CytoSorbents Corporation (CTSO)

[Good Sport]

Single-use Hemoperfusion Device Market by Type, by Technology, by End User: Global Opportunity Analysis and Industry Forecast, 2023-2028
Published: Feb. 1, 2023 at 3:55 a.m. ET

The MarketWatch News Department was not involved in the creation of this content.

Feb 01, 2023 (The Expresswire) -- The “Single-use Hemoperfusion Device Market” report provides an in-depth analysis of the size of the global market. It also discusses market size and segmentation at the regional and national levels, market share and growth, the competitive environment, sales analysis, and the impacts of domestic and foreign market participants.

Along with assessments of opportunities, strategic market growth, product introductions, and technological improvements, the Single-use Hemoperfusion Device market study provides in-depth evaluations of price chain improvement, trade legislation, and recent changes. The research also examines, revenue, sales, pricing, profit margin, market risks, opportunities, entry barriers, challenges and market by types (Activated Carbon Adsorption, Resin Adsorption).

Get a Sample Copy of the Report at - https://www.industryresearch.co/enquiry/request-sample/21586880

Some of the key players are:

Baxter International
Asahi Kasei Corporation
Toray Medical
Jafron Biomedical
Kaneka Medix Corporation
CytoSorbents
Baihe Medical

Some of the key questions answered in this report:

What will the Single-use Hemoperfusion Device market growth rate during the forecast period?
Which are the key factors driving the Single-use Hemoperfusion Device market?
What was the size of the Single-use Hemoperfusion Device market by 2028?
Which region is expected to hold the highest market share in the Single-use Hemoperfusion Device market?
What trends, challenges and barriers will impact the development and sizing of the Global Single-use Hemoperfusion Device market?
What are the opportunities in the global Single-use Hemoperfusion Device Industry?


Market Segment by Type:

Activated Carbon Adsorption
Resin Adsorption

Market Segment by Applications:

Hospital
Clinic

Geographical regions include in this report are “North America, Europe, Africa, Asia Pacific region, South America, Middle east and South east Asia”

To Understand How Covid-19 Impact Is Covered in This Report - https://www.industryresearch.co/enquiry/request-covid19/21586880

Url:
https://www.marketwatch.com/press-release/single-use-hemoperfusion-device-market-by-type-by-technology-by-end-user-global-opportunity-analysis-and-industry-forecast-2023-2028-2023-02-01

[Good Sport]

CytoSorbents Issues Stockholder Letter and Reports Preliminary Fourth Quarter and Full Year 2022 Revenue
Tue, January 31, 2023 at 7:15 AM EST

Tue, January 31, 2023 at 7:15 AM EST

In this article:

Cumulative CytoSorb treatments surpassed 195,000. Q4 2022 product sales rebounded from Q3 2022 low. Adjusted for constant currency, Core non-COVID 2022 product sales were within 5% of that achieved in 2021 and greater than 30% increased from pre-pandemic 2019

PRINCETON, N.J., Jan. 31, 2023 /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 via its proprietary polymer adsorption technology, issues a stockholder letter from its Chief Executive Officer, Dr. Phillip Chan, and announces preliminary unaudited fourth quarter 2022 and full year 2022 results ahead of filing its Form 10-K.

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)
More
Preliminary Unaudited Full Year 2022 Results

Cumulative CytoSorb treatments delivered exceeded 195,000 at the end of 2022, up 20% from the end of 2021, and marking the 10th year of CytoSorb commercialization

Preliminary unaudited 2022 Total Revenue, which includes Product Sales and Grant Revenue, was approximately $34.7 million versus $43.2 million in 2021, and $24.9 million in pre-pandemic 2019

Overall preliminary unaudited 2022 Product Sales were approximately $29.4 million versus $40.1 million in 2021, which included $0.3 million and $6.3 million in COVID-19 related Product Sales, respectively, and versus $22.8 million in pre-pandemic 2019

2022 Core (non-COVID-19) Product Sales were approximately $29.1 million versus $33.8 million in 2021. This reflects an 11% drop in the average Euro to dollar exchange rate from 1.18 in 2021 to 1.05 in 2022. On a constant currency basis, Core Product Sales would have been approximately $32.2 million versus $33.8 million in 2021, a decrease of 4.6%

Solid cash balance at the end of 2022 of approximately $23.8 million

Preliminary Unaudited Q4 2022 Results

Q4 2022 Total Revenue was approximately $9.4 million versus $10.8 million in Q4 2021, and versus $7.4 million in pre-pandemic Q4 2019

Q4 2022 Product Sales were approximately $7.6 million, which rose 18% sequentially from $6.5 million in Q3 2022, but were lower than the $9.7 million in Q4 2021, which benefitted from $1.7 million in COVID-related sales. Pre-pandemic Q4 2019 Product Sales were $6.6 million.

Core (non-COVID-19) Product Sales in Q4 2022 were approximately $7.6 million, compared to approximately $8.0 million in Q4 2021. On a constant currency basis, core Q4 2022 product sales would have been $8.5 million, a 6% increase over $8.0 million in Q4 2021

CytoSorbents targets pivotal STAR-T trial completion this year, with massive U.S. & Canadian markets in its sights

The Company expects to report fully-audited financial results for Q4 2022 and full year 2022 on Thursday, March 9, 2023, with a conference call held at 4:30PM ET. Further details for the earnings call will be provided at a later date.


https://finance.yahoo.com/news/cytosorbents-issues-stockholder-letter-reports-121500605.html

[andy55q]

Case of the Month


Literature Database
Use of CytoSorb in a patient with hyperinflammatory syndrome following extensive 3-vessel coronary surgery

Dr. Angelika Oblin | Department of Cardiology, Cardiological Intensive Care Unit, Floridsdorf Hospital, Vienna, Austria
02/01/2023
New!Post-OpReduction in catecholaminesSafetyImprov. fluid balanceAortic SurgeryAnticoagulation CitrateCardiac surgeryCase of the Week / MonthCase reportCritical CareCRRT pre filterInflammatory parameters
Download documentDownload document
Summary

CoM 02/2023 – This case reports on a 60-year-old male patient who presented to hospital for elective aortocoronary bypass surgery.

Case presentation

His extensive cardiac medical history included chronic ischemic (3-vessel) heart disease, post-aortocoronary bypass, post-endovascular aortic repair for abdominal aortic aneurysm, peripheral arterial occlusive disease with serial high-grade stenosis of the left femoral artery, cerebral arterial occlusive disease, left ventricular hypertrophy, arterial hypertension, post-nephrectomy left, chronic nicotine abuse and hyperlipidemia
The operation was initially performed without complications and included a triple LIMA and LAD, RIMA and CX and vein [brachial left] and RCA. Repeated administration of low doses of norepinephrine was required for hemodynamic stabilization. The intraoperative cumulative fluid balance was +7400 ml (8800 in, 1400 out)
On postoperative transfer to the intensive care unit (ICU), the patient was deeply sedated (Richmond Agitation Sedation Scale [RASS] -5) and hemodynamically stable with still only low catecholamine requirements
During the night, however, catecholamine requirement increased (norepinephrine >1 µg/kg/min, additional administration of vasopressin) with simultaneously increasing lactate values (3.7 mmol/l). Hydrocortisone therapy was also started
Continuous renal replacement therapy (CRRT) was initiated 18 hours after postoperative transfer to the ICU because of progressively increasing retention parameters and to compensate for the metabolic acidosis (pH 7.3)
Given the simultaneously increasing inflammatory parameters (leukocytes 13.6×10³/µl, C-reactive protein [CRP] 37.45 mg/dl, interleukin-6 [IL-6] 16,586 pg/ml) in the context of a hyperinflammatory post-cardiopulmonary bypass syndrome and with the aim to hemodynamically stabilize the patient, a CytoSorb hemoadsorber was additionally integrated into the CRRT circuit
Treatment

A total of 10 treatments with CytoSorb were performed over a period of 96 hours (change of adsorber every 8 hours on day 1, and every 12 hours thereafter)
CytoSorb was used in combination with CRRT (Fresenius, Mulitfiltrate CiCa) run in continuous veno-venous hemodialysis (CVVHD) mode
Blood flow rate: 100 ml/min
Anticoagulation: Citrate
Position of the CytoSorb adsorber: pre-hemofilter
Measurements

Hemodynamics and norepinephrine requirements
Inflammatory parameters (leukocytes, CRP, IL-6)
Lactate
Fluid balance
Renal function


Results

Initially, blood pressure values fluctuated and he exhibited intermittent tachycardia as well as slightly increasing norepinephrine values (as part of the attempt to reduce volume). Catecholamine therapy with norepinephrine and vasopressin could then be significantly reduced from the second day onwards while vasopressin was discontinued after only 48 hours. Norepinephrine dosage was 0.43 µg/kg/min (under generous volume administration) on postoperative day 3. On the 4th postoperative day, only a low maintenance dose of norepinephrine (0.1 µg/kg/min) was required, which could be discontinued over the following days
In addition, the hyperinflammatory situation was well controlled during treatment, as evidenced by a reduction in IL-6 plasma levels to 360 pg/ml within 48 hours and further decreases thereafter. Leukocytes and CRP initially remained at an elevated level, but progressively decreased over time
Lactate values also reached normal ranges on the 4th postoperative day
After stabilization of his hemodynamic condition and a cumulative positive fluid balance of 18 litres, continuous negative fluid balancing could be achieved from day 3 onwards
Furthermore, the combined treatment with CRRT and CytoSorb was associated with a significant improvement in renal function with good diuresis from day 5 onwards
Patient Follow-Up

Successful extubation on postoperative day 5, initially without problems. However, over time he became tachypneic and stressed. This was followed by the start of a non-invasive high-flow ventilation regime
Removal of pleural drains on postoperative day 6
Also, discontinuation of renal replacement therapy after 2 therapy cycles 6 days after surgery
Transfer of the patient with non-invasive O2 application to the general ward after a total of 12 days of intensive care
Conclusions

In this patient with profound cardiac history with hyperinflammatory syndrome secondary to extensive 3-vessel coronary surgery, the postoperative combined use of CRRT and CytoSorb resulted in hemodynamic stabilization, control of hyperinflammation, resolution of metabolic acidosis, improvement in renal function and the possibility of a negative fluid balance
According to the authors, CytoSorb therapy helped to rapidly reduce the inflammatory parameters and thus stabilize the hyperinflammatory situation in this complex case
In this challenging setting, application of CytoSorb in combination with CRRT was safe and easy.

[ranchhand71]

FULLY AGREE but it does not seem as high a priority for current management.
Excellent that they got several government funding grants and support.
Their long term belief in sepsis market has been narrowed to several smaller markets.
NAE has the cash, existing distribution in plasma, hospitals and blood banks already. In an acquisition HAE would not need any of CTSO executives. I hope it leads to a stock acquisition in the $10-15 value range.

[biotech48]

Hemodefend has huge potential. Military and civilian use.

[ranchhand71]

Someone on other blog site suggested HAE shouid acquire CTSO for the HemoDefend opportunity.

[fantomphan]

News out regarding Canada

[Good Sport]

CytoSorbents Appoints Irina B. Kulinets, PhD, as Senior Vice President of Global Regulatory Affairs

Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents' executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities

PRINCETON, N.J., January 17, 2022 — 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, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs. Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others. She will serve as a member of CytoSorbents' executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.

Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc., a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices. She has also worked for major U.S. and international life science corporations such as Johnson & Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and BioSphere Medical. She has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices. Dr. Kulinets has also provided executive strategic and operational leadership to help launch new products in the U.S., E.U., China, Japan, and many other Asian and Latin American markets.

Dr. Kulinets also has extensive experience as a regulator and worked for TUV America, Product Service - Medical Division and was appointed as a third-party FDA Inspector and 510(k) reviewer on behalf of the FDA to review, assess and approve new technologies.

