Healthcare Industry News: AngioDynamics
News Release - December 18, 2008
First Lung Lesion and First Lymph Node Metastasis Treated With AngioDynamics’ IRE Technology at Australia’s The Alfred HospitalNanoKnife™ system used to perform cases
Previous cases at The Alfred continue to show success
QUEENSBURY, N.Y. December 18, 2008 — (HSMN NewsFeed) - AngioDynamics, Inc. (NASDAQ: ANGO) announced the use of its irreversible electroporation (IRE) technology on a lymph node metastasis and the first lung lesion case, 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 the procedures, which were judged by The Alfred to be successful from a safety perspective. The hospital will conduct further patient follow-up before determining final outcomes in terms of tumor response.
Dr. Thomson reported that the two patients who were treated did not report pain related to the procedures. These are the fifth and sixth cases using NanoKnife at The Alfred, with three liver cases and a kidney case preceding them, all with procedural success.
“I have been an interventional radiologist since 1974 and this is the most exciting development in minimal access therapy I have seen,” said Thomson. “For the patient, the absence of post-operative pain is unique and remarkable. We have also treated tumors in the liver and kidney with NanoKnife, with similar experiences – no postoperative pain at all – and the procedures have raised no safety concerns. This is probably due to the fact that the supporting structure of the tissue treated is not destroyed and vascular and nerve function is unaffected.”
Regarding a previously announced liver case from The Alfred, sequential triple phase liver CT scans and ultrasound at two weeks and four weeks post-procedure have shown that a 2 cm tumor has disappeared on imaging. At the site of a 3.5 cm tumor near the diaphragm in the same patient there is only a minor non-enhancing scar. Dr Thomson noted these outcomes contrast very favorably with the cavities left following thermal ablation procedures.
Eamonn Hobbs, President and CEO of AngioDynamics, said “We are delighted by the additional, positive progress at The Alfred, and very pleased that our thought leader program, which includes Dr. Thomson’s important work, continues to demonstrate the value of this exciting new technology.”
NanoKnife causes cell death by impacting the cell membranes of targeted tissue with pulses of electricity, effectively sparing nearby nerves, blood vessels, lymphatic system, and other delicate structures. Targeted cells are removed from the body through blood vessels and lymphatic systems.
This is different from thermal ablation modalities like cryo-ablation, microwave, and radiofrequency ablation. These other modalities destroy all cells including 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, as all normal pathways to remove damaged tissue have been destroyed.
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 Food and Drug Administration.
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.
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.
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.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
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