CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation
CytoSorbents Corporation (NASDAQ: CTSO) announces an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the pivotal U.S. and Canadian STAR-T trial. The study did not meet the primary effectiveness endpoint in the overall patient population undergoing different types of cardiac surgeries, but demonstrated evidence of reduced bleeding complications in patients undergoing isolated coronary artery bypass graft surgery. The safety and effectiveness data may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada. The full results of the STAR-T trial are expected to be presented at the American College of Cardiology 2024 conference.
Positive
The safety and effectiveness data may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada.
The study demonstrated reduced bleeding complications in patients undergoing isolated coronary artery bypass graft surgery.
Negative
The study did not meet the primary effectiveness endpoint in the overall patient population undergoing different types of cardiac surgeries.
The recent update from CytoSorbents Corporation regarding the STAR-T trial's initial data analysis represents a significant development in the realm of medical devices, particularly those used in the context of cardiac surgery. The DrugSorb-ATR device, which aims to reduce perioperative bleeding in patients undergoing cardiothoracic surgery without completing the recommended washout period for ticagrelor, addresses a critical unmet need in the medical field.
From a research perspective, the fact that the device met the primary safety endpoint is a positive outcome, underscoring the potential for the device to be used without introducing additional risks to patients. However, the study's inability to meet the primary effectiveness endpoint in the overall patient population warrants a nuanced analysis. The demonstrated evidence of reduced bleeding complications in the isolated coronary artery bypass graft (CABG) surgery subpopulation is noteworthy, as this group represents the majority of the study population and aligns with the common clinical scenario where ticagrelor-treated patients require urgent cardiac surgery.
Further comprehensive data analysis and subsequent regulatory submissions will be critical in determining the device's future in the market. The Breakthrough Device Designation previously granted by the FDA is indicative of the agency's recognition of the potential impact of DrugSorb-ATR on patient care, which could expedite the review process. The real-world usage data from the International STAR Registry supports the clinical findings, adding weight to the potential regulatory submissions.
The implications of the STAR-T trial results extend beyond clinical outcomes and into the economic sphere. Perioperative bleeding associated with ticagrelor use in cardiac surgery presents not only a clinical challenge but also a substantial economic burden on healthcare systems. The current standard of care involves a washout period of 3-5 days, which can lead to prolonged hospital stays and associated costs.
DrugSorb-ATR's ability to potentially reduce the need for this washout period could translate into significant cost savings for healthcare providers by minimizing the length of hospitalization and reducing the risk of complications associated with delayed surgeries. Additionally, the reduced incidence of serious bleeding events in the CABG subpopulation could decrease the need for additional medical interventions, blood transfusions and postoperative care, further contributing to cost reductions.
Should the device receive regulatory approval, the economic impact could be substantial. However, it is important to consider the cost of the device itself and the potential implications for insurance coverage and reimbursement policies. The balance between the device's cost and the savings generated from reduced perioperative complications will be a key factor in its adoption and utilization in clinical practice.
The regulatory landscape for medical devices such as DrugSorb-ATR is complex and involves rigorous scrutiny to ensure patient safety and effectiveness. The STAR-T trial's results are pivotal in shaping the device's regulatory pathway. Meeting the primary safety endpoint is a crucial step towards gaining approval from regulatory bodies like the U.S. FDA and Health Canada.
The device's performance in the isolated CABG surgery population is particularly relevant from a regulatory perspective. Demonstrating clinical effectiveness in a pre-specified subpopulation can be a strategic advantage, especially when it represents a significant portion of the intended patient population. It is also beneficial that the FDA has already acknowledged the unmet medical need and granted Breakthrough Device Designation, which could streamline the review process.
However, the overall failure to meet the primary effectiveness endpoint in the full patient cohort will require careful consideration. The company must present a compelling case that the benefits observed in the CABG subpopulation are clinically meaningful and justify the device's use. The regulatory submissions will need to be supported by robust data analysis and real-world evidence to maximize the chances of approval.
12/28/2023 - 07:00 AM
PRINCETON, N.J., Dec. 28, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation S afe and T imely A ntithrombotic R emoval of T icagrelor) randomized controlled trial.
STAR-T is a double-blind, randomized, controlled, multi-center pivotal trial that investigated the ability of DrugSorb® -ATR to reduce perioperative bleeding in 140 enrolled patients on ticagrelor (Brilinta® , Brilique® - AstraZeneca) undergoing cardiothoracic surgery before completing the recommended washout period. Patients were randomized in a 1:1 ratio to receive either DrugSorb-ATR or a sham device during cardiopulmonary bypass, with a primary composite effectiveness endpoint measuring perioperative bleeding.
