[ranchhand71]

Wishing you good luck. Such huge missed opportunities by this incompetent leadership.

[biotech48]

I am looking forward to FDA and Canadian approvals and the analysts prediction of $5 and $10 targets. The share price is less than a lottery ticket with much upside with approval. Dr. Chan did get the company off pink sheets to the Nasdaq and has kept the share count to a very small level compared to most early biotechs.

[ranchhand71]

Chan continues for now SEVEN YEARS to miss plan, undeliver and mislead employees, the Board and shareholders. Worse than the captain of the Titanic. WHAT about severance pay?? Anyone wonder why employees and vendors have concerns? Watching the parking lot over the past six months tells us a lot. Doomed IMHO

[Good Sport]

What exactly was this (below) regarding in the application process?

"citing non-compliance with certain medical devices regulations"

https://www.marketwatch.com/story/cytosorbents-to-appeal-canadian-rejection-of-license-application-for-drugsorb-atr-83ac28d7

[Good Sport]

Explain Chan what exact "compliance" you failed to meet/provide to Canada please !

[Good Sport]

"No" ~ Canada
He's batting a Zero ...

We demand an explanation Chan !

CytoSorbents Provides U.S. FDA and Health Canada Regulatory Update for DrugSorb-ATR

07/02/25 7:00 AM

"PRINCETON, N.J., July 2, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner."

Health Canada Update:

"On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, citing non-compliance with certain Medical Devices Regulations. As part of Health Canada's prescribed reconsideration process, the Company intends to file a Level 1 "Request for Reconsideration" with the Medical Devices Directorate Bureau Director by July 25, 2025. The prescribed reconsideration process allows for supervisory review and provides the opportunity to directly address issues raised in the Notice of Refusal with staff not involved in the original review and may include input from qualified external subject matter experts. If marketing authorization is not received as part of the reconsideration process, the Company can then file a formal Appeal with the Director General of the Medical Devices Directorate."

https://www.prnewswire.com/news-releases/cytosorbents-provides-us-fda-and-health-canada-regulatory-update-for-drugsorb-atr-302496461.html

[Good Sport]

June 25, 2025

CytoSorb‘s role in Endothelial Integrity Protection in Sepsis and Systemic Hyperinflammation

About the Author
Dr. Jörg Scheier is anesthetist and intensive care physician, and has been working in leading positions in the medical-scientific department of ??CytoSorbents since 2015. His scope of duties currently includes medical responsibility for the intensive care application fields of the CytoSorb therapy and the related clinical and preclinical study projects. He disposes of long-standing practical experience in clinical intensive care medicine as well as medical-scientific work in various companies in the medical device industry.

https://cytosorbents.com/endothelial-integrity

[biotech48]

upcoming FDA threakthrough approval with a $5 price target, thtat is 396% within the next year.

[ranchhand71]

A drowning pig with bad management

[Good Sport]

CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR

PR Newswire

Tue, June 24, 2025 at 7:00 AM EDT

PRINCETON, N.J., June 24, 2025 /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 that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.

CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)
CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)
The denial letter identified remaining deficiencies that must be addressed before the De Novo Request can be granted and the device authorized for U.S. commercialization. In response, the Company engaged with the FDA review team to clarify and discuss the remaining deficiencies. After careful consultation with its regulatory counsel and advisors, the Company determined that a supervisory review through the administrative appeals process was the best path to resolve the remaining deficiencies.

The administrative appeals process allows the Company to engage with upper management of FDA's Center for Devices and Radiological Health (CDRH) in a prescribed procedure that includes a formal hearing, with a final decision typically issued approximately 60 days after the appeal is filed.

https://finance.yahoo.com/news/cytosorbents-files-appeal-u-fda-110000992.html

[ranchhand71]

Product market quite small; management still weak; cash level not sufficient.

[Good Sport]

Health & Safety Industry Today

Plasma Filter Market Plasma Filter Market Set to Grow at an Impressive CAGR of 5.9% Through 2032 | USD 21.13 Billion

Plasma Filter Market is expected to play a central role in modern healthcare delivery. With projections showing significant growth through 2032, B2B enterprises must align with trends in material science, clinical demand, and global health policy.

