Healthcare Industry News: vascular access
News Release - April 24, 2008
First Human Use Demonstrates Effectiveness of Irreversible Electroporation TreatmentPositive Results to Trigger AngioDynamics' Acquisition of Oncobionic
QUEENSBURY, N.Y.--(HSMN NewsFeed)--AngioDynamics (NASDAQ:ANGO) today reported that the first human clinical use employing irreversible electroporation (IRE) to ablate soft tissue was completely successful based on analysis of biopsies performed on five patients two weeks after their treatment.
The IRE treatment was conducted during the first week of April, 2008 as part of a pilot trial focused on determining the success of treating soft tissue with IRE. Biopsies taken from the treated patients’ prostates were normal and the patients had no side effects. The trial is expected to continue to develop clinical data on the technology's therapeutic effectiveness.
“We are very pleased with the first clinical results achieved in human use,” commented Dr. Gary Onik MD, President of Oncobionic Inc. and Director of Surgical Imaging at Celebration Health Florida Hospital. “This confirms our belief in the value of the technology and its promise to become the next generation of ablation technology.”
IRE is a non-thermal tissue ablation 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 this trial. The technology is exclusively licensed by the University of California to Oncobionic, Inc. for commercial development.
In October 2006, AngioDynamics announced that it had reached an agreement with Oncobionic to acquire the company, and that the acquisition would be completed upon the first four consecutive cases of successful treatment of soft tissue in humans. In November 2006, the U.S. Food and Drug Administration cleared the IRE technology for human use for the indication of soft tissue ablation.
Under a share purchase agreement dated October 12, 2006, AngioDynamics agreed to pay a total purchase price of $25 million, less Oncobionic’s long-term debt as of the closing date of the acquisition. $5 million of the purchase price was paid at the execution of the purchase agreement. The results reported today will trigger the second installment of approximately $10 million upon the closing of the acquisition, which is expected to be completed in May 2008. In addition, approximately $5 million is payable six months after the closing date and the remaining balance of approximately $5 million is payable 18 months after the closing date.
“This landmark first use of IRE to treat soft tissue in humans is the latest of several recent studies that have further validated our commitment to deliver this important new technology into the hands of physicians,” said Eamonn Hobbs, AngioDynamics President & CEO. “While the trial organized in the U.S. will continue, another trial in Italy is expected to commence in the near future. With the closing of the transaction, we will move towards our next milestone of providing 20 IRE systems to thought leaders in the field of focal soft tissue ablation who will begin using the systems to treat patients and develop clinical data on the technology's effectiveness. We are very excited about this breakthrough technology and its tremendous potential.”
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 systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products.
The statements made in this document contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. Investors are cautioned that actual events or results may differ from the Company's expectations. In addition to the matters described above, the ability of the Company to develop its 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, 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 June 2, 2007, may affect the actual results achieved by the Company.
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