US Market News
3月前
CytoSorbents Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business HighlightsMarch 25, 2026 4:05 PM
PR Newswire (US)
2025 revenue of $37.1 million, up 4% year-over-year, and 71% Full-year gross marginsEnhanced Balance Sheet Flexibility with an Additional $2.5 million Proceeds from Amended Credit Facility in NovemberImplemented Strategic Workforce and Cost Reduction Program in Q4 to Accelerate Timing to Cash Flow Breakeven in 2026Ongoing Interactive Discussions with FDA to Determine Content and Timing of New De Novo Application for DrugSorb™ -ATR PRINCETON, N.J., March 25, 2026 /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, today reported financial results for the fourth quarter and full year ended December 31, 2025, and recent business highlights.
Full Year 2025 Financial ResultsRevenue was $37.1 million, an increase of 4% compared to $35.6 million in 2024, or flat on a constant currency basis.Gross margin was 71% in 2025 compared to 70% in 2024.Operating loss for 2025 improved by 10% to $14.7 million compared to $16.5 million in 2024.Net loss, improved to $8.2 million or $0.13 per share, compared to net loss of $20.7 million or $0.38 per share in 2024.Adjusted net loss for 2025 was $14.2 million, or $0.23 per share, compared to an adjusted net loss of $12.7 million, or $0.23 per share, in 2024.Adjusted EBITDA loss for 2025 improved to $10.5 million, compared to a loss of $11.5 million in 2024.Fourth Quarter 2025 Financial ResultsRevenue was $9.2 million, an increase of 1% over the prior year, and down 8% on a constant currency basis. Gross margin expanded to 74% in the quarter compared to 70% in Q4 2024.Operating loss, which included a restructuring charge of approximately $0.5 million due to our Q4 workforce and cost reduction program, was $4.6 million, compared to $3.7 million in Q4 2024. Net loss was $5.5 million or $0.09 per share, compared to a net loss of $7.6 million or $0.14 per share in Q4 2024.Adjusted net loss was $4.3 million or $0.07 per share, compared to an adjusted net loss of $1.7 million or $0.03 per share in Q4 2024, which includes a net income tax benefit accrual of $1.7 million recorded in Q4 2024 from the sale of Net Operating Loss and R&D tax credits.Adjusted EBITDA loss was $3.2 million compared to a loss of $2.4 million in Q4 2024.Total cash, cash equivalents, and restricted cash of $7.8 million on December 31, 2025, compared to $9.1 million as of September 30, 2025. "2025 was a transitional year for our business as we made good progress in four key objectives," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "We ended the year with positive clinical and commercial momentum for 2026, with a lower cost structure and improved balance sheet to support our growth. Additionally, we continue to make progress with the FDA to align on the content and timing of a new De Novo submission for DrugSorb-ATR™ and look forward to providing further updates in the future. Four key areas of focus include the following:A. Sales PerformanceSales in 2025 grew by 4% to $37.1 million led by a 13.0% increase in direct sales outside of Germany to $8.6 million and an 11.4% increase in distributor sales to $16.5 million, that together accounted for approximately 68% of our business. This was offset by a 10% reduction in Germany sales to $11.8 million, reflecting the near-term impact of our proactive restructuring of German sales operations and the implementation of strategies that are expected to drive more consistent and scalable growth. Improvements implemented during this initiative include enhanced customer targeting, structured weekly sales planning, increased focus on new account development, and improved allocation of sales resources. Early indicators in 2026 suggest improving commercial activity, including increased customer engagement and new account development. We are encouraged by these signs and expect to see incremental improvement across the year.B. Clinical MomentumBy the end of 2025, we surpassed a key milestone of more than 300,000 cumulative CytoSorb® treatments delivered globally – an increase of more than 50% over the past few years – highlighting the broad and growing adoption of our therapy across more than 70 countries and a wide range of clinical applications. As highlighted at last week's International Symposium of Critical Care and Emergency Medicine (ISICEM) conference, a steady stream of new clinical data continues to support the use of CytoSorb across multiple critical care indications. Sepsis and septic shock remain among the leading use cases.A recent multinational survey of 442 physicians, endorsed by ESICM and SIAARTI and published in Intensive Care Medicine Experimental (2026), found that more than three-quarters of respondents use extracorporeal blood purification primarily for refractory septic shock, with broad-spectrum hemoadsorption such as CytoSorb identified as the most commonly used and preferred modality (43%). During World Sepsis Day and Sepsis Awareness Month in September 2025, we hosted a webinar entitled, "Turning the Tide in Sepsis and Septic Shock" highlighting why and how CytoSorb is used to control deadly inflammation, stabilize patients, reverse capillary leak, and facilitate fluid removal from patients. Interim results from the septic shock cohort of the prospective COSMOS (CytOSorb TreatMent Of Critically Ill PatientS) registry, published in Annals of Intensive Care (2026), evaluated 140 patients across 18 sites. Treatment with CytoSorb was associated with highly significant reductions (p
