News & Events

Latham, New York, November 5, 2019 – AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today hosted a “Beacon of Hope” media event at its global headquarters to support Pancreatic Cancer Awareness Month.

During the month of November, the Company’s global headquarters will be lit in purple light to serve as a symbolic “Beacon of Hope” for the patients, doctors and advocates in search of improved treatment outcomes for pancreatic cancer.

“We are excited to kick-off Pancreatic Cancer Awareness Month and welcome the opportunity to hear from patients and advocates about their experiences fighting this terrible disease,” said Brent Boucher, AngioDynamics Senior Vice President and General Manager for Oncology. “Our determination to improve the standard of care for those diagnosed with Stage III pancreatic cancer is evidenced by our DIRECT Study for the use of NanoKnife in the treatment of Stage III pancreatic cancer. We are privileged to give pancreatic cancer survivors a platform to share their journeys fighting the disease and offer hope to other pancreatic cancer patients around the world.”

AngioDynamics received approval from the FDA for the Company’s investigational device exemption (IDE) application for its DIRECT Clinical Trial on April 1 of this year. Shortly after, the Company received central Institutional Review Board (IRB) approval, accelerating its ability to engage with local IRBs and make Irreversible Electroporation (IRE) technology available to patients through the DIRECT Trial. The Trial’s first patient was enrolled in May, and in the six months since its launch, AngioDynamics has expanded clinical trial partnerships to 10 sites.

There are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States annually^[1]. Total deaths due to pancreatic cancer are projected to increase dramatically to become the second leading cause of cancer-related deaths before 2030^[2]. The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs, and less than 20 percent of patients are candidates for surgical resection at time of diagnosis^[3]. Approximately 35 to 40 percent of patients will present with Stage III and 45 to 55 percent with metastatic disease^[3]. Regardless of the stage of pancreatic cancer, it is one of the least survivable cancers, and survival rates have not improved substantially for more than forty years^[3]. For all stages combined, the five-year relative survival rate is 8 percent and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3 percent^[3].

AngioDynamics’ DIRECT Trial features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation trial is classified as a Category B IDE by the FDA, which allows participating sites to obtain coverage for procedures performed in addition to any related routine costs.

To facilitate the enrollment of participants in the DIRECT Trial, AngioDynamics launched AngioDIRECT.com. The online platform provides patients and their families with information about pancreatic cancer and details about the Trial. It also features a physician locator to help prospective participants and referring healthcare professionals identify clinical trial locations.

About AngioDynamics, Inc.

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.

About the NanoKnife System

The NanoKnife System has received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes^[4]. These permanent pores, or nano-scale defects, in the cell membranes result in cell death^[4]. The treated tissue is then removed by the body’s natural processes mimicking natural cell death^[4],[5]. Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy^[4],[6].

The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery creates ablations that are hyperechoic and can be monitored under real-time ultrasound[7].

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,” “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 from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, 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 fourth 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 health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, challenges with respect to fourth-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 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, 2019. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

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[1] American Cancer Society. (2019). Cancer Facts & Figures. Retrieved March 14th, 2019, from https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html

[2] Projecting Cancer Incidence and Deaths to 2030: The Unexpected Burden of Thyroid, Liver, and Pancreas Cancers in the United States. Lola Rahib, Benjamin D. Smith, Rhonda Aizenberg, Allison B. Rosenzweig, Julie M. Fleshman and Lynn M. Matrisian DOI: 10.1158/0008-5472.CAN-14-0155 https://www.ncbi.nlm.nih.gov/pubmed/24840647

[3] American Society of Clinical Oncology. (2019). Pancreatic Cancer: Statistics. Retrieved March 14th, 2019, from https://www.cancer.net/cancer-types/pancreatic-cancer/statistics

[4] Lee EW, Chen C, et al. Radiology. 2010 May;255(2):426-33.doi: 10.1148/radiol.10090337

[5] Tekle E, Wolfe MD, et al. Biochem Biophys Res Commun. 2008 Nov 14; 376(2): 256-260. Doi: 10.1016/j.bbrc.2008.08.060

[6] Rubinsky B, Onik G, Mikus P. Technol Cancer Res Treat. 2007 Feb;6(1):37-48.doi: 101177/153303460700600106

[7] NanoKnife ® System User Manual v2.2.0