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CytoSorbents Corporation

CytoSorbents Corporation (CTSO)

0.96
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( 5.47% )
업데이트: 01:53:06

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Good Sport Good Sport 1 주 전
That guy is on every cc and he (most of the time in the past) gets a question in at the end of each call. He hasn't hit or even come close to his target (below or above) in over a decade plus !
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ranchhand71 ranchhand71 2 주 전
Longtime supporter now lead less so-/
Cytosorbents Co. (NASDAQ:CTSO – Free Report) – Stock analysts at HC Wainwright dropped their FY2024 earnings estimates for shares of Cytosorbents in a research note issued on Monday, November 11th. HC Wainwright analyst S. Lee now expects that the medical research company will post earnings of ($0.30) per share for the year, down from their prior forecast of ($0.29). HC Wainwright has a “Neutral” rating and a $1.00 price objective on the stock.
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ranchhand71 ranchhand71 3 주 전
India deal announced. How much cash might they be paying/investing ?
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ranchhand71 ranchhand71 3 주 전
EF Hutton says:
https://efhuttongroup.bluematrix.com/links2/pdf/0f38ff9c-e219-4baf-ba37-56242bb40ecb
Huge outlier analyst….
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ranchhand71 ranchhand71 4 주 전
Is EF Hutton like SCR Zacks paid by company to write research?
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ranchhand71 ranchhand71 1 월 전
“Already approved “ ? How would you know that’s??? No way. “time will tell”
Do not expect this team to suddenly behind better managers after horrible record. An important tell tale sign that longtime CFO left!!!!
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Good Sport Good Sport 1 월 전
We might not be impacted by new FDA medical device "boss". I think our approval for this MUCH needed problem is already approved and in the books. Probably just needs the i's doted and the t's crossed before approval. We'll have to wait and see.
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ranchhand71 ranchhand71 1 월 전
A new FDA boss might not be good for CTSO and their tight schedule before they run out of cash.
https://www.nytimes.com/2024/10/22/health/fda-medical-devices.html?smid=nytcore-ios-share&referringSource=articleShare
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ranchhand71 ranchhand71 2 월 전
Excerpts from EF Hutton Oct 1 report:
"Was the Trial a Failure or a Success? The initial data analysis showed that the
primary effectiveness endpoint in the overall patient population that underwent
different cardiac surgeries was unmet. However, the pre-specified subpopulation of
patients undergoing isolated coronary artery bypass graft (CABG) surgery, which
accounted for 90% of patients enrolled in the trial, showed evidence of reduced
bleeding complications, including serious bleeding events"

Also disclosed new info about manufacturing problem:
. "A planned slowdown in production to rebalance inventory, combined with a shortterm manufacturing issue, led to fewer CytoSorb devices produced and lower product gross margins of 50% to 60%, down from 71% in Q3 2023"
Has Management disclosed this to shareholders????
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ranchhand71 ranchhand71 2 월 전
Reposted from Stocktwiitts-Zack’s report from last week:
https://s27.q4cdn.com/906368049/files/News/2024/Zacks_SCR_Research_10012024_CTSO_Kerr.pdf
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Good Sport Good Sport 2 월 전
Ranch, nice job with hemo plasma post. Thanks for going the extra and adding much needed substance here.
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ranchhand71 ranchhand71 2 월 전
Under the Freedom of Information Act one can retrieve some of the DOD filings of progress under CTSO Award W81XWH-22-C-0046.
In a recent April 2024 filing statement by Dr. Maryann Gruda she stated:
"Greater availablilty of universal plasma products wil significantly simplfy logistics and reduce costs for both military and civilian transfusion services. Phase II SBIR studies perfomred at WRNMMC showed the BGA-Absorber prototype removed anti-A-titer and anti-B titers by 99% from high titer human plasma, without affecting coagulation factors. Building on these exciting results, our proposed efforts are directed towards combining BGA reduction with spray or freeze-drying efforts to generate universal dried plasma that is suitable and readily available under austere conditions".
The May filing actually shows how the product packaging would work.

