AngioDynamics Enrolls First Patient in AMBITION BTK Trial Advancing Treatment for Critical Limb Ischemia

Trial Investigates Use of Auryon Atherectomy System in Cases with Challenging Below-the-Knee Blockages

LATHAM, N.Y.--Jul. 28, 2025-- AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announced enrollment of the first patient in the Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK).

AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon Atherectomy System combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). The primary endpoint will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularization (CD-TLR), and primary patency.

The RCT will include up to 224 patients at up to 30 sites. In parallel, a companion registry will enroll up to 1,500 additional patients who are ineligible for the RCT and are treated with the Auryon System above or below the knee.

“The enrollment of the first patient in the AMBITION BTK trial is a significant milestone in our commitment to advancing clinical evidence for the treatment of below-the-knee peripheral artery disease (PAD),” said Laura Piccinini, Senior Vice President/General Manager, Cardiovascular & International, AngioDynamics. “There is a pressing need for new treatment strategies to help patients suffering from chronic limb ischemia, and we are proud to partner with clinicians to evaluate the Auryon System in this important setting.”

The overall risk of limb loss in CLI is estimated at 20–25% at one year if left untreated, reflecting a large impact on quality of life and healthcare costs.¹ Incidence of infrapopliteal disease in patients with CLI, particularly in the diabetic population, is estimated to be >70%.²

“Treatment options for below-the-knee lesions are still limited and often depend heavily on balloon angioplasty,” said AMBITION BTK Co-Principal Investigator Ehrin Armstrong, FACC, FSCAI, FSVM, MD, MSc, Interventional Cardiologist and Vascular Disease, Director of Clinical Research, Advanced Heart and Vein Center. “The Auryon laser can restore laminar flow and therefore has the potential to improve outcomes in this challenging patient population significantly.”

The first patient in the trial was treated by Anahita Dua, MD, MS, MBA, FACS, a vascular surgeon at Massachusetts General Hospital and associate professor of Surgery at Harvard Medical School, and Co-Principal Investigator of AMBITION BTK.

“I’m excited to perform the first patient case in the AMBITION BTK study. Patients with below-the-knee disease often face limited treatment options and poor long-term outcomes,” said Dr. Dua. “Across the world, there has been a significant increase in patients with below-the-knee (BTK) disease, which is, unfortunately, resulting in an amputation epidemic. Having new tools and techniques to restore blood flow to the foot, allowing wounds to heal, and patients to preserve both their limbs and lives, is critically important and the focus of this trial. This trial will allow us to collect high-quality, real-world data using a robust research design, helping us truly evaluate the impact of laser technology in BTK disease.”

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), BTK, and In-Stent Restenosis (ISR)^3-6 and, to date, it has been used to treat more than 100,000 patients in the United States and worldwide^.7

Visit https://www.angiodynamics.com/studies/ambition-btk/ and https://clinicaltrials.gov/study/NCT06777901 for more information about the AMBITION BTK RCT and Registry.

For important risk information, visit www.angiodynamics.com/about-us/risk-information/.

About the Auryon Atherectomy System

The Auryon Atherectomy System uses innovative technology to deliver powerful treatment of arterial occlusions. The Auryon Atherectomy System is the first laser atherectomy system to efficiently treat any lesion type, any lesion length, at any lesion location, with minimal impact on vessel walls.^3,5,8,9

The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is FDA cleared with an indication for treatment, including atherectomy, of infrainguinal stenoses and occlusions, including ISR.^4,6 The Auryon System’s targeted biological reactions minimize the risk of perforation and preserve the ability to vaporize lesions without thermal ablation.^3,5,8,9 The Auryon System uses a 355nm wavelength laser platform which enables the use of longer wavelengths and shorter pulses to produce a groundbreaking delivery of short UV laser pulses.⁴ For more information, please visit www.Auryon-PAD.com.

About AngioDynamics, Inc.

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.

The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC10531516/

2. https://www.jacc.org/doi/10.1016/j.jcin.2023.11.040

3. Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8.

4. Auryon System Indications for Use

5. Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EXPAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92

6. Built-in aspiration available only with the 2.0- and 2.35-mm catheters

7. AngioDynamics’ J.P. Morgan Healthcare Conference Presentation. https://investors.angiodynamics.com/static-files/f7e7b49f-744d-4169-9a66-95a78d2f1525. Published 2025.

8. Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287

9. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644