PRINCETON, N.J., Oct. 27, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report third quarter 2023 operating and financial results after the market close on Thursday, November 9th, 2023. CytoSorbents’ management will host a live presentation webcast and a question and answer session at 4:30PM EDT the same day.
Participant Dial-In: United States – New York +1.646.968.2525 USA & Canada – Toll-Free +1.888.596.4144
It is recommended that participants dial in approximately 10 minutes prior to the start of the call.
An archived recording and written transcript of the conference call will be available under the Investor Relations section of the Company’s website at https://ir.cytosorbents.com/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide with more than 212,000 devices cumulatively used as of Q2 2023. CytoSorb is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses seen in the ICU and cardiac surgery that can lead to massive inflammation, organ failure, and a high risk of patient death. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively. CytoSorb is also E.U. approved to remove the blood thinners, ticagrelor and rivaroxaban, during cardiothoracic surgery to reduce the risk of perioperative bleeding. 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.
Meanwhile, the DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, targets U.S. FDA and Health Canada marketing approval with the now completed pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial. With topline data expected later this year, the study was designed to evaluate the potential ability of DrugSorb-ATR to reduce ticagrelor-related perioperative bleeding when used intraoperatively during cardiac surgery. DrugSorb-ATR has received two FDA Breakthrough Device Designations for this application, one to remove ticagrelor and another to remove the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, highlighting these major unmet medical needs.
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®, VetResQ®, CytoSorb-XL™, HemoDefend-BGA™, HemoDefend-RBC™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and X (fka 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, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
PRINCETON, N.J., Oct. 05, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that Dr. Phillip Chan, Chief Executive Officer, will present at the Dawson James Small Cap Growth conference at the Wyndham Grand Jupiter at Harbourside Place in Jupiter, FL on Thursday, October 12th, 2023. Company management will also meet in-person with investors in 1×1 meetings during the conference. To schedule a meeting with management, please contact your Dawson James representative.
When: Thursday, October 12th, 2023 at 2:30 PM EST Where: Wyndham Grand Jupiter at Harbourside Place, Jupiter, FL in Track Two Webcast: https://wsw.com/webcast/dawson8/ctso/2051460
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 with more than 212,000 devices cumulatively used as of Q2 2023. CytoSorb is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses seen in the ICU and cardiac surgery that can lead to massive inflammation, organ failure, and a high risk of patient death. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively. CytoSorb is also E.U. approved to remove the blood thinners, ticagrelor and rivaroxaban, during cardiothoracic surgery to reduce the risk of perioperative bleeding. 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.
Meanwhile, the DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, targets U.S. FDA and Health Canada marketing approval with the now completed pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial. With topline data expected later this year, the study was designed to evaluate the potential ability of DrugSorb-ATR to reduce ticagrelor-related perioperative bleeding when used intraoperatively during cardiac surgery. DrugSorb-ATR has received two FDA Breakthrough Device Designations for this application, one to remove ticagrelor and another to remove the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, highlighting these major unmet medical needs.
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®, VetResQ®, CytoSorb-XL™, HemoDefend-BGA™, HemoDefend-RBC™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and X (fka 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, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
PRINCETON, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the upcoming original presentations at the 37th European Association of Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria, from October 4-7, 2023, including the second analysis from the international Safe and Timely Antithrombotic Removal (STAR) Registry.
Second Analysis of the International STAR Registry
The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) in the acute hospital setting. The registry collects cases using CytoSorb to purify the blood of the major modern antithrombotic agents* such as Brilinta®/Brilique®, Plavix®, Effient®, Pradaxa®, Savaysa®/Lixiana®, Xarelto®, and Eliquis® in a variety of clinical scenarios, but particularly in cardiothoracic surgery, where the blood thinners can potentially cause serious and even fatal bleeding. The STAR Registry, not to be confused with the completed U.S. and Canada STAR-T pivotal trial, is enrolling ahead of internal projections with plans for ongoing presentations at large, international conferences.
The first registry analysis entitled, “Insights from the International Safe and Timely Antithrombotic Removal (STAR) Registry” was presented at the EuroPCR conference in May 2023, the largest interventional cardiology conference in the E.U., attracting 11,500+ participants this year. This analysis included 67 patients from 7 centers in the U.K. and Germany who underwent coronary artery bypass graft (CABG) surgery within 2 days of Brilinta® (ticagrelor) administration with a high risk of perioperative bleeding. The analysis reported no device related adverse events and low rates of BARC-4 bleeding (6%), reoperation for bleeding (4%), and 24-hour chest tube drainage (537 ± 231 mL). BARC-4 bleeding is defined as CABG-related bleeding that includes at least one of the following: perioperative intracranial bleeding, reoperation after closure of the chest for the purpose of controlling bleeding, transfusion of 5 units or more of whole blood or packed red blood cells within a 48-hour period, or chest tube output of 2 liters or more within a 24-hour period.
These results compared favorably to the results, referred to in the presentation, from an often cited analysis of the SWEDEHEART registry, the national Swedish registry of all patients hospitalized for acute coronary syndrome or undergoing percutaneous coronary intervention or heart surgery, published in the European Heart Journal. In this study, Hannson and colleagues reported an average 31.4% incidence of severe BARC-4 bleeding in a cohort of patients who similarly required CABG surgery within 48 hours of ticagrelor (Brilinta®) administration but did not get CytoSorb. In addition, patients in this cohort had 12-hour chest tube drainage (CTD) of 813 ± 478 mL and 641 ± 337 mL following CABG surgery within 24 and 48 hours, respectively, from last ticagrelor administration, which was more CTD than seen in patients treated with CytoSorb in the first STAR Registry analysis, yet in only half the time. In the entire study, which included patients who had a chance to wash out the drug for more than 5 days prior to surgery which accounted for approximately 2/3rds of all patients, reoperations due to bleeding was 6.1%.
The second analysis of the International STAR Registry being presented at the 2023 EACTS conference next week, entitled “Intraoperative hemoadsorption for antithrombotic drug removal during cardiac surgery: the International Safe and Timely Antithrombotic Removal (STAR) Registry,” summarizes the use of CytoSorb in patients on blood thinners undergoing a much broader range of heart surgeries than reported previously, mixing isolated CABG patients with more complex and invasive procedures at higher risk of perioperative bleeding including valve replacement, CABG + valve replacement, aortic surgery, and heart transplant. It also includes, for the first time, data on patients being treated with CytoSorb to reduce seven different antithrombotic medications. The analysis is divided between two groups: 114 patients on antiplatelet drugs including Brilinta® (ticagrelor), Plavix® (clopidogrel), and Effient® (prasugrel); and 51 patients on the direct oral anticoagulants (DOACs) including Eliquis® (apixaban), Xarelto® (rivaroxaban), Savaysa®/Lixiana® (edoxaban), and Pradaxa® (dabigatran). The overall study population was taken from 8 centers in Germany, the United Kingdom, Austria, and Sweden.
