Sepsis

The FDA on Friday said it’s pulling two final guidance documents published earlier this year that sought to help entities manufacturing cell- and tissue-based medical products to make better donor eligibility determinations. At the time the guidance documents were finalized in January, the FDA said it determined a need for updated recommendations for making such eligibility determinations to reduce the risk of infections due to sepsis. The guidances, reissued as drafts on Friday, followed a nationwide outbreak in 2021 of more than 110 tuberculosis infections in recipients of allograft bone products. A Delaware hospital in 2021 initially noted an “unusual cluster of tuberculosis cases in patients who had undergone spinal surgery, involving implantation of bone allograft material from a single product lot,” the CDC said . Both final guidance documents said that establishments should implement certain recommendations “as soon as feasible, but not later than 4 weeks after the guidance issue date.” On Feb. 3, the FDA revised its final guidance and set a new implementation date of May 4. As of Friday, the “FDA has now withdrawn the final guidance ‘Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)’ and has reissued this draft guidance with certain revisions in response to comments FDA received on the now-withdrawn final guidance issued in January 2025,” the agency said without clarifying which comments it was responding to, as it typically does in the Federal Register. The agency published new draft guidance on Friday that’s nearly identical to the previous version, but no longer includes the implementation dates. The FDA also withdrew another final guidance from January and reissued it as draft guidance on reducing the risk of transmission of mycobacterium tuberculosis, which the agency previously identified as “a public health safety concern.” The agency noted “multi-state outbreaks” of Mtb, citing a CDC report from Jan. 2024, that “indicate that there is a risk of transmission of Mtb infection by HCT/Ps, and Mtb is a disease agent that can cause sepsis.”

PRINCETON, N.J., May 1, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner. On April 25, 2025, the U.S. Food and Drug Administration (FDA) issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. CytoSorbents has since met with the FDA and will continue to have interactive conversations with the agency to try to resolve the remaining issues. However, if these conversations do not lead to a resolution, a formal appeal will be filed within 60 days. "We remain deeply committed to bringing DrugSorb-ATR to market as an important solution to address the serious, unmet medical need of preventing life-threatening bleeding in CABG patients treated with Brilinta®," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "With no therapies currently available in the U.S., tens of thousands of patients remain at risk every year. We will continue working closely with FDA and believe we can resolve the remaining issues in a timely manner and still anticipate a final regulatory decision in 2025." About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing authorization for the DrugSorb-ATR medical device to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR has not been authorized for commercialization in the U.S. or Canada. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve remaining deficiencies in the FDA denial letter and/or successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1b/2a diSArm trial evaluated AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia Topline data anticipated in Q2 2025 to support potential future pivotal bacteremia efficacy trial LOS ANGELES, May 1, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has received an additional $4.65 million of non-dilutive funding pursuant to a previously announced Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. The award, currently totaling $26.2 million, was awarded to Armata to support clinical development of its optimized phage candidate, AP-SA02, as a potential treatment for complicated Staphylococcus aureus bacteremia (SAB). The additional $4.65 million will be used to support Phase 2a study close out activities as well as for the preparation and execution of an end-of-phase 2 meeting with the U.S. Food and Drug Administration. "The DoD has been an essential partner throughout the development of AP-SA02, and we are very grateful for their continued support of this important program," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "We remain committed to efficiently advance AP-SA02 through full clinical development and introduce this novel phage-based anti-infective for the benefit of military personnel and civilians alike." "At Armata, we remain laser focused on demonstrating, in rigorously designed placebo-controlled clinical trials, the potential of phage therapy to successfully combat evolving deadly bacteria, including systemic Staphylococcus aureus infections. In parallel, we have developed our proprietary manufacturing process with complete in-house U.S.-based capacity to support clinical development as well as full future commercial production. This not only allows us to be efficient but is also expected to ensure immediate access to patients in need if AP-SA02 is found to be effective," Dr. Birx concluded. The diSArm study is a Phase 1b/2a, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with SAB. This study was conducted in two phases: Phase 1b evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SAB. Phase 2a evaluated the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study achieved full enrollment of 50 subjects in November 2024, with the last patient visit having taken place in January 2025. During the execution of the trial, Armata was able to dose escalate to 5e10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood consistent with in vivo phage amplification. This suggests that, despite the best available antibiotic treatment for greater than five days, reservoirs of active SAB remained that Armata's phages targeted, infected and killed before recirculating in the intravascular space. As of now, the Company anticipates receipt of topline data in the next few weeks, where it can explore the two aforementioned subsets in an unblinded manner. Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive efficacy study. For more information on the diSArm study, see NCT05184764. In addition, Armata filed its Annual Report for the year ended December 31, 2024 on Form 10-K with the Securities and Exchange Commission (the "SEC") on March 21, 2025. The audit opinion included in the Company's Form 10-K for the year ended December 31, 2024 contains a going concern explanatory paragraph. This announcement is made pursuant to the disclosure requirements of NYSE American Company Guide Sections 401(h) and 610(b) and does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2024. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific cGMP manufacturing to support full commercialization. Forward Looking Statements This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2025, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Pierre Kyme Armata Pharmaceuticals, Inc. [email protected] 310-665-2928 x234 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 SOURCE Armata Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED