First Percutaneous Liver and Kidney Lesions Treated With AngioDynamics' IRE Technology at Australia's The Alfred Hospital
QUEENSBURY, N.Y., Nov 24, 2008 (BUSINESS WIRE) -- AngioDynamics, Inc. (NASDAQ:ANGO) announced that the first percutaneous uses of irreversible electroporation (IRE) technology on liver and kidney lesions were conducted at The Alfred in Melbourne, Australia. Using the NanoKnife system, Dr. Ken Thomson, Professor and Director of the Department of Radiology at The Alfred, Monash University, performed a kidney case and two liver cases between November 6th and 20th.
The Alfred announced that all three cases were procedurally flawless and encountered no safety issues. In addition, The Alfred determined the first liver case initially successful, showing clear improvement after two weeks for the patient, whose lesions decreased markedly in size. The Alfred intends to conduct further patient follow-up before determining final outcomes. In addition, two patients reported no pain post-procedure and the third patient reported a small amount of pain which was transient and resolved completely overnight.
NanoKnife causes cell death by impacting the cell membranes with electrical pulses in targeted tissue, sparing nearby nerves, blood vessels, lymphatic system, and other delicate structures. Targeted cells are removed by the body via blood vessels and lymphatic systems.
This is different from thermal ablation modalities like cryo-ablation, microwave, and radiofrequency ablation. These modalities destroy all cells and critical structures in targeted tissue, leaving destroyed material in place for years. The body can only remove it slowly and tediously by attacking from the outside, since all normal pathways to remove damaged tissue have been destroyed.
"Traditionally there has been a variety of methods used to destroy tumors, most of which cause damage to nearby healthy tissue. This technique does not affect the surrounding supportive tissues or nearby nerves and blood vessels," said Dr. Thomson. "With IRE, what I believe we're looking at is a whole new treatment modality that can be used on a wider spectrum of patients which potentially reduces risk or impact to their body. I believe the NanoKnife represents a new paradigm in radiologically guided microsurgery."
The Alfred explained that each NanoKnife procedure comprised a sequence of 90 pulses taking a total of approximately 45 seconds. Each procedure administered four to seven pulse sequences.
"These cases are part of our ongoing process to provide 25 NanoKnife systems to thought leaders like Dr. Thomson," said Eamonn Hobbs, President and CEO of AngioDynamics. "We are making excellent progress with the thought leader program, especially with the response we are getting from some of the world's leading cancer treatment institutions, and are excited about building the momentum of our commercial rollout by generating increasing amounts of data as additional clinical cases take place."
AngioDynamics intends to file investigational device exemptions (IDE) with the Food & Drug Administration to pursue additional and more specific tissue indications. The device has been cleared for a general soft tissue ablation indication by the FDA.
About Irreversible Electroporation
Irreversible Electroporation (IRE) is a surgical resection technique in which electrical fields are used to create nano-scale defects in a cell's membrane, which causes cell death only in the targeted tissue, without destroying critical structures such as ducts, blood vessels and nerves. A research team headed by Boris Rubinsky, Distinguished Professor of Bioengineering at the University of California, Berkeley, invented the IRE technology used in the ongoing trials. The technology was exclusively licensed by the University of California to Oncobionic for commercial development. With the close of the acquisition of Oncobionic in April 2008, AngioDynamics has taken ownership of the exclusive license along with a developing portfolio of Intellectual Property in the area of IRE.
About The Alfred and Dr. Ken Thomson
The Alfred is a major referral teaching hospital in Melbourne, Australia. It has a major role in the provision of services on a statewide and national basis. The hospital enjoys a reputation as one of the world's leading health care providers - largely attributable to its concentration of specialist leading edge services, including Oncology, Cardiovascular Medicine, Heart and Lung Transplant, Trauma Care and Respiratory Medicine. The Alfred provides the most comprehensive range of specialist medical and surgical services in the Australian state of Victoria and offers every form of medical treatment - with the exception of obstetrics and pediatrics.
Dr. Thomson has expertise in cardiovascular and interventional radiology and is a founding member of the Society of Minimally Invasive Therapy and the Interventional Radiology Society of Australasia. He has published and lectured widely on aspects of interventional radiology and his research interests are vascular stents, molecular imaging, endografts and therapeutic embolic agents. He is the past President of the Asian & Oceanian Society of Radiology.
About AngioDynamics
AngioDynamics, Inc. is a leading provider of innovative medical devices used by interventional radiologists, surgeons, and other physicians for the minimally invasive treatment of cancer and peripheral vascular disease. The Company's diverse product line includes market-leading radiofrequency ablation and irreversible electroporation resection systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.
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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," 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 the Company's expectations. Factors that may affect the actual results achieved by the Company include, without limitation, the ability of the Company to develop its existing and new products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of the Company to integrate the purchased Diomed businesses as well as the risk factors listed from time to time in the SEC filings of AngioDynamics, Inc., including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2008. The Company does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
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