AngioDynamics (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced oral presentations on NanoKnife ® System clinical experience took place at the Society of Interventional Radiology (SIR) 2012 Annual Scientific Meeting, March 24-29, 2012, in San Francisco, Calif. An oral presentation titled “A prospective, multicenter phase II clinical trial using irreversible electroporation for the treatment of early stage HCC,” was given March 28, 2012. The authors of this Company-sponsored European study included Professors Riccardo Lencioni and Laura Crocetti of the University of Pisa, Pisa, Italy; Francesco Izzo of Istituto Nazionale Tumori – Fondazione Pascale, Naples, Italy; Valerie Vilgrain and Mohamed Abdel-Rehim of Hopital Beaujon, Paris, France; Jens Ricke and Maciej Pech of Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin, Magdeburg, Germany; Jordi Bruix and Luis Bianchi of the Hospital Clinic i Provincial de Barcelona (BCLC), Barcelona, Spain. The trial is a phase II prospective, multicenter clinical study to evaluate the efficacy and safety of the NanoKnife System as a first-line treatment for early-stage hepatocellular carcinoma (HCC), the most common form of liver cancer. It is registered with www.ClinicalTrials.gov as number NCT01078415. The following retrospective data analyses also were presented at SIR’s 2012 Annual Scientific Meeting. An oral presentation titled “Downstaging locally advanced pancreatic adenocarcinoma (LAPC) with vascular encasement using percutaneous irreversible electroporation (IRE),” was given March 27 2012. The authors included Doctors Govindarajan Narayanan, Geetika Arora, Katuska Barbery, Tatiana Froud, Alan Livingstone, Dido Franceschi, Peter Hosein, Caio Rocha Lima, and Jose Yrizarry of the University of Miami, Miami, Fla. Eight patients with biopsy-proven pancreatic cancer underwent percutaneous ablation of pancreatic tumors using the NanoKnife System. Imaging demonstrated intact veins in all patients’ treatment zones immediately, and 24-hours, after the procedure. Complications included spontaneous pneumothorax during anesthesia in one case and pancreatitis in one case. Both recovered completely. No mortalities occurred within 30 days. Follow up was conducted with each patient in the months after the procedure. This analysis also was the subject of a press release issued by SIR regarding the conference, as well as a press event hosted by the organization on March 26, 2012.
An oral presentation titled “Vessel patency post Irreversible Electroporation ablation – a 15 month follow up,” was given March 26, 2012. The authors included Doctors Govindarajan Narayanan, Geetika Arora, Jose Yrizarry, David Quintana, Umamaheshwari Mukkamalla, Katuska Barbery and Peter Hosein of the University of Miami, Miami, Fla.Ablation using the NanoKnife ® System was performed in 79 procedures on 56 patients between January 2010 and June 2011. Overall, narrowing or thrombosis occurred in three out of 84 vessels in close proximity to the treatment zone. An oral presentation titled “Percutaneous Irreversible Electroporation of Surgically Unresectable Pancreatic Carcinoma: Single Center Safety Experience,” was given March 26, 2012. The authors included Doctors Sandeep Bagla, Dimitrios Papadouris, and Arina van Breda, of INOVA Alexandria Hospital, Springfield, Va. In this clinical experience, four consecutive patients with surgically unresectable pancreatic carcinoma received seven ablations of five tumors. No mortalities occurred within 30 days. No episodes of intra-operative arrhythmia occurred. Intra-operative transient hypertension occurred with all treatments. No patients had prolonged hypertension after completion of the procedure with the NanoKnife System. There were no incidents of hemorrhage, infection, pancreatic fistula, or bowel injury. One treatment was complicated by partial splenic infarction, which required no treatment. No patients required analgesics on discharge. An oral presentation titled “Percutaneous irreversible electroporation in the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC) to the liver,” was given March 26, 2012. The authors included Doctors Govindarajan Narayanan, Katuska Barbery, Jose Yrizarry, and Peter Hosein of the University of Miami, Miami, Fla. Forty-nine patients underwent percutaneous ablation of unresectable HCC and mCRC liver tumors using the NanoKnife System. A total of 76 lesions were treated in 62 sessions. After a procedure with the system, 20 patients had a complete response, 19 had a partial response and one had stable disease as their best response. Two of the HCC patients were transplanted. The Kaplan-Meier estimated average progression free survival was 11.3 months for all patients, 11.6 for HCC patients, and 10.4 months for mCRC patients. Six patients experienced complications during the procedure of the following types: pneumothorax, pleural effusion and atrial flutter during anesthesia. All patients recovered fully from these complications. One patient died within one month of a procedure with the NanoKnife System due to disease progression.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the treatment or therapy of a specific disease or condition.About AngioDynamics AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at 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,” “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, 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, 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 purchased 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, 2011, and AngioDynamics’ Form 10-Q for the quarterly period ended November 30, 2011. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.