The independent DSMB met recently to perform the final review of the full unblinded data on all 140 patients in the STAR-T trial and concluded there were no issues with device safety, meeting the primary safety endpoint of the study. The Company has also performed the initial data analysis on the primary effectiveness endpoint of STAR-T. Based on this analysis, the study did not meet the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries. However, the study did demonstrate evidence of reduced bleeding complications in patients in the pre-specified isolated coronary artery bypass graft (“CABG”) surgery population, representing more than 90% of the overall study population.
The Company expects to complete the analysis of the full trial results in the next several weeks. Pending this final analysis, the Company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada. Meanwhile, the Company had previously submitted a promissory abstract to the American College of Cardiology 2024 conference, triggering a “silent” period for publicly discussing detailed study results. If accepted, the full results of the STAR-T trial are expected to be presented next April 2024 in Atlanta.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents, stated, “We are encouraged that the use of the DrugSorb-ATR device in this high-risk population was deemed safe by the independent DSMB. Although the primary effectiveness endpoint of the study was not met in the overall population, we identified evidence of benefit of reduced bleeding complications in patients undergoing isolated CABG surgery, including serious bleeding events. This suggests a favorable benefit-to-risk profile in this population that represents the vast majority of ticagrelor-treated patients requiring cardiac surgery. Additional analyses are ongoing and we look forward to sharing the detailed results at a major medical conference in the near future.”
Dr. Irina Kulinets, Senior Vice President of Global Regulatory of CytoSorbents, stated, “In the next several weeks, we aim to complete the full data analysis of the study that is intended to form the basis of anticipated regulatory submissions. From a regulatory perspective, it is important that DrugSorb-ATR successfully met the primary safety endpoint of the study and has demonstrated clinical evidence of effectiveness in the pre-specified isolated CABG subpopulation. These data are supported by the successful real-world usage of CytoSorb® for this same indication, as captured by our International STAR Registry and as seen in multiple world markets including Europe, Latin America, Middle East, and others. Although we cannot predict how FDA will view our results, we are encouraged that FDA has already granted Breakthrough Device Designation to DrugSorb-ATR for this application, recognizing the problem as a major unmet medical need that causes significant patient morbidity and mortality and has no approved therapy in the U.S.”
Ticagrelor is one of the leading anti-thrombotic drugs used as part of dual-antiplatelet therapy in patients with acute coronary syndrome. However, up to 10% of these patients will need to undergo CABG surgery and risk serious bleeding complications if the surgery is performed within the first few days from the last ticagrelor dose. Waiting in the hospital to washout the drug over the span of 3-5 days is the only acceptable alternative, but comes with potential clinical risk for complications while waiting, and high additional hospital costs. The goal of DrugSorb-ATR is to allow patients to safely get the critical CABG surgery they need without requiring extensive drug washout.
DrugSorb-ATR has been previously granted U.S. FDA Breakthrough Device Designation ® is specifically approved for this indication. The Breakthrough Devices Program de novo 510(k), or premarket approval (PMA)) consistent with the Agency’s mission to protect and promote public health.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation CytoSorb ® ticagrelor rivaroxaban FDA Emergency Use Authorization FDA Breakthrough Device Designations ticagrelor direct oral anticoagulants (DOAC) apixaban and rivaroxaban
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY® , CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ® , K+ ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com www.cytosorb.com Facebook X
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about our preliminary analysis and expectations with respect to the STAR-T clinical trial results and our expectations regarding the content and timing of sharing further detailed results in the future 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.
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U.S. Company Contact: kbloch@cytosorbents.com
What is the update from CytoSorbents Corporation (NASDAQ: CTSO)?
CytoSorbents Corporation (NASDAQ: CTSO) announced an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the pivotal U.S. and Canadian STAR-T trial.
What were the results of the STAR-T trial?
The study did not meet the primary effectiveness endpoint in the overall patient population undergoing different types of cardiac surgeries, but demonstrated evidence of reduced bleeding complications in patients undergoing isolated coronary artery bypass graft surgery.
What regulatory submissions may be supported by the data?
The safety and effectiveness data may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada.
When will the full results of the STAR-T trial be presented?
The full results of the STAR-T trial are expected to be presented at the American College of Cardiology 2024 conference.