US Market News
3月前
CytoSorbents Announces HotSwap™ Launch, Renewed Aferetica Partnership, and New Clinical Evidence at ISICEM 2026March 19, 2026 9:44 AM
PR Newswire (US)
PRINCETON, N.J., March 19, 2026 /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, today announced three major developments at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) this week in Brussels, Belgium - one of the largest global conferences dedicated to critical care medicine:
The introduction of HotSwap™ by CytoSorbents – The New CytoSorb exchange systemThe renewal of its long-standing partnership with Aferetica Srl in Italy, andNew clinical data reinforcing the growing body of evidence supporting CytoSorb® therapyCytoSorbents Launches HotSwap™ to Simplify and Optimize TherapyCytoSorbents announced the immediate availability of HotSwap™, an innovative solution designed to enable rapid, seamless exchange of CytoSorb adsorbers during the treatment of critically-ill patients. HotSwap™ is designed to:Enable faster, easier device exchanges – particularly in high-acuity patients requiring frequent changesFacilitate the safe return of blood from used devices back to the patientStreamline workflows for ICU staff, reducing nursing burden and improving treatment consistency"In critically ill patients, timing, dosing, and treatment intensity are essential to improving outcomes," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "HotSwap enables clinicians to more easily and efficiently treat the right patient, at the right time, with the right dose. Early user feedback has been highly positive, reinforcing our decision to make this technology broadly available." Dr. Chan added, "In life-threatening diseases such as sepsis, acute respiratory distress syndrome, liver failure, and trauma, unstable patients often require multiple device changes per day in the early phase of treatment to control deadly massive inflammation or to reduce high concentrations of toxic substances that can otherwise lead to organ failure and death. HotSwap makes this process faster, safer, and more practical, while preserving valuable blood volume and reducing the workload on ICU teams."CytoSorbents Renews Strategic Partnership with AfereticaCytoSorbents also announced the renewal of its exclusive distribution agreement with Aferetica Srl in Italy, extending a successful collaboration spanning more than a decade. The partnership has supported widespread adoption of CytoSorb across critical care and cardiac surgery in Italy. The companies have also collaborated on Aferetica's innovative PerLife® organ perfusion platform, which integrates CytoSorbents' PerSorb® cartridge to improve organ preservation and rehabilitation for transplantation."Aferetica has been an exceptional long-term partner," stated Dr. Chan. "CEO Mauro Atti and his team, working closely with leading clinicians and researchers in the country, have played a critical role in advancing both the clinical adoption and scientific understanding of CytoSorb therapy. We are excited to continue working together to expand innovation in blood purification and organ transplantation."Mr. Mauro Atti, Chief Executive Officer of Aferetica SRL stated, "We are happy to continue our successful collaboration with CytoSorbents that has contributed to the growth of our companies and importantly, the care and recovery of many patients. For more than ten years, we have shared the vision that blood purification can significantly improve outcomes in critically ill patients. Together we have successfully expanded from sepsis into liver failure and other critical illnesses, and now organ transplantation. We look forward to many more years of continued progress and shared success."New Clinical Data and Scientific Leadership at ISICEM 2026Today, CytoSorbents is hosting a featured symposium at ISICEM entitled:"Hemoadsorption as part of an individualized patient concept in Intensive Care – Key Learnings and Best Practices"
Chair: Dr. Ricard Ferrer, Barcelona/Spain and Dr. Zsolt Molnar, Budapest/HungaryThe importance of timing and dosing in different indications
Dr. Gerd Klinkmann, Rostock/GermanyUpdate on drug removal – we are on the safe side if we do it right
Dr. Gabriella Bottari, Rome/ItalyThe new kid on the block – Cytokine Release Syndrome (CRS) after CAR-T cell therapy
Dr. Peter Pickkers, Nijmegen/The NetherlandsIn addition, multiple abstracts and poster presentations presented at ISICEM further strengthen the clinical evidence base for CytoSorb therapy (click on title for full abstract):COSMOS Registry – Real-World Critical Care Outcomes (n=306, 23 sites, 6 countries)Significant reductions in vasopressor requirements, improved oxygenation, and fluid balance (all p90% dialysis independenceRhabdomyolysis Substudy (n=45)Significant reduction in myoglobin levels (~8,800 ? ~3,000 µg/L, p
US Market News
4月前
CytoSorbents to Report Fourth Quarter and Full Year 2025 Financial Results and Recent Business HighlightsMarch 5, 2026 7:00 AM
PR Newswire (US)
PRINCETON, N.J., March 5, 2026 /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, will report fourth quarter and full year ended December 31, 2025, on Wednesday, March 25, 2026.
