A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.

Start Date27 Mar 2019

Sponsor / Collaborator

Instituto Grifols SA

NCT03461406 / CompletedPhase 3

A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).

Start Date18 Jan 2019

Sponsor / Collaborator

Instituto Grifols SA

EUCTR2016-004489-24-HU / Unknown statusPhase 3

Start Date21 Jun 2018

Sponsor / Collaborator

Instituto Grifols SA

100 Clinical Results associated with Fibrin Sealant (Human)(Instituto Grifols)

100 Translational Medicine associated with Fibrin Sealant (Human)(Instituto Grifols)

100 Patents (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)

Literatures (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)

01 Nov 2024·Journal of Pediatric Surgery

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

Article

Author: Jenovari, Zoltan ; James, Michael K. ; Mondou, Elsa ; Balanescu, Laura ; Bozzo, Jordi ; Kalinova, Krasimira ; Camprubí, Sandra ; Sharif, Khalid ; Camprubí, Sandra ; Ninov, Borislav ; Mikickovic, Maja ; Vajda, Péter ; Querolt, Montse ; Sretenović, Aleksandar ; Gajdobranski, Djordje ; Mondou, Elsa ; Slavkovic, Andjelka ; Simeonov, Simeon ; Hanna, Kim ; Hanna, Kim ; Irtan, Sabine ; Querolt, Montse ; Kamenov, Krasimir ; Wiener, Isodoro

BACKGROUNDIn this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.METHODSThis phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T₄ - primary endpoint), seven (T₇) and 10 (T₁₀) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.RESULTSAt T₄, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T₄ were undergoing soft tissue surgery. All patients achieved hemostasis by T₇. At T₁₀, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.CONCLUSIONSFS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.LEVEL OF EVIDENCEI.

01 Jun 2024·CARTILAGE

Mechanical Evaluation of Commercially Available Fibrin Sealants for Cartilage Repair

Article

Author: Amirhekmat, Arya ; Wang, Dean ; Hu, Jerry C. ; Brown, Wendy E. ; Athanasiou, Kyriacos A. ; Salinas, Evelia Y.

Objective Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model. Design Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated. Results There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant. Conclusions Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.

01 Apr 2023·Journal of Biomedical Materials Research Part A

A comparative high‐resolution physicochemical analysis of commercially available fibrin sealants: Impact of sealant osmolality on biological performance

Article

Author: Manhartseder, Stefan ; Hartmann, Jaana ; Singh, Rahul ; Heher, Philipp ; Gulle, Heinz ; Reichsöllner, Raffael ; Slezak, Paul

AbstractFibrin sealants are well‐established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue‐adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in‐depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ (“FS”) and VISTASEAL™/VERASEAL™ (“FS+Osm”). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis—a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.

News (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)