Dr. Kulinets stated, "I am excited to join CytoSorbents at such an important time in the Company's history as it nears the completion of the STAR-T pivotal trial, evaluating the ability of the DrugSorb®-ATR system to reduce the risk of perioperative bleeding in cardiothoracic surgery caused by the antithrombotic drug, Brilinta®. During my career I have led the regulatory approval of many cardiovascular and neurovascular medical devices. I believe the DrugSorb®-ATR system is a unique breakthrough therapy that can reduce bleeding complications in this setting and we will be working diligently to bring this product to help clinicians and patients as the Company's first commercialized product in the U.S. and Canada. Meanwhile, CytoSorbents has so many other compelling technologies, such as CytoSorb® and HemoDefend®-BGA. I look forward to leveraging my U.S. and international regulatory and clinical expertise to help rapidly advance these programs around the world."

Mr. Vincent Capponi remarked, "I am excited that Irina is joining the CytoSorbents team to lead Global Regulatory Affairs. She comes to us with a wealth of regulatory experience in medical devices, tissue products, and drugs and has received numerous FDA approvals. In addition to U.S. approvals, Irina has led international approvals in Europe, China, Japan, South Korea, Latin America, Australia, and Canada."

Mr. Capponi continued, "First and foremost, Irina's focus will be to help drive FDA marketing approval of DrugSorb-ATR for our initial indication of Brilinta® removal, currently under study in the STAR-T trial, and then later for direct oral anticoagulant (DOAC) removal under the STAR-D trial. Irina's regulatory experience with cardiovascular devices aligns well with this intended use. Meanwhile, her background will no doubt be useful in expanding the DrugSorb-ATR market to hospital-wide applications where preoperative removal of antithrombotics could be helpful, as before emergency orthopedic or neurologic surgeries. At the same time, Irina is well-suited to help refine our global regulatory strategy for CytoSorb, HemoDefend-BGA (universal plasma), and other technologies currently under development. We are fortunate to have a regulatory professional of Irina's caliber to join our team and look forward to her future success."

Dr. Kulinets holds an M.S. in Mechanical Engineering from Belarus Polytechnic Academy, M.S. in Quality Systems from California State University, and a Ph.D. in Health Science from Trident University. She is RAPS (Regulatory Affairs Professionals Society) certified RAC (Regulatory Affairs Certification) and Board Certified in Medical Affairs. Irina also has strong ties to Academia. She served as a Faculty Director and lecturer for the Master of Science in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in Regulatory Science and Clinical Research program in Georgetown University, Washington DC. She has authored or co-authored 3 books and has multiple peer-reviewed publications in areas of her expertise.

[Idunno]

Well, further, I’m taking the liberty of posting this recent video. Wes Christian. FWIW. Worth the watch. IMO.

Best to CTSO, lives saved, CTSO investors.

[Idunno]

Well, likely many ways to illegally manipulate the stock. These little biotechs are ripe for abuse. As our their retail investors. Moms and pops. I believe it needs to end, if.

The NWBO lawsuit alleges a particular form of illegal stock manipulation known as “spoofing”. If it gets to discovery, well, other forms of associated illegal manipulation may be, well, discovered.

Perhaps CTSO, Dr Chan, CTSO shareholders, have felt that CTSO shares have been illegally manipulated. Cohen Milstein may be able to assist. Looks like they brought a pretty solid case forward.

I doubt NWBO is the only company/equity illegally manipulated, if. It is likely a pattern and practice, of sorts, if.

They (NWBO/Cohen Milstein) appear to have solid evidence suggesting such, illegal, manipulation.

These are companies working to to save lives. Unconscionable.

Best, biotech48.

[biotech48]

I dunno, great find. I have felt that Dr. Lowenstein and his multiple aliases have been doing the same manipulation at CTSO over the years. I believe that they are still here. Here's the thing. I read everything I can regarding CTSO and also believe that they manipulated it both up and down.

[Idunno]

And, to whom it may concern, if, … https://www.cohenmilstein.com/practice-area/sec-and-cftc-whistleblower-programs

Anyway. Just find it all so, intriguing.

Good to see CTSO moving up. It sure got hit hard on the way down. Hope it was all legit, and not in any way illegally manipulated down, in any way, by any illegal stock manipulation, in concert with any other activities. Hope not.

I wonder if Cohen Milstein could offer any insight. If.

Best. Just thinking out loud.,

[Idunno]

Friends. I think this law suit is WELL worth the read. The entire complaint. You might find some similarities.

I think Dr Chan could be interested.

https://www.cohenmilstein.com/sites/default/files/NWBO%20v.%20Canaccord%20et%20al%20-%20Complaint%2012012022%20-.pdf

[Idunno]

Dr lowenstein ?? Are you still here? It’s been how long?? What, 10-12 -14 YEARS???

And you moved over to NWBO, to “warn” retail investors there, too, much like you’ve been doing in CTSO for years…???

Huh. Interesting. I wonder if CTSO investors would be interested to learn that another company, NWBO, which you have also spent considerable time and effort, mocking, (NWBO, and their CEO Linda Powers, working on a treatment for cancers) has sued Citadel and other market makers for manipulating their stock price for YEARS.

Much as you’ve done here, to CTSO. Mocking CTSO and Dr Chan. Coincidence?? Coincidence?? Coincidences???

Stock manipulation. Dr lowenstein? Thoughts? Coincidence?

https://www.cohenmilstein.com/update/northwest-biotherapeutics-files-lawsuit-against-major-market-makers-market-manipulation

[andy55q]

Case of the Week
Use of CytoSorb in a patient with severe polytrauma and ARDS following a motorbike accident

Dr. med. Christoph Busjahn Clinic and Polyclinic for Anesthesiology and Intensive Care, Rostock University Medical Centre, Rostock, Germany
01/04/2023
MyoglobinNew!Reduction in catecholaminesSafetyTraumaImprov. fluid balanceAnticoagulation HeparinARDSCase of the Week / MonthCase reportCritical CareECMO-VVInflammatory parameters
Download documentDownload document
Summary

CoM 01/2023 – This case reports on a 20-year-old patient with no relevant medical history, who was admitted to the emergency room with severe polytrauma after hitting a stationary car whilst on his motorbike.

Case presentation

In the shock room, while he was still breathing spontaneously, rapid pulmonary deterioration occurred so that emergency intubation was performed immediately
The main injuries diagnosed in the course of the initial assessment included: avulsion of the left main bronchus with bilateral hemato-pneumothorax, extensive pulmonary contusions with hemorrhages, cervical soft tissue emphysema and soft tissue hematoma, various rib fractures, right clavicle fracture, left scapula fracture, fracture of the manubrium sterni, left tripod fracture, dislocated multi-fragmentary fractures of the left maxillary sinus walls, right petrous bone longitudinal fracture, fractures of the left proc. transversi, non-displaced fracture of the proc. spinosus, multi-fragmentary fractures of the left pelvic scapula, left distal ulnar shaft fracture, suspected rupture of the anterior cruciate ligament and medial collateral ligament of the left knee joint, contusio cordis (contusion of the heart in the context of the thoracic trauma), splenic laceration (grade II), a craniocerebral trauma as well as a subcapsularly dorsal liver contusion/hematoma in the right liver lobe and also diffuse intraparenchymal hematoma in the right liver lobe
Subsequently, veno-venous extracorporeal membrane oxygenation (vv-ECMO) therapy was commenced due to his actively bleeding bronchus injury and the patient was transferred to the perioperative intensive care unit (ICU) intubated and ventilated in a controlled ventilation mode, already requiring high catecholamines (0.6 µg/kg/min)
The bronchus injury was treated with a thoracotomy with resection of the left upper lobe by colleagues from the thoracic surgical team
Diagnostic laparoscopy and gastroscopy were performed in the same time without further therapeutic consequences
In addition, mass transfusions were necessary in the context of his hemorrhagic shock with anemia (a total of 19 red cell concentrates, 19 units of fresh frozen plasma, 9 platelet concentrates)
Already intraoperatively, increased lactate levels were noted. Postoperatively, the patient then exhibited increased volume and catecholamine requirements with ongoing increases in lactate levels
Due to pronounced acute respiratory distress syndrome (ARDS), proning therapy was required and maintained for 4 days
After postoperative transfer to the ICU, CytoSorb therapy was started to control the hyperinflammatory situation, to achieve hemodynamic stabilization and to potentially avoid pulmonary hyperhydration and edema through reduced volume requirements
Treatment

Consecutive use of 2 CytoSorb adsorbers over a period of 41 hours (1st adsorber 15 hours, 2nd adsorber 26 hours)
Integration of the adsorber as bypass into the vv-ECMO circuit (Xenios console, Fesenius Medical Care) via the ECMO connections offered by CytoSorbents
Anticoagulation: initially without, then in the second treatment 200 IU/h heparin, with a target pTT of 40 – 45 sec
Measurements

Hemodynamics and catecholamine requirements
Inflammatory parameters
Metabolic parameters
Fluid balance
Myoglobin
Results

Under combined CytoSorb and vv-ECMO therapy, catecholamine requirements could be clearly reduced. Within 24 hours, norepinephrine demand was lowered to 0.09 µg/kg/min and could be stopped already on the first post op day
Treatment also led to a control of the hyperinflammatory situation as evidenced by a rapid reduction in interleukin-6 plasma levels and a normalization in leukocyte levels after the start of the hemoadsorption therapy
Already 5 hours after initiation of CytoSorb therapy, serum lactate had decreased from 9.8 to 4.8 mmol/l. Levels trended downwards over time reaching normal values 26 hours after the start of Cytosorb therapy
In parallel, the pH value normalized already during the first CytoSorb treatment
In addition, total fluid balance for the first 24 hours was only 1.5 litres and 2.6 litres for the first 48 hours. On day 3, this increased again by 2.3 litres. Afterwards, a negative fluid balance could be achieved throughout
Furthermore, therapy was associated with a rapid and sustained reduction in myoglobin and creatine kinase plasma levels
Patient Follow-Up

Bronchoscopies were repeatedly required due to viscous secretions and diffuse bleeding tendencies. HSV-1 was detected in the tracheal secretions, so that anti-viral therapy with aciclovir was started
Due to wide-complex tachycardia following contusio cordis, continuous amiodarone therapy was started, which was terminated after he converted back to sinus rhythm
As the duration of ventilation was expected to be long, a dilatative tracheotomy was performed on day 5 in the ICU. During the subsequent weaning period, the patient could tolerate spontaneous breathing trials and was able to breath adequately with stable gas exchange on Continuous Positive Airway Pressure (CPAP)
With sufficient improvement of pulmonary gas exchange and an increasing bleeding tendency in the context of an acquired von Willebrand syndrome, vv-ECMO therapy was discontinued after a total of 8 days
The last tracheal cannula change was performed on day 10 after admission to the ICU
Surgical treatment of the ulna fracture was performed by the trauma surgery team one week later
Given his pronounced stress reaction and agitation, sedation was extended until the patient could finally be weaned
At the time of transfer, the patient was awake, fully oriented, normotensive, catecholamine-free and breathing 3 x 2 hours a days using a heat and moisture exchanger
Conclusions

In this patient with severe polytrauma, hemorrhagic shock, traumatic brain injury and ARDS, the use of CytoSorb in combination with other therapeutic measures was associated with hemodynamic stabilization, control of the hyperinflammatory response, resolution of metabolic acidosis and reduction in myoglobin and creatine kinase levels
According to the authors, CytoSorb was helpful in this particular case for rapid control of the hyperinflammation in the setting of trauma and for achieving hemodynamic stability without massive volume overload. Contrary to all expectations, the use of CytoSorb prevented a significant positive fluid balance and thus an additional burden, especially to the lungs
The use of CytoSorb in combination with vv-ECMO proved to be safe and simple.

[biotech48]

Andy, another miracle and life saved by Cytosorb.

[hemidriver]

Downside to owning losers like this garbage, one day losses of 18% for end of year tax write offs..

[Good Sport]

CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications

PRINCETON, N.J., December 21, 2022 — 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, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.



Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “The independent DSMB has completed the review of the full unblinded dataset from the first 40 patients enrolled in the STAR-T trial and we are very pleased to receive the recommendation to continue the study as planned without any modifications. All our clinical resources continue to focus on enrollment with the goal of achieving the next milestone of 80 patients enrolled by Spring 2023, triggering another safety review and the execution of the trial’s prespecified interim analysis by the independent DSMB.”



The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

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 more than 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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 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 label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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 is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 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 FDA marketing approval in the United States 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 $48 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™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.



Forward-Looking Statements



This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management's current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.

[andy55q]

Case of the Week
The Sequential Use of Extracorporeal Cytokine Removal Devices in an Adolescent With COVID-19 Receiving Continuous Renal Replacement Therapy

Wun Fung Hui1, Renee Wan Yi Chan2,3,4,5 , Chun Kwok Wong6, Ka Hang Andy Kwok1, Wing Lum Cheung1, Fung Shan Chung1, Karen Ka Yan Leung1, Kam Lun Hon1, Shu Wing Ku1 1Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital, Hong Kong. 2Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 3Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong. 4Laboratory for Paediatric Respiratory Research, Li Ka Shing Institute of Health Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 5CUHK-UMCU Joint Research Laboratory of Respiratory Virus & Immunobiology, Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. 6Department of Chemical Pathology, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong. ASAIO J 2022; 68(12):e230-e234
12/21/2022
New!Peer Reviewed Published DataViral infectionCase of the Week / MonthCase reportCOVID-19Critical CareCRRT post filterInflammatory parameters
Download documentDownload documentLink to source
Summary

CoW 43/2022 – This case reports on an a 14-year-boy (43 kg) without any respiratory symptoms, who was admitted to a regional hospital with a fever of one day associated with vomiting and breakthrough seizures.

Summary
A 14-year-old male (43kg) developed multisystem inflammatory syndrome in children (MIS-C) after acquiring the SARS-CoV-2 infection. He deteriorated rapidly requiring inotropic and ventilatory support as well as continuous renal replacement therapy (CRRT) due to rhabdomyolysis-associated acute kidney injury. CytoSorb was first incorporated into the post-CRRT filter circuit for myoglobin and cytokine removal (hour 18 – 40), which was followed by sequential use of Oxiris (hour 40 – 80), followed by another CytoSorb adsorber (hour 85 – 110), giving a total of 100 hours of extracorporeal blood purification [EBP] therapy. There were no major complications related to the EBP therapy including hemodynamic compromise. Cytokine profile revealed a marked reduction of levels of several cytokines including tumor necrosis factor-alpha (TNFa), interleukin (IL)-6, IL-8, and IL-10 after the EBP therapy. It was noted that both pro-inflammatory and anti-inflammatory cytokines were removed, and the removal efficacy varied between different devices. The authors note that the two devices appeared to complement each other’s adsorption capacity. His condition improved and the serum ferritin, C-reactive protein, and procalcitonin levels also dropped gradually, which correlated well with his clinical progress and the trend of cytokine levels. The authors conclude that this case demonstrates that extracorporeal cytokine removal can be safely applied in children with MIS-C and can be considered as adjunctive therapy in selected patients with critically ill conditions.

Case presentation

Known medical history included a de novo G-Protein Subunit Alpha O1 (GNAO1)-mutation with movement disorder, epilepsy, and severe intellectual disability receiving baclofen, tetrabenazine, carbamazepine, and clobazam
On admission, his temperature was 40.1°C, heart rate 150/min, blood pressure 90/50 mmHg, and desaturation requiring oxygen supplementation
He exhibited vigorous involuntary movements and developed a status dystonicus
Blood tests on admission showed a white blood cell count of 9.1×109/L (neutrophil and lymphocyte count of 7.7×109/L and 0.9 × 109/L, respectively), urea 2.9 mmol/L, creatinine 41 µmol/L (baseline creatinine level was 31 µmol/L) and creatine kinase (CK) level of 117575 IU/L. Moreover, he was also found to pass brownish-red (myoglobin-positive) urine
He went on to develop disseminated intravascular coagulation with thrombocytopenia with an abnormal clotting profile (INR 1.7, aPTT >120 s, D-dimer 5072.9 ng/ml and fibrinogen 2.24 g/L)
The nasopharyngeal swab proved positive for SARS-CoV-2
He was started on hyperhydration, empirical piperacillin/tazobactam and one dose of remdesivir
Oral chloral hydrate was used for sedation
Urine output was maintained at 2–3 ml/kg/hour but the persistent fever and tachycardia continued, as did the excessive movements
He later developed stage 2 acute kidney injury (AKI) with an estimated glomerular filtration rate (eGFR) of 75 ml/min/1.73 m2 and was therefore transferred to the pediatric intensive care unit (PICU) for further management
His CK level rose sharply to the peak level of 449,100 IU/L with hypernatremia (sodium level of 155 mmol/L) and metabolic acidosis (pH 7.33, bicarbonate level of 13.8, and base excess of -11.8 mmol/L)
The lactate level was 2.3 mmol/L, troponin-T level was 170 ng/L and the eGFR reduced to 66 ml/min/1.73m2
He developed abnormal liver function tests with serum levels of alanine aminotransferase (ALAT) 1469 IU/L, aspartate aminotransferase (ASAT) 6577 IU/L, and ammonia 52 µmol/L
There were also elevated levels of inflammatory markers including ferritin 5842 pmol/L, procalcitonin 13.63 ng/ml, and C-reactive protein (CRP) 130 mg/L
The clinical diagnosis was multisystem inflammatory syndrome in children (MIS-C) related to SARS-CoV-2 infection triggering status dystonicus and subsequent rhabdomyolysis-associated AKI
After his transfer to the PICU, his blood pressure dropped to 60/40mmHg and SpO2 was 90%
A bedside echocardiogram showed impaired septal motion and mildly impaired left ventricular contractility with fractional shortening of 25%
He subsequently required intubation for respiratory failure, and a norepinephrine infusion was started at 0.03 µg/kg/min for hemodynamic support
Multiple sedative medications were used for sedation and control of his dystonia and dyskinesia in addition to his usual medications
Remdesivir was not continued due to his impaired liver function. Tocilizumab was starter later
He was started on continuous renal replacement therapy (CRRT) due to rhabdomyolysis-associated AKI
Ten hours after CRRT initiation, a CytoSorb hemoadsorption column was integrated into the CRRT circuit to enhance myoglobin and cytokine removal
Treatment

CytoSorb was first incorporated into the CRRT circuit for myoglobin and cytokine removal (hour 18 – 40), which was followed by sequential use of Oxiris (hour 40 – 80), followed by another CytoSorb adsorber (hour 85 – 110), giving a total of 100 hours of extracorporeal blood purification [EBP] therapy
CytoSorb was used in conjunction with CRRT run in high-volume continuous veno-venous hemodiafiltration (HF CVVHDF) mode using the Prismaflex system
Position of the adsorber: post-CRRT filter
Measurements

Hemodynamics and catecholamine requirements
Inflammatory parameters
Creatine kinase
Results

Initially, he continued to deteriorate with persistent hypotension requiring escalation of inotropes. However, there were no major complications related to the EBP therapy including hemodynamic compromise
Cytokine profile revealed a marked reduction of levels of several cytokines including tumor necrosis factor-alpha (TNFa), interleukin (IL)-6, IL-8, and IL-10 after the EBP therapy. His condition improved under both EBP therapies and the serum ferritin, C-reactive protein, and procalcitonin levels also dropped gradually, which correlated well with his clinical progress and the trend of cytokine levels
The serum levels of CK gradually decreased
Patient Follow-Up

A dose of intravenous immunoglobulin (IVIG) and dexamethasone were added during therapy
It was possible to stop all inotropes 4 days after PICU admission
Extubation was possible on 8th day of PICU admission
The CRRT doses were gradually reduced, and it was possible to stop CRRT support 8 days after admission
The clinical course was complicated by secondary Pseudomonas aeruginosa pneumonia requiring an additional course of antibiotics for two weeks
The patient was finally discharged from the PICU to his original hospital one month after admission
Conclusions

In this case of an adolescent with MIS-C following SARS-CoV-2 infection as well as rhabdomyolysis-associated acute kidney injury, the application of extracorporeal blood purification therapy was associated with pronounced hemodynamic stabilization, as well as a marked reduction in levels of several cytokines and creatine kinase
It was noted that both pro-inflammatory and anti-inflammatory cytokines were removed, and the removal efficacy varied between different devices. However, the authors note that the two devices (CytoSorb + Oxiris) appeared to complement each other’s adsorption capacity
The authors conclude that this case demonstrates that extracorporeal cytokine removal can be safely applied in children with MIS-C and can be considered as adjunctive therapy in selected patients with critically ill conditions.

[J G R]

I voted against Chan and all the board of directors except the latest one hired. Chan has been in charge for 13 years and look at the price of the stock today! The best thing he is good at is making excuses.

[hemidriver]

Wow. what garbage, How do these losers keep their jobs?

[andy55q]

New on PubMed
Case Reports
A rare case of acute liver failure with intrahepatic cholestasis due to dengue hemorrhagic fever: CytoSorb® and plasma exchange aided in the recovery: case report
Arosha Minori Gunasekera et al. BMC Infect Dis. 2022.
Hide details

BMC Infect Dis
. 2022 Dec 13;22(1):938.
doi: 10.1186/s12879-022-07933-y.
Authors

Arosha Minori Gunasekera 1 , Udeshan Eranthaka 2 , Dilshan Priyankara 2 , Ranjith Kalupahana 2
Affiliations

1 National Hospital of Sri Lanka, Colombo, Sri Lanka. [e-mail].
2 National Hospital of Sri Lanka, Colombo, Sri Lanka.
PMID: 36514003
DOI: 10.1186/s12879-022-07933-y
Cite

Abstract

Background: Dengue haemorrhagic fever is a severe form of acute dengue infection characterized by leakage of plasma through capillaries into body spaces resulting in circulatory insufficiency leading to shock. Despite varying degrees of liver involvement occurring in acute dengue infection, intrahepatic cholestasis is very rare in the literature with only two cases reported so far. We report a challenging case of a middle-aged woman with DHF complicated by acute liver failure, coagulopathy, acute renal failure and prolonged intrahepatic cholestasis. She was successfully managed in the intensive care unit with supportive therapy, Cytosorb® and therapeutic plasma exchange.

Case presentation: A 54-year-old Sri Lankan obese woman with multiple comorbidities presented with fever, headache, vomiting and generalized malaise for 3 days and was diagnosed with dengue haemorrhagic fever. Despite the standard dengue management, she clinically deteriorated due to development of complications such as, acute liver injury, intrahepatic cholestasis and acute renal injury. Acute liver failure was evidenced by transaminitis, lactic acidosis, coagulopathy with pervaginal bleeding and severe encephalopathy necessitating elective intubation and mechanical ventilation. She was immediately transferred to intensive care facilities where she underwent supportive management for liver failure, continuous renal replacement therapy coupled with cytosorb and therapeutic plasma exchange with which she made a remarkable recovery.

Conclusion: Acute liver failure with a prolonged phase of intrahepatic cholestasis is a very rare complication of acute dengue illness which is sparsely documented in medical literature so far. This patient was managed successfully with supportive therapy, aided by cytoSorb hemo-adsorption and therapeutic plasma exchange.

Keywords: Acute liver failure; Cholestasis; Cytosorb®; Dengue fever; Dengue haemorrhagic fever; Therapeutic plasma exchange.

[fantomphan]

I was being sarcastic. Unfortunately the jokes on me/all of us.