CytoSorbents' management will host a live presentation webcast, and a question-and-answer session starting at 4:30PM ET the same day. Webcast Details:
Date: Wednesday, March 25, 2026
Time: 4:30 PM ET
Live webcast link: https://app.webinar.net/2aLvZaLpb6BIt is recommended that participants join in approximately 10 minutes prior to the start of the webinar.An archived recording of the webinar will be available under the Investor Relations section of the Company's website at https://ir.cytosorbents.com/About CytoSorbents Corporation (NASDAQ: CTSO)CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine storm and cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. 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 or cleared in the United States.In the U.S. and Canada, CytoSorbents is developing the DrugSorb®-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb®, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It 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 surgery. The Company is actively pursuing regulatory approval of DrugSorb®-ATR with the U.S. FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA. DrugSorb®-ATR is not yet granted or approved in either the U.S. or Canada.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 website at https://ir.cytosorbents.com/ and follow us on Facebook and X and LinkedIn. Forward-Looking StatementsThis 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, and the outcome of our regulatory submissions, 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, our restructuring of our direct sales team and strategy in Germany, ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve cash-flow break-even in the first quarter of 2026, our ability to appropriately finance the Company, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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 XU.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
pmariani@cytosorbents.com Investor Relations Contacts:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare ir@cytosorbents.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/cytosorbents-to-report-fourth-quarter-and-full-year-2025-financial-results-and-recent-business-highlights-302705032.htmlSOURCE Cytosorbents Corp
Original: CytoSorbents to Report Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
Good Sport
6月前
Press Release: CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Results and Business Update
01/12/26 7:00 AM
Fourth quarter and Full-Year 2025 revenue are expected to be approximately $9.2 million and $37.0 million, respectively, with expected Q4 gross margins in the range of 73% to 75%
DrugSorb(R)-ATR De Novo Pre-Submission Meeting scheduled with the FDA this month, with anticipated De Novo Application filing this quarter and regulatory decision in mid-2026.
Results of the pivotal STAR-T study for DrugSorb(R)-ATR have recently been accepted for publication in a top cardiac surgery journal
Management will host in-person investor meetings in San Francisco during J.P. Morgan Healthcare Conference week
PRINCETON, N.J., Jan. 12, 2026 /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, today announced preliminary unaudited fourth quarter and full-year 2025 financial results and business update.
Preliminary, Unaudited Selected Fourth Quarter and Full-Year Financial Results
-- Fourth quarter 2025 revenue is expected to be approximately $9.2 million
compared to $9.2 million in the fourth quarter of 2024
-- Full-year 2025 revenue is expected to be approximately $37.0 million,
representing approximately 4% growth versus $35.6 million for the
full-year 2024
-- Fourth quarter gross margin is expected to be in the range of 73% to 75%,
compared to 71% in the fourth quarter of 2024, and 70% in the third
quarter of 2025
-- Full-year gross margin is expected to be approximately 72%, compared to
71% for full-year 2024
Recent Business Updates
-- Cumulative CytoSorb treatments have now surpassed 300,000 worldwide.
-- Results of the pivotal STAR-T study for DrugSorb(R)-ATR have recently
been accepted for publication in a top cardiac surgery journal. The
publication is currently in press and should be available online soon.