In many ways this opporunity seems much lager, more profitable and sooner benefit to shareholders than current FDA approvals underway.
Why is Dr. Chan not talking about this?
Maybe to some investors looking at the new Jefferies $20 million raise?
Looking forward to additional filings.
Maybe a major medical device company like Boston Scientfic or Medtronic could swoop in, buy CTSO under an unfriedly tender for $60-80 milion, fire the Board and all the overhead people, keep the new manufacturing facility and use their own global distribution to quickly build a $200-500 million annual business (with 75% plus gross margins) selling to every naval ship, cruise ship, amubulance, EMS, police and fire fleet?
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Paulness Paulness 2 월 전
NEWS -- CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Business Update



The De Novo medical device application for DrugSorb™-ATR is eligible for FDA priority review as an FDA Breakthrough Designated Device for this indicationThe Health Canada Medical Device License application is ready for submission, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near futureExpecting FDA and Health Canada decisions in 2025PRINCETON, N.J., Oct. 01, 2024 (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, announces the submission of its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024, to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review.

“The DrugSorb-ATR De Novo submission to FDA is the culmination of multiple years of significant clinical, regulatory, and manufacturing accomplishments company-wide, centered on the execution and data analysis from the U.S. and Canadian pivotal STAR-T randomized controlled trial and the product development of DrugSorb-ATR,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “We are very proud of our dedicated CytoSorbents team and external clinicians, collaborators, and consultants who helped to achieve this major milestone. We look forward to interactions with FDA and the timely review of our application. Meanwhile, we have also completed our DrugSorb-ATR Health Canada Medical Device License (MDL) application, which will be submitted with the expected near-term receipt of MDSAP certification.”

Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering from a heart attack. If patients are not eligible for a coronary stent, they will often require CABG surgery to restore blood flow to heart muscle. Current guidelines recommend the delay of surgery by three to five days to allow “washout” or natural elimination of the drug to reduce the high risk of serious and potentially fatal perioperative bleeding from the use of the blood thinner. The 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial evaluated the safety and efficacy of DrugSorb-ATR in patients undergoing urgent CABG surgery on ticagrelor to remove the drug and reduce the severity of perioperative bleeding complications compared with patients operated without the device. These safety and efficacy data from STAR-T form the basis of our marketing approval submissions.

About the U.S. and Canadian Regulatory Pathways

The U.S. FDA De Novo process for medical devices provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Following application acceptance by FDA, De Novo submissions enter the substantive review phase where FDA Breakthrough Device designation and an associated interactive priority review, called “sprint discussions,” can accelerate the process.

The Health Canada Medical Device License (MDL) authorizes manufacturers to import or sell Class II, III, and IV medical devices in Canada. The license ensures that these devices meet the necessary safety, quality, and efficacy standards as per the Medical Devices Regulations. MDL requires MDSAP certification, which the Company expects to receive shortly, at which point it will file its MDL application.

Final regulatory decisions on DrugSorb-ATR are expected from FDA and Health Canada in 2025. DrugSorb-ATR is not yet approved or cleared in the U.S. or Canada.

Preliminary, Selected Third Quarter 2024 Financial Results and Business Update

We estimate that our Q3 2024 Product Sales (excluding grant income) will be in the range of approximately $8.3 million to $8.5 million, representing growth of 7% to 10%, versus $7.8 million in Q3 2023.A planned temporary slowdown in production to rebalance inventory levels coupled with a short-term manufacturing issue resulted in a significantly lower number of CytoSorb devices produced in the quarter. Because of this, we estimate that our product gross margins for Q3 2024 will be in the range of approximately 50% - 60%, compared to 71% in Q3 2023. The Company believes the short-term manufacturing issue has been resolved and expects a return to more normalized production levels and product gross margins in Q4 2024. The Company continues to have sufficient inventory to meet demand.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, ECMO, heart-lung machines). CytoSorbents’ technologies are used in a number of broad applications. Two important ones 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 in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.

CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in 76 countries worldwide, with more than 250,000 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 remove ticagrelor and reduce the severity of perioperative bleeding in CABG patients on the drug. The Company expects to submit its completed Health Canada Medical Device License (MDL) application, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near future. DrugSorb-ATR is not yet approved or cleared in the United States and 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://www.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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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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
Investor Relations, ICR-Westwicke
(443) 450-4191
mailto://ir@cytosorbents.com
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ranchhand71 ranchhand71 2 월 전
Company files $150 million effectiveness prospectus today;
https://www.sec.gov/Archives/edgar/data/1175151/000110465924103199/tm2424757d1_s3a.htm#sp1-001
Delusinal management? This is almost TWICE the total market capitalization of company!
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ranchhand71 ranchhand71 3 월 전
Unfortunately they have not been able to get approval for a broad sepsis treatment. 7-8 years ago they had research grant and hired a research team at University of Pittsburgh. It failed to prove a broad solution so they pivoted to much narrower applications.

Some think Chan and their scientific team made a HUGE blunder in not accelerating their HemoDefend application ( also under $15 million + grants) with Department of Defense to provide a kit to take any blood type , run it through a special cartridge bag, and create a UNIVERSAL blood plasma. A HUGE global market to be carried in every ambulance , EMS vehicles, naval ships, cruise ships etc. could be easily manufactured in their new NJ facility. Easily a $300-400 million global market annually within 2years of introduction with 85% gross margins. DOD wants a freeze dried version which is being worked on. IMHO this product would get FDA approval relatively quickly and would save the company and easily move the stock to $7-10. Chan has tied his fortune and that of the company to a weaker opportunity. CFO has left with handwriting on the wall. A shame.
After they run out of cash whoever acquires CTSO assets and intellectual property on this product line will make a fortune. There are several medical device companies with great balance sheets and superb global marketing/sales forces waiting in the wings to scoop up the carcass Chan will leave in 18 months.
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Good Sport Good Sport 3 월 전
https://wtop.com/health-fitness/2024/09/sepsis-remains-a-relatively-unknown-condition-despite-killing-more-than-300000-americans-every-year/
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ranchhand71 ranchhand71 3 월 전
Phil Chan here at CTSO and Neil Chan at IGEN have both destroyed a tremendous amount of shareholder capital through bad choices and mismanagement. Board a disaster.
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fung_derf fung_derf 3 월 전
You seem the type who buys into every lie told to you by penny stock pump and dumpers. A 3 second look at the financials and your claim and I see short interest small and falling.

Short Interest
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DTC
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ranchhand71 ranchhand71 3 월 전
Nasdaq coming for them in new purge?
https://www.wsj.com/finance/stocks/nasdaq-penny-stock-proposed-rule-change-74677b00?st=9d6hc8olx75pnon&reflink=article_copyURL_share
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Good Sport Good Sport 4 월 전
Sounds like Kathleen has had enough of this nut show. What a shame.
So just exactly how much $ money does the company actually have today August 13, 2024?
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Good Sport Good Sport 4 월 전
Who do you guess the bonehead exec from CTSO that set that up was ? ;)
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ranchhand71 ranchhand71 4 월 전
A reminder from today's 10K SEC filing:
Pursuant to an agreement dated August 11, 2003, an existing investor agreed to make a $4 million equity investment in the Company. These amounts were received by the Company in 2003. In connection with this agreement the Company granted the investor a perpetual royalty of 3% on all gross revenues received by the Company from the sale of its CytoSorb device which such rights were assigned to an existing investor in 2017. For the three months ended June 30, 2024 and 2023, the Company recorded royalty expenses of approximately $264,000 and $240,000, respectively. For the six months ended June 30, 2024 and 2023, the Company recorded royalty expenses of approximately $531,000 and $474,000, respectively. These expenses are included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss.
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Good Sport Good Sport 4 월 전
EF Hutton initiated a $10 Target yesterday on CTSO. I can let you know the link is inside Schwab "thinkorswim" trading platform under news tab. Shorts are trying to play it down. I smell a short squeeze big time.
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Good Sport Good Sport 4 월 전
https://www.reddit.com/r/Cytosorbents/s/6Hc9OvNeha
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Paulness Paulness 4 월 전
NEWS -- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website



“Working to Save Lives Together” Theme Highlights Two Decades of Successful Collaboration with the International Medical and Research Communities to Help Patients Survive Life-Threatening Illnesses

PRINCETON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at https://www.cytosorbents.com. The theme of “Working to Save Lives Together” highlights two decades of successful collaboration with the international medical and research communities to continuously refine how our therapies, such as CytoSorb®, ECOS-300CY®, and VetResQ® are being used to help patients survive life-threatening illnesses.