[Harbor6460]

Down .40 in a month

[Harbor6460]

He is not a businessman. He is a scientist. At least his shares are worthless now also. It’s unbelievable a product like this hasn’t got traction in this amount of time. The uses are endless. Yet nothing. But they do 30 mil rev. That keeps the float in check till they give Chan more that POS FUK

[andy55q]

Case of the Week

Literature Database
Use of hemadsorption in pediatric meningococcal sepsis, Waterhouse-Friderichsen-Syndrome, and multiple organ failure

Guido Mandilaras, Simone Katrin Dold, Robert Dalla Pozza Division of Pediatric Cardiology and Pediatric Intensive Care, University Hospital, LMU Munich, Munich, Germany. Open Journal of Clinical & Medical Case Reports 2022; 8(12):1889
12/13/2022
New!PediatricsReduction in catecholaminesSafetySeptic ShockAnticoagulation HeparinCase of the weekCase reportCritical CareCRRT (pre or post filter)Inflammatory parameters
Download documentDownload documentDownload document
Summary

CoW 42/2022 – This case reports on an 18-year-old male without relevant medical history, who presented at the emergency room of a peripheral primary care hospital with nausea and headaches.

Summary
Community-acquired bacterial meningitis still represents one of the most important infectious diseases worldwide and remains a substantial cause of mortality and morbidity, particularly in both the very young and the elderly patients. The disease is characterized by a hyperinflammatory response with a rapid and excessive production of inflammatory mediators, accompanied by disseminated intravascular coagulation (DIC) and development of Waterhouse–Friderichsen syndrome. Extracorporeal blood purification thera­pies represent a new therapeutic approach since they seem to be able to attenuate this detrimental process by lowering systemic cytokine levels. We herein report on an 18-year-old previously healthy male who had to be intubated and mechanically ventilated shortly after hospital admission followed by confirmation of Neisseria meningitidis infection. Antibiotic as well as catecholamine and volume therapy were initiated. Over time he developed excessive hyperinflammation, Waterhouse-Friderichsen-syndrome with purpura fulminans, hyperlactatemia and progressive renal failure, leading to the initiation of combined renal replacement and CytoSorb hemoad­sorption therapy. This resulted in significant decrease in inflammatory parameters and a progressive re­duction in catecholamine and lactate levels while peripheral perfusion was restored preventing any loss of extremities. The patient could be extubated 10 days after PICU admission. No adverse or unwanted device-related side effects were documented. In conclusion, this case report is supporting other promising results in this highly sensitive patient cohort, by showing rapid hemodynamic stabilization and control of hyperinflammation being associated with the use of CytoSorb, however, evidence on the application of the CytoSorb adsorber in pediatrics remain rather sparse and more clinical data are needed.

Case presentation

During the hospital admission process, the patient rapidly developed petechiae over his entire body, resulting in the preliminary diagnosis of meningococcal sepsis
Following initiation of antibacterial therapy with cefotaxime (2 x 4g iv) and ampicillin (3 x 5g iv) as well as administration of dexamethasone (3 x 10 mg iv), the patient had to be intubated due to respiratory insufficiency and a central venous and arterial catheters were inserted
Subsequently, catecholamine (norepinephrine 0.8 mg/h) and volume therapy (2 l isotonic saline, 2000 IE prothrombin complex, 2x fresh frozen plasma, 1x platelet concentrate) were started due to progressive hemodynamic instability
Microbiological analysis of the liquor puncture confirmed presence of Neisseria Meningitidis type B bacteria
The mechanically ventilated patient was then transferred under ongoing catecholamine therapy to the pediatric intensive care (PICU) unit for further diagnosis and therapy
At this time, clinically the patient was exhibiting a picture of full-blown Waterhouse-Friderichsen-syndrome with purpura fulminans accompanied by ubiquitous petechial hemorrhages and hyperlactatemia (max. 10.8 mmol/l)
Hydrocortisone administration was started according to the guidelines (50 mg/m² body surface) along with sedation with midazolam, and sufentanyl, which was later complemented by propofol and dexmedetomidine
Antibiotic therapy was supplemented by tobramycin and his disseminated intravascular coagulopathy (DIC) was treated by means of repeated doses of fresh frozen plasma, platelet concentrates, and vitamin K
Echocardiography revealed a restricted cardiac function with an ejection fraction of 31% and inotropic therapy was extended by epinephrine and milrinone, accordingly
Mechanical ventilation had to be intensified because of increasing bronchial secretions and left atelectasis (max positive end-expiratory pressure [PEEP] 10 mbar)
Due to progressive renal failure with elevated retention parameters, continuous renal replacement therapy (CRRT) was started five hours after PICU admission and approximately twelve hours later a CytoSorb hemoadsorber was additionally added to the circuit to control excessive hyperinflammation (Interleukin – IL-6 >200,000 pg/ml)
Treatment

Two CytoSorb treatment sessions were performed for a total duration of approximately 50 hours
CytoSorb was used in combination with CRRT run in continuous veno-venous hemodiafiltration (CVVHDF) mode
Blood flow rate: 120 ml/min
Anticoagulation: heparin
Measurements

Hemodynamics and catecholamine requirements
Inflammation
Lactate
Respiratory status
Cardiac function
Sequelae of DIC
Results

Therapy resulted in early and rapid hemodynamic stabilization accompanied by a prompt decrease in norepinephrine and epinephrine doses. The epinephrine infusion could already be tapered off at the end of the second hemoadsorption session
During combined CVVHDF and hemoadsorption treatment, there was also a significant decrease in inflammatory parameters noted, pointing towards control of the hyperinflammatory state. IL-6 levels reduced from >200,000 to 770 pg/ml within the first 48 hours of combined therapy
Lactate levels also reduced progressively
The respiratory situation stabilized during treatment and cardiac function started to improve
Additionally, there were no further petechial hemorrhages, and no peripheral ischemia observed with no loss of extremities in the follow-up period
Patient Follow-Up

Continuous hemodiafiltration was switched to intermittent dialysis as renal function consecutively improved as evidenced by a normalization in retention parameters and return of spontaneous diuresis
The pulmonary situation slowly improved with inhalation and repeated bronchoscopy with bronchial lavage, so that the patient could be extubated 10 days after PICU admission
Ongoing follow-up was characterized by mild delirium and development of critical illness neuropathy with pronounced tremors, which, however, resolved during his stay
Two weeks after admission to the PICU, the patient was transferred to the general pediatric ward in a stable clinical condition with a normal cardiac function (EF 70%) and was discharged from the hospital shortly afterwards
Conclusions

Treatment in this adolescent patient with meningococcal sepsis, Waterhouse-Friderichsen-Syndrome, and multiple organ failure was associated with a rapid and significant reduction in plasma cytokine levels, accompanied by improved hemodynamics, normalization of plasma lactate levels and restored peripheral perfusion preventing any loss of extremities
As such, this case report supports other promising results in this highly sensitive patient cohort
The very positive clinical course in our case does not imply that there was relevant removal of any of the antibiotics used
No adverse or device-related side effects were documented during or after the treatment sessions and the combination was practical, technically feasible and appeared to be highly beneficial for the patient.

[andy55q]

New on PubMed
Hemoadsorption in Complex Cardiac Surgery-A Single Center Experience
Murali Manohar et al. J Clin Med. 2022.
Hide details

J Clin Med
. 2022 Nov 27;11(23):7005.
doi: 10.3390/jcm11237005.
Authors

Murali Manohar 1 , Vivek Jawali 1 2 , Siddu Neginahal 3 , Sudarshan Gt 1 , Geetha Muniraj 4 , Murali Chakravarthy 4
Affiliations

1 Cardiac Surgery Department, Fortis Hospital, Bengaluru 560076, India.
2 Cardiac Sciences Board, Fortis Hospital, Bengaluru 560076, India.
3 Cardiac Surgery Perfusion Department, Fortis Hospital, Bengaluru 560076, India.
4 Anaesthesia Department, Fortis Hospital, Bengaluru 560076, India.
PMID: 36498579
DOI: 10.3390/jcm11237005
Cite

Abstract

(1) Background: Cardiac surgery may evoke a generalized inflammatory response, typically magnified in complex, combined, redo, and emergency procedures with long aortic cross-clamp times. Various treatment options have been introduced to help regain control over post-cardiac surgery hyper-inflammation, including hemoadsorptive immunomodulation with CytoSorb®. (2) Methods: We conducted a single-center retrospective observational study of patients undergoing complex cardiac surgery. Patients intra-operatively treated with CytoSorb® were compared to a control group. The primary outcome was the change in the vasoactive-inotropic score (VIS) from pre-operatively to post-operatively. (3) Results: A total of 52 patients were included in the analysis, where 23 were treated with CytoSorb® (CS) and 29 without (controls). The mean VIS increase from pre-operative to post-operative values was significantly lower in the CS group compared to the control group (3.5 vs. 5.5, respectively, p = 0.05). In-hospital mortality in the control group was 20.7% (6 patients) and 9.1% (2 patients) in the CS group (p = 0.26). Lactate level changes were comparable, and the median intensive care unit and hospital lengths of stay were similar between groups. (4) Conclusions: Despite notable imbalances between the groups, the signals revealed point toward better hemodynamic stability with CytoSorb® hemoadsorption in complex cardiac surgery and a trend of lower mortality.

Keywords: aortic surgery; blood purification; complex cardiac surgery; cytokines; cytosorb; hemoadsorption; hyperinflammation; redo.

[vinovista]

Chan just bought some shares @ $1.26 & $1.264. Guess he at least likes the stocks and its potential.

[J G R]

What we are missing is a good CEO! We have one that is self -centered self-serving over paid and compensated for the job he has done. He is great at making excuses!

[fantomphan]

Thank you! Reading these, it's inconceivable/inexplicable as to why the stock performs as it does, or why they can't sell more. What are we all missing?

[andy55q]

Case of the Week 41
Hemadsorption: A New Therapeutic Option for Selected Cases of Bromazepam Intoxication

Mekeirele M, Verheyen S, Van Lancker R, Wuyts S, Balthazar T. Case Reports in Nephrology and Dialysis 2022; 12(3):163-166
12/06/2022
New!Peer Reviewed Published DataCase reportCritical CareCRRT (pre or post filter)Drug removalIntoxicationLiver failure
Download documentDownload documentLink to source
Summary

CoW 41/2022 – This case reports on an a 67-year-old woman with CHILD-C liver cirrhosis, who was admitted to the tertiary intensive care unit (ICU) after intoxication with bromazepam.

Benzodiazepine ingestion can account for around 21% of all intoxications requiring admission to Intensive Care (IC). Management is normally with a supportive approach and with the use of flumazenil, an antidote for benzodiazepines, however, flumazenil does not influence elimination. In this case report, a 67 yr old patient with impaired liver function (CHILD-C cirrhosis) was admitted after intoxication with the benzodiazepine, bromazepam. The initial plasma concentration was very high (874 mg/L, upper limit of normal 170 mg/L). She became increasingly drowsy with respiratory insufficiency so a flumazenil infusion was started resulting in her becoming more alert, however, the infusion rate could not be decreased due to her repeatedly relapsing into stupor. Due to her liver failure (and consequent slow metabolism), it was calculated that the half-life of bromazepam would be 10 days rather than 10 hrs, requiring a stay of 23 days on the ICU, so CytoSorb hemoadsorption was initiated using continuous venovenous hemofiltration (CVVHF). Pre and post CytoSorb adsorber blood levels were taken. Results showed that elimination of bromazepam by CytoSorb was quick and efficient (-31% after 1 h, -56% after 11 h). After the first 11 hrs there was a quick decline in adsorbing capacity suggesting saturation, however, by this time the patient was in the upper limit of normal for bromazepam, so no second hemoadsorber was needed and the flumazenil infusion could be quickly tapered off within 1 day. The authors conclude that hemadsorption is a viable option to reduce length of IC stay or need for intubation in slow metabolizers. They state that the cost of a prolonged stay in the intensive care unit is significantly higher than the cost of an adsorber.

