Dr. Irina
Kulinets, seasoned U.S. and international medical device
regulatory expert, joins CytoSorbents' executive management team to
lead FDA marketing approval of DrugSorb®-ATR and other global
regulatory priorities
PRINCETON, N.J., Jan. 17,
2023 /PRNewswire/ -- CytoSorbents Corporation
(NASDAQ: CTSO), a leader in the treatment of life-threatening
conditions in the intensive care unit and cardiac surgery using
blood purification via its proprietary polymer adsorption
technology, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice
President of Global Regulatory Affairs. Dr. Kulinets brings
more than 30 years of experience in regulatory affairs and clinical
research of medical devices, biologics, and combination products in
multiple therapeutic areas, including cardiovascular,
neurovascular, oncology, orthopedics, biologic implants, and
others. She will serve as a member of CytoSorbents' executive
management team and will report to Vincent
Capponi, President and Chief Operating Officer of
CytoSorbents.
Dr. Irina
Kulinets, seasoned U.S. and international medical device
regulatory expert, joins CytoSorbents
Dr. Kulinets was most recently the SVP of Regulatory Affairs,
Clinical Research, and Quality at MicroVention, Inc., a division of
Terumo Corporation and a global manufacturer of neuroendovascular
medical devices. She has also worked for major U.S. and
international life science corporations such as Johnson &
Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and
BioSphere Medical. She has an extensive track record of
international regulatory success with the approval/clearance of
medical products in numerous therapeutic areas, including many
Class II 510(k) and Class III Premarket Approval (PMA) medical
devices. Dr. Kulinets has also provided executive strategic
and operational leadership to help launch new products in the U.S.,
E.U., China, Japan, and many other Asian and Latin American
markets.
Dr. Kulinets also has extensive experience as a regulator and
worked for TUV America, Product Service - Medical Division and was
appointed as a third-party FDA Inspector and 510(k) reviewer on
behalf of the FDA to review, assess and approve new
technologies.
Dr. Kulinets stated, "I am excited to join CytoSorbents at such
an important time in the Company's history as it nears the
completion of the STAR-T pivotal trial, evaluating the ability of
the DrugSorb®-ATR system to reduce the risk of perioperative
bleeding in cardiothoracic surgery caused by the antithrombotic
drug, Brilinta®. During my career I have led the regulatory
approval of many cardiovascular and neurovascular medical devices.
I believe the DrugSorb®-ATR system is a unique breakthrough
therapy that can reduce bleeding complications in this setting and
we will be working diligently to bring this product to help
clinicians and patients as the Company's first commercialized
product in the U.S. and Canada.
Meanwhile, CytoSorbents has so many other compelling
technologies, such as CytoSorb® and HemoDefend®-BGA. I look
forward to leveraging my U.S. and international regulatory and
clinical expertise to help rapidly advance these programs around
the world."
Mr. Vincent Capponi remarked, "I am excited that Irina is
joining the CytoSorbents team to lead Global Regulatory Affairs.
She comes to us with a wealth of regulatory experience in
medical devices, tissue products, and drugs and has received
numerous FDA approvals. In addition to U.S. approvals, Irina
has led international approvals in Europe, China, Japan,
South Korea, Latin America, Australia, and Canada."
Mr. Capponi continued, "First and foremost, Irina's focus will
be to help drive FDA marketing approval of DrugSorb-ATR for our
initial indication of Brilinta® removal, currently under study in
the STAR-T trial, and then later for direct oral anticoagulant
(DOAC) removal under the STAR-D trial. Irina's regulatory
experience with cardiovascular devices aligns well with this
intended use. Meanwhile, her background will no doubt be
useful in expanding the DrugSorb-ATR market to hospital-wide
applications where preoperative removal of antithrombotics could be
helpful, as before emergency orthopedic or neurologic
surgeries. At the same time, Irina is well-suited to help
refine our global regulatory strategy for CytoSorb, HemoDefend-BGA
(universal plasma), and other technologies currently under
development. We are fortunate to have a regulatory
professional of Irina's caliber to join our team and look forward
to her future success."
Dr. Kulinets holds an M.S. in Mechanical Engineering from
Belarus Polytechnic Academy, M.S. in Quality Systems from
California State University, and a
Ph.D. in Health Science from Trident University. She is RAPS
(Regulatory Affairs Professionals Society) certified RAC
(Regulatory Affairs Certification) and Board Certified in Medical
Affairs. Irina also has strong ties to Academia. She
served as a Faculty Director and lecturer for the Master of Science
in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in
Regulatory Science and Clinical Research program in Georgetown University, Washington DC. She has
authored or co-authored 3 books and has multiple peer-reviewed
publications in areas of her expertise.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and in
cardiac surgery through blood purification. Its lead product,
CytoSorb®, is approved in the European Union and distributed in 75
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. As of September 30,
2022, more than 186,000 CytoSorb devices have been used
cumulatively. CytoSorb was originally launched in the
European Union under CE mark as the first cytokine adsorber.
Additional CE mark extensions were granted for bilirubin and
myoglobin removal in clinical conditions such as liver disease and
trauma, respectively, and for ticagrelor and
rivaroxaban removal in cardiothoracic surgery
procedures. CytoSorb has also received FDA Emergency Use
Authorization in the United
States for use in adult critically ill COVID-19 patients
with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA Breakthrough
Device Designations, one for the removal of ticagrelor and
another for the removal of the direct oral anticoagulants (DOAC)
apixaban and rivaroxaban in a cardiopulmonary bypass circuit
during urgent cardiothoracic procedures. The Company is
currently conducting the FDA-approved, randomized, controlled
STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of
120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use
of DrugSorb-ATR can reduce the perioperative risk of bleeding in
patients receiving ticagrelor and undergoing cardiothoracic
surgery. This pivotal study is intended to support FDA
marketing approval in the United
States and Health Canada marketing approval for DrugSorb-ATR
in this application.
CytoSorbents' purification technologies are based on
biocompatible, highly porous polymer beads that can actively remove
toxic substances from blood and other bodily fluids by pore capture
and surface adsorption. Its technologies have received
non-dilutive grant, contract, and other funding of approximately
$48 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. The Company has numerous marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more
information, please visit the Company's websites
at www.cytosorbents.com and www.cytosorb.com or
follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended
to qualify for the safe harbor from liability established by the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements about our plans, objectives, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and
are not historical facts and typically are identified by use of
terms such as "may," "should," "could," "expect," "plan,"
"anticipate," "believe," "estimate," "predict," "potential,"
"continue" and similar words, although some forward-looking
statements are expressed differently. You should be aware that the
forward-looking statements in this press release represent
management's current judgment and expectations, but our actual
results, events and performance could differ materially from those
in the forward-looking statements. Factors which could cause or
contribute to such differences include, but are not limited to, the
risks discussed in our Annual Report on Form 10-K, filed with the
SEC on March 10, 2022, as updated by
the risks reported in our Quarterly Reports on Form 10-Q, and in
the press releases and other communications to shareholders issued
by us from time to time which attempt to advise interested parties
of the risks and factors which may affect our business. We caution
you not to place undue reliance upon any such forward-looking
statements. We undertake no obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise, other than as required
under the Federal securities laws.
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CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
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