A Modern, Unified Online Presence

The new website, built from the ground up, unifies our corporate and product information into a single, cohesive and comprehensive information hub for healthcare professionals, investors, and other key stakeholders. Visitors will find a streamlined modern design, intuitive navigation, and extensive content on our company, technology, therapies, pipeline that includes DrugSorb™-ATR and HemoDefend-BGA™, clinical studies, investor conferences, and much more.

Key Features of the New Website:

User-Friendly Layout and Intuitive Navigation - with easy access to essential information and optimized for both desktop and mobile browsing.Enhanced Easy-to-Understand Content - tailored for different stakeholders.News and Updates - dedicated to the latest developments and events.Comprehensive and Searchable Resource Library - from a collection of 1,000+ peer-reviewed publications, poster presentations, abstracts, white papers and case reports highlighting the use of our therapies in many applications.Introduction to Our Experts - who are there to provide guidance and support.Voices Around the World - with insights and feedback from users worldwide.Dedicated Investor Relations site - for quick access to investor materials.Improved Contact Forms - facilitating faster communications and interactions.Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents, stated, “We are grateful to all of the pioneering physicians, nurses, perfusionists, researchers, and other healthcare professionals who use our therapies in daily clinical practice or who have contributed to the many studies and the more than 1,000 references that can be found in our CytoSorb literature database on our new website. Your dedication and insights have been instrumental in shaping the success of our technology and improving patient outcomes worldwide. Likewise, as we have in the past, it is our commitment to you to be a trusted and dependable partner who will be there to support you whenever you need us.”

Dr. Steiner added, “We invite everyone to explore the new CytoSorbents website which is a celebration of all that we have accomplished together, and to learn how CytoSorbents is helping to save lives and ‘Expand the Dimension of Blood Purification™’ with our products around the world.”

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved in the United States.

The DrugSorb™-ATR antithrombotic removal system, an investigational device based on the same polymer technology as CytoSorb, has received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and X.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

Please Click to Follow Us on Facebook and X

U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
mailto://kbloch@cytosorbents.com

Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
mailto://ir@cytosorbents.com
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fantomphan fantomphan 5 월 전
Financing news is out.
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Monksdream Monksdream 5 월 전
CTSO new 52 week low
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ranchhand71 ranchhand71 5 월 전
Too little too late. Cash crunch is the challenge. Their distribution model through third parties in 60 countries brings in zilch!!
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Paulness Paulness 5 월 전
NEWS -- CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan



Brings a powerful blood purification technology used to treat critically ill and cardiac surgery patients in nearly a quarter million treatments across 75 countries to date to one of the most progressive healthcare systems in the world

PRINCETON, N.J., June 24, 2024 (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 via its proprietary polymer adsorption technology, announces the regulatory approval of CytoSorb® in Taiwan by the Taiwan Food and Drug Administration (TFDA). The approved indications include the extracorporeal removal of cytokines (e.g. cytokine storm, sepsis), bilirubin (e.g. liver disease), and myoglobin (e.g. trauma) from a patient’s circulating blood. The removal of the antithrombotic drugs Brilinta® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Janssen/Bayer) during cardiothoracic surgery is also approved, with the goal of reducing perioperative bleeding. CytoSorb will be distributed throughout Taiwan by Hemoscien Corporation.

Ms. Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents stated, “We are thrilled to announce this milestone which underscores the value and efficacy of our CytoSorb therapy and was achieved after navigating a long and complex approval process. We look forward to collaborating with Hemoscien and leveraging their long-standing customer relationships in Taiwan to bring this innovative therapy to patients in need.”

Mr. Tom Juan, Managing Director of Hemoscien Corporation emphasized, “There is an ongoing critical need for more effective therapies to combat infections and to prevent or treat organ failure. I firmly believe that advanced blood purification devices such as CytoSorb® can complement the limitations of traditional pharmaceuticals by restoring peripheral blood homeostasis and balance. Given the widespread and successful application of CytoSorb therapy in numerous countries to treat life-threatening critical illnesses, we are confident in our ability to take what has been learned and to market and support CytoSorb in Taiwan's ICU sectors through our deep critical care network to help save the lives of severely ill patients.”