Published 16 June 2025

Cytosorbents mentioned !
More than likely the cause of today's bump up...

https://industrytoday.co.uk/health_and_safety/plasma-filter-market-plasma-filter-market-set-to-grow-at-an-impressive-cagr-of-59-through-2032-usd-2113-billion

[Good Sport]

Bump up today probably related to Trump meeting with Canada and hopes of better relations to come.

chatGPT
"Donald Trump is currently in Canada for the G7 summit and has meetings scheduled with Canadian Prime Minister Mark Carney and others."

Maybe we can get approval(s) soon !

[Good Sport]

CytoSorbents Warrants Expire Worthless as Stock Price Fails Threshold
Investing.com

Published Jun 11, 2025 04:54PM ET

"CytoSorbents Corporation (NASDAQ:CTSO), a medical device company based in Princeton, New Jersey, with a market capitalization of approximately $69 million and current trading price of $1.09, disclosed in a recent SEC filing that its Series B Right Warrants have expired without value. On Tuesday, the company reported that the 5-day volume-weighted average price of its common stock, leading up to Monday, fell short of the $2.00 minimum required price specified in the Prospectus for the Rights Offering. According to InvestingPro analysis, the company is quickly burning through cash, though it maintains a healthy current ratio of 2.61.

As a result of the price shortfall, the warrants issued in connection with the Rights Offering became void according to their terms. Consequently, any funds received for the exercise of these warrants that were not applied will be returned to the respective investors without interest or penalty. Despite recent challenges, the company has shown strong revenue growth of 15.37% and maintains a robust gross profit margin of 69.23%.

This financial update is disclosed in compliance with Regulation FD and does not constitute a filing for Section 18 of the Securities Exchange Act of 1934, nor is it incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as explicitly referenced in such a filing."

https://www.investing.com/news/sec-filings/cytosorbents-warrants-expire-worthless-as-stock-price-fails-threshold-93CH-4092017

[Paulness]

NEWS -- CytoSorbents to Participate at the Jefferies Global Healthcare Conference



PRINCETON, N.J., May 29, 2025 /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 that management will present and participate in one-on-one meetings with investors at the Jefferies Global Healthcare Conference in New York, NY on June 4 – 5, 2025.

Presentation Details:
Date: Thursday, June 5, 2025
Time: 9:20 AM ET
Live webcast link: Here

Live webcast of the presentation will be available by selecting Events and Presentations under the News & Events tab in the Investors section on https://cytosorbents.com. A replay of the webcast will be archived for up to 90 days following the session date.

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 release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure 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 a quarter million 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 procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts. Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

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/ 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, 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, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, 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 X

U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
mailto://[e-mail]

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
mailto://[e-mail]

View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-to-participate-at-the-jefferies-global-healthcare-conference-302467922.html

SOURCE Cytosorbents Corp

[Good Sport]

CytoSorbents Therapy Significantly Reduces Bleeding in Urgent CABG Patients on Ticagrelor in New Data Presented at EuroPCR 2025

Real-World Analysis Shows Statistically Significant Reduction in Severe Bleeding and Transfusion Needs in CABG Patients on the Blood Thinner, Ticagrelor, with CytoSorbents Therapy

PRINCETON, N.J., May 22, 2025 /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, announced today's presentation at EuroPCR 2025 of a new contemporary real-world data analysis highlighting the intraoperative use of its technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period.

Presented by Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust (U.K.) and co-Principal Investigator of the international STAR (Safe and Timely Antithrombotic Removal) Registry, the findings were shared during the session titled, "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data.

The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the guideline-recommended 3-day washout period. The device group consisted of an updated cohort of 150 patients from the STAR Registry who were all operated on with the use of CytoSorbents' device, while the control group comprised 644 similar patients from a recent publication who were all operated on without the use of the device.