The antiplatelet analysis focuses on the use of intraoperative CytoSorb on 114 patients on antiplatelet agents undergoing isolated CABG (78%), or higher risk cardiothoracic surgeries including valve replacement, aortic surgery, and heart transplant (22%). The rate of BARC-4 bleeding for isolated CABG surgery alone was 4.5%, while overall BARC-4 bleeding was 13.2%, reflecting the higher bleeding risk of the more complex surgeries and the use of Plavix® (17%) and Effient® (3%), historically thought to be irreversible platelet inhibitors, in 20% of the patients. In the future, in addition to generating more data on the clinical impact of removing Brilinta®/Brilique®, the STAR Registry is also expected to help answer the question of whether CytoSorb can mitigate the bleeding risk in patients on Plavix® and Effient® in ways not related to drug binding to the platelet.
The Direct Oral Anticoagulant (DOAC) analysis reports on the use of CytoSorb intraoperatively in patients on Eliquis® (47%), Xarelto (27%), Savaysa®/Lixiana® (24%), and Pradaxa® (2%) undergoing a more evenly divided set of procedures including isolated CABG (23.5%), CABG + valve replacement (15.7%), isolated valve replacement (17.6%), Aortic surgery (15.7%), and other procedures (27.5%). There was no BARC-4 bleeding in the 12 patients undergoing isolated CABG surgery, with 15.7% BARC-4 bleeding overall, reflecting the higher proportion of higher risk and more invasive surgeries.
The international STAR Registry authors concluded that for this analysis, for “patients undergoing cardiac surgery before the recommended washout period, the use of intraoperative antithrombotic drug removal is associated with lower incidence of serious bleeding compared with historical rates,” and “importantly, no serious device-related adverse events were observed.”
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents, stated, “We believe the STAR Registry provides a powerful platform to systematically collect high quality, real-world outcomes data on the ability of CytoSorb to reduce perioperative bleeding risk in patients on a variety of antithrombotic drugs undergoing cardiothoracic surgery on an international scale. Given that DrugSorb-ATR uses an equivalent polymer technology as CytoSorb, we believe the outcomes seen in the STAR registry analysis are encouraging and provide greater insights into the clinical benefits of antithrombotic removal that are also investigated in our U.S. and Canada STAR-T and STAR-D programs.”
Other Key Presentations at EACTS
In addition to the STAR Registry analysis, another study was selected for presentation entitled, “Antithrombotic drug removal during off-pump coronary artery bypass grafting using hemoadsorption” highlighting the successful use of CytoSorb, in conjunction with a simple hemoperfusion machine, to prophylactically remove Brilinta® or Xarelto® during off-pump CABG surgery. According to the study investigators, Mair et al., stated, “Decoupling of the hemoadsorber from the cardiopulmonary bypass machine will open new future indications in various medical specialties (e.g. trauma, neurosurgery) and in emergency patients on antithrombotic medication.”
CytoSorbents will also host a satellite research symposium on Friday, October 6, 2023 at 12:15-13:30 CET.
The Paris experience – Which patients benefit most? Guillaume Lebreton, France
The Oslo experience – Removal of antithrombotics to reduce complications and costs Gry Dahle, Norway
The Essen experience – Hemoadsorption in aortic surgery Heinz Jakob, Germany
*These trademarks are owned by their respective pharmaceutical manufacturers: Eliquis® (Pfizer, BMS), Xarelto® (Bayer, Janssen), Brilinta®/Brilique® (AstraZeneca), Plavix® (BMS, Sanofi), Effient® (Daiichi Sankyo, Eli Lilly), Savaysa®/Lixiana® (Daiichi Sankyo), and Pradaxa® (Boehringer Ingelheim)
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 with more than 212,000 devices cumulatively used as of Q2 2023. CytoSorb is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses seen in the ICU and cardiac surgery that can lead to massive inflammation, organ failure, and a high risk of patient death. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively. CytoSorb is also E.U. approved to remove the blood thinners, ticagrelor and rivaroxaban, during cardiothoracic surgery to reduce the risk of perioperative bleeding. 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.
Meanwhile, the DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, targets U.S. FDA and Health Canada marketing approval with the now completed pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial. With topline data expected later this year, the study was designed to evaluate the potential ability of DrugSorb-ATR to reduce ticagrelor-related perioperative bleeding when used intraoperatively during cardiac surgery. DrugSorb-ATR has received two FDA Breakthrough Device Designations for this application, one to remove ticagrelor and another to remove the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, highlighting these major unmet medical needs.
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®, VetResQ®, CytoSorb-XL™, HemoDefend-BGA™, HemoDefend-RBC™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and X (fka 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, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the re-appointment of Kathleen P. Bloch as full-time Chief Financial Officer, effective retroactively to September 2, 2023. Ms. Bloch served as the Company’s Chief Financial Officer for 10 years until her retirement in March 2023, when she became Interim CFO as a consultant. She resumed as Interim CFO after the investigation of, and mutual termination and release agreement with, former CFO Alexander D’Amico, as detailed here and here, respectively.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “Following this unexpected turn of events, it is great to have Kathy back as full-time Chief Financial Officer. Kathy’s accomplished career speaks for itself as discussed here and here. We thank Kathy for her unquestioned dedication to the Company, the management team, and our employees over the past decade, and particularly now as we enter this exciting time for the Company. Kathy’s commitment secures this leadership position and provides the time and expertise to focus and execute upon our critical near-term business goals and priorities.”
Ms. Bloch stated, “The next six to twelve months is expected to bring a potential wealth of opportunities as we target U.S. and Canadian approval for the first time with DrugSorb®-ATR, and we work to capitalize on both anticipated improvements in the acute care markets and investments made with our existing CytoSorb® business. Like the rest of this outstanding team, I am passionate about our mission to help save lives and am proud of the Company we have built to date. It was an easy decision to come back and provide continuity and stability to our Company and business at this pivotal moment.”
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 with more than 212,000 devices cumulatively used as of Q2 2023. CytoSorb is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses seen in the ICU and cardiac surgery that can lead to massive inflammation, organ failure, and a high risk of patient death. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively. CytoSorb is also E.U. approved to remove the blood thinners, ticagrelor and rivaroxaban, during cardiothoracic surgery to reduce the risk of perioperative bleeding. 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.
Meanwhile, the DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, targets U.S. FDA and Health Canada marketing approval with the now completed pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial. With topline data expected later this year, the study was designed to evaluate the potential ability of DrugSorb-ATR to reduce ticagrelor-related perioperative bleeding when used intraoperatively during cardiac surgery. DrugSorb-ATR has received two FDA Breakthrough Device Designations for this application, one to remove ticagrelor and another to remove the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, highlighting these major unmet medical needs.
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®, VetResQ®, CytoSorb-XL™, HemoDefend-BGA™, HemoDefend-RBC™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and X (fka 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, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
In the first human retrospective study, CytoSorb and ex vivo lung perfusion prior to lung transplant increased in-hospital and one-year survival
PRINCETON, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, highlights the growing momentum of ex vivo organ perfusion in organ transplantation and the vital role CytoSorb® and ECOS-300CY® are playing in this burgeoning field. In particular, these technologies may help to improve the quality and number of usable organs while improving transplant success rates. Importantly, data from recent peer-reviewed publications highlight how these innovative therapies may improve outcomes in the specific field of lung transplantation.
