ANGO 最新10-K变化

相对上期新增的文字 · 来源:10-K · 2026-07-14

• The Auryon Atherectomy System represents one of our latest advancements in the treatment of peripheral arterial disease. The device is engineered to deliver an optimized wavelength and short pulse width to remove a wide range of lesion types while minimizing damage to the vessel wall endothelium. In…

• In February 2026, the NanoKnife system received BSI approval for the product to bear the MDR CE mark supporting expanded indications for the ablation of pancreas, kidney, liver or prostate tumors, including intermediate risk prostate cancer.

• Healthcare; Stryker Corporation; Penumbra, Inc.; Siemens Healthineers; Abbott Laboratories; Profound Medical; EDAP TMS; and Total Vein Systems.

• We manufacture certain products from two leased manufacturing properties, one in Queensbury, NY and one small facility in Glens Falls, NY, providing capabilities which include manufacturing, service, offices, engineering and research and we lease distribution warehouses. We also utilize third-party …

• FDA submissions require extensive validations and testing which requires a significant amount of time and financial resources. Changes in both regulations and FDA perspectives have increased time and testing requirements, which have caused

相对上期删除的文字 · 来源:10-K · 2025-07-18

• The Auryon Atherectomy System is one of our latest advancements in peripheral arterial disease. The Auryon system is designed to deliver an optimized wavelength and short pulse width to remove lesions while preserving the vessel wall endothelium. Additionally, the Auryon system features integrated a…

• We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents designed to shorten treatment time, and the SpeedLyser infusion system built for dialysis grafts and fistulas.

• We manufacture certain proprietary components and products and then assemble, inspect, test and package our finished products. By designing and manufacturing many of our products from raw materials, and assembling and testing our subassemblies and products, we believe that we are able to maintain be…

• AngioDynamics entered into a supply agreement with Biomerics (previously Precision Concepts) in Alajuela, Costa Rica. Biomerics is manufacturing, storing, and handling certain products for the Company and is registered with the FDA and certified to the ISO 13485 standard. The Company also relies on …

• On January 5, 2024, the Company announced a restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan"). In the second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the manufacturing of s…

相对上期新增的文字 · 来源:10-K · 2026-07-14

• Our products are used in medical procedures and purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthca…

• the growth of health care utilization. Common techniques include policies on price regulation, competitive pricing, bidding and tender mechanics, coverage and payment, comparative effectiveness of therapies, technology assessments, and managed-care arrangements. These changes are causing the marketp…

• seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages. The magnitude of the potential losses relating to these lawsuits may remain unknown for substantial periods of time.

• Sales outside the U.S. accounted for approximately 14% of our net sales during our fiscal year ended May 31, 2026. We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we

• Our business could be harmed if we cannot hire or retain qualified personnel or fail to successfully manage the transition to a new Chief Executive Officer.

相对上期删除的文字 · 来源:10-K · 2025-07-18

• Our products are used in medical procedures and purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthca…

• measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and…

• Our business could be harmed if we cannot hire or retain qualified personnel.

• Artificial intelligence, or AI, based platforms are increasingly being used in the medical device and consumer health industries. We are committed to providing a safe and secure environment for all of our personnel, our business partners and our

• customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”). We have developed policies governing the use of AI Systems to help reasonably ensure that such AI Systems are used in a trustworthy manner by our employees, contractors and authorized ag…

相对上期新增的文字 · 来源:10-K · 2026-07-14

• On December 24, 2024, the Company entered into an agreement to sell the manufacturing facilities in Queensbury, NY and Glens Falls, NY for a purchase price of $5.5 million and $1.2 million, respectively, and net proceeds of $5.2 million and $1.1 million, respectively. The Company simultaneously ente…

• On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A. The Credit Agreement has a two-year maturity and provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a borrowing base co…

• In evaluating the operating performance of our business, management focuses on revenue, gross margin, operating income, earnings per share and cash flow from operations. A summary of these key financial metrics for the year ended May 31, 2026 compared to the year ended May 31, 2025 follows:

• •Med Tech and Med Device growth of 18.4% and 2.6%, respectively

• Our Med Tech business, comprised of Auryon, the thrombus management platform and NanoKnife grew 18.4% in fiscal year 2026, driven by growth across all product lines. Our Med Device business increased 2.6% in fiscal year 2026, driven mainly by growth in the Core and Venous product lines which was par…

相对上期删除的文字 · 来源:10-K · 2025-07-18

• On December 24, 2024, the Company entered into an agreement to sell the manufacturing facilities in Queensbury, NY and Glens Falls, NY for a purchase price of $5.5 million and $1.2 million, respectively, and net proceeds of $5.2 million and

• $1.1 million, respectively. The Company simultaneously entered into lease agreements with future lease payments of $4.6 million over seven years for the Queensbury, NY facility and $0.4 million over three years for the Glens Falls, NY facility.

• On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A. The Credit Agreement has a two-year maturity and provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a borrowing base co…

• In evaluating the operating performance of our business, management focuses on revenue, gross margin, operating income, earnings per share and cash flow from operations. A summary of these key financial metrics for the year ended May 31, 2025 compared to the year ended May 31, 2024 follows:

• For the year ended May 31, 2025, the decrease in revenue is due to the divestiture of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation and Syntrax product lines, the total of which impacted sales by $33.4 million compared to the yea…