The results showed statistically significant and clinically meaningful reductions in severe bleeding complications with device use, including:

Reductions in the rate of BARC-4 (validated measure of severe bleeding after CABG) severe bleeding: 10.7% vs. 33% control, p<0.001)

Reduction in large transfusion events (=5 units of blood): 6% vs. 27% control, p<0.001)

Reduction in the need for re-operations to control bleeding (4% vs. 9.6% control, p=0.02)

Importantly, no device-related adverse events or device deficiencies were reported by participating centers, underscoring the device's ease-of-use and safety in real-world clinical practice.

Professor Storey concluded his presentation, stating, "A device that removes free ticagrelor from blood and is easily integrated into the CPB circuit appears safe and effective in mitigating excess bleeding in ticagrelor-treated patients undergoing CABG surgery before completing the 3-day washout,"

Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "Today's presentation in Paris is a vital addition to the growing evidence base of blood thinner removal with our technology. The data show that device use is simple and safe but more importantly establish that patients on ticagrelor undergoing urgent CABG at heart centers using our device as part of their standard care, experience significantly lower bleeding complications compared to patients operated without the device. We are thrilled with these new data that support routine use of our device as an effective solution to address the major unmet medical need of patients on blood thinners like ticagrelor requiring urgent cardiac surgery."

https://finance.yahoo.com/news/cytosorbents-therapy-significantly-reduces-bleeding-131000833.html

[Good Sport]

Listen, I've been buying thousands of shares at and below a buck range last several months. Leave it at that ! ;)

[biotech48]

so you may have prematurely blamed Dr. Chan?

[Good Sport]

Copied from Yahoo board....

MAK

"Received feedback from the company. In previous administrations, the FDA would allow you to pass the 150 day evaluation period without a denial letter. The current administration has drawn a line in the sand and requires the denial letter if you have not resolved all of the deficiencies.
The denial letter was received, and the FDA immediately scheduled a continuation call with the company to continue working through the deficiencies.
It is the opinion of management that will will be able to work through the remaining deficiencies. If they cannot resolve them within the next 60 days, the company will file an appeal.
So the process is not complete and they still have a chance for approval."

[Good Sport]

No transparency to shareholders from a Nasdaq listed company !

[Good Sport]

Guess what you want on what happened but Tattoo botched it up again - plain and simple...!

[Good Sport]

Shareholders deserve more details on today's FDA denial letter news update Chan !

[Paulness]

NEWS -- CytoSorbents Appoints Melanie Grossman, CPA as Vice President and Corporate Controller



Ms. Grossman brings 25 years of accomplished finance and accounting experience in global, publicly-traded companies

Company announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., April 17, 2025 /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 the appointment of Melanie Grossman, CPA as Vice President and Corporate Controller. Ms. Grossman joins CytoSorbents with over 25 years of accomplished finance and accounting experience in global, publicly-traded companies.

"We are pleased to announce the appointment of Melanie to this important role," stated Peter J. Mariani, Chief Financial Officer of CytoSorbents. "Melanie brings extensive expertise in financial operations, planning and analysis, as well as the establishment of robust financial reporting systems, processes, internal controls, and regulatory compliance in publicly-traded companies. Her experience and leadership will be a real benefit to CytoSorbents as we continue to drive growth and efficiencies in our core business and prepare for the potential launch of DrugSorb™-ATR in the U.S. and Canada."

Melanie is an accomplished leader and joins CytoSorbents from Staffing 360 where she served as the Senior Vice President and Group Controller. Her previous experience includes Director of Finance and Accounting for Vaxxinity, Controller for Byram Healthcare, and eight years with Stryker Orthopedic. She began her career in public accounting as an auditor with Ernst & Young serving a breadth of clients and industries.

Reporting Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Upon Ms. Grossman's appointment, the Compensation committee of the Board of Directors approved the following inducement awards pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market Listing Rules:

• Non-Qualified Stock Options to purchase a total of 25,000 shares of common stock. The stock options have a 10-year term and an exercise price per share of $0.99, the fair market value of the Company's common stock on April 14, 2025, the date of grant. The stock options vest 50% on the first-year anniversary of the date of grant and 25% of the award on each of the second year and third anniversaries of the date of grant;
  
  
• Signing Restricted Stock Units of 35,000 units which will vest upon the earlier of i) a change-in-control of the Company, or ii) cliff vest in four years; and
  
  
• Change-of-Control Restricted Stock Units of 35,000 units that will vest only in the event of a change-of-control of the Company.