In addition to Taiwan, CytoSorb is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses such as sepsis and septic shock, trauma, acute respiratory distress syndrome, burn injury, pancreatitis, and others that can lead to massive inflammation, organ failure and patient death. CytoSorb is also used as an extracorporeal liver support therapy in acute liver disease (e.g. acute on chronic liver failure, alcoholic hepatitis) and removes both liver toxins, such as bilirubin and bile acids, as well as cytokines. It is also used to treat rhabdomyolysis (e.g. trauma) and the removal of myoglobin. In these diseases, the risk of death can be extremely high, and there are few, if any, effective or practical treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively around the world.

Taiwan, with approximately 24 million inhabitants, offers universal coverage to its citizens through its National Health Insurance System and serves them through a network of nearly 400 medical centers and regional hospitals. With rising medical standards, use of advanced technology to increase administrative and provider efficiency, and access to high quality healthcare, Taiwan boasts one of the most progressive healthcare systems globally. Like many other parts of the world, critical illness including sepsis is a major problem in Taiwan. For example, there are 150,000 estimated new cases of sepsis reported each year in Taiwan with mortality rates as high as 30%, driven by diseases such as pneumonia, which is the third leading cause of death in Taiwan.

About Hemoscien Corporation

Hemoscien Corporation, a specialized hemo-epuration service provider, was established in 2008 as a spinoff from Smile Group Corp., originally founded in 1980. Since 1998, Hemoscien has maintained a strong partnership with Infomed S.A., a respected ICU hemo-therapy platform developer, achieving over 50% market share. The company is dedicated to its mission of addressing unmet medical needs in ICU care, as well as advancing regenerative medicine and other immune therapies.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. CytoSorb, the Company’s flagship product, was originally launched in the European Union under CE mark as the first cytokine adsorber. In addition to the description in the text above, CytoSorb 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.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and X.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

Please Click to Follow Us on Facebook and X

U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
mailto://kbloch@cytosorbents.com

Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
mailto://ir@cytosorbents.com
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Good Sport Good Sport 9 월 전
https://finance.yahoo.com/news/cytosorbents-nasdaq-ctso-investors-sitting-101132136.html

"who have seen the share price tank a massive 90% over a three year period. That might cause some serious doubts"
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Good Sport Good Sport 9 월 전
What does a narcissistic sociopath do on a daily basis?
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fantomphan fantomphan 9 월 전
Besides heading to the bank every Friday with their ridiculous compensation checks, does anyone have a clue what this overpaid loser management is doing there everyday? Anyone? Buehler?
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Good Sport Good Sport 10 월 전
We'll have to see what unfolds ranch ! Something definitely smells bad imo.
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ranchhand71 ranchhand71 10 월 전
What did they tell investors to get them to buy shares right before they collapsed? Chan vulnerable?
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Good Sport Good Sport 10 월 전
SHAREHOLDER ALERT:

Pomerantz Law Firm Investigates Claims on Behalf of Investors of Cytosorbents Corporation - CTSO
NEWS PROVIDED BY

ACCESSWIRE

Jan 28, 2024, 12:00 PM ET

NEW YORK, NY / ACCESSWIRE / January 28, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Cytosorbents Corporation ("Cytosorbents" or the "Company") (NASDAQ:CTSO). Such investors are advised to contact Danielle Peyton at newaction[ @, ext. 7980.