Background – Organ Transplantation, Ex Vivo Organ Perfusion, and CytoSorb/ECOS-300CY
Organ transplantation is the gold standard treatment for end-stage organ failure. However, suitable donor organs are scarce and many patients often die waiting for an organ to become available. According to the Global Observatory on Donation and Transplantation, there were approximately 158,000 solid organ transplants in 2022 globally. According to the United Network of Organ Sharing (UNOS) and the European Directorate for the Quality of Medicine and Healthcare (EDQM), in 2022 in the U.S. and E.U. alone, there were approximately an equal number of patients, roughly 153,000, on the transplantation waitlist, primarily due to the lack of suitable organs. Every 10 minutes, someone is added to the waitlist, and roughly every half hour, someone dies on the waiting list, waiting for an organ that never comes.
The vast majority of donated organs are from deceased donors, often due to irreversible cardiac or brain death. However, due to a variety of factors, including ischemia and reperfusion injury, cold storage, and the manner by which the donor died, these organs are often damaged with significant inflammation, jeopardizing organ health and importantly the success of the transplantation. In the U.S., according to a 2020 Millman research report, a single lung transplant costs approximately $930,000, a two lung transplant: $1.3 million, a kidney transplant: $443,000, a liver transplant: $878,000, and a heart transplant: $1.7 million. Due to the expense of failure, many organs are discarded, despite the significant need. In addition, many organs, despite being deemed transplantable, develop problems of delayed graft function or primary graft dysfunction after surgery. This is different from organ rejection and can happen with any organ. For example, in lung transplantation, the rates of potentially life-threatening lung failure within the first several days after transplant, called severe primary graft dysfunction (PGD), can be as high as 30%, resulting in high 90-day (20-25%) and 1-year (30-35%) mortality, which is 3-5 times higher than if PGD did not occur. Strategies that can improve the health of organs or improve postoperative outcomes are key to the future of solid organ transplant.
Ex vivo organ perfusion is an increasingly used strategy to preserve and potentially improve the functioning of lungs, hearts, livers and kidneys following organ harvest and during transport by reducing ischemic, reperfusion, and cold storage injuries caused by conventional static cold storage. It also has the potential to increase the available donor pool of organs by salvaging substandard ones that would otherwise be discarded. Ex vivo perfusion circulates temperature controlled, oxygenated, nutrient rich fluid or blood products through the organ to improve its viability. However, ex vivo perfusion does not adequately address the ongoing release of cytokines and other inflammatory mediators generated by the damaged organ that cause ongoing injury and compromised function. Based on recent data, we believe the integration of our cytokine adsorptive technologies (i.e. CytoSorb, ECOS-300CY) with ex vivo organ perfusion has the potential to transform the field of organ transplantation by not only elevating organ preservation and rehabilitation to a new level, but by improving clinical outcomes after the surgery. The combination has been used successfully in heart, liver, and kidney transplants to date, but the largest body of data comes from lung transplantation.
CytoSorb and ECOS-300CY in Lung Transplantation
The final analysis of the U.S. CytoSorb Therapy in COVID-19 (CTC) Registry was published recently in the journal Critical Care and demonstrated that the combination of CytoSorb and extracorporeal membrane oxygenation (ECMO) therapy resulted in 74% 90-day survival in 100 critically ill patients from 5 major U.S. ECMO centers who had COVID-19 with severe acute respiratory distress syndrome (ARDS) and who failed mechanical ventilation. This compared favorably to the 52% 90-day survival rate reported by the Extracorporeal Life Support Organization (ELSO) in over 15,000 comparably ill COVID-19 patients using ECMO alone. The paper highlighted the concept of “enhanced lung rest,” where CytoSorb is used to remove circulating inflammatory cytokines and toxins that can cause or worsen lung injury via capillary leak syndrome, pulmonary edema (i.e. fluid in the lungs), and severe inflammation. The ultimate goal of CytoSorb therapy is to help stop severe inflammation and promote lung healing and recovery.
This same “enhanced lung rest” concept has carried over to lung transplant, where inflammation in donated lungs causes the same capillary leak syndrome, pulmonary edema, and compromised lung function, and is a major contributor to primary graft dysfunction (PGD), as mentioned earlier.
In 2017, Iskender and Inci, et al., from University Hospital Zurich in Switzerland, published the first study in the Journal of Heart and Lung Transplantation using CytoSorb with ex vivo lung perfusion (EVLP) in a controlled pig lung model, demonstrating decreased circulating cytokines, decreased microscopic lung injury, improved electrolyte balance, and improved lung mechanics with easier ventilation of the lung. In 2021, the team published a follow-up study in the Journal of Heart and Lung Transplantation where they took the model to the next step by transplanting the EVLP-treated lungs (with or without CytoSorb) into pig recipients. They found that EVLP with CytoSorb significantly improved the functioning of the transplanted lung from both a mechanics and gas exchange standpoint.
In the 2022 landmark paper published in the prestigious journal Nature Communications, Ghaidan and Lindstedt, et. al., studied the impact of CytoSorb and EVLP in a pig lung transplantation model. Lung injury and ARDS were induced in pig donors by endotoxin injection. Once harvested, these compromised lungs all underwent EVLP and single lung transplantation into a new pig recipient. The study was divided into three groups. The “untreated” group did not have CytoSorb at any time. The “treated” group was subdivided into a) the “One-step” group that did not receive CytoSorb during EVLP but received CytoSorb postoperatively following lung transplant, and b) the “Two-step” group had CytoSorb both during EVLP, and then again postoperatively following lung transplant. In a detailed and well-controlled study, the researchers followed many parameters, including cytokines and inflammatory cells in the blood and lung, level of lung inflammation, changes in histopathology and gross pathology in the lungs, and many clinical parameters including recovery of lung function, oxygenation, hemodynamic stability, and development of severe (Grade 3) primary graft dysfunction (PGD). Importantly, the rates of PGD in the first 72 hours after transplantation, which directly correlates with risk of death, were much lower when CytoSorb was used. Researchers noted that 83% (5/6) in the Two-Step group, and 50% (2/4) in the One-Step group had no PGD at all, compared to the 83% (5/6) in the non-treated group that developed Grade 3 severe PGD. Overall, researchers concluded that the use of CytoSorb both during EVLP and in the recipient after transplantation was superior in virtually all respects compared to not using it at all, or using it only after transplantation. They concluded that the use of CytoSorb in this model has been shown to:
“(i) reduce inflammation and restore pulmonary function during EVLP, (ii) restore function and decrease inflammation following transplantation, and (iii) reduce the incidence of PGD (primary graft dysfunction) in transplanted recipients. The work outlined here represents the utilization of the cytokine adsorber in the context of lung transplantation using severely damaged donor lungs. It is thus envisioned that adsorption may be an intervention that could lead to the acceptance of more lungs for transplantation. It may also further increase the tolerability of such lungs in a recipient, a needed outcome given the role that PGD continues to play as the leading cause of early mortality and as a contributor to the development of chronic graft dysfunction.”