Case presentation

The initial plasma concentration was 874 µg/L (upper limit of normal 170 µg/L)
The patient developed respiratory failure due to decreased consciousness
Given the expected slow decrease in plasma levels of bromazepam due to cirrhosis and the inherent risk of a prolonged need for mechanical ventilation, an infusion of flumazenil was initiated to avoid intubation
The patient regained consciousness and remained stable, but the flumazenil infusion rate could not be decreased due to a relapse in stupor following this intervention
As expected, only a very slow decrease in bromazepam titer was observed
Based on the decline in titer, the half-life of bromazepam was calculated to be 10 days rather than the expected 10 h. This implied that a reduction of the bromazepam titer to 170 µg/L could only be expected after 23 days of ICU admission, warranting a search for further therapeutic options
Hence hemadsorption was initiated in combination with continuous renal replacement therapy (CRRT)
Treatment

CytoSorb was used in conjunction with CRRT run in continuous veno-venous hemofiltration (CVVHF) mode using the Prismax® (Baxter, IL, USA) system
Measurements

Sequential quantifications of bromazepam levels from blood taken pre and post CytoSorb adsorber
Results

Application of CytoSorb resulted in the quick and efficient elimination of bromazepam (-31% after 1 h, -56% after 11 h). There was no rebound in plasma titer after cessation of the hemadsorption therapy and the patient attained the target level of bromazepam 13 days earlier than predicted without the hemoadsorber
Patient Follow-Up

After the first 11 hrs there was a quick decline in adsorbing capacity suggesting saturation. However, by this time the patient was in the upper therapeutic limit for bromazepam, so no second hemoadsorber was needed
The flumazenil infusion could be quickly tapered off within 1 day
Conclusions

The application of CytoSorb proved to be effective in eliminating bromazepam in a patient with CHILD-C cirrhosis
The authors conclude that hemoadsorption is a viable option to reduce length of ICU stay or need for intubation in slow metabolizers
They state that the cost of a prolonged stay in the intensive care unit is significantly higher than the cost of an adsorber.

[andy55q]

Case of the Week
Hemoadsorption as part of a multimodal therapy concept to treat Capnocytophaga sepsis with thrombocytopenia and multiple organ failure

Kreutz J, Choukeir M, Chatzis G, Schieffer B, Markus B. Int Journal Art Organs 2022; epub
11/30/2022
MyoglobinNew!Other indicationsPeer Reviewed Published DataRhabdomyolysisSafetySeptic ShockAnticoagulation CitrateCase of the weekCase reportCritical CareCRRT (pre or post filter)Inflammatory parameters
Link to sourceDownload documentDownload document
Summary

CoW 40/2022 – This case reports on a 68-year-old male with known arterial hypertension, who presented at the hospital by ambulance following severe deterioration of his general condition including fever up to 39°C, oliguria and repeated vomiting over the recent days.

In this case report a 68-year-old presented at the hospital following a severe deterioration in his general condition, including fever up to 39°C, oliguria and repeated vomiting for a couple of days following a dog bit to his right foot whilst on holiday. On admission, the patient showed pronounced marbling and cyanosis to all extremities and ears. The reddened bite wound to the second toe did not appear infected so there was no medical or surgical intervention at this time. Despite standard therapy including antibiotics and multiple blood products he developed septic shock with acute renal failure, liver dysfunction, cognitive dysfunction and respiratory deterioration so was started on continuous renal replacement therapy (CRRT), and eventually intubated and ventilated. Given the patients hyperinflammatory condition a CytoSorb hemoadsorber was additionally integrated into the CRRT circuit. In total 4 adsorbers were used during this 1st therapy interval (changed every 12 hrs). CytoSorb was then stopped for 24 hrs as he improved clinically, however, due to a relapse in his clinical condition, CytoSorb was then restarted for another 5 treatment sessions for 24 hours each (2nd therapy interval). All of the applied therapeutic measures led to rapid clinical stabilization, control of the hyperinflammatory situation, and improvement in his neurological status. The therapy was well tolerated with no complications encountered. The patient was able to be extubated after 3 days of mechanical ventilation and he was finally able to be transferred to a rehabilitation unit in a stable condition after a total hospital stay of 32 days. This is the first clinical case describing the successful application of a multimodal treatment approach including extracorporeal blood purification therapy in a patient with septic shock, acute renal failure and severe thrombocytopenia with signs of DIC and TMA due to Capnocytophaga infection following a dog bite.

Case presentation

Two days previously, he had returned from a vacation where he had had a dog bite to his right foot and subsequently complained of chills, sweating, tachycardia, and general malaise
On admission, the patient showed pronounced marbling to all extremities and ears with cyanosis of his extremities. The reddened bite wound to the second toe did not appear infected so there was no need for any medical or surgical intervention at this time
Subsequent chest X-ray examination for a focus proved inconclusive
Echocardiography revealed a mild to moderately reduced systolic function, which was consistent with septic cardiomyopathy
In addition, an infection-triggered atrial fibrillation was detected during this acute phase
Laboratory diagnostics revealed clearly elevated infection parameters (leucocytes 33 G/l, procalcitonin (PCT) >100 µg/l, C-reactive protein (CRP) 298 mg/l, interleukin (IL)-6 1866 pg/ml) and in light of all of these findings, the patient was diagnosed with sepsis progressing to septic shock
In addition, his coagulation status was markedly deranged (thrombocytes 6 G/l, Quick 22%, International Normalized Ratio [INR] 3.1, activated Partial Thromboplastin Time [aPTT] 112 sec) consistent with disseminated intravascular coagulopathy (DIC) and thrombotic microangiopathy (TMA), resulting in the administration of fresh frozen plasma (FFP) and platelet concentrates to stabilize his coagulopathy
Also, over time, a red blood cell transfusion was needed due to considerable volume administration of blood products leading to dilution, low hemoglobin (13.8 g/dl) and signs of hemolysis as evidenced by clearly increased levels of lactate dehydrogenase (3164 U/l)
Following detection of intracellular and extracellular rod-shaped bacteria in the initial differential blood count and in the blood smear with suspected Capnocytophaga canimorsus infection, anti-infective therapy was initiated with ampicillin/sulbactam and clarithromycin. The antibiotic regimen was then escalated to piperacillin/tazobactam (18 g/24h) and levofloxacin (500 mg twice daily). As infection parameters continued to increase further, antibiotic therapy was again escalated to imipenem (4 g per day) on day 2
Additionally, the patient received 2 units of FFP every 6 hours
In the context of increasing retention parameters (creatinine 4.34 mg/dl) and oliguria (24 hours diuresis 150 ml) under ongoing volume resuscitation, the decision was made to initiate continuous renal replacement therapy (CRRT)
Furthermore, high-flow oxygen therapy was started because of assumed cardiac decompensation with incipient pulmonary edema and his significantly reduced general condition
Radiological examination, however, only revealed a slight congestion with bilateral pulmonary infiltrates
The patient also exhibited signs of liver dysfunction (aspartate aminotransferase [AST] 1094 U/l, alanine aminotransferase [ALT] 365 U/l, lactate dehydrogenase [LDH] 3164 U/l, bilirubin 2.89 mg/dl) as well as increased creatine kinase (418 U/l) and myoglobin levels (1674 µg/l)
Laboratory diagnostics further revealed severe hyperlactatemia (6.3 mmol/l)
Over time, the patient showed progressive respiratory deterioration whilst on high-flow oxygen therapy and so he was switched to non-invasive oxygen therapy
However, due to clearly reduced vigilance (Glasgow Coma Scale [GCS] 8) and incipient respiratory insufficiency with progressive metabolic acidosis (pH 7.34), the patient eventually had to be intubated and mechanically ventilated on the same day
During this episode of respiratory decompensation, norepinephrine and dobutamine infusions were required briefly
Given the patients hyperinflammatory condition in the context of septic shock, a CytoSorb hemoadsorber was additionally integrated into the CRRT circuit
After clinical improvement under CytoSorb treatment, therapy was discontinued. However, due to a recurrence in clinical deterioration, hemoadsorption therapy had to be reinstituted for a second therapy interval
Treatment

The patient received a total of 9 CytoSorb hemoadsorption therapy sessions over the following 8 days (4 adsorbers during the first two days changed every 12 hours [1st therapy interval], pause interval of 24 hours, thereafter another 5 treatment sessions for 24 hours each [2nd therapy interval])
CytoSorb was used in conjunction with CRRT run in continuous veno-venous hemodiafiltration (CVVHDF) mode
Blood flow rate: 100 ml/min
Anticoagulation: citrate
Measurements

Inflammatory parameters
Myoglobin
Lactate
Neurologic status
Results

During the course of combined hemoadsorption and renal replacement therapy treatment, stabilization in his overall clinical condition was noticed accompanied by clear control of the hyperinflammatory situation as evidenced by a significant decrease in inflammatory parameters by the end of the treatment cycle (e.g. PCT from >100 to 1.2 µg/L after CytoSorb treatment, CRP from 298 to 94 mg/L. IL- 6 levels decreased from 1866 to 833 pg/ml within one day of CytoSorb initiation)
Plasma concentrations of myoglobin could be reduced from 1674 to 108 µg/L
Lactate decreased from 6.3 to 0.9 mmol/L during the course of the 9 therapy sessions
Combined CRRT+CytoSorb therapy was further associated with neurological improvement finally resulting in swift extubation after 3 days of mechanical ventilation
Patient Follow-up

On the 7th day on the intensive care unit, blood cultures, which have already been preserved at the time of admission, yielded the Gram-negative bacillus Capnocytophaga canimorsus
Markers of inflammation increased after discontinuation of imipenem most probably in the context of a concomitant pneumonia, requiring escalation of antimicrobial therapy to vancomycin plus ceftazidime
His reduced left ventricular function recovered during his inpatient stay
With improved urinary output, CRRT was discontinued
Of note, during his hospital stay, the patient received prednisolone (100 mg/d) for 3 days as additional therapy as well as a total of 51 units of FFP
He was finally transferred to a rehabilitation unit in a cardio-respiratory stable general condition after a total hospital stay of 32 days
At the time of discharge, the patient still had dry necroses on two toes of both feet which will probably lead to amputation over time
Conclusion

This is the first clinical case describing the successful application of a multimodal treatment approach including extracorporeal blood purification therapy in a patient with septic shock, acute renal failure, and severe thrombocytopenia with signs of DIC and TMA due to Capnocytophaga infection following a dog bite
Application of therapeutic measures including antibiotic therapy, mass transfusions, CRRT and CytoSorb hemoadsorption therapy was associated with rapid clinical stabilization, control of the hyperinflammatory situation, and improvement in his neurological status
The therapy was well tolerated with no complications encountered
This case supports the clinical recognition of severe Capnocytophaga infection that can lead to critical conditions even in immunocompetent patients.

[dr_lowenstein]

based on the 5 year chart, I would have to say NO

[dr_lowenstein]

been a while. thought i would check in. has this company made any progress?

[fantomphan]

Andy, where are you with the cases? Give us something positive. Badly needed.

[Harbor6460]

They can announce all they want shareholders are fed up 11.00 to 1.45. With no credible info to show rev growth. Just bullsh@t chan wake up

[Paulness]

NEWS -- CytoSorbents Announces Pivotal STAR-T Trial Reaches First Milestone With 40 Patients Enrolled



PRINCETON, N.J., Nov. 14, 2022 /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 via its proprietary polymer adsorption technology, announced that 40 of the targeted 120 patients have been enrolled in the Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial, achieving the first enrollment milestone and triggering a pre-specified Data and Safety Monitoring Board (DSMB) review. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, to remove the anti-thrombotic agent, ticagrelor (Brilinta®, AstraZeneca), during cardiothoracic surgery.