The investigation concerns whether Cytosorbents and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

https://www.kron4.com/business/press-releases/accesswire/828556/shareholder-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-cytosorbents-corporation-ctso/
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ranchhand71 ranchhand71 10 월 전
Join the class action lawsuit and vote against Chan at upcoming annual meeting.
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fantomphan fantomphan 10 월 전
Silence from these incompetent overpaid buffoons. Not expecting any news today as they're all down at the bank cashing bloated checks paid for by the recent financing. What a disgusting group of clowns.
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ranchhand71 ranchhand71 10 월 전
Companies used to pay Zack’s for coverage in their SCR service. Does not take away from any good news updates …
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Good Sport Good Sport 10 월 전
New article post from Zacks scr over on Yahoo about START-T numbers just out, has target of $4. Thanks Zee!

https... Zacks_SCR_Research_01172024_CTSO_Kerr.pdf
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ranchhand71 ranchhand71 10 월 전
Pay attention to the claims in the coming class action lawsuit. You can certainly signup with the law firm for an earlier look. Interesting to learn what the investors were told to entice them into direct investment at $1.77 compared to where stock went afterwards. Trial results so far a bit of a disappointment. Maybe finally a time for management change ? We like Director Kim background and experience. Check her out. With long time Chairman having retired last year maybe no one on Board would oppose a change. Just one shareholder opinion…
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fantomphan fantomphan 10 월 전
What are the so called "claims" that are being made? Does anybody have specifics on this?
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ranchhand71 ranchhand71 11 월 전
Pomerantz Law Firm Investigates Claims on Behalf of Investors of Cytosorbents Corporation - CTSO
January 14, 2024 at 11:46 am EST
NEW YORK, Jan. 14, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Cytosorbents Corporation ("Cytosorbents" or the "Company") (NASDAQ: CTSO). Such investors are advised to contact Danielle Peyton at newaction @Oboeman-9980, ext. 7980.
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Monksdream Monksdream 11 월 전
CTSO new 52 week low
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Good Sport Good Sport 11 월 전
Here comes the Class Action against Cytosorbents !!!

https://www.accesswire.com/viewarticle.aspx?id=822116&lang=en

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Cytosorbents Corporation - CTSO

NEWS PROVIDED BY

ACCESSWIRE

Jan 04, 2024, 3:00 PM ET

"NEW YORK, NY / ACCESSWIRE / January 4, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Cytosorbents Corporation ("Cytosorbents" or the "Company") (NASDAQ:CTSO). Such investors are advised to contact Danielle Peyton at newaction[ @, ext. 7980.

The investigation concerns whether Cytosorbents and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

On December 28, 2023, Cytosorbents issued a press release announcing that its pivotal trial investigating the ability of its device candidate, DrugSorb®-ATR, to reduce perioperative bleeding in patients on ticagrelor (Brilinta®, Brilique® - AstraZeneca) undergoing cardiothoracic surgery before completing the recommended washout period, "did not meet the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries."

On this news, Cytosorbents' stock price fell $0.545 per share, or 33.44%, to close at $1.085 per share on December 28, 2023."

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

SOURCE: Pomerantz LLP



View the original press release on accesswire.com
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Good Sport Good Sport 11 월 전
Can't delete the duplicates anymore they removed me from being a moderator.
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ranchhand71 ranchhand71 11 월 전
Why do you think he hired a CFO that he had to let go after 3 months? Why did the longtime Chairman retire this year? Why isn’t he disclosing more about their grants and progress for the HemoDefend program?Are they still paying rent on the old facility?What did Bailee Gifford tell the investors to induce them to invest just a few weeks before their trial failure was announced? Transparency is not his ethic?
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Good Sport Good Sport 11 월 전
First thing that needs done after Chan is moved to CMO and an experienced successful CEO is chosen is to move over to the OTC market ASAP. They will burn up funds as fees are huge being on a major exchange. Every single dollar needs scrutinized going forward. I'd also like a huge more transparency shared to shareholders. What exactly is happening with new manufacturing facility now for instance?
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J G R J G R 11 월 전
That's all due to our great leadership which by the way needs to be replaced!
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J G R J G R 11 월 전
That's all due to our great leadership which by the way needs to be replaced!
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Harbor6460 Harbor6460 11 월 전
Now they need only 30 mil more for a trial. Lol. Imagine got 90 mil when stock was at 9.00 and thats gone and Another another offering to dilute company 20% at 1.00. This thing is cooked 4ever. I will say either the product is all lies which it now appears to be or was just a scam all along. What a shame. I really thought this was a diamond in the rough but can it be if 15 years nothing done. And 1st 10 years nothing even tried. Just BS talk and lies. Joke and sad and delisted soon I’m sure. Dangerr
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