OrbusNeich Files Lawsuit Against Dr. Pavel Cervinka for Defamation

By Orbusneich, PRNE
Sunday, March 20, 2011

HONG KONG, March 21, 2011 - OrbusNeich today announced that it has filed a lawsuit in the Netherlands
against Dr. Pavel Cervinka and Masaryk Hospital in Usti nad Labem, Czech
, where Dr. Cervinka is head of the hospital's Cardiology Department.
The suit relates to a clinical study conducted at the Masaryk Hospital, in
which Dr. Cervinka was the Principal Investigator, which purported to
randomly compare OrbusNeich's Genous stent with a bare metal stent for
treatment of a class of heart attack patients. The results of the study
reported certain adverse events with the OrbusNeich stent. However, upon a
review of the study by OrbusNeich and independent evaluators, it was revealed
that there were many inaccuracies, misrepresentations and inconsistencies in
the study, the study methods, and the reporting of the study conclusion.

The lawsuit alleges that Dr. Cervinka and the Masaryk Hospital have
committed unlawful acts and asks for an injunction against further
presentations or publications of the study. Additionally, OrbusNeich requests
that the court's decision be submitted for publication in the U.S. Journal in
which the study was published by Dr. Cervinka and an acknowledgement of the
decision also be placed by Dr. Cervinka in the Journal, as well as other

After the first presentation of the study at the American College of
Cardiology in March 2009, in accordance with the practice of proper corporate
responsibility and a serious concern for patient welfare, OrbusNeich
personnel contacted Dr. Cervinka to discuss the study and investigate the
circumstances surrounding the reported adverse events. In response, Dr.
Cervinka provided limited information on three patients who experienced a
stent thrombosis (blood clot). An independent evaluation of the data relating
to those patients revealed procedural complications for all three patients,
namely under-expansion, geographic miss and malapposed struts in a jailed
diagonal branch, which are recognized risk factors for stent thrombosis. It
also revealed discrepancies in the reported data and inconsistencies and
misrepresentations in the study and the reporting of the study. Upon
presentation of the findings of the independent evaluation, Dr. Cervinka
admitted that he had made mistakes; however, changes which he made to
subsequent presentations and the publication of the study in a medical
Journal did not correct the reporting of the defects in the study, nor admit
nor publish the errors and invalidity of the study.

Dr. Cervinka presented the results and conclusions of the study a number
of times after he and the Masaryk Hospital were made aware of the defects in
the study and the study reporting. As a result of the wide dissemination of
the study and its erroneous conclusions that were not supported by the data,
numerous clinicians stopped using the product and terminated clinical trials,
and OrbusNeich suffered reputational damage. Despite many requests by
OrbusNeich, neither Dr. Cervinka nor the Masaryk Hospital has made public
disclosure of the defects or deficiencies in this invalid study.

Alfred J. Novak, Chairman and Chief Executive Officer of OrbusNeich,
said, "OrbusNeich stents and its other products provide innovative therapies
that improve the lives of patients around the world. We have taken this
action only after many unsuccessful attempts to try to work with Dr. Cervinka
and the Masaryk Hospital to correct the record. We informed Dr. Cervinka and
the Masaryk Hospital about the inaccuracies, misrepresentations and
inconsistencies that were unveiled by an independent reviewer of the study,
and they acknowledged our position. Nevertheless Dr. Cervinka and Masaryk
Hospital continued to widely present and publish the flawed and invalid
study, resulting in damages to OrbusNeich's business and reputation. While we
attempted to resolve this issue amicably, the actions by Dr. Cervinka and
Masaryk Hospital have left us no other choice but to protect the reputation
of OrbusNeich and our products in court."

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and
markets innovative medical devices for the treatment of vascular diseases.
Current products are the world's first pro-healing stent, the Genous Stent,
as well as other stents and balloons marketed under the names of Azule(TM), R
stent, Scoreflex(TM), Sapphire(TM), Sapphire II and Sapphire NC. Development
stage products include the Combo(TM) Bio-engineered Sirolimus Eluting Stent,
or Combo Stent, which combines the Genous pro-healing technology for rapid
endothelial coverage with an abluminal sirolimus drug elution for the control
of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has
operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The
; and Tokyo, Japan. OrbusNeich, which has provided medical devices
to physicians through its predecessor companies since 1979, supplies products
today to interventional cardiologists in more than 60 countries. For more
information, visit www.OrbusNeich.com. Follow OrbusNeich on Twitter at

    Global Media Contacts:
    Dan Katcher/Aaron Palash
    Joele Frank, Wilkinson Brimmer Katcher

    David Kujawa
    +1-954-730-0711 (office)
    +1-305-733-7216 (mobile)

Dan Katcher or Aaron Palash of Joele Frank, Wilkinson Brimmer Katcher, +1-212-355-4449; David Kujawa, OrbusNeich, +1 954-730-0711 (office), +1 305-733-7216 (mobile), dkujawa at orbusneich.com

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