Amplifi Vascular Announces Major Clinical Milestone by Launching the AMPLIFI-1 Pivotal Trial to Expand Forearm Fistula Options for Hemodialysis Patients

Amplifi Vascular, a clinical-stage medical technology company developing the Amplifi™ Vein Dilation System, today announced the successful initiation of the AMPLIFI-1 Trial at Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system. The first North American patients were treated by a multidisciplinary clinical team led by Dr. Mohamad Hussain and Dr. Dirk Hentschel.

The AMPLIFI-1 Trial is designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula creation for hemodialysis access. A central objective of the study is to determine whether Amplifi therapy can enable functional AVF maturation at two weeks, a clinically meaningful acceleration compared with the traditional AVF maturation pathway, which can often take several weeks to months and may require prolonged catheter dependence.

This two-week maturation endpoint is especially important because prolonged catheter use remains one of the most significant drivers of infection, hospitalization, thrombosis, delayed care, and excess cost in hemodialysis access. By preparing the target vein before surgery, Amplifi is intended to shift AVF creation from a ""wait and see"" maturation model to a more predictable, planned vascular remodeling strategy.

The first cases were completed at Brigham and Women's Hospital in Boston following just over two days of Amplifi therapy. Both patients began with cephalic veins below conventional thresholds for distal AVF creation and subsequently underwent successful surgical AVF creation, with immediate post-creation ultrasound findings indicating early physiologic AVF maturation, as defined in the protocol.

""Using the AMPLIFI system at Mass General Brigham, we were able to successfully create arteriovenous fistulas in patients who previously had no conventional AVF options after just over two days of treatment,"" said Dr. Mohamad Hussain, Principal Investigator for AMPLIFI-1 at Brigham and Women's Hospital. ""This first-in-North America experience not only highlights the potential of this technology but also underscores the importance of a highly coordinated multidisciplinary approach to safely deliver novel therapies for patients with advanced kidney disease. We are excited about this innovation and look forward to the results of the AMPLIFI-1 Trial.""

Durable hemodialysis access remains one of the most persistent challenges in kidney failure care. Distal radiocephalic AVFs are often preferred because they preserve future access sites and avoid more proximal access when feasible, but many patients lack adequate superficial vein diameter for reliable creation and timely maturation. As a result, patients may remain dependent on central venous catheters, receive grafts, or be forced into upper-arm fistulas despite the clinical advantages of a distal forearm AVF.

Amplifi Vascular is developing its technology to address anatomical limitations by remodeling the target vein before surgery. The system was engineered to deliver controlled, directional, continuous flow-mediated dilation therapy to the cephalic vein over a short treatment period prior to AVF creation, with the goal of converting veins that are too small for conventional distal fistula creation into vessels suitable for surgery and early use.

""The initiation of AMPLIFI-1 in North America is a major milestone for Amplifi Vascular and for the broader dialysis access community,"" said Sean Morris, Chief Executive Officer. ""We are, by design, working upstream by addressing the vasculature before the AVF is even created.  In addition, we are focusing on where creation of AVF's are traditionally more difficult, in the distal forearm. The primary endpoint of maturation at two weeks goes directly at one of the greatest unmet needs in dialysis access: reducing the time patients spend dependent on catheters while waiting for a fistula to mature. If successful, Amplifi could meaningfully change the patient journey by enabling more forearm fistulas, accelerating time to usability, and reducing the clinical and substantial economic burden associated with catheter-based dialysis.""

AMPLIFI-1 is expected to enroll patients across leading vascular surgery, interventional, and nephrology centers in North America. Amplifi Vascular is actively engaging additional clinical sites with expertise in hemodialysis access, multidisciplinary kidney care, and advanced vascular innovation.

""Today, too many patients either cannot receive a forearm fistula or must wait months before their fistula is usable,"" added Morris. ""Amplifi is designed to change that equation. A two-week maturation pathway has the potential to improve patient care, reduce catheter exposure, lower downstream complications, and create meaningful value for hospitals and payers.""

The Amplifi™ Vein Dilation System is an investigational device and is not approved or cleared by the U.S. Food and Drug Administration. Safety and effectiveness have not yet been established.

About the AMPLIFI-1 Trial

AMPLIFI-1 is a randomized, multicenter pivotal clinical investigation evaluating the safety and effectiveness of the Amplifi™ Vein Dilation System in patients with end-stage kidney disease who require distal arteriovenous fistula creation for hemodialysis access. The study's primary effectiveness endpoint assesses AVF maturation at two weeks, reflecting Amplifi's goal of accelerating the pathway from AVF creation to usable dialysis access and reducing prolonged catheter dependence.

About Amplifi Vascular

Amplifi Vascular is a clinical-stage medical technology company developing a novel vascular remodeling platform intended to expand access to durable forearm arteriovenous fistulas for patients requiring hemodialysis. The company's lead product, the Amplifi™ Vein Dilation System, is designed to temporarily deliver controlled flow-mediated dilation therapy to the cephalic vein prior to AVF creation, with the goal of enabling successful fistula creation and earlier functional maturation in patients with small or otherwise inadequate veins.

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