The terms of each award are subject to the applicable award agreement and vesting is subject to continued service as of the applicable vesting date.

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 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 270,000 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 procedures. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

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/ 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, 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 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 X

U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
mailto://[e-mail]

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
mailto://[e-mail]

View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-appoints-melanie-grossman-cpa-as-vice-president-and-corporate-controller-302431176.html

SOURCE Cytosorbents Corp

[Good Sport]

CytoSorbents Appoints Thomas Shannon as Vice President of Marketing for North America
April 14, 2025

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 the appointment of Thomas Shannon as Vice President of Marketing for North America. With anticipated marketing approval, Mr. Shannon will lead the marketing strategy and execution for DrugSorb™-ATR in the U.S. and Canada.

“We are thrilled to welcome Tom to the CytoSorbents team as we prepare for the potential launch of DrugSorb-ATR in the U.S. and Canada,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Tom brings outstanding leadership and a proven track record of commercial success in introducing groundbreaking cardiovascular and critical care technologies to stakeholders across the U.S. and globally. His expertise will be invaluable in driving the successful commercialization of DrugSorb-ATR, as we work to reduce the risk of serious perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta®.”

Mr. Shannon is a global strategic marketing executive who brings over 25 years of experience commercializing life-saving technologies for high growth cardiovascular surgery and extracorporeal therapy-focused medical device companies. Previously, Mr. Shannon served as Vice President of Sales and Marketing at Genesee Biomedical, an innovator in cardiac heart valve repair, and Director of Marketing at Fresenius Medical Care, where he established their Heart and Lung Acute Care division and launched the first ever FDA-cleared long-term extracorporeal membrane oxygenation (ECMO) life support device. At Getinge (formerly Maquet), Mr. Shannon commercialized 20 new products across the Americas, including the successful launch of the market-leading CardioHelp® ECMO platform, managed a $450 million cardiac and vascular surgery portfolio, and consistently delivered double digit growth year-over-year. During his tenure at Medtronic, Tom led initiatives in sales, therapy development and marketing, and product launches including anti-coagulation monitoring devices, blood pumps, and autotransfusion technologies. Earlier in his career, Tom spent 17 years as a healthcare practitioner, including 12 years as a cardiovascular perfusionist, supporting complex cardiothoracic surgeries.

“I have had the good fortune to help lead the launch and commercialization of some major innovations in critical care and cardiac surgery during my career,” commented Tom Shannon. “Of them all, I am impressed by the straight-forward and compelling value proposition that DrugSorb-ATR can represent for patients, surgeons, and hospital systems. In particular, intraoperative and postoperative bleeding in CABG patients due to blood thinning medications such as Brilinta® is a major problem for cardiac surgeons that only continues to get worse. As a former cardiovascular perfusionist, I cannot overstate the importance of intraoperative stability and low bleeding to the cardiovascular surgeon and surgical team. They want a smooth operation without complications. I am excited to have this new opportunity to collaborate closely with the dedicated and passionate team at CytoSorbents to ensure that patients have access to this innovative breakthrough technology.”

https://www.citybiz.co/article/681883/cytosorbents-appoints-thomas-shannon-as-vice-president-of-marketing-for-north-america/

[ranchhand71]

New accounting recognition policies adopted for grant recognition after 15+’years. Unfortunately no new progress reported on DOD grant efforts to commercialize a freeze dried universal blood solution . Such a HemoDefend product would be a much better b opportunity for shareholders returns IMHO

[ranchhand71]

VP and controller death postponed quarterly release. Was not that long ago CEO hire of. CFO was a disaster when CFO was fired relatively soon after being hired. Weak financials; weak marketing; weak management

[ranchhand71]

CEO “laser focus “ has destroyed shareholder value the part 7 years, squandered over $40 million of taxpayer provided grants, cost jobs and employee benefits. He knowingly focused on broad sepsis focus , used distributors rather than direct sales team and other than Germany has gotten insufficient share in any other of the 60 companies they claim . Can running low, morale running low, missing HUGE global patented and proprietary opportunity for universal blood with HEMODEFEND freeze dried opportunity. Read the DOD reports available under FOI request procedures. Bad strategy, bad focus, bad CEO, bad CFO hiring incident and weak Board of Advisors. Where are the glimmers of hope? Hard to see.