Based upon this work, Prof. Sandra Lindstedt and her team at Lund University Hospital, Sweden are now conducting a ten patient randomized controlled pilot study in human lung transplantation using CytoSorb. They recently published a brief communication based on the first 4 human lung transplant subjects, where 2 received CytoSorb intraoperatively, and 2 did not. Those treated with CytoSorb had lower circulating nucleosome levels (inversely correlated with PGD) and did not develop PGD, while the two patients not treated with CytoSorb had higher nucleosome levels and developed Grade 1 and Grade 3 (severe) PGD postoperatively, respectively.
Recently, Prof. Massimo Boffini and his group from the University of Turin, Italy published the largest retrospective human clinical study to date investigating the feasibility and safety of CytoSorb® adsorption during EVLP in the peer-reviewed journal, Transplant International. From July 2011 to March 2020, physicians performed a total of 54 EVLP procedures on lungs that had originally failed to qualify for transplantation. Of these, 33 were performed without CytoSorb and 21 were performed with CytoSorb integrated with EVLP. Among the 38 patients who ultimately underwent lung transplant, the CytoSorb treated group had significantly decreased cytokines in the perfusate compared to the control group, with 76% (16/21) of lungs from the CytoSorb group qualifying for transplantation after the EVLP procedure versus 67% (22/33) from the non-treated control. Importantly, patients receiving lung transplants treated with CytoSorb during EVLP had significantly lower in-hospital mortality (0% vs. 13%; p=0.03) and a lower 1-year mortality rate (0% vs. 36%; p=0.01) compared to those who received lungs treated with EVLP alone. In addition, the use of CytoSorb was associated with a trend of fewer cases of Grade 3 severe PGD, and less need for ECMO support, which likely was associated with significant cost savings. These results were observed despite none of these patients receiving additional intraoperative or postoperative CytoSorb treatment.
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents, stated, “Collectively, these data are very exciting for a number of reasons. First, the data support the potentially pivotal role that our cytokine adsorption technologies, including CytoSorb and ECOS-300CY – which is specifically approved in the E.U. for ex vivo organ perfusion, has in lung transplantation. We see multiple opportunities in improving the functioning of the lung graft, expanding the donor pool of transplant-eligible lungs by reconditioning substandard ones, and most importantly reducing the rates of severe primary graft dysfunction and mortality. Secondly, although lung transplantation is not as common as kidney or liver transplantation, we believe the fundamental principles of cytokine reduction and treating inflammation in both the organ and the host will translate into similar benefits in other solid organ transplants. For example, Hosgood, et al., published that ex vivo kidney perfusion with CytoSorb reduced inflammation, inflammatory mediators, and improved renal blood flow in pig kidneys. One of our key partners, Aferetica, is currently working with transplant surgeons to investigate the benefit of our technology, private-labeled as PerSorb® in their ex vivo organ perfusion system PerLife®, in human kidney and liver transplants, and PerLungs® platform for lung transplant. We plan to increase awareness of these publications and concepts in the organ transplant community to foster increasing innovation and opportunities in this space.”
Dr. Chan continued, “Finally, these important data corroborate the ability of CytoSorb to help improve lung function in multiple different settings and importantly provide mechanistic data on how CytoSorb can help to treat acute respiratory distress syndrome (ARDS) by promoting lung rest and healing. Even prior to the COVID pandemic, ARDS was highly prevalent, diagnosed in approximately 10% of all ICU admissions. ARDS and associated complications such a respiratory failure and hospital acquired infections, were the primary cause of morbidity and mortality in both the 2009 H1N1 influenza and 2020-2022 COVID-19 pandemics. We believe CytoSorb represents a new innovation to treat ARDS, which has the potential to drive significant revenue growth.”
Commenting on the Boffini study specifically, Mr. Mauro Atti, Chief Executive Officer of Aferetica SRL, stated, “This published study comes from a project started in 2015 with the City of Health and Science University Hospital of Turin in the field of organ transplantation, where researchers were among the first pioneers to use CytoSorb for this purpose. In fact, their early findings with CytoSorb were a major driving force leading us to develop our PerLife® and PerLungs® platforms to enable perfusion and purification of liver and kidneys, and lungs, respectively. Both integrate perfectly with the PerSorb® sorbent that CytoSorbents provides us thanks to an international strategic agreement. These data demonstrate how the perfusion and purification of organs can recover marginal organs, reduce post-transplant side effects, and even improve the survival of transplanted patients – further confirming our correct decision to invest in this field and partner with CytoSorbents.”
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 flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce “cytokine storm” and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
PRINCETON, N.J., Sept. 01, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that Alexander D’Amico has resigned as the Company’s Chief Financial Officer as part of a mutual termination and release agreement with the Company, effective August 28, 2023.
As part of the agreement, CytoSorbents and Mr. D’Amico have agreed to terminate his employment agreement with the Company dated July 10, 2023 in its entirety, and have agreed to customary and mutual non-disparagement and release provisions, payment of specific accrued expenses, and no severance payments or vesting of equity.
Ms. Kathleen Bloch will continue to serve as the Company’s Interim Chief Financial Officer pursuant to the existing consulting agreement arrangement between the Company and Ms. Bloch.
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 flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce “cytokine storm” and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
Advances CytoSorb as a Potentially Revolutionary Therapeutic Advance to Reverse Deadly Shock in Critically Ill and Cardiac Surgery Patients
PRINCETON, N.J., Aug. 31, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that CytoSorb® was granted an expanded medical device registration by the Brazilian Health Regulatory Agency (ANVISA) to treat shock.
After receiving its first ANVISA registration in September 2020 to treat cytokine storm in cardiac surgery and critical illnesses such as COVID-19 in the midst of the COVID pandemic, CytoSorb has now received an expanded ANVISA registration to also include the treatment of shock – a common and frequently fatal complication of critical illness and cardiac surgery. Shock is a persistent and rapid drop in blood pressure that deprives vital organs of adequate blood flow and oxygen that can lead to organ failure and death. To give an example of the burden of shock in critical care: Septic shock – the most serious form of sepsis, afflicts approximately one in ten patients in the ICU, where despite historical standard of care treatment which includes antibiotics, fluids, and vasopressors, approximately 40-50% will die. CytoSorb therapy helps to reverse shock, restore natural blood pressure, and stabilize the patient, representing a potentially revolutionary therapeutic advance in the treatment of this deadly condition.
CytoSorb is now commercialized in Brazil through Fresenius Medical Care (FMC) in the Critical Care segment, and by Contatti Medical in the field of Cardiac Surgery. Brazil is the 7th most populous country in the world and Latin America’s largest medical device market.