CytoSorbents' pivotal STAR-T trial using DrugSorb-ATR to remove ticagrelor during cardiac surgery now a third complete

Dr. Michael J. Mack, Director of the Cardiovascular Service line at Baylor Scott & White Health System, Chairman of the Baylor Plano Research Center in Texas and co-Principal Investigator of the STAR-T trial commented: "Reaching our first trial enrollment milestone of 40 patients is a critical first step in the execution of the landmark STAR-T trial. Currently, cardiac surgeons are either forced to delay life-saving heart surgery in patients who are on antithrombotic drugs or proceed to operation when they are at very high risk for bleeding. The DrugSorb-ATR device is a novel approach that could potentially allow these high-risk surgeries to proceed in a safe and timely manner. We have designed two rigorous, pivotal trials to test the efficacy and safety of this novel device that if successful could make it available to all U.S. cardiac surgeons, so they can join their international colleagues who have it available and use it routinely in their everyday practice. We are currently focused on bringing the STAR-T trial across the finish line, so we can then turn our attention to STAR-D. I'd like to thank all of the participating centers and investigators for helping us reach this first crucial enrollment milestone and we remain very excited to welcome our Canadian colleagues who should begin contributing to enrollment very soon."

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We are pleased to have enrolled a third of our STAR-T pivotal study, which now triggers the first safety review by the independent DSMB of the study. We are now working diligently to complete the necessary operational steps including data collection and validation to support the upcoming DSMB safety review which is estimated in approximately 2 months. With our full attention and resources now dedicated to STAR-T and the upcoming addition of Canadian sites, we anticipate the momentum to continue and project that we can achieve the next study milestone of 80 patients enrolled in Spring 2023 that will trigger the next DSMB safety review and the pre-specified interim analysis.

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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 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. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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 is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers 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 intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, for this application. The STAR-T trial will be followed by the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) pivotal trial evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.

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 $48 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™, DrugSorb™-ATR, 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 Twitter.

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, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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CytoSorbents Contact: 
Kathleen Bloch
[phone]
mailto://[e-mail]

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://[e-mail]

European Company Contact:
Josephine Kraus
[phone]
mailto://[e-mail]

Public Relations Europe:
Marcus Schult
commponists
[phone] ext. 960
[phone]
mailto://[e-mail]

View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-announces-pivotal-star-t-trial-reaches-first-milestone-with-40-patients-enrolled-301676656.html

SOURCE CytoSorbents Corporation

[fantomphan]

Up a penny AH on Friday to $1.53. Somebody knows something.

[Harbor6460]

Chan 15 years of tech wasted. My god. Tge people that died because of him

[Cytobeliever]

Biotech48,

Of course you must be joking. I have been a member of this board since 2018 and have placed 12 posts. Why not take a look. It is right there for you and anyone else to see.

I am not one to post as often as you and some of the others do however yes, I did see the article regarding sepsis. I read anything and everything regarding this company as I know you do as well. My statement was that we hardly see anything regarding sepsis any longer and that was the reason that I purchased the stock back in 2010.

Now we hope that they do succeed in another year or two and get any kind of an approval for whatever indication. I as many others will continue to hope for the best however, you should be able to agree that It has been a very long haul and now we have to hope that they do not do another reverse split next year. The cash burn is concerning. One 25 reverse split was enough for me! That said, it is very frustrating and I can understand Fantomphans frustration. Do you?

[biotech48]

Cyto believer, I am surprised that you have been here for 10 years and never posted. I am also surprised that you did not see last weeks sepsis PR since you seem to think that they have abandoned sepsis.

NATIONAL INSTITUTES OF HEALTH GRANTS PHASE I SBIR AWARD TO CYTOSORBENTS TO TEST NOVEL POLYMERS FOR CYTOKINE AND ENDOTOXIN REMOVAL FROM SEPTIC PORCINE PLASMA
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killerPRINCETON, N.J., Oct. 31, 2022 /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 via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death

[Cytobeliever]

I am sorry to say that I have to agree with you. We have suffered threw this and his bumbling long enough. Doctor Chan has to go. No wonder Kathy is packing it in. As CFO, she knew what was coming! He should be following her out the door.

I bought into this company more than 10 years ago as a way to fight sepsis. Today, hardly a word regarding sepsis! I already went through a reverse split. And now we may be facing another! This is disgusting! Chan needs to be fired immediately!

[fantomphan]

Looks like the market just loves this management team and the latest news. Bravo. We're going places. (PS H.C. Wainright, a big supporter, has lowered their target to $5.50.....even that is a pipe dream)

[Good Sport]

Q3 2022 Results & Webcast 4:30pm dial into info

Conference Call Details:
Date: Thursday, November 3rd, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-800-458-4121
International: 1-929-477-0402
Conference ID: 1375266
Live Presentation Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1576192&tp_key=7e23c8c13c


CytoSorbents expects to achieve first milestone of the U.S. pivotal STAR-T Trial this month

PRINCETON, N.J., Nov. 3, 2022 /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 via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended September 30, 2022.

Third Quarter 2022 Financial Results

Total revenue, including product sales and grant income, for Q3 2022 was $8.1 million, a decrease of 17% compared to $9.8 million in Q3 2021

Q3 2022 product sales were $6.5 million (negligible COVID-related sales) versus $8.9 million (includes $1.1 million in COVID-related sales) in Q3 2021. The decrease in the average Euro to U.S. dollar exchange rate lowered Q3 2022 product sales by approximately $771,000. On a constant currency basis, Q3 2022 core non-COVID sales would have been approximately $7.2 million, which represents a 7% decrease from approximately $7.8 million in core non-COVID sales a year ago

As expected, COVID-19 related sales during the quarter were negligible, reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination and natural immunity

Product gross margins were approximately 55% in Q3 2022, versus 82% in Q3 2021. The decrease in the gross margin percentage was due primarily to an inventory write-off related to an equipment failure and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility. Excluding the inventory write-off, product gross margin in Q3 2022 would have been 64%

The Company maintains a healthy balance sheet with cash and cash equivalents of $24.2 million (which includes $1.7 million in restricted cash) as of September 30, 2022, and no debt

Recent Operating Highlights:

More than 186,000 cumulative CytoSorb devices have been utilized worldwide as of September 30, 2022, compared to more than 152,000 devices utilized cumulatively a year ago

The U.S. STAR-T Trial is enrolling well with the expectation of achieving the first milestone with 40 patients enrolled this month

Presented final data from the U.S. CytoSorb Therapy in COVID-19 (CTC) Registry at the European Society of Intensive Care Medicine conference last week, highlighting the early use of CytoSorb with ECMO (extracorporeal membrane oxygenation) to achieve "enhanced lung rest" and high survival in 100 critically ill COVID-19 patients with refractory lung failure treated at 5 U.S. academic centers

Achieved ISO 13485 certification of our new Princeton, New Jersey manufacturing facility

The Israeli Ministry of Health assigned national reimbursement coverage to CytoSorb for key intraoperative cardiac surgery indications such as antithrombotic drug removal, infective endocarditis, and aortic dissection

The Turkish Ministry of Health granted national reimbursement to CytoSorb, which is now a reimbursed catalog product in the State Supply of Turkey (DMO) portal and can be purchased directly by hospitals and physicians without restrictions

CytoSorbents received funding for HemoDefend-BGA™, a development stage product designed to enable life-saving universal plasma, under two separate Department of Defense contracts. This includes a two year contract valued at $1,977,024 to develop a fully-finished, commercial device that will be evaluated in a pre-clinical porcine study and a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter to enable freeze-dried universal plasma

Released new cardiac surgery data at the European Association for Cardio-Thoracic Surgery (EACTS) highlighting the benefits of CytoSorb when used intraoperatively during cardiothoracic surgery in Staphylococcus aureus infective endocarditis, heart transplantation, and to remove antithrombotic agents

The National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, granted a Phase I SBIR award, valued at $281,835, to CytoSorbents to test novel polymers for cytokine and endotoxin removal from septic porcine plasma, with the goal of advancing new blood purification technologies to treat Gram negative sepsis, a deadly global killer

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Based upon the increased pace of enrollment, we are excited to be very close to achieving the first of three milestones of the U.S. STAR-T pivotal randomized, controlled study, where we expect to have 40 patients enrolled this month. Should the pace of the study continue, we expect to achieve the second milestone of 80 patients enrolled this Spring 2023, which would trigger a formal interim analysis, and if needed, expected potential completion of enrollment of all 120 patients by Summer 2023. We expect that if the STAR-T study is successful, we would be in a position to submit for U.S. FDA marketing approval for DrugSorb-ATR® in the second half of 2023.

Based upon these projections, and based upon the current macroenvironment, market conditions, and cash conservation imperative, we are taking a number of proactive steps as we work towards the expected achievement of this key objective.

1. Prioritize completion of the U.S. STAR-T Trial

The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding by removing the antithrombotic agent, Brilinta® (ticagrelor, Astra Zeneca) in patients undergoing cardiothoracic surgery. Today, Brilinta usage is being fueled by the fact that, according to the U.S. Centers of Disease Control and Prevention (CDC), heart disease is the leading cause of mortality in the U.S., accounting for 1 in every 5 deaths. Coronary artery disease is the most common form of heart disease, killing nearly 400,000 people from heart attacks each year. The CDC states that someone in the U.S. has a heart attack every 40 seconds, or more than 800,000 people annually. This is relevant for Brilinta because when patients have signs and symptoms of having a heart attack and cannot get a stent placed or coronary artery bypass graft (CABG) surgery right away, they are often placed on dual antiplatelet therapy (DAPT) in the hospital consisting of aspirin and a "super-asprin" like Brilinta, to thin the blood and reduce the risk of a worsening heart attack and death. If they are not candidates for a stent, they may require surgery but now face the risk of severe or uncontrolled bleeding because of DAPT intervention. The risk of bleeding depends on when the surgery takes place, but the risk of major fatal or life-threatening CABG-related bleeding can be higher than 50% if the surgery happens that day.

The goal of DrugSorb-ATR® is to allow patients to get the critical surgery that they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery.

This indication has received FDA Breakthrough Device Designation, and is already approved in the European Union, with very positive published data on a reduction in bleeding risk, which is the primary endpoint of the STAR-T trial. In addition to this, there are a number of other reasons why we are excited about this study and believe it is the right time to primarily focus our resources on this trial.

a. STAR-T has overcome the typical inertia of new studies and is enrolling well with many centers participating

b. FDA has given approval to expand the study to Canadian hospitals, who are high users of ticagrelor and have been historically top enrollers in cardiac surgery trials. Expansion to Canada has the potential to accelerate enrollment and completion of the trial. We also believe inclusion of Canadian centers in the STAR-T study may support Health Canada marketing approval for DrugSorb-ATR, potentially helping to expand our commercial sales opportunities in North America

c. Ticagrelor will become generic globally in 2024, likely eliminating cost as the current barrier to usage, and should we stay on schedule, may be ideal timing for the expected commercial availability of DrugSorb-ATR in the U.S. and Canada

d. Ticagrelor monotherapy is now increasingly considered by the cardiology community as a more effective approach than aspirin to reduce cardio-thrombotic events, strokes, and ischemia in patients at high risk. As this treatment paradigm shift evolves, it may potentially change the recommendations on ticagrelor usage from 1 year, to lifelong therapy

e. Based on recent events and certain competitive dynamics, we believe we have the potential to have first-mover advantage in the U.S. market

f. And finally, we have received strong cardiothoracic surgeon feedback for this application internationally, highlighted by the rapidly enrolling STAR registry, which is ahead of schedule and has now enrolled 125 patients

2. Pause the U.S. STAR-D Trial

The U.S. STAR-D randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding by removing the direct oral anticoagulants (DOACs), Xarelto® (rivaroxaban, Janssen/Bayer) and Eliquis® (apixaban, Bristol-Myers Squibb/Pfizer), in patients undergoing cardiothoracic surgery. DOACs are used as chronic therapy to thin the blood to reduce the risk of stroke and heart attack in patients with atrial fibrillation, or a history of stroke, heart attack, or vascular disease, but uses a different mechanism of action than ticagrelor and are not directly interchangeable. However, like ticagrelor, patients on DOACs who require urgent cardiothoracic surgery have a particularly high risk of perioperative bleeding. The goal of DrugSorb-ATR in this population is identical to that for ticagrelor – remove the drug and reduce or prevent perioperative bleeding. In fact, we believe DrugSorb-ATR will eventually become the "one-stop-shop" for the removal of all classes of antithrombotic agents during cardiothoracic surgery, and potentially other surgeries such as orthopedic and neurosurgery, in the future.