[biotech48]

Ranchhand, they have laser focused getting the FDA approval soon. After that I feel that they will shift to the HemoDefend products, I also think that is where the money is.

[Good Sport]

Texas banned abortion. Then sepsis rates soared.

By Lizzie Presser, Andrea Suozzo, Sophie Chou and Kavitha Surana, ProPublica 11 minute read
Published 7:00 AM EST, Fri February 21, 2025

This story was originally published by ProPublica.
?ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive its biggest stories as soon as they’re published.

Pregnancy became far more dangerous in Texas after the state banned abortion in 2021, ProPublica found in a first-of-its-kind data analysis.

The rate of sepsis shot up more than 50% for women hospitalized when they lost their pregnancies in the second trimester, ProPublica found.

The surge in this life-threatening condition, caused by infection, was most pronounced for patients whose fetus may still have had a heartbeat when they arrived at the hospital.


ProPublica previously reported on two such cases in which miscarrying women in Texas died of sepsis after doctors delayed evacuating their uteruses. Doing so would have been considered an abortion.

The new reporting shows that, after the state banned abortion, dozens more pregnant and postpartum women died in Texas hospitals than had in pre-pandemic years, which ProPublica used as a baseline to avoid COVID-19-related distortions. As the maternal mortality rate dropped nationally, ProPublica found, it rose substantially in Texas.

ProPublica’s analysis is the most detailed look yet at a rise in life-threatening complications for women losing a pregnancy after Texas banned abortion. It raises concerns that the same pattern may be occurring in more than a dozen other states with similar bans.

To chart the scope of pregnancy-related infections, ProPublica purchased and analyzed seven years of Texas’ hospital discharge data.



https://www.cnn.com/2025/02/21/health/texas-sepsis-abortion-propublica/index.html

[Good Sport]

PubMed From 2022...

Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent
Ritu Tripathi et al. Eur Heart J Cardiovasc Pharmacother. 2022.

Abstract
Aim: To evaluate the ability of the DrugSorb™-AntiThrombotic Removal (ATR) haemoadsorption device utilizing porous polymer bead sorbent technology to remove three commonly used antithrombotic drugs from whole blood.

Methods and results: We evaluated the removal of apixaban, rivaroxaban, and ticagrelor by the DrugSorb-ATR haemoadsorption device in a benchtop clinical scale model using bovine whole blood. Blood spiked at clinically relevant concentrations of an antithrombotic agent was continuously circulated through a 300-mL DrugSorb-ATR haemoadsorption device at a flow rate of 300 mL/min. Drug concentration was monitored over 6 h to evaluate drug removal. Results were compared with a control circuit without the haemoadsorption device. Removal rates at 30, 60, 120, and 360 minutes were: apixaban: 81.5%, 96.3%, 99.3% >99.8%; rivaroxaban: 80.7%, 95.1%, 98.9%, >99.5%; ticagrelor: 62.5%; 75%, 86.6%, >95% (all P <0.0001 vs. control). Blood pH and haematological parameters were not significantly affected by the DrugSorb-ATR haemoadsorption device when compared with the control circuit.

Conclusion: DrugSorb-ATR efficiently removes apixaban, rivaroxaban, and ticagrelor in a clinical-scale benchtop recirculation circuit with the bulk of removal occurring in the first 60 minutes. The clinical implications of these findings are currently investigated in patients undergoing on-pump cardiothoracic surgery in two US pivotal trials
(ClinicalTrials.gov Identifiers: NCT04976530 and NCT05093504).

https://pubmed.ncbi.nlm.nih.gov/35657375/

[Good Sport]

SEC filing of a 13G was all I could locate from yesterday. Volume almost 3x !