Mr. Alexandre Franco, Marketing Director of FMC Brazil, stated, “Fresenius Brazil is very proud of the registration approval of CytoSorb by ANVISA, which will help anchor our Critical Care portfolio. The use of CytoSorb, combined with other innovations we have implemented in recent years, will provide us with increasingly complete solutions in the care of severely ill patients.”
Mr. Mateus Biazus, Head of Marketing and Sales of Contatti Medical added, “There are around 60,000 cardiac surgeries per year in Brazil where surgeons may have to deal with the consequences of an overshooting inflammatory response, especially in complex and emergency procedures. Thanks to the ANVISA approval of CytoSorb, Contatti is able to offer a solution to this problem, contributing to the improvement of patient outcomes.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “CytoSorb is used across the world in different clinical fields and can be integrated into various extracorporeal platforms to treat life-threatening conditions. We are pleased to commercialize CytoSorb in Brazil under this expanded registration through our partners FMC and Contatti Medical, both well-established and connected experts in their respective clinical fields. Importantly, we plan to build upon the momentum of CytoSorb usage during the pandemic in Brazil, and a long track record of reversing shock in patients worldwide, to make CytoSorb broadly available to help save patient lives throughout the country.”
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 flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce “cytokine storm” and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
Readout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage for potential regulatory submission to FDA and Health Canada as the first reversal agent for the blood thinner, Brilinta®
PRINCETON, N.J., August 14, 2023 — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up. The STAR-T trial is evaluating the ability of DrugSorb®-ATR to reduce perioperative bleeding due to the widely-used blood thinner, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are very pleased to complete all patient related procedures in the STAR-T trial without a single study subject lost to follow-up. This is another critical step of the process delivered on time and with 100% success. We are focused on ensuring complete and high-quality study data collection, ultimately leading to database lock and triggering the statistical analyses that will provide the readouts of the trial. We continue to expect topline results by the end of the year.”
Brilinta® is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. However, in the up to 10% of patients that are not eligible for a cardiac stent and now require coronary artery bypass graft (CABG) surgery, Brilinta confers a risk of major fatal or life-threatening CABG-related bleeding as high as 50-65%, particularly if the surgery is performed within the first five days of receiving the drug. Waiting in the hospital to wash out the drug is the only acceptable alternative, but comes at high cost and potential clinical risk. The goal of using 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 from blood during the surgery when installed in the heart-lung machine. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study was conducted by many 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 flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce “cytokine storm” and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
Q2 2023 Total Revenue was $9.4 million, an 11% increase from $8.5 million in Q2 2022.
Product sales rose 10% to $8.1 million vs $7.3 million in Q2 2022. Product gross margins grew 700 basis points to 74%
PRINCETON, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended June 30, 2023.
Second Quarter 2023 Financial Results
Total revenue for Q2 2023, including product sales and grant income, was $9.4 million, an increase of 11% compared to $8.5 million in Q2 2022
Q2 2023 product sales were $8.1 million versus $7.3 million in Q2 2022, an increase of 10%. The increase in the average exchange rate of the Euro to the U.S. dollar positively impacted Q2 2023 product sales by approximately $187,000
As expected, there were no COVID-19 related sales during the quarter, reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination, anti-viral therapy, and natural immunity
Product gross margins were approximately 74% in Q2 2023, compared to 68% in Q1 2023 and 67% in Q2 2022
Total cash, including cash and cash equivalents, and restricted cash was $14.8 million as of June 30, 2023
More than 212,000 CytoSorb devices have been cumulatively delivered across more than 75 countries worldwide as of the end of Q2 2023
Appointed Alexander D’Amico as Chief Financial Officer, who brings over 20 years of broad finance, SEC reporting, merger and acquisition, fundraising, and accounting experience to CytoSorbents, to start August 7, 2023. Interim CFO Kathy Bloch will continue to serve in a consulting capacity
Introduced Michael Bator as the new Chairman of the Board of Directors at the Annual Meeting in June, following the retirement of Al Kraus as former Chairman. A director of CytoSorbents since July 2015, Michael is founder and Partner of Quartz Advisory Group, a capital markets investment bank, and was formerly Managing Director of Healthcare Research at Jennison Associates, a multi-strategy buy-side family of investment funds with more than $175 billion of assets under management
Announced a theranostic collaboration with Humedics in the field of liver disease, focused on a joint promotion of CytoSorb, a superior extracorporeal liver support blood purification therapy, and Humedics’ LiMAx® test, a rapid and precise E.U. approved diagnostic using its innovative breath analysis technology to quantitatively assess liver function
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to report another successful quarter of executing on our three key business objectives for 2023. Most importantly, we expect to complete the pivotal STAR-T randomized, controlled trial imminently, following the 30-day follow-up of the last patient, which we believe puts us on target for topline data before the end of the year.
1. Opening the U.S. and Canadian markets with DrugSorb®-ATR
We continue to march towards our goal of opening the U.S. and Canadian markets with DrugSorb-ATR through the STAR-T (Safe and Timely Antithromobotic Removal of Ticagrelor) and pending STAR-D programs. We thank our U.S. and Canadian STAR-T clinical trial investigators and centers, study Principal Investigators, contract research organizations, and the clinical team at CytoSorbents, for an outstanding performance in the study and for completing enrollment well ahead of schedule. We are also pleased the independent DSMB, following two scheduled reviews of unblinded safety data on the first 80 patients, recommended completion of the study without modifications in June.
We have been working with centers in parallel during the STAR-T study to ensure timely entry and monitoring of data, and despite enrolling the final 60 patients in the last 2.5 months of the study with a lot of work ongoing, we expect to formally complete the study shortly and drive data cleaning and database lock in the next several months. This will be followed by statistical analysis of the data, which we believe will enable us to achieve our goal of announcing topline data before year-end. Meanwhile, our regulatory personnel have been coordinating the resources of the company to assemble the regulatory dossier needed to submit for marketing approval to U.S. FDA and Health Canada, which we plan to do as soon as possible assuming positive clinical study data. We plan to follow this with a formal presention of the data at a major U.S. cardiovascular conference. With improved visibility on future approval, we expect to execute our pre-commercialization strategy and begin building our sales and marketing infrastructure next year.
DrugSorb-ATR targets a large and growing market opportunity that exists today and we expect it to further accelerate as low-cost generic versions of ticagrelor become available starting in 2024. For example, the need to remove Brilinta® (ticagrelor, AstraZeneca) in patients with acute coronary syndrome who have received dual anti-platelet therapy (aspirin and a P2Y12 platelet inhibitor), but now require coronary artery bypass graft (CABG) surgery, is highlighted by the rapid speed of patient enrollment in the U.S. and Canadian STAR-T trial. Today, physicians have the choice of using different P2Y12 anti-platelet drugs, including Brilinta®, Plavix® (clopidogrel, BMS/Sanofi), and Effient® (prasugrel, Eli Lilly, Daiichi Sankyo, UBE). Although Brilinta has superior antithrombotic efficacy to Plavix, Plavix is still widely used because it is generic and less expensive. However, since Brilinta is expected to become generic ticagrelor in 2024, we believe it will take market share from both Plavix and Effient as the price of ticagrelor drops. In addition, if DrugSorb-ATR is approved to remove Brilinta, Brilinta will become the only P2Y12 platelet inhibitor with a solution available to allow timely surgery in patients on the drug – a powerful marketing message to prescribing cardiologists and emergency room physicians who know that 5-10% of patients with acute coronary syndrome treated with a P2Y12 inhibitor will not be candidates for stent placement and will require surgery and be at high risk of potentially fatal perioperative bleeding.
