Simbionix Receives FDA Clearance to Take Medical Simulation Technology One Step Further Into Clinical Settings

By Simbionix Ltd., PRNE
Tuesday, September 28, 2010

CLEVELAND, Ohio, September 29, 2010 - Simbionix Ltd., a subsidiary of Simbionix USA Corporation, the world's
leading provider of medical education and simulation technology, is proud to
announce the receipt of FDA clearance for the PROcedure Rehearsal Studio(TM)
Software.

The PROcedure Rehearsal Studio software is intended for use as a software
interface and image segmentation system for the transfer of imaging data from
a medical scanner such as a CT scanner to an output file. It is also intended
as pre-operative software for simulating and evaluating surgical treatment
options. Unique to the Simbionix simulation systems, the 3D segmentation
model can be exported to the Simbionix ANGIO Mentor(TM) Simulator practice
environment. The results are an advanced method of creating an ever expanding
library of modules for training and post-operative debriefing.

Dr Karl A. Illig, Professor of Surgery and Neurosurgery and Chief,
Division of Vascular Surgery, University of Rochester Medical Center
comments: "We have been using the PROcedure Rehearsal Studio in our research
and educational programs, and it has lived up to our fullest expectations. We
began to practice using our carotid stents on the simulator before performing
them in the operating room in 2008, and have been very impressed by its
ability to improve our subsequent procedures. In my opinion, this is clearly
the next step for medical simulation, where simulators will be able to be
used to plan a procedure."

"We are extremely pleased to have received the FDA clearance, allowing us
to offer new and advanced technologies for use in daily clinical practice as
well as in training", says Gary Zamler, Simbionix CEO. "The PROcedure
Rehearsal Studio software was designed to help clinicians deliver better
patient care and to enhance patient safety through timely and realistic
practice. Once again, we are able to prove that Simbionix is constantly
innovating and stretching technological boundaries."

About Simbionix USA Corporation

Simbionix is the world's leading provider of simulation and training
products for medical professionals and the healthcare industry. Founded in
1997, the company is committed to delivering high quality products, advancing
clinical performance and optimizing procedural outcomes.

For more information on Simbionix, visit www.simbionix.com

    Contact:

    Rebecca Zitter
    Manager of Marketing Communications and Distributor Relations
    rebecca@simbionix.com
    +1-216-2292040

Contact: Rebecca Zitter, Manager of Marketing Communications and Distributor Relations, rebecca at simbionix.com , +1-216-2292040.

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