AngioDynamics’ DIRECT Clinical Study Receives Institutional Review Board Approval for the Treatment of Stage III Pancreatic Cancer

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative,
minimally invasive medical devices for vascular access, peripheral
vascular disease, and oncology, today announced that the Company
received central Institutional Review Board (IRB) approval to conduct
its NanoKnife® Irreversible Electroporation “Direct
IRE Cancer
Treatment” clinical study (DIRECT).
The IRB approval closely follows the United States Food and Drug
Administration’s (FDA) approval of AngioDynamics’ investigational device
exemption (IDE) application announced on April 1.

Today’s approval enables AngioDynamics to accelerate its engagement with
local IRBs and marks a significant milestone in the process of making
Irreversible Electroporation (IRE) available to patients through the
DIRECT clinical study. The Western IRB (WIRB) will serve as
AngioDynamics’ IRB of record for the DIRECT clinical study.

“AngioDynamics is committed to providing physicians and patients with
additional options for the treatment of Stage III pancreatic cancer. The
DIRECT IRB approval demonstrates our commitment to initiating this
next-generation clinical study as quickly as possible to advance our
pursuit of innovative, lifesaving treatments,” said Brent Boucher,
AngioDynamics Senior Vice President and General Manager of Oncology.

AngioDynamics’ DIRECT clinical study features a comprehensive data
collection strategy that will provide meaningful clinical information to
healthcare professionals, support a regulatory indication for the
treatment of Stage III pancreatic cancer, and facilitate reimbursement
for hospitals and treating physicians. The next-generation study is
classified as a Category B IDE by the FDA, allowing participating sites
to obtain coverage for procedures performed as well as related routine

The DIRECT clinical study comprises a Randomized Controlled Trial (RCT)
at up to 15 sites, as well as a Real-World Evidence (RWE),
next-generation registry at up to 30 sites, each with a NanoKnife System
treatment arm and a control arm. AngioDynamics expects each NanoKnife
arm to consist of approximately 250 patients with an equal number of
control patients. The primary endpoint of the study is overall survival.

As part of the DIRECT clinical study, AngioDynamics launched
to facilitate the enrollment of participants. The online platform
provides patients and their families with information about pancreatic
cancer and details about the study. It also features a physician locator
to help prospective participants and referring healthcare professionals
identify clinical study locations.

The DIRECT clinical study supports a proposed expanded indication for
the NanoKnife System in the treatment of Stage III pancreatic cancer.

About AngioDynamics, Inc.

AngioDynamics, Inc. is a leading provider of innovative, minimally
invasive medical devices used by professional healthcare providers for
vascular access, peripheral vascular disease, and oncology.
AngioDynamics’ diverse product lines include market-leading ablation
systems, fluid management systems, vascular access products,
angiographic products and accessories, drainage products, thrombolytic
products and venous products. For more information, visit

About the NanoKnife System

The NanoKnife System has received 510(k) clearance from the Food and
Drug Administration for the surgical ablation of soft tissue. The
NanoKnife Ablation System utilizes low energy direct current electrical
pulses to permanently open pores in target cell membranes. These
permanent pores, or nano-scale defects, in the cell membranes result in
cell death. The treated tissue is then removed by the body’s natural
processes in a matter of weeks, mimicking natural cell death. Unlike
other ablation technologies, the NanoKnife Ablation System does not
achieve tissue ablation using thermal energy.

The NanoKnife Ablation System consists of two major components: a Low
Energy Direct Current, or LEDC Generator and needle-like electrode
probes. Up to six (6) electrode probes can be placed into or around the
targeted soft tissue. Once the probes are in place, the user enters the
appropriate parameters for voltage, number of pulses, interval between
pulses, and the pulse length into the generator user interface. The
generator then delivers a series of short electric pulses between each
electrode probe. The energy delivery is hyperechoic and can be monitored
under real-time ultrasound.

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,
infringement of AngioDynamics’ technology or assertions
that AngioDynamics’ technology infringes the technology of fourth
parties, the ability of AngioDynamics to effectively compete against
competitors that have substantially greater resources, 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, challenges with respect to fourth-party distributors or
joint venture partners or collaborators, the results of sales efforts,
the effects of product recalls and product liability claims, changes in
key personnel, the ability of AngioDynamics to execute on strategic
initiatives, 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 acquired 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, 2018. AngioDynamics does not assume any obligation to
publicly update or revise any forward-looking statements for any reason.

In the United States, the NanoKnife System has received a 510(k)
clearance by the Food and Drug Administration for use in the surgical
ablation of soft tissue and is similarly approved for commercialization
in Canada, the European Union, and Australia. The NanoKnife System has
not been cleared for the treatment or therapy of a specific disease or


Investor Relations Contact:
AngioDynamics, Inc.

Media Contact:
AngioDynamics, Inc.
Saleem Cheeks