We view STAR-D as the sister trial to STAR-T, that leverages many of the same study centers, trial design and user training, but trails STAR-T by at least 6 months. Rather than run this study in parallel, we have decided to pause STAR-D to focus our internal resources on our lead program, STAR-T, including opening new Canadian trial sites to potentially accelerate enrollment and drive STAR-T to completion. This will save an estimated $4 million in expenses in 2023. We fully intend to return to STAR-D when either STAR-T nears, or is at, completion or when we have the financial resources to do so.

3. Restore sales growth and product gross margins

We strongly believe that our commercial markets will recover, but it will take some time. To this point, 2022 continues to be a work-in-progress as hospitals in our core markets continue to struggle to recover from the worst of the COVID pandemic, while grappling with macroeconomic issues such as inflation and high energy costs. Internationally, many hospitals are operating in the red, with rising costs and decreased revenue from issues such as healthcare workforce shortages that negatively impact bed capacity, scheduled operations and procedures, and patient volume. Given our focus on critical care, cardiac surgery, and the hospital market, we are witnessing these issues firsthand. That said, we recorded approximately $6.5 million in core non-COVID product sales in a historically weak seasonal quarter, which on a constant currency basis, was approximately $7.2 million. Adjusting for currency effects, core sales were down 7% year over year, which we view as a modest decline.

As we wait for these global headwinds to clear, we are actively pursuing new exciting growth initiatives and sales optimization strategies to drive sales, despite the challenging environment. We have previously detailed a number of important programs that we are executing upon, such as our standalone blood pump initiative with Nikkiso, our global marketing agreement with Fresenius Medical Care, our therapy area focus in critical care, cardiac surgery, and liver & kidney, and our preferred supplier agreements with the top two largest private hospital networks in Germany, Asklepios and Helios. We believe each of these initiatives has the potential for a tangible return on investment and the ability to add significantly to our growth prospects. We also believe there are some exciting areas of growth in the treatment of acute respiratory distress syndrome (ECMO and CytoSorb), liver dysfunction and failure (CytoSorb), blood thinner removal (DrugSorb-ATR and CytoSorb), and ex vivo organ perfusion for transplant (e.g., ECOS-300CY® and PerSorb®), some of which we will discuss in more detail in the earnings call. In the meantime, we currently expect to return our product gross margins to historic levels (≥ 80%) in 2023, once we consolidate manufacturing completely to the new Princeton, New Jersey facility and close the old facility, and upon an expected resumption in CytoSorb sales growth, pending an improvement in market conditions.

4. Strengthen our cash balance with debt

We currently expect to bolster our balance sheet and current cash position by drawing down a portion of the $15 million in debt under our existing term loan facility before year-end. We believe this amount of debt is very manageable and will provide a suitable financial cushion for us as we drive our clinical and commercial initiatives.

5. Control expenses

Cash conservation is a priority and we continue to focus on controlling expenses. During 2022, we have already reduced our headcount by approximately 10% across our company, including full and part-time employees, and consultants, and shifted our R&D headcount to funded grant programs, where we have an extensive $13.2 million backlog as of the end of Q3 2022. Some of the cost savings of our headcount reduction are not yet visible in our results due to notice periods and labor laws in Europe, but will be reflected in our 2023 operating budget. Meanwhile, we are working diligently to prioritize activities that we believe have a near-term return on investment and advance our strategic priorities, while cutting non-core or non-essential activities and spend. Our goal is, through a combination of driving an increase in sales and gross margin, and cutting costs, to significantly reduce our cash burn and to extend our operating runway with the resources we have.

Dr. Chan concluded, "We are excited to rally around the progress of our U.S. STAR-T program and if successful, strongly believe this has the potential to unlock significant value in our Company and open up a very important commercial growth opportunity for years to come."

Results of Operations

Comparison for the three months ended September 30, 2022 and 2021:

Revenues:

Total revenues were approximately $8.1 million for the three months ended September 30, 2022, as compared to total revenues of approximately $9.8 million for the three months ended September 30, 2021, a decrease of approximately $1.6 million, or 17%. Revenue from product sales was approximately $6.5 million in the three months ended September 30, 2022, as compared to approximately $8.9 million in the three months ended September 30, 2021, a decrease of approximately $2.4 million or 27%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $.7 million. For the three months ended September 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.01 as compared to an average exchange rate of $1.18 for the three months ended September 30, 2021. We estimate that demand for CytoSorb to treat COVID-19 patients was de minimis in the third quarter of 2022 as compared to approximately $1.1 million in the third quarter of 2021. Overall direct sales declined by approximately $1,407,000 resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions, and unfavorable currency conversions. Although improved, continued staffing shortages, reduction in ICU bed capacity, decreased elective surgical procedures, hospital budgets, and hospital restrictions which at some hospitals continue to limit our access to hospital personnel, continue to impact the hospital market.

Grant income was approximately $1.6 million for the three months ended September 30, 2022, as compared to approximately $859,000 for the three months ended September 30, 2021, an increase of approximately $790,000, or 92%. During the three months ended September 30, 2021, our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb. In 2022, research and development employees were assigned exclusively to grant and other research and development activities.

Cost of Revenues:

For the three months ended September 30, 2022 and 2021, cost of revenue was approximately $4.5 million and $2.5 million, respectively. Product gross margins were approximately 55% for the three months ended September 30, 2022 as compared to approximately 82% for the three months ended September 30, 2021. The decrease in the gross margin percentage was due to an equipment failure of a refrigeration unit at our new manufacturing facility that caused a write-off of approximately $0.6 million of work-in-process inventory and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility. Excluding the write-off of inventory related to the equipment failure, product gross margin would have been 64% in Q3 2022.

Operating Expenses:

For the three months ended September 30, 2022, operating expenses were approximately $12.6 million, as compared to approximately $12.7 million for the three months ended September 30, 2021, a decrease of approximately $0.1 million. Selling, general and administrative (SG&A) expenses increased approximately $0.9 million to $8.7 million in the quarter from $7.8 million in the prior year. This increase was due to an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.4 million, an increase in occupancy costs of approximately $0.4 million related to the rent expense on our new manufacturing facility, increases in salaries, severance, commissions, and related costs of approximately $0.1 million and an increase in other general and administrative expenses of approximately $0.2 million. This was offset by a decrease in royalty expenses of approximately $0.2 million due to the decrease in product sales. Research and development expenses decreased approximately $1.0 million due to a decrease of approximately $0.7 million in clinical trial expenditures and a decrease in non-grant R&D activities of approximately $0.3 million.

Loss on Foreign Currency Transactions:

For the three months ended September 30, 2022, the loss on foreign currency transactions was approximately $3.2 million as compared to a loss of approximately $1.0 million for the three months ended September 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar, which was $0.98 as of September 30, 2022 as compared to $1.05 at June 30, 2022.

Comparison for the nine months ended September 30, 2022 and 2021:

Revenues:

Total revenues were approximately $25.3 million for the nine months ended September 30, 2022, as compared to total revenues of approximately $32.4 million for the nine months ended September 30, 2021, a decrease of approximately $7.1 million, or 22%. Revenue from product sales was approximately $21.1 million in the nine months ended September 30, 2022, as compared to approximately $30.4 million in the nine months ended September 30, 2021, a decrease of approximately $8.7 million, or 29%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $2.3 million. For the nine months ended September 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.06 as compared to an average exchange rate of $1.20 for the nine months ended September 30, 2021. Though difficult to quantify, we estimate that approximately $0.3 million of total product sales in the nine months ended September 30, 2022 was due to the demand for CytoSorb to treat COVID-19 patients as compared to $4.6 million in the nine months ended September 30, 2021. Overall direct sales declined by of approximately $6.8 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions and unfavorable currency exchange conversions. Although improved, continued staffing shortages, reduction in ICU bed capacity, decreased elective surgical procedures, hospital budgets, and hospital restrictions which at some hospitals continue to limit our access to hospital personnel, continue to impact the hospital market.

Grant income was approximately $3.6 million for the nine months ended September 30, 2022 as compared to approximately $2.0 million for the nine months ended September 30, 2021, an increase of approximately $1.6 million or 81%. During the nine months ended September 30, 2021, our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb. In 2022, research and development employees were assigned exclusively to grant and other research and development activities.

Cost of Revenues:

For the nine months ended September 30, 2022 and 2021, cost of revenue was approximately $10.3 million and $7.9 million, respectively, an increase of approximately $2.4 million. Product gross margins were approximately 68% for the nine months ended September 30, 2022 and approximately 80% for the nine months ended September 30, 2021. The decrease in the gross margin percentage in 2022 was primarily due to an equipment failure of a refrigeration unit at our new manufacturing facility that caused a write-off of approximately $0.6 million of work-in-process inventory and to inefficiencies associated with lower production due to a decrease in sales and the process of relocating our production activities to the new facility, including a scheduled four-week production hiatus in Q2 2022.

Operating Expenses:

For the nine months ended September 30, 2022, operating expenses were approximately $40.1 million as compared to approximately $37.6 million for the nine months ended September 30, 2021, an increase of approximately $2.5 million, or 7%, for the nine months ended September 30, 2022. Research and development expenses were approximately $11.7 million as compared to approximately $10.2 million for nine months ended September 30, 2021, an increase of approximately $1.5 million or 14%. This increase was primarily due to an increase in costs associated with our STAR-T and STAR-D trials in the United States. Selling, general and administrative expenses were approximately $26.3 million for the nine months ended September 30, 2022, as compared to $25.3 million for the nine months ended September 30, 2021, an increase of $1.0 million. This increase is related to an increase in sales and marketing costs, which include advertising and conference attendance of approximately $1.1 million, an increase in salaries, severance, commissions, and related costs of approximately $1.3 million, an increase in travel and entertainment costs of approximately $0.5 million and an increase in occupancy costs of approximately $1.1 million related to the rent expense on our new manufacturing facility. These increases were offset by a decrease in royalty expenses of approximately $0.7 million, a decrease in non-cash restricted stock expense of approximately $1.7 million related to restricted stock units granted to the Company's executive officers, a decrease in non-cash stock compensation expense of approximately $0.7 million.

Loss on Foreign Currency Transactions:

For the nine months ended September 30, 2022, the loss on foreign currency transactions was approximately $7.0 million as compared to a loss of approximately $2.1 million for the nine months ended September 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar which was $0.98 as of September 30, 2022 as compared to $1.14 as of December 31, 2021.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of September 30, 2022, we had current assets of approximately $32.4 million including unrestricted cash on hand of approximately $22.6 million and current liabilities of approximately $10.1 million. As of September 30, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which remains available. In addition, we have $15 million of debt availability, providing financial flexibility, if needed. In April of 2022, we received approximately $0.7 million in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.

We are also managing our resources proactively, continuing to invest in key areas such as our U.S. clinical program. while driving cost-cutting throughout our Company. At the beginning of Q2 2022, we began instituting tighter cost controls and have reduced our headcount internationally by 10%, with the goal of reducing our cash burn. A reduction in product sales and product gross margins, as well as a delay in realizing headcount reduction cost savings in Europe, have offset these cost cutting efforts. We are currently actively engaged in making further reductions to our operating costs to reduce our future cash burn.

Including cash related to the use of a portion of our available debt facility, we believe that we have sufficient cash to fund the Company's operations beyond twelve months from the issuance of these consolidated financial statements.

Outlook Guidance

The macro environment in which we operate remains difficult to predict given the complex drivers of our business, the global nature of our operations, and external factors such as the COVID-19 pandemic, the Russia-Ukraine war, inflation, foreign currency exchange rate volatility, and other factors that are not under our direct control.

We expect that our business, and in particular product sales, will continue to be challenging for the remainder of 2022 and into 2023. However, we expect a gradual recovery of normalized hospital activity and sales access in Germany and other key countries in the coming quarters. With improved access, we expect a resumption of growth in our core non-COVID-19 product sales.