-- The Company has scheduled a Pre-Submission Meeting this month with the
U.S. Food and Drug Administration (FDA) to confirm regulatory
requirements for a new De Novo Application for DrugSorb(R)-ATR, the
Company's investigational medical device to reduce the severity of
perioperative bleeding in patients on ticagrelor (Brilinta(R),
AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery.
Pending the outcome of the Pre-Submission Meeting, the Company expects to
file a new De Novo Application by the end of the first quarter of 2026.
-- As previously announced, on November 13, 2025, the Company amended its
credit agreement which strengthened its balance sheet with an additional
$2.5 million of cash and extended the interest-only-period through
December 31, 2026. The amendment also provides for an additional $2.5
million of cash and an additional extension of the interest-only period
to June 30, 2027 with DrugSorb(R)-ATR FDA marketing approval.
-- Further, the Company implemented a previously announced strategic
workforce and cost reduction program in the fourth quarter and expects to
be approximately cash-flow breakeven (excluding restructuring payments)
for the first quarter of 2026.
https://www.morningstar.com/news/pr-newswire/20260112ny60709/cytosorbents-reports-preliminary-unaudited-fourth-quarter-and-full-year-2025-results-and-business-update
Good Sport
7月前
AI Overview:
"The CytoSorbents (CTSO) Virtual Fireside Chat with D. Boral Capital on December 15, 2025, likely focused on their DrugSorb-ATR device, where they discussed positive FDA feedback for a new De Novo application for ticagrelor removal in urgent heart surgery, aiming for FDA review by mid-2026 after addressing prior denial issues. Management (Dr. Phillip Chan, Peter Mariani) also shared updates on their broader blood purification tech, market products like ECOS-300CY, and plans for Health Canada submissions following FDA clarity, with the goal of getting their innovative treatments to patients faster.
Key Discussion Points:
DrugSorb-ATR (Ticagrelor): CytoSorbents received constructive feedback from the FDA after a previous denial and will submit a new De Novo application with more real-world data for urgent CABG (heart bypass) patients on ticagrelor, with potential approval by mid-2026.
FDA Path: The FDA sees an expedited path for market authorization and found no safety issues, focusing on expanding the label for urgent heart surgery.
Health Canada: They're withdrawing their Health Canada request for now and will resubmit after getting clarity from the FDA process.
Technology & Pipeline: Updates covered their core blood purification technology, other marketed products (ECOS-300CY, HemoDefend), and ongoing development.
Management: CEO Dr. Phillip Chan and CFO Peter J. Mariani led the discussion with D. Boral Capital's Jason Kolbert.
In essence, the outcome was an update reinforcing progress and a clear path forward for their key investigational device in the U.S., despite previous hurdles."
Good Sport
7月前
"Warwick EMS will soon carry antibiotics to treat sepsis"
Updated: 6:54 PM EST Dec 5, 2025
Video Clip Source: WGAL
LITITZ, Pa. —
Sepsis is a life-threatening emergency caused by the body's extreme reaction to infection. It can lead to organ damage and even organ failure.
UPMC Lititz Emergency Department physician, Dr. Christine Dang, said, "It is also a very common cause of readmissions to the hospital, more so than heart attacks, congestive heart failure, even COPD."
Dang is also the medical director for Warwick EMS, which is about to start a pilot program to treat possible sepsis patients with antibiotics in the field, which is currently not permitted in Pennsylvania.
Warwick EMS Chief and Executive Director Rob Walker said, "There have been some studies that have shown antibiotics for patients with sepsis, even 15 minutes earlier, can reduce the length of stay in the hospital, reduce the amount of time in the ICU, and improve their outcomes."
Crews will be trained and will use a checklist to screen high-risk patients based on symptoms, vital signs, and suspected infection. They will give the patient IV fluids and, if needed, administer the antibiotic.
The pilot program has to be approved by the Pennsylvania Department of Health's Bureau of EMS.
The department said it is currently in the review process and is expected to be approved in the near future.
Dang said the hope is that it will save lives.
https://www.wgal.com/article/warwick-ems-will-soon-carry-antibiotics-treat-sepsis/69647682
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
Double Dragon
2月前
メールアドレスで登録