The preference for Brilinta (ticagrelor) by U.S. cardiologists has been highlighted recently in the prestigious JAMA Network Open publication, entitled, “Assessing the Clinical Treatment Dynamics of Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention in the US” where in a cohort study of more than 62,000 patients from 2010-2019 demonstrated that “ticagrelor has emerged as the most commonly prescribed P2Y12 inhibitor” following acute coronary syndrome and percutaneous coronary intervention. The rise of ticagrelor usage in this setting can be easily seen in Figure 1, where in 2019, ticagrelor was the drug of choice in 60.4% of cases, while clopidogrel (Plavix®) dropped to 29.6%, and prasugrel (Effient®) dropped to 10.0% of cases. We believe this trend bodes well for DrugSorb-ATR and supports our contention that the U.S. and Canadian ticagrelor market will expand over time.
With STAR-T enrollment complete, our clinical team is now focused on the activities leading up to the analysis of the results, and if positive, preparation of the documentation needed for our planned U.S. and Health Canada regulatory submissions for DrugSorb-ATR. When appropriate, we plan to continue our STAR (Safe and Timely Antithrombotic Removal) program with the resumption of the STAR-D trial, that will evaluate the use of DrugSorb-ATR to remove the direct oral anticoagulant (DOAC) Factor Xa inhibitors, Eliquis and Xarelto (among the highest revenue generating pharmaceuticals in the world), and to reduce bleeding risk in cardiothoracic surgery patients on these agents. We plan to leverage the same site network as in STAR-T and based on their feedback that they routinely encounter patients on DOACs needing cardiac surgery and their proven track record of trial execution, we believe the STAR-D trial can be run quickly and cost-effectively.
Finally, CMS recently announced details surrounding the Transitional Coverage for Emerging Technologies (TCET) program and are currently in the public comment period. The current proposed program falls short of what was widely anticipated by the medical device community and its trade organization, Advamed, providing a transparent pathway for securing dedicated CMS national coverage of FDA Breakthrough Designated Devices within 6 months of FDA clearance or approval, but departing from the automatic four-year national coverage upon FDA approval of qualified Breakthrough Devices that was discussed by CMS previously. We expect there to be ongoing discussion and possible modification of the program. We believe DrugSorb-ATR, as a Breakthrough Designated Device whose core target population falls squarely in the age group covered by Medicare, would still be an excellent candidate for this TCET program and we will continue to follow the story as it develops. Meanwhile, the STAR-T trial is expected to provide significant health economics data to support reimbursement through traditional private and public insurance pathways.
2. Return to Sales Growth for CytoSorb
CytoSorb targets the massive critical care and cadiac surgery markets outside the U.S., helping to control deadly inflammation and other life-threatening conditions such as sepsis, lung injury, trauma, burn injury, liver failure, complications of surgery, cytokine release syndrome in cancer immunotherapy, and many others. Following a post-COVID slowdown in hospital-based markets globally in 2022, we are pleased to report our third consecutive quarter of sequential product sales growth and a 10% increase in Q2 2023, year-over-year. With many new growth initiatives, and importantly new leadership in key positions in our therapy area verticals and our overall commercialization organization, we anticipate further momentum of our business over time. Importantly, product gross margins have rebounded 700 basis points to 74%, a trend consistent with our guidance of returning to 75-80% product gross margins on a quarterly basis this year. Our new manufacturing facility is fully online and producing CytoSorb devices in volume.
We believe there is now no question of what we have known for years – that CytoSorb is a powerful treatment of cytokine storm, particularly following the landmark publication in the journal Critical Care, describing the excellent effect of CytoSorb on reducing systemic cytokine levels in a well-controlled human endotoxin challenge model. We have learned a lot over the past 11 years of CytoSorb commercialization and the more than 200,000 human treatments administered to date in patients that are literally battling between life and death. Every study that has been published – positive, neutral, or negative – has taught us more about how to best treat patients with CytoSorb. We have distilled it down to the very simple message of “Right Patient, Right Timing, Right Dose.”
The concept of treating the right patient at the right time with the right dose to have good clinical outcomes is, in fact, relevant to most therapies. For example, antibiotics are some of the most commonly used drugs in the intensive care unit and are a perfect analogy for CytoSorb. Certainly you need antibiotics to kill the pathogen and to survive a life-threatening infection, just as you need to control the deadly massive inflammatory response in sepsis with CytoSorb. But despite antibiotics and the best standard of care (excluding CytoSorb), approximately 20-25% of patients with sepsis and organ dysfunction will die, and 35-50% of patients with septic shock will still die. A lot of these failures can be traced back to not following the “Right Patient, Right Timing, Right Dose” mantra. For example, if a patient with an infection is misdiagnosed and treated with the wrong antibiotic, it will not work (e.g. treating COVID-19 with penicillin instead of Paxlovid®). Or if an infection is not treated with antibiotics until the infection has spiraled out of control and the patient develops sepsis – then this is ‘too little too late.’ Or if the dose of the antibiotic is not adjusted for the severity of illness, the antibiotic may not work optimally.
This is why for the past several years, thanks to the observations of many dedicated CytoSorb users around the world, we have been emphasizing the “Right patient, right timing, and right dose” with the early and aggressive treatment of patients with clear evidence of hyperinflammation. Many of the older studies, for example, used CytoSorb relatively late in patients that had already developed kidney failure and were on dialysis, a generally later stage complication in critical illness that itself increases the risk of death, making it more difficult to demonstrate a benefit. Other studies did not evaluate the inflammatory status of patients. But when CytoSorb is used early and aggressively in documented hyperinflamed patients, we have seen some outstanding results. This includes the recently published final CTC (CytoSorb Therapy in COVID-19) Registry results in the journal, Critical Care, detailing the clinical outcomes in 100 critically-ill COVID-19 patients with severe inflammation and refractory lung failure using CytoSorb with ECMO to achieve “enhanced lung rest”. Overall, 90-day survival was high at 74% and in a post-hoc analysis, patients who were treated before the median treatment time of 87 hours had 82% survival, compared to 66% survival in patients treated after 87 hours. In addition, those treated in the early group had significantly shorter median durations of mechanical ventilation (7 [2–26] vs. 17 [7–37] days, p=0.02), ECMO support (13 [8–24] vs. 29 [14–38] days, p=0.021) and ICU stay (17 [10–40] vs 36 [19–55] days, p=0.002). Importantly, no device-related adverse events were reported. Overall, our results compare favorably to the approximately 50% survival reported by the Extracorporeal Life Support Organization (ECMO) COVID-19 registry looking at ECMO use alone in this population. Our data support the strategy of early combined usage of CytoSorb with ECMO to treat severe ARDS and refractory lung failure and is a prime example of our “hit early, hit hard” treatment philosophy.
