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,
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.
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.
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.
D. Joseph Gersuk, CFO
EVC Group, Inc.
Greg Gin/Doug Sherk
Chris Gale, 646-201-5431