AngioDynamics Enrolls First Patient in AMBITION BTK Trial Advancing Treatment for Critical Limb Ischemia
MWN-AI** Summary
AngioDynamics, Inc. (NASDAQ: ANGO) has taken a significant step forward in treating Critical Limb Ischemia (CLI) by enrolling its first patient in the AMBITION BTK trial. This multicenter, randomized controlled trial aims to assess the safety and effectiveness of the Auryon Atherectomy System when used alongside standard balloon angioplasty compared to balloon angioplasty alone in patients with below-the-knee blockages. As CLI affects over 20% of those untreated, this trial targets a pressing need for improved treatment options, especially for the diabetic population, who face higher incidences of infrapopliteal disease.
The trial will include up to 224 patients across 30 sites, with a primary endpoint evaluated through a win-ratio approach that considers factors like freedom from major amputation and clinically driven target lesion revascularization at the 12-month mark. Additionally, a companion registry will enroll up to 1,500 patients treated with the Auryon System, providing robust real-world data on its efficacy.
Dr. Anahita Dua, a vascular surgeon at Massachusetts General Hospital and Co-Principal Investigator of AMBITION BTK, expressed excitement about the trial, highlighting the increasing prevalence of below-the-knee disease and the urgent need for new treatment methodologies to prevent amputations. The Auryon Atherectomy System’s innovative laser technology optimizes the treatment of arterial occlusions with minimal vessel wall impact, offering the potential to significantly enhance patient outcomes in this challenging demographic.
AngioDynamics positions itself as a forefront player in medical innovation, aiming to restore blood flow and improve quality of life for patients suffering from vascular diseases. More information about the trial and technology can be found on AngioDynamics' website and clinical trial registries.
MWN-AI** Analysis
AngioDynamics, Inc. (NASDAQ: ANGO) recently made headlines by enrolling its first patient in the AMBITION BTK trial, an essential phase in evaluating the Auryon Atherectomy System as a treatment for Critical Limb Ischemia (CLI). This trial has the potential to significantly influence the market dynamics for both AngioDynamics and the broader vascular treatment landscape.
As CLI continues to pose serious health risks, with significant amputation rates for untreated patients, the introduction of effective and innovative treatments is critical. The AMBITION BTK trial seeks to establish the efficacy of the Auryon System in conjunction with standard balloon angioplasty, addressing the gap in treatment options for below-the-knee lesions.
From a market perspective, the successful results of this trial could position AngioDynamics as a leader in the peripheral artery disease treatment segment, particularly in a growing demographic increasingly affected by diabetes-related vascular complications. Additionally, the companion registry aiming to enroll up to 1,500 additional patients could provide vital real-world data that further strengthens the evidence supporting the Auryon System's effectiveness.
Investors should closely monitor the trial's progress, as positive outcomes could boost AngioDynamics’ share price and market share. However, they should also remain cognizant of potential risks associated with clinical trials, including regulatory hurdles and competitive responses from larger medical device firms with established products.
In summary, AngioDynamics represents a compelling opportunity for growth within the medical technology sector, particularly as they advance treatments for CLI. Strategic investment in ANGO could yield favorable returns, provided the AMBITION BTK trial confirms the efficacy and safety of the Auryon Atherectomy System. Regular updates from the clinical trial will be crucial indicators for investor sentiment and stock performance.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Trial Investigates Use of Auryon Atherectomy System in Cases with Challenging Below-the-Knee Blockages
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 A uryon Atherecto m y System Used in Combination with Standard B alloon Ang i oplasty Versus S t andard Balloon Angioplasty Alone Treating I nfrapopliteal Lesi on s in Subjects with Critical Limb Ischemia B elow- t he- K nee (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) 3,4,5,6 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 .
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, tariffs, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2025. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo and Auryon are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.
| 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 |
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Investor Contact:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com
Media Contact:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com
FAQ**
How might the results of the AMBITION BTK trial impact the future market positioning of AngioDynamics Inc. (ANGO) in the treatment of critical limb ischemia?
What are the potential financial implications for AngioDynamics Inc. (ANGO) if the Auryon Atherectomy System demonstrates superior efficacy in the AMBITION BTK trial compared to standard balloon angioplasty?
Given the increasing incidence of below-the-knee disease, what strategies might AngioDynamics Inc. (ANGO) employ to leverage the findings from the AMBITION BTK trial for expanded market penetration?
How does AngioDynamics Inc. (ANGO) plan to address potential risks highlighted in their forward-looking statements, particularly regarding the outcomes of the AMBITION BTK trial?
**MWN-AI FAQ is based on asking OpenAI questions about AngioDynamics Inc. (NASDAQ: ANGO).
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