To this end, our current Company-sponsored trials, such as the PROCYSS refractory septic shock randomized trial, and the international COSMOS critical illness registry, incorporate our evolving understanding of how to achieve better and more consistent results with CytoSorb. We have also been working to drive earlier usage of CytoSorb in the appropriate patients through a number of different ways, including for example, pursuing a theranostic strategy (i.e. using a diagnostic test to guide patient selection and timing of CytoSorb therapy) as we are doing in our collaboration with Humedics in the field of liver disease, or by selling a simple-to-use, relatively low cost hemoperfusion machine that can run CytoSorb quickly and efficiently, without needing to wait for patients to develop kidney failure and go on dialysis.
3. Reduced Cash Burn and Tight Control Over Expenses
Based upon our various cost controls implemented over the past 12 months, along with an improvement in sales and product gross margins, our quarterly cash burn during the first half of 2023 averaged approximately $4.5 million, down significantly from the average quarterly burn in the first half of 2022 of approximately $11 million. We closed the quarter with approximately $14.8 million in cash and we believe a runway to multiple catalysts for our business.”
Dr Chan continued, “Overall, we are excited about completing the STAR-T trial and potentially being on the cusp of reporting topline data by the end of the year and the full data set analysis shortly thereafter. If positive, these data could lead to U.S. FDA and Health Canada marketing approval for DrugSorb-ATR, and importantly, commercial revenue targeting an initial $300 million total addressable market in these two countries alone. Meanwhile, the gradual but steady recovery we are seeing for CytoSorb is expected to build momentum as the hospital markets recover, with anticipated future growth of the therapy in so many different clinical indications addressing multi-billion dollar markets. If we are successful, we believe CytoSorb and DrugSorb-ATR could transform CytoSorbents into a dual U.S. and international growth company, fueled by two major high margin revenue engines, helping to drive significant shareholder value.”
Dr. Chan concluded, “Finally we would like to thank former Chairman Al Kraus and CFO Kathy Bloch for their 20 and 10 years of service, respectively, and their countless contributions to the success of the Company, and wish them well in retirement. We also would like to congratulate Michael Bator as our new Chairman of the Board of Directors and to welcome Alex D’Amico as our new Chief Financial Officer.”
Results of Operations
Comparison for the three months ended June 30, 2023 and 2022:
Revenues:
Revenue from product sales was approximately $8,072,000 in the three months ended June 30, 2023, as compared to approximately $7,331,000 in the three months ended June 30, 2022, an increase of approximately $741,000, or 10%. Direct sales increased approximately $331,000, or 8%. Distributor sales increased approximately $410,000, or 14%. The increase in the average exchange rate of the Euro to the U.S. dollar positively impacted second quarter 2023 product sales by approximately $187,000. For the three months ended June 30, 2023, the average exchange rate of the Euro to the U.S. dollar was $1.09 was compared to an average exchange rate of $1.06 for the three months ended June 30, 2022. There were no sales related to the demand for CytoSorb to treat COVID-19 patients during the three months ended June 30, 2023, or for the three months ended June 30, 2022.
Grant income was approximately $1,348,000 for the three months ended June 30, 2023, as compared to approximately $1,165,000 for the three months ended June 30, 2022, an increase of approximately $183,000, or 16%. This increase was a result of a strategic decision to deploy our research and development employees exclusively to grant related activities during the three months ended June 30, 2023.
Total revenues were approximately $9,421,000 for the three months ended June 30, 2023, as compared to total revenues of approximately $8,496,000 for the three months ended June 30, 2022, an increase of approximately $925,000, or 11%.
Cost of Revenues:
For the three months ended June 30, 2023, and 2022, cost of revenue was approximately $3,402,000 and $3,551,000, respectively, a decrease of approximately $149,000. Product cost of revenue was approximately $2,093,000 and $2,453,000, respectively, for the three months ended June 30, 2023, and 2022, a decrease of approximately $360,000. The decrease is due primarily to inefficiencies associated with the relocation of our production activities to our new manufacturing facility in Princeton, New Jersey during the second quarter of 2022 that did not recur in the second quarter of 2023. Product gross margins were approximately 74% for the three months ended June 30, 2023, as compared to approximately 67% for the three months ended June 30, 2022.
Research and Development Expenses:
For the three months ended June 30, 2023, research and development expenses were approximately $3,669,000, as compared to research and development expenses of approximately $4,183,000 for the three months ended June 30, 2022, a decrease of approximately $514,000. This decrease was due to a decrease in our clinical trial activities of approximately $627,000 related to the pause of our STAR-D trial in November 2022. This decrease was offset by approximately $70,000 of costs incurred related to pre-production manufacturing activities required to bring the new manufacturing plant to a state of commercial readiness and an increase in non-grant related research and development costs of approximately $43,000.
Legal, Financial, and Other Consulting Expenses:
Legal, financial, and other consulting expenses were approximately $1,185,000 for the three months ended June 30, 2023, as compared to approximately $679,000 for the three months ended June 30, 2022, an increase of approximately $506,000. This increase was due to an increase in legal fees and expected settlement costs of pending litigation of approximately $306,000, other increases in legal expenses of approximately $174,000, and the write-off of certain patent costs and an increase in accounting fees and other consulting fees of approximately $26,000.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were approximately $7,724,000 for the three months ended June 30, 2023, as compared to approximately $8,439,000 for the three months ending June 30, 2022, a decrease of $715,000. This decrease was due to a decrease in non-cash stock compensation expense of approximately $191,000, a decrease in travel and entertainment expenses of approximately $99,000, a decrease in public relations costs of approximately $96,000, a decrease in advertising costs of approximately $82,000, a decrease in royalty expense of approximately $73,000, a decrease in commercial insurance of approximately $56,000, a decrease in salaries, commissions and related costs of approximately $43,000, and a decrease in other general and administrative expenses of approximately $75,000.
Gain (Loss) on Foreign Currency Transactions:
For the three months ended June 30, 2023, the gain on foreign currency transactions was approximately $415,000 as compared to a loss of approximately $2,523,000 for the three months ended June 30, 2022. The 2023 gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar at June 30, 2023 as compared to March 31, 2023. The spot exchange rate of the Euro to the U.S. dollar was $1.091 per Euro at June 30, 2023, as compared to $1.086 per Euro at March 31, 2023. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro at June 30, 2022 as compared to March 31, 2022. The spot exchange rate of the Euro to the U.S. dollar was $1.05 per Euro as of June 30, 2022, as compared to $1.11 per Euro as of March 31, 2022.
