Paulness
3 weeks ago
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.
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U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
mailto://pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
mailto://ir@cytosorbents.com
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
4 weeks ago
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
Paulness
2 months ago
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://pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
mailto://ir@cytosorbents.com
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
2 months ago
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/
Good Sport
5 months ago
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
6 months ago
Cytosorbents CFO Peter Mariani buys $27,974 in stock
Investing.com
Published 12/13/2024, 08:01 AM
These open market purchases reflect Mariani's ongoing investment in the company, increasing his total holdings to 381,363 shares. With analyst price targets ranging from $1 to $10, investors seeking deeper insights can access comprehensive analysis and additional ProTips through InvestingPro's detailed research reports. With analyst price targets ranging from $1 to $10, investors seeking deeper insights can access comprehensive analysis and additional ProTips through InvestingPro's detailed research reports. These open market purchases reflect Mariani's ongoing investment in the company, increasing his total holdings to 381,363 shares.
In other recent news, CytoSorbents Corporation has announced the terms of an upcoming Rights Offering. The medical technology company aims to raise between $3.0 million and $5.0 million through the offering, which is expected to significantly improve liquidity. The proceeds are intended for general corporate purposes and to support operations through anticipated regulatory decisions on the company's DrugSorb-ATR marketing applications in 2025.
Simultaneously, CytoSorbents reported an 11% year-over-year increase in product sales for the third quarter of 2024, totaling $8.6 million. The company's flagship product, CytoSorb, has generated approximately $34 million in sales over the past year. Additionally, the company has made progress in its blood purification technology, particularly for critical care and cardiac surgery applications.
CytoSorbents is also preparing for the launch of DrugSorb ATR, a device aimed at reducing perioperative bleeding. The device has received two FDA breakthrough designations and is awaiting regulatory decisions from the FDA and Health Canada, expected in 2025. Amid these developments, CytoSorbents has managed to decrease its operating expenses by 25% and reduce its cash burn to $2.7 million.
https://www.investing.com/news/insider-trading-news/cytosorbents-cfo-peter-mariani-buys-27974-in-stock-93CH-3771413