-its-kind approach designed to increase eligibility and improve creation and early maturation of arteriovenous fistulas for hemodialysis patients. The technology aims to tackle the root cause of extended time to maturation and the historically high degree of failure that has plagued AVF procedures, potentially leading to increased rates of forearm AVF success while reducing dependence on dialysis catheters and grafts.
Surendra Shenoy, MD, from Washington University, St. Louis School of Medicine, emphasized the clinical significance: "Early outcomes suggest that proactive vein dilation prior to AVF surgery can significantly improve the likelihood of achieving a usable fistula sooner—an outcome that matters greatly to our dialysis patients."
Regulatory Advancement and Future Trials
The FDA's approval of Amplifi's Investigational Device Exemption (IDE) enables the company to initiate AMPLIFI-1, a comprehensive U.S. clinical investigation. This pivotal study will evaluate the system's safety, performance, and time to functional maturation compared with standard care approaches.
"The FDA IDE approval empowers us to commence a U.S. clinical investigation, directly addressing the underlying causes of extended maturation times and elevated failure rates in AVF creation," Morris explained.
Technology and Market Position
The Amplifi Vein Dilation System delivers controlled, temporary therapy to enlarge target veins prior to surgical fistula creation. This approach aims to increase success rates, reduce catheter days and re-interventions, and lower overall costs of care for hemodialysis patients. The company's focus on enabling reliable, early maturing forearm AVFs addresses a significant clinical challenge in nephrology care.
The successful Series A financing of $6.9 million provides the company with resources to advance its clinical development program and support the upcoming AMPLIFI-1 trial, positioning Amplifi Vascular to potentially transform the standard of care for hemodialysis access creation.