29 Oct 2024

·www.globenewswire.com

Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant Solution

Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasisGrifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding has received approval from the United States Food and Drug Administration (FDA) for pediatric patients. The U.S. indication for children and adolescents extends the availability of FS, which is already approved for this patient segment in Europe, in addition to adults. During surgery Grifols FS promotes hemostasis and tissue sealing, resulting in reduced blood loss and potentially fewer complications. Grifols FS biosurgery treatment is commercialized as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe and elsewhere. Both brands are marketed and distributed by Johnson & Johnson MedTech, as part of a strategic collaboration between the two companies announced in 2019. Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. The FS solution is now available in 18 countries. In early 2023, Grifols announced that it had met all primary and secondary endpoints of its phase 3b study evaluating the administration of Grifols FS to pediatric patients, defined as those not having reached 18 years of age. Researchers conducted a global prospective, randomized, active-controlled, single-blind, parallel group clinical trial designed to evaluate the safety and efficacy of the FS as an adjunct to hemostasis during surgery in pediatric patients (compared with an active control). The study included a total of 178 patients enrolled and treated across 18 recruitment centers. A greater than 95% efficacy rate was achieved in both treatment arms, with hemostasis within four minutes of application. In addition, Grifols FS demonstrated a good safety and tolerability profile, as the distribution of adverse events was comparable between arms. “Developing innovative biosurgery solutions reflects Grifols’ ability to provide patients with more medicines across many therapeutic areas to enhance their well-being,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer. It’s estimated that between roughly one-third and two-thirds of open surgeries experience disruptive bleeding,1 while challenging and uncontrollable bleeding during surgery is associated with high mortality rates.1,2 About VISTASEAL VISTASEAL is a single-use product that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue. VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION INDICATIONVISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL™ is effective in heparinized patients. CONTRAINDICATIONSDo not inject directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding.Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. WARNINGS AND PRECAUTIONS Thromboembolic events may occur if VISTASEAL™ is administered intravascularly. Hypersensitivity reactions can occur. May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ADVERSE REACTIONSThe most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.MEDIA CONTACTS: Grifols Press Office media@grifols.comTel. +34 93 571 00 02 SpainDuomo ComunicaciónTel.: +34 91 311 92 89 – +34 91 311 92 90Raquel Lumbreras (Tel. +34 659 572 185)Raquel_lumbreras@duomocomunicacion.comBorja Gómez (Tel. + 34 659 572 185)Borja_gomez@duomocomunicacion.com InvestorsInvestors Relations & Sustainabilityinversores@grifols.com - investors@grifols.comTel. +34 93 571 02 21 About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information about Grifols, please visit grifols.com LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions.” Words and expressions such as “believe,” “hope,” “anticipate,” “predict,” “expect,” “intend,” “should,” “will seek to achieve,” “it is estimated,” “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group. 1 Corral M, Ferko N, Hollmann S, Broder MS, Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409-421. doi:10.2147/CEOR.S863692 Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814. doi:10.1016/j.transproceed.2006.01.047

Phase 3Clinical ResultDrug Approval

28 Feb 2024

·www.pharmaceutical-technology.com

Grifols prepares for late-stage plans with plasma-derived medicines in 2024

In an exclusive interview with Pharmaceutical Technology, Grifols declared plans for multiple Phase III readouts in 2024. Credit: Bloomberg via Getty Images Grifols plans to release Phase III results of its long-term albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites in 2024, says chief scientific innovations officer Jorg Schüttrumpf. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Related Company Profiles Grifols SA Ethicon US LLC Johnson & Johnson Biotest AG View all In an exclusive interview with Pharmaceutical Technology, Schüttrumpf outlined the plasma derived-medicines company’s 2024 goals for its late-stage candidates as several trials come to a head. The aforementioned Preciosa trial (NCT03451292) studying human albumin is focused on patients awaiting a suitable transplant. Grifols also plans to release data from its Phase III ESsCAPE study (NCT05722938), investigating trimodulin, triple action immunoglobulin with IgM, IgA and IgG, at some point this year. In February, the company reported positive efficacy results from a trial investigating Grifols’ fibrinogen concentrate (FC), BT524, for the treatment of acquired fibrinogen deficiency (AFD). The company now plans to complete European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulatory submissions, in pursuit of approval. “We are working with different partners. In the immunology, and pulmonary disease space, to support their growth,” says Schüttrumpf. Additionally, the Spain-headquartered company is exploring partnerships similar to the one it has with Ethicon, says Schüttrumpf. Grifols began its collaboration with Ethicon, a subsidiary of Johnson & Johnson , in 2017, wherein Grifols agreed to exclusively manufacture and supply plasma-derived products for use in the biosurgery field for 10 years. See Also: Pelage secures funds to develop regenerative medicine for hair loss Praxis Precision Medicines sees highest patent filings and grants during November in Q4 2023 In 2021, Grifols announced the acquisition of Tiancheng (Germany) Pharmaceutical Holding s, which owned 89.88% of another plasma products specialist Biotest . Grifols is developing trimodulin and B524 with Biotest. Before the acquisition, Grifols had already explored fibrinogen concentrate for the development of Vistaseal (fibrinogen (human) + thrombin (human), commercialised as Veraseal in Europe. Schüttrumpf highlights Grifol’s ability to complete in-house manufacturing for plasma-derived therapeutics like BT524. He said that this gave the company a major advantage in its operations, also allowing it to offer its manufacturing services to other pharmaceutical companies. Grifols has plans to release its 2023 annual financial report on 29 February. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Phase 3AcquisitionClinical Result