Comparison for the six months ended June 30, 2023, and 2022:
Revenues:
Revenue from product sales was approximately $15,982,000 for the six months ended June 30, 2023, as compared to approximately $15,255,000 for the six months ended June 30, 2022, an increase of approximately $727,000, or 5%. Distributor sales increased by approximately $597,000, or 10%. Overall direct sales increased by approximately $130,000, or 1%. The change in the exchange rate of the Euro to U.S. dollar did not have a significant impact on product sales during the six months ended June 30, 2023.
Grant income was approximately $2,888,000 for the six months ended June 30, 2023, as compared to approximately $1,932,000 for the six months ended June 30, 2022, an increase of approximately $956,000 or 49%. During the six months ended June 30, 2022, 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 2023, research and development employees were assigned exclusively to grant and other research and development activities.
Total revenues were approximately $18,870,000 for the six months ended June 30, 2023, as compared to total revenues of approximately $17,187,000 for the six months ended June 30, 2022, an increase of approximately $1,683,000, or 10%.
Cost of Revenues:
For the six months ended June 30, 2023 and 2022, cost of revenue was approximately $7,396,000 and $5,828,000, respectively, an increase of approximately $1,568,000. Product cost of revenue was approximately $4,624,000 and $4,008,000, respectively, for the six months ended June 30, 2023 and 2022, an increase of approximately $616,000 and grant cost of revenue increased by approximately $952,000. These increases were due primarily to increases in both product sales and grant revenue. Product gross margins were approximately 71% for the six months ended June 30, 2023, and approximately 74% for the six months ended June 30, 2022. The reduction in product gross margin is due primarily to start-up costs associated with our new manufacturing facility in Princeton, New Jersey during the six months ended June 30, 2023.
Research and Development Expenses:
For the six months ended June 30, 2023, research and development expenses were approximately $7,883,000 as compared to research and development expenses of approximately $8,427,000 for the six months ended June 30, 2022, a decrease of approximately $544,000. This decrease was due to a decrease in costs associated with our clinical trial activities of approximately $1,434,000 related to the pause of our STAR-D trial in November 2022, and a decrease in non-grant related research and development activities of approximately $29,000. These decreases were offset by approximately $919,000 of costs incurred related to pre-production manufacturing activities required to bring the new manufacturing plant to a state of commercial readiness.
Legal, Financial, and Other Consulting Expenses:
Legal, financial, and other consulting expenses were approximately $1,854,000 for the six months ended June 30, 2023, as compared to approximately $1,480,000 for the six months ending June 30, 2022. The increase of approximately $374,000 was due an increase in legal fees and expected settlement costs of pending litigation of approximately $306,000 and an increase in employment agency fees of approximately $80,000. These increases were offset by a decrease in consulting fees of approximately $12,000.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were approximately $16,187,000 for the six months ended June 30, 2023, as compared to $17,600,000 for the six months ended June 30, 2022, a decrease of $1,413,000. This decrease was due to a decrease in salaries, commissions and related costs of approximately $683,000, a decrease in non-cash stock compensation expense of approximately $148,000, a decrease in commercial insurance expenses of approximately $131,000, a decrease in travel and entertainment expenses of approximately $127,000, a decrease in public relations costs of approximately $119,000, a decrease in advertising costs of approximately $100,000, a decrease in royalty expense of approximately $68,000 and a decrease in other general and administrative expenses of approximately $37,000.
Gain (Loss) on Foreign Currency Transactions:
For the six months ended June 30, 2023, the gain on foreign currency transactions was approximately $1,076,000 as compared to a loss of approximately $3,736,000 for the six months ended June 30, 2022. The 2023 gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2023, as compared to December 31, 2022. The spot exchange rate of the Euro to the U.S. dollar was $1.09 per Euro as of June 30, 2023, as compared to $1.07 per Euro at December 31, 2022. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro as of June 30, 2022, as compared to 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 June 30, 2023, we had current assets of approximately $23,644,000 and current liabilities of approximately $10,351,000. As of June 30, 2023, $25 million of our total shelf amount was allocated to our ATM facility, of which approximately $22.8 million is still available. In April of 2023, we received approximately $1,000,000 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. pivotal STAR-T trial. We have instituted tight cost controls which are expected to materially reduce our planned cash burn in 2023.
We believe that we have sufficient cash to fund the Company’s operations through 2023. We will need to raise additional capital to support our ongoing operations in the future.
Q2 2023 Earnings Conference Call
The Company will conduct its second quarter 2023 results call today at 4:30 p.m. Eastern time.
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q2 2023, more than 212,000 CytoSorb devices had 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 completing the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $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™, 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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except per share data)
Three months ended June 30,
Six months ended June 30,
2023
2022
2023
2022
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Revenue:
CytoSorb sales
$
8,066
$
7,038
$
15,972
$
14,905
Other sales
6
293
10
350
Total product sales
8,072
7,331
15,982
15,255
Grant income
1,349
1,165
2,888
1,932
Total revenue
9,421
8,496
18,870
17,187
Cost of revenue
3,402
3,551
7,396
5,828
Gross profit
6,019
4,945
11,474
11,359
Other Expenses:
Research and development
3,669
4,184
7,883
8,427
Legal, financial and other consulting
1,185
679
1,854
1,480
Selling, general and administrative
7,724
8,439
16,188
17,600
Total expenses
12,578
13,302
25,925
27,507
Loss from operations
(6,559
)
(8,357
)
(14,451
)
(16,148
)
Other income/(expense):
Interest income (expense), net
(9
)
24
(72
)
32
Gain (loss) on foreign currency transactions
415
(2,523
)
1,076
(3,736
)
Miscellaneous Income (Expense)
—
(23
)
(32
)
6
Total other income (expense), net
406
(2,522
)
972
(3,698
)
Loss before benefit from income taxes
(6,153
)
(10,879
)
(13,479
)
(19,846
)
Benefit from income taxes
—
—
—
—
Net loss
$
(6,153
)
$
(10,879
)
$
(13,479
)
$
(19,846
)
Basic and diluted net loss per common share
$
(0.14
)
$
(0.25
)
$
(0.31
)
$
(0.46
)
Weighted average number of shares of common stock outstanding
44,015,380
43,560,481
43,758,888
43,524,414
Net loss
$
(6,153
)
$
(10,879
)
$
(13,479
)
$
(19,846
)
Other comprehensive income (loss):
Currency translation adjustment
(393
)
2,053
(1,001
)
3,016
Comprehensive loss
$
(6,546
)
$
(8,826
)
$
(14,480
)
$
(16,830
)
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands)
PRINCETON, N.J., July 26, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report second quarter 2023 operating and financial results after the market close on Tuesday, August 1st, 2023. CytoSorbents’ management will host a live presentation webcast and a question and answer session at 4:30PM EDT the same day.
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q1 2023, more than 203,000 CytoSorb devices had 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, and has now completed patient enrollment at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $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 includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, 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.
CytoSorbents is a leader in critical care immunotherapy. The company is committed to serving the best interests of our patients and their families, our customers, our employees, and our shareholders.
CytoSorb® is a unique blood purification therapy.The product is currently approved in the European Union and distributed in 58 countries around the world
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U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection. Call 848-667-8990 to Order.