Volume 2/14/2025 - 737,237 Shares

It got really crazy on Level II late in the afternoon yesterday. Avenir has held a large position of CTSO for some time and I'm very sure this couldn't have been the culprit of yesterday's trading. Somebody must have jumped the gun and triggered fomo mayhem imo.

Name of person filing:
AVENIR CORP

Signature: James H. Rooney
Name/Title: President
Date: 02/14/2025

Amount beneficially owned:
3,093,946

This Schedule 13G ("Schedule") is being filed on behalf of Avenir
Corporation ("Avenir"), a Virginia corporation, and James H.
Rooney (Mr. Rooney along with Avenir are "Reporting Persons").

Avenir is an investment adviser registered under the Investment Advisers Act of
1940, as amended ("Advisers Act").
Mr. Rooney is the portfolio manager and a shareholder of Avenir.
Percent of class represented by amount in row (9)
5.7 %

https://www.sec.gov/Archives/edgar/data/1033475/000103347525000004/xslSCHEDULE_13G_X01/primary_doc.xml

[Good Sport]

FDA News out???

[ranchhand71]

After 7 years of declining performance and giving shareholders nothing for $4O million in government grants ( which they ran though income statement as revenues) this incompetent CEO still overstates their opportunities . The really BIG GLOBAL opportunity is IMHO the HemoDefend product for blood purification that every blood bank, ambulance , cruise ship , submarine and naval vessel would carry. $20 million in DOD grants so far and zilch! . Freeze dried version could be a $500 million annual revenue business with over 70% gross margins in a few years. A great opportunity for whoever owns this company in 2026.

[Good Sport]

CytoSorbents

#PuriFi successfully put into operation at Cardiacsurgery Department, KBC Hospital Split, Croatia

"We are proud to announce the successful installation of the PuriFi standalone machine at the Cardiacsurgery Department at KBC Hospital Split, Croatia. Known for their pioneering approach, the team at KBC Split continues to lead the way in adopting cutting-edge medical technologies.
With this standalone configuration, you can use CytoSorb Therapy whenever and wherever your patients need its proven benefits."
Find out more and get in touch with our team at https://cytosorbents.com/purifi/
#CytoSorb #InnovationInHealthcare #Hemoadsorption #MedicalTechnology KBC Split

[Good Sport]

Revolutionizing Severe Malaria Management: The Role of CytoSorb® Hemoadsorption in Treating Malaria-Induced Liver Dysfunction

Rosanna Carmela De Rosa • Antonio Romanelli • Roberto Giurazza • Fabrizio Falso • Gianfranco Viola

Published: January 20, 2025

Conclusions
In conclusion, the use of the EHA is safe and effective in achieving a favorable outcome for patients with PF malaria waiting for the effect of antimalarial therapy. The bilirubin removal by CytoSorb® hemofilter allowed us to create a "bridge" for specific therapy, improve symptoms, and prevent organ damage. This case supports further exploration of the use of EHA with CytoSorb® in managing severe malaria cases. Specific areas of research could include evaluating its impact on inflammatory markers, bilirubin clearance, and organ function recovery in patients with malaria-induced multiorgan dysfunction. Additionally, studies should investigate optimal timing, duration of therapy, and patient selection criteria to maximize the benefits.

https://www.cureus.com/articles/327010-revolutionizing-severe-malaria-management-the-role-of-cytosorb-hemoadsorption-in-treating-malaria-induced-liver-dysfunction#!/

[Good Sport]

Why not more recent light given to other products as well such as VetResQ?

CytoSorbents Press Release
CytoSorbents Launches VetResQ™ for U.S. Veterinary Market

VetResQ Adds Advanced, First-In-Kind Blood Purification Treatment of Inflammatory Toxins to the U.S. Veterinary Market. Debuts at American College of Veterinary Emergency and Critical Care Post-Graduate Review Conference.