18 Jul 2023

·www.biospace.com

Grifols Completes Enrollment in Phase 3 Study of Long-term Albutein® (albumin-human injection) Therapy for Patients with Decompensated Cirrhosis

PRECIOSA clinical trial is designed to evaluate efficacy and safety of Grifols Albutein® plus standard medical treatment to increase survival time in patients with decompensated cirrhosis awaiting transplant Albumin’s antioxidant and anti-inflammatory properties have the potential to mitigate the complications associated with decompensated cirrhosis Grifols continues innovating across its plasma-protein franchise and is committed to applying its ever-growing expertise in a range of therapeutic areas to help treat pressing societal healthcare challenges BARCELONA, Spain, July 18, 2023 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced it has completed enrollment in PRECIOSA (NCT03451292), its phase 3 clinical trial designed to determine the potential of long-term albumin treatment with Grifols Albutein® to increase survival time in patients with decompensated cirrhosis and ascites until a suitable transplant is available. Cirrhosis, a condition in which the liver is permanently scarred and can lead to liver failure, is the leading cause of liver-related deaths globally,1 with more than 1.32 million deaths reported in 2017.2 In the U.S. alone, researchers estimate that about 1 in 400 adults have cirrhosis,3 including those who have progressed into decompensated cirrhosis once complications such as ascites appear. Ascites is a buildup of fluid in the abdomen and signals that a patient’s risk for poor outcomes, including death, have significantly increased. Albumin, the most abundant protein in plasma, has antioxidant and anti-inflammatory properties with the potential to mitigate the complications associated with decompensated cirrhosis and its progression into the next stage of the disease, acute-on-chronic liver failure (ACLF). Treatment with albumin has the potential to reduce the high one-year mortality rates observed in decompensated cirrhosis. Over 400 patients with decompensated cirrhosis with ascites are participating in this multi-center, randomized (1:1), controlled, parallel-group, open-label study in 69 sites across North America and Europe. It will evaluate the efficacy and safety of long-term Albutein® administration (dosed every 10 ± 2 days for up to 12 months) plus standard medical treatment. “There is great potential for albumin to improve the survival prospects of patients suffering from decompensated cirrhosis until they can get a liver transplant, a large unmet need given the limited availability of livers for patients,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in the fourth quarter of 2024 and evaluating next regulatory steps to provide patients with a much-needed treatment.” Grifols is committed to strengthening its innovation pipeline, which consists of multiple plasma and non-plasma programs across various clinical stages, all dedicated to potential treatments to help patients live longer, better-quality lives. About Decompensated Cirrhosis and Ascites Chronic liver disease is an all too common and growing problem in the developed world, with worldwide prevalence rates of around 20%.4 One such condition is cirrhosis, in which the liver is permanently scarred and, in many cases, can lead to liver failure. Decompensated cirrhosis is defined by the complications that can occur in a patient with cirrhosis, which include ascites, variceal bleeding, hepatic encephalopathy, and bacterial infections. These complications are associated with worse survival (2-4 years) compared with compensated cirrhosis (10-15 years).5 About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership. In 2022, Grifols’ economic impact in its core countries of operation was EUR 9.6 billion. The company also generated 193,000 jobs, including indirect and induced. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information, please visit . MEDIA CONTACT: Media Press Office media@grifols.com Tel. +34 93 571 00 02 INVESTORS: Investors Relations Department & Sustainability inversores@grifols.com - investors@grifols.com Tel. +34 93 571 02 21 LEGAL DISCLAIMER The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, insofar as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group. 1 GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1736-1788. doi:10.1016/S0140-6736(18)32203-7 2 GBD 2017 Cirrhosis Collaborators. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(3):245-266. doi:10.1016/S2468-1253(19)30349-8 3 Scaglione S, Kliethermes S, Cao G, et al. The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin Gastroenterol. 2015;49(8):690-696. doi:10.1097/MCG.0000000000000208 4 Moon AM, Singal AG, Tapper EB. Contemporary epidemiology of chronic liver disease and cirrhosis. Clin Gastroenterol Hepatol. 2020;18(12):2650-2666. doi: 10.1016/j.cgh.2019.07.060 5 López-Sánchez GN, Dóminguez-Pérez M, Uribe M, Nuño-Lámbarri N. The fibrogenic process and the unleashing of acute-on-chronic liver failure. Clin Mol Hepatol. 2020;26(1):7-15. doi:10.3350/cmh.2019.0011; Fanali G, di Masi A, Trezza V, Marino M, Fasano M, Ascenzi P. Human serum albumin: from bench to bedside. Mol Aspects Med. 2012;33(3):209-290. doi:10.1016/j.mam.2011.12.002