Meanwhile, we remain focused on completing enrollment of our U.S. STAR-T randomized, controlled trial for ticagrelor removal during cardiothoracic surgery, estimated for Summer 2023, and if successful, being in a position to apply for U.S. FDA marketing approval in the second half of 2023.

For additional information, please see the Company's Form 10-Q for the period ended September 30, 2022, filed on November 3, 2022, on http://www.sec.gov.

Conference Call

The Company will conduct its third quarter 2022 results call today at 4:30 p.m. Eastern time.

Conference Call Details:
Date: Thursday, November 3rd, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-800-458-4121
International: 1-929-477-0402
Conference ID: 1375266
Live Presentation Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1576192&tp_key=7e23c8c13c

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: : https://viavid.webcasts.com/starthere.jsp?ei=1576192&tp_key=7e23c8c13c

An archived recording of the conference call will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/.

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 more than 70 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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 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. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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 initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the 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 and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others.

https://finance.yahoo.com/news/cytosorbents-reports-third-quarter-2022-201500173.html

[Good Sport]

'Enhanced Lung Rest' with CytoSorb and ECMO Achieves High Survival in 100 Critically Ill COVID-19 Patients with Refractory Lung Failure from Five Major U.S. Hospitals

PR Newswire
Wed, November 2, 2022 at 7:10 AM

90-day survival was 74% overall, with early intervention with ECMO and CytoSorb associated with improved survival, and shorter duration on ECMO, mechanical ventilation, and ICU stay compared to late intervention

PRINCETON, N.J., Nov. 2, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using its CytoSorb® blood purification technology, announced the presentation of the final key results from the U.S. multicenter CytoSorb Therapy in COVID-19 (CTC) Registry at the 35th Annual Congress of the European Society of Intensive Care Medicine (ESICM) in Paris last week. CytoSorb was granted U.S. FDA Emergency Use Authorization (EUA) in April 2020 for use in adult, critically ill COVID-19 patients with imminent or confirmed respiratory failure to reduce cytokines and other inflammatory toxins that can cause hyperinflammation. Severe hyperinflammation is strongly correlated with more severe COVID-19 illness, need for mechanical ventilation, and risk of death.

The CTC registry captured outcomes data on 100 critically ill hyper-inflamed COVID-19 patients with severe acute respiratory distress syndrome (ARDS) and refractory respiratory failure who were treated with an "Enhanced Lung Rest" strategy using CytoSorb and extracorporeal membrane oxygenation (ECMO) at five major U.S. ECMO centers. ECMO helps to rest the lungs and avoid ventilator-induced lung injury (VILI) by pumping blood and conducting gas exchange outside of the body, and reducing or eliminating the need for mechanical ventilation. CytoSorb® is easily installed into the ECMO circuit and actively removes a broad range of cytokines and other inflammatory toxins from the bloodstream that can cause blood vessel injury and capillary leak syndrome – a key pathology in ARDS that results in pulmonary edema, severely compromised gas exchange, and unrelenting damage to the lungs. The goal of this "Enhanced Lung Rest" strategy is to allow the lungs to rest and heal, which we believe is the key to reversing ARDS, getting patients off of ECMO and mechanical ventilation, and ultimately to survive.

Primary Outcome: Survival

In 100 patients treated with CytoSorb and ECMO at 5 U.S. centers, survival was 86% at 30 days and 74% at 90 days. For context, the International Extracorporeal Life Support Organization (ELSO) COVID-19 registry, reported survival of 52% at 90 days in the North American cohort (11/2/22, n=9,509)

Secondary analyses:

CytoSorb was initiated significantly earlier following ICU admission in survivors compared with non-survivors: 64 (34-151) vs. 151(44-260) hours, p=0.007*

Compared to non-survivors, survivors had significantly lower levels of inflammatory mediators after 3 days of CytoSorb treatment, such as CRP: 6.9 (2.1-11.0) vs 9.5 (6.0-17.1) mg/dL, p=0.04, and ferritin: 743.0 (339.5-1237.0) vs 1,622.0 (986.0-3411.0) ng/mL, p=0.0002, and required less time on ECMO: 302 (161-932) vs. 630 (268-1187) hours, p=0.04*

Among survivors, those where CytoSorb was initiated early before the median start time of = 86.7 hours after ICU admission, had a trend to improved survival (78% early vs 62% late, p=0.08) and significantly shorter average duration on ECMO (532.76 ± 533.05 vs. 800.74 ± 701.67 hours; p=0.021). Time on mechanical ventilation [167 (43-597) vs. 321 (67-909) hours, p=0.045] and time to ICU discharge [17 (10 – 40) vs. 36 (19 – 55) days, p=0.002] were also significantly reduced in patients treated earlier*

Combined ECMO and CytoSorb treatment was performed with no device related adverse events reported by any of the centers

* Values represented as median (interquartile range)

Dr. J.W. Awori Hayanga, MD, MPH, FACS, FRCS, FCCP, Professor in Cardiovascular & Thoracic Surgery and Director of the ECMO program at West Virginia University School of Medicine, led a team of investigators from 5 U.S. academic institutions to implement the strategy of "enhanced lung rest" in this population. Dr. Hayanga commented, "We are pleased with the very favorable survival rates that we observed in the CTC Registry among the sickest possible COVID-19 patients that are on life support with ECMO. These results suggest that hyperinflammation plays a critical role in the severity of respiratory failure in patients with ARDS and support the strategy of integrating CytoSorb with ECMO to simultaneously rest and heal the lungs. This multicenter dataset is very exciting and sets the stage for further investigation into this novel approach to treat severe ARDS."

Dr. Joerg Scheier, Vice President, Medical Affairs - Critical Care at CytoSorbents commented, "These compelling results support the concept of improved lung protection and recovery with CytoSorb in combination with veno-venous ECMO treatment. We see from the data that, very similar to other CytoSorb application fields, early initiation of CytoSorb therapy seems to be a key to positive treatment outcomes. Overall, these very positive results on ECMO-integrated CytoSorb therapy support the further evaluation of the promising and safe approach of "enhanced lung rest" by the combination of ECMO and CytoSorb in the treatment of ARDS."

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "This is the largest multicenter case series using CytoSorb with ECMO in critically ill COVID-19 patients in the world to date. It highlights that when CytoSorb is used in the right patients, at the right time, with the right dose, the outcomes are excellent and reproducible among different centers. Specifically, we targeted early intervention with CytoSorb and ECMO in COVID-19 patients with hyperinflammation who developed refractory respiratory failure and severe ARDS and rapidly failed mechanical ventilation, and who did not yet have fulminant thromboembolic disease as measured by D-dimers. These criteria were based upon knowledge gained from the CytoSorb-ECMO user community around the world during the rapidly evolving pandemic, most of whom have had years of experience integrating the two therapies together to treat non-COVID ARDS, our own insights, and those from our former Chief Medical Officer and pioneer of ECMO, Dr. Robert Bartlett. We are grateful to have had the opportunity to positively impact the lives of critically ill COVID patients here in the U.S. under FDA EUA and those around the world and look forward to advancing this concept of "enhanced lung rest" for the primary treatment of moderate to severe ARDS in the future."

About CytoSorb FDA Emergency Use Authorization

In April 2020, the United States Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to CytoSorb® for use in patients with COVID-19 infection. The EUA allows CytoSorb to be commercially sold to, and used in, all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have either severe disease, early acute lung injury or acute respiratory distress syndrome (ARDS), or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure. As with all EUA therapies, the CytoSorb device has neither been cleared nor approved for the indication to treat patients with COVID-19 Infection. The EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.

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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 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. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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 initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.

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 $48 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™, DrugSorb™-ATR, ContrastSorb, and others.

https://finance.yahoo.com/news/enhanced-lung-rest-cytosorb-ecmo-111000041.html

[Good Sport]

Update on CytoSorb® therapy in liver dysfunction | Webinar Liver | 2022

Nov 1, 2022
Talk and Discussion: Maria Soledad Taborda Garcia, M.D

Moderation: Stefan Baudis

?? Disclaimer ??

Cytosorb®? is approved in the European Union with distribution in 65 countries around the world.
CytoSorb is indicated for use in conditions where elevated levels of cytokine and/or bilirubin and/or myoglobin exist. CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for removal of the P2Y12 inhibitor Ticagrelor and/or the Factor Xa inhibitor Rivaroxaban.

The statements here represent the personal opinions and views of the speaker only and do not necessarily reflect accepted medical knowledge in general or indications covered by the intended use of CytoSorb. CytoSorb must be used by health care professionals only.

On 10 April 2020 CytoSorb has also received FDA Emergency Use Authorization (EUA) in the United States for use in COVID-19 patients in the ICU with imminent or confirmed respiratory failure to reduce pro-inflammatory cytokine levels, in defined circumstances.

In the USA the CytoSorb device has neither been cleared or approved for the indication to treat patients with COVID-19 infection. The CytoSorb device has been authorized by the FDA under an Emergency Use Authorization (EUA). The CytoSorb device is approved only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

In Canada the CytoSorb device has neither been cleared or approved for the indication to treat patients with COVID-19 infection. The CytoSorb device has been authorized by Canadian authorities for importation and sale.

CytoSorb and CytoSorbents are trademarks of the CytoSorbents Corporation, USA.
©? Copyright 2022 CytoSorbents Europe GmbH. All rights reserve

[kjpcrna]

bt48, did you happen to follow up on ATNM that I told you about?
When both issues were trading in the $5-6 range? Today was a $60,000 day for me which makes the pain I’ve endured here a tiny bit less painful. Maybe if they clean sweep the pitiful top management (and I use the term management loosely) CTSO can achieve a similar day of impressive gain. Time will tell. Not too late for the ATNM train!

[ranchhand71]

Why is she bailing out before a replacement has been found?
Not a good sign?

[ranchhand71]

lLnk to Dawson James Research recent CTSO report:
https://dawsonjames.com/wp-content/uploads/2022/10/CTSO.10.6.22-final1.pdf

[Paulness]

NEWS -- National Institutes of Health Grants Phase I SBIR Award to CytoSorbents to Test Novel Polymers for Cytokine and Endotoxin Removal from Septic Porcine Plasma



Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer

PRINCETON, N.J., Oct. 31, 2022 /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 via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death.

Goal is to advance new combined blood purification technologies to treat Gram negative sepsis - a deadly global killer

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Gram-negative infections play an important and feared role in sepsis, accounting for approximately 40% of cases of septic shock, and more than 30% of hospital-acquired infections. These patients tend to be very sick and have a high risk of death. We are the pioneer in the treatment of sepsis and septic shock by targeting cytokine storm and deadly inflammation with our European Union approved extracorporeal cytokine adsorber, CytoSorb®. But we believe the combination of extracorporeal cytokine and endotoxin removal from blood, in conjunction with antibiotics, may be an even more effective therapy for Gram-negative infections, and will help us to save more lives. We are grateful for the support from NIGMS to conduct the preliminary in vitro work needed before we evaluate our new polymers in a pig model of Gram-negative sepsis in the future."

Sepsis is the overzealous immune response to an infection and is responsible for approximately one in every five deaths worldwide each year. This has led the World Health Organization (WHO) to declare it a "global health priority." Sepsis accounts for approximately 10-20% of all intensive care unit (ICU) admissions, where patients either have sepsis when admitted to the ICU, or develop sepsis as a result of a nosocomial or hospital-acquired infection while in the ICU. Gram-negative infections commonly trigger septic shock, a serious complication of sepsis where the blood pressure drops to dangerously low levels and organ failure and death can ensue. Despite antibiotics and the best standard of care, septic shock still has a mortality of 35-50%.

The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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 inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 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. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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 initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.

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 more than $48 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™, DrugSorb™-ATR, 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 Twitter.

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, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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Company Contact:
Kathleen Bloch 
[phone]
mailto://[e-mail]

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://[e-mail]

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SOURCE CytoSorbents Corporation