MONMOUTH JUNCTION, N.J., Jan. 20, 2017 /PRNewswire/ --

"CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announces the marketing launch and commercial availability of the VetResQ™ sorbent cartridge for the United States veterinary market. VetResQ is a broad spectrum blood purification adsorber designed to help treat deadly inflammation and toxic injury in animals with critical illnesses such as septic shock, toxic shock syndrome, severe systemic inflammation, toxin-mediated diseases, pancreatitis, trauma, liver failure, and drug intoxication."

[Good Sport]

We should be good here. I'm not selling. Universal Plasma next on the list.

[MAGCPA]

Agreed!
I wasn’t sure how the rights offering would pan out. Now I know. Cytosorbents bought themselves another year of cash flow which should be enough time for the FDA “nod”. I’m optimistic that they will get the approval, and that analyst Jason Kolbert $10 price target is attainable. 🙂
Getting a little nostalgic but maybe even getting back into the lower teens like 2019.
Have a great investing day!!

[Good Sport]

We need the FDA "nod" or it won't matter !

[MAGCPA]

The Rights Offering was oversubscribed by 68% with total demand of 10,514,896 Units, including the exercise of both basic subscription rights and oversubscriptions.

[Good Sport]

CytoSorbents Expands Global Footprint with Opening of New Regional Sales Subsidiary in Dubai

Mon, January 6, 2025 at 7:00 AM EST 6 min read

PRINCETON, N.J., Jan. 06, 2025 (GLOBE NEWSWIRE) -- 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 the opening of a new regional sales subsidiary in Dubai, United Arab Emirates (UAE). The new subsidiary provides a gateway into the Middle East and Africa - regions with increasing demand for advanced medical technologies and high-quality therapies in critical care and cardiac surgery.

“Establishing a central commercial presence in Dubai represents a major milestone in our regional expansion strategy, reflecting our commitment to accelerating sales growth in this critical international market," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Our business in the region has been growing over the past several years, and this new subsidiary is expected to be a key international sales center that will help us strengthen and better support existing partnerships, foster closer on-the-ground interactions with customers to augment sales, forge new alliances, and drive long-term value creation.”

CytoSorbents has established its new commercial office in the heart of Dubai’s Science Park, a commercial, healthcare-focused, “free zone” with special economic benefits, that will serve as a hub for regional sales and business development, training, customer support, and regulatory affairs. The UAE is the regional home of many multinational medical device companies and was selected because of its strategic location, strong economy and favorable tax policies, advanced infrastructure, well-developed healthcare system, and supportive economic and regulatory policies.

Dr. Chan continued, “The Middle East and Africa continue to experience rapid growth in the demand for cutting-edge healthcare technologies such as CytoSorb® and we are thrilled to be at the forefront of this transformation. We look forward to working closely with healthcare providers, regulators, and key stakeholders to establish CytoSorbents as a leader in critical care and cardiac surgery across this dynamic region.”

https://finance.yahoo.com/news/cytosorbents-expands-global-footprint-opening-120000074.html

[Good Sport]

Wow ! Premarket Shank... Somebody left the toilet seat up, jumped the gun and bought premarket on pr qtr news release and got burned by buying way over a buck early this morning. Hundreds of thousands of shares. Yikes! A real arse serving 🤣

[biotech48]

I believe in Santa Claus, but I don't belive you will see .65. It has never been that low, and now it is near FDA approval and will zoom.

[Good Sport]

Just wait for .65 & F the share rights offering.

[ranchhand71]

View all Cytosorbents Medical Inc reviews
1.0

Sub-Zero Morale
Former Employee (Former Employee) - Princeton, NJ - August 12, 2024
This is a place that you should only consider in desperation, morale is at sub-zero levels. There are no perks, no bonus, there are only upsidedown stock option offerings. Everyone is asked to wear too many "hats" due to the extremely high turnover rate. It is really unsettling to see your coworkers just disappearing due to the turnover and surprise layoffs.

[ranchhand71]

How many employees are they down to now?

[biotech48]

if you read more, you would see that you get one share of the company PLUS the opportunity to purchase furture shares at at lower than market price. That is, if the share price increases.

[Good Sport]

Shorts aren't gonna let them raise money. WOW ! 😄

[Good Sport]

& Falling .82 now.

[Good Sport]

.85 HORRIBLE !!!