Phase 3

100 Deals associated with Fibrin Sealant (Human)(Instituto Grifols)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Blood Coagulation Disorders	EU	Instituto Grifols SA	10 Nov 2017
Blood Coagulation Disorders	LI	Instituto Grifols SA	10 Nov 2017
Blood Coagulation Disorders	IS	Instituto Grifols SA	10 Nov 2017
Blood Coagulation Disorders	NO	Instituto Grifols SA	10 Nov 2017
Hemorrhage	US	Instituto Grifols SA	01 Nov 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Discovery	ES	Instituto Grifols SA	01 Feb 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03461406 (CTgov)	Phase 3	Hemorrhage	186	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	gtfgbdndje(nxctbsjeij) = htskotxvvv lhxadlsbfj (zyeivatezt, hcvyauwtes - efbqtvovku) View more	-	07 Apr 2023
				EVICEL (EVICEL)	gtfgbdndje(nxctbsjeij) = rupjuonkse lhxadlsbfj (zyeivatezt, fuhhqkycbo - fjqwbofnmv) View more
NCT01662856 (CTgov)	Phase 3	Hemorrhage	225	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	ohbiohpxwe(bbggtryful) = lbrxdnqujk twaovnsbbu (jjokqtoggr, wmqoczviqo - tpqdmfzhdr) View more	-	06 Apr 2017
				Manual Compression (Manual Compression)	ohbiohpxwe(bbggtryful) = ntnvarewjt twaovnsbbu (jjokqtoggr, epwxucqjau - kdznojepdh) View more
NCT01731938 (CTgov)	Phase 3	Hemorrhage	327	Fibrin Sealant (FS) Grifols (Fibrin Sealant (FS) Grifols)	xxsddyddcz(bmimnfkonc) = vxvdowgxjg lnjjpacrys (ebwnpeknvy, wplzprfqsj - ffkvikcqlo) View more	-	23 Feb 2017
				Surgicel® (Surgicel®)	xxsddyddcz(bmimnfkonc) = ymmbegnbnl lnjjpacrys (ebwnpeknvy, rkwazfvofj - vdqfpgglaf) View more
NCT01754480 (CTgov)	Phase 3	Hemorrhage	325	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	xlubgapxme(wgojwsmpda) = wvislxihms ccvfkfaffj (xvxolxxwit, kslexljuuw - bmzyeitefy) View more	-	08 Feb 2017
				Surgicel® (Surgicel®)	xlubgapxme(wgojwsmpda) = ebjozuxjkl ccvfkfaffj (xvxolxxwit, heyvyzzybj - mwjbzzrlta) View more
NCT00684047 (CTgov)	Phase 2/3	Hemorrhage	239	FS Grifols (FS Grifols Primary Part (II))	nevrtlmcas(xfwrovlvvo) = uagvblrvql raosiylqel (wsbtoqwflm, gdkpxcfftb - cnyntbytoa) View more	-	25 Jan 2016
				Manual Compression (Manual Compression Primary Part (II))	nevrtlmcas(xfwrovlvvo) = dnmxthoknl raosiylqel (wsbtoqwflm, iyntnsoebv - mrzayoveqv) View more

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