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, announces the appointment of Peter
J. Mariani as Chief Financial Officer (CFO), effective August 14,
2024. Mr. Mariani will report to Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents. Concurrently, Kathleen P. Bloch,
CytoSorbents’ current CFO, announced her retirement from the
Company effective as of the close of business today, and will
continue to serve in an advisory role as a consultant to enable an
effective transition.
Mr. Mariani brings over 25 years of experience
as a valued partner and strategic financial leader across several
high growth medical device companies. Prior to joining
CytoSorbents, Mr. Mariani served as CFO of Axogen, Inc (NASDAQ:
AXGN), a medical technology company focused on peripheral nerve
repair, from March 2016 to December 2023, most recently as its
Executive Vice President & CFO from March 2021 to December
2023. At Axogen, Mr. Mariani was responsible for all finance and
accounting functions, investor relations, information technology
and security, and Global Quality. During his tenure, Axogen grew
annual revenue from $27 million to nearly $160 million, expanded
from one to four nerve repair clinical applications, raised
approximately $250 million of capital, executed a comprehensive
clinical evidence development and publication strategy, and
completed a long-term facility build-out.
Dr. Chan stated, “Pete is a seasoned and
accomplished medical device CFO whose many successes at high growth
publicly-traded companies such as Axogen, Hansen Medical, and
Guidant Corporation, speak for themselves. He has consistently
demonstrated a disciplined and rigorous approach to financial
management, operational excellence, and strategic development both
domestically and internationally that aligns perfectly with our
next phase of expected rapid growth. Importantly, CytoSorbents
today shares many similarities to Axogen when Pete joined as CFO in
2016, including with respect to its size, revenue base, U.S. market
opportunity, and high margin business model. He has proven his
ability to fund, scale, and manage impressive growth. As we pursue
U.S. and Canadian marketing approval for DrugSorb-ATR and drive our
OUS business with CytoSorb, we believe Pete will be an outstanding
fit where his deep global experience and insight is expected to be
vital to our success. We are thrilled to have Pete join
CytoSorbents and be a key member of the management team.”
Prior to Axogen, Mr. Mariani was the Chief
Financial Officer of Lensar, Inc., which at the time was
privately-held and a global leader in next generation femtosecond
laser technology for refractive cataract surgery. Prior to Lensar,
he served as Chief Financial Officer at Hansen Medical, Inc., a
publicly traded company that designed and manufactured medical
robotics for positioning and control of catheter-based
technologies. Mr. Mariani’s career also includes 12 years
with Guidant Corporation, a global leader in the development and
sale of medical devices for the treatment of cardiovascular
disease. During his tenure at Guidant, he held senior financial
positions of increasing importance, including Vice President of
Finance and Administration, Guidant Japan, and Corporate Vice
President, Controller and Chief Accounting Officer. He
started his career at Ernst and Young, LLP, where he served a
diverse client base as a Certified Public Accountant. Mr. Mariani
earned a Bachelor of Science in accounting from Indiana
University.
“I am excited to
join CytoSorbents during this pivotal time in the
Company’s history.” stated Mr. Mariani. “The potential future
marketing approval of DrugSorb-ATR by the U.S. Food and Drug
Administration (FDA) and Health Canada would provide an exciting
U.S. and Canadian entry point for the Company’s technology in the
large and important cardiac surgery market. The
anticipated win-win-win value proposition for patients, surgeons,
and hospitals, if approved, appears extremely compelling. Meanwhile
the opportunity for CytoSorb® in critical care and cardiac surgery
worldwide is massive with the anticipated prospects of stronger and
sustained growth ahead. I look forward to partnering with this
talented and dedicated team to further develop and execute our
long-term growth strategy and bring improved outcomes to as many
patients as possible with CytoSorbents’ life-saving blood
purification therapies.”
Dr. Chan concluded, “As we welcome Pete to
CytoSorbents, we remain indebted to Kathy Bloch for her
more than 11 years of dedication and leadership at the Company as a
trusted colleague and friend, and for all of her contributions that
have helped us achieve the success we have today. In particular,
after her retirement as our CFO in March 2023, and interim CFO
consultancy, Kathy selflessly came back in August 2023 to reprise
her role as full-time CFO, and in the intervening 12 months, helped
to secure the future of the Company with two key financings and
orchestrating our cash conservation strategy. We are glad she will
continue as a consultant to help manage a smooth CFO transition. On
behalf of the CytoSorbents Board of Directors, its management team,
and employees, we wish Kathy an enjoyable, relaxing, and
well-deserved retirement.”
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 76 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 June 30, 2024, more than 248,000 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. CytoSorb
is not yet approved in the United States.
The DrugSorb™-ATR antithrombotic removal system,
an investigational device based on the same polymer technology as
CytoSorb, has 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 has
completed the FDA-approved, randomized, controlled STAR-T (Safe and
Timely Antithrombotic Removal-Ticagrelor) study of 140 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 U.S. FDA 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 $50 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™, 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 X.
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, representations and contentions, the
timing of our expected regulatory submissions and our expectations
with respect to the accretive value that Mr. Mariani will bring to
the Company, 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 14, 2024, 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.
Please Click to Follow Us
on Facebook and X
U.S. Company Contact:Dr. Phillip Chan, CEO305
College Road EastPrinceton, NJ 08540pchan@cytosorbents.com
Investor Relations Contact:Eric RibnerLifeSci
Advisors, LLC250 W 55th St, #3401New York,
NY 10019ir@cytosorbents.com
Axogen (NASDAQ:AXGN)
Historical Stock Chart
From Jul 2024 to Aug 2024
Axogen (NASDAQ:AXGN)
Historical Stock Chart
From Aug 2023 to Aug 2024