INTERCEPT® Blood System USA’s Post

In a recent publication in the journal Blood Advances, Wheeler et al. report on additional findings from the largest platelets transfusion study assessing pulmonary injury to date. This new analysis assesses the impact of transfusion intensity with pathogen reduced platelets* compared to conventional platelets on pulmonary injury requiring assisted mechanical ventilation in hematology-oncology patients. This patient population frequently requires platelet transfusion due to antineoplastic therapy to address the underlying disease. Read the open access publication here: https://lnkd.in/g3Gp_ekj #platelets #transfusion #patientsafety *Platelets treated with the INTERCEPT Blood System have not been approved by FDA for reducing the probability of assisted mechanical ventilation during platelet transfusion. See package insert (https://ow.ly/yTLo50SStfe) for full prescribing information. CONTRAINDICATIONS Contraindicated for preparation of platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth less than 375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only INTERCEPT Processing Sets for platelets are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion. © 2024 Cerus Corporation. Cerus, INTERCEPT, and the Cerus logo are registered trademarks of Cerus Corporation. MKT-EN 00685-53 v1.0

NEW CLINICAL STUDY SHOWS CHITOCARE® MEDICAL WOUND HEALING GEL INCREASES THE HEALING RATE OF CHRONIC DIABETIC FOOT ULCERS. Primex Iceland is proud to announce the publication of full results from a clinical trial of its proprietary ChitoCare® medical Wound Healing Gel in the British Medical Journal (BMJ) Open Diabetes Research & Care.  The trial investigated the treatment of diabetic foot ulcers (DFUs), which are one of the leading causes of lower-limb amputations worldwide. Current standard-of-care (SOC) may not properly address the adequate healing and recurrence of DFUs. The study reported that at the end of a 10-week treatment period, more patients had fully healed, and 50% and 75% wound closure was significantly higher, using the chitosan-based Wound Healing Gel in addition to SOC compared to SOC plus a placebo gel. Patients treated with the Wound Healing Gel experienced a significant reduction in wound surface area compared to placebo at the end of the study. In addition, wound state was significantly improved in patients using the Wound Healing Gel vs placebo.  The Wound Healing Gel proved to be a safe and effective adjuvant to standard-of-care therapy for the treatment of DFUs. One of the advantages of the Wound Healing Gel is its ease of application, which enables home use, and thus eliminates the need for frequent clinic visits. This could considerably reduce DFU treatment costs while also improving patient outcomes. Read the full press release here: https://lnkd.in/enSY5A4N Read the full report, "A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study)" here: https://lnkd.in/e7PKUdH3 #Primex #chitosan #Chitowound #BritishMedicalJournal #DiabeticUlcers #ChitoCareMedical #WoundHealing #ClinicalStudy

NEW CLINICAL STUDY SHOWS CHITOCARE® MEDICAL WOUND HEALING GEL INCREASES THE HEALING RATE OF CHRONIC DIABETIC FOOT ULCERS. Primex Iceland is proud to announce the publication of full results from a clinical trial of its proprietary ChitoCare® medical Wound Healing Gel in the British Medical Journal (BMJ) Open Diabetes Research & Care.  The trial investigated the treatment of diabetic foot ulcers (DFUs), which are one of the leading causes of lower-limb amputations worldwide. Current standard-of-care (SOC) may not properly address the adequate healing and recurrence of DFUs. The study reported that at the end of a 10-week treatment period, more patients had fully healed, and 50% and 75% wound closure was significantly higher, using the chitosan-based Wound Healing Gel in addition to SOC compared to SOC plus a placebo gel. Patients treated with the Wound Healing Gel experienced a significant reduction in wound surface area compared to placebo at the end of the study. In addition, wound state was significantly improved in patients using the Wound Healing Gel vs placebo.  The Wound Healing Gel proved to be a safe and effective adjuvant to standard-of-care therapy for the treatment of DFUs. One of the advantages of the Wound Healing Gel is its ease of application, which enables home use, and thus eliminates the need for frequent clinic visits. This could considerably reduce DFU treatment costs while also improving patient outcomes. Read the full press release here: https://lnkd.in/enSY5A4N Read the full report, "A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study)" here: https://lnkd.in/e7PKUdH3 #Primex #chitosan #Chitowound #BritishMedicalJournal #DiabeticUlcers #ChitoCareMedical #WoundHealing #ClinicalStudy ChitoCare Beauty

Serial lactate measurements to guide resuscitation: more evidence not to? My Take... The discussion surrounding the use of serial lactate measurements to guide resuscitation in sepsis is complex and evolving. Lactate, a biomarker traditionally linked with tissue perfusion and septic shock, is now questioned regarding its utility in guiding fluid resuscitation and therapeutic decisions. The Sepsis-3 guidelines incorporate lactate levels as a criterion for septic shock, underscoring its prognostic significance. However, its role as a therapeutic guide is debatable, with only weak recommendations supporting this from the latest Surviving Sepsis Campaign due to limited evidence. Recent clinical trials challenge the effectiveness of a lactate-guided resuscitation strategy. For instance, a Dutch study found that a lactate-guided approach (aiming for a 20% reduction every two hours) was associated with a lower in-hospital mortality compared to controls who were only aware of their initial lactate levels. However, the difference in fluids administered between the two groups was minimal, suggesting other factors, such as increased use of vasodilators in the lactate group, could be influencing outcomes. Contrastingly, the ANDROMEDA-SHOCK study compared lactate clearance with peripheral perfusion assessment as resuscitation guides and found no significant survival benefit with the lactate strategy. In fact, the peripheral perfusion-guided group had better outcomes with less fluid administered, suggesting that focusing on lactate levels might divert attention from more holistic patient assessments. The research also touches on the inherent limitations of lactate as a marker. Its production is influenced by factors beyond hypoperfusion, such as aerobic glycolysis and reduced hepatic clearance. Notably, the post hoc analysis from the CLASSIC trial reported no significant differences in lactate clearance or outcomes between restrictive and liberal fluid strategies, further questioning the impact of fluid management based on lactate levels alone. The ongoing debate and the findings from these studies suggest that while lactate remains a valuable prognostic marker, its utility in guiding resuscitation needs reevaluation. The future of sepsis treatment may lie in more individualized approaches, integrating clinical phenotyping and potentially peripheral perfusion assessments, rather than focusing solely on lactate clearance. Ongoing and future clinical trials will be crucial in defining the optimal strategies for fluid therapy and resuscitation in sepsis. https://lnkd.in/gVxBmbyR

Article Title: Acute Pyelonephritis with Renal Vein and Inferior Vena Cava Thrombosis: A Case Report Journal of Case Reports and Medical History (JCRMH) Acquire Publications Authors: Wissal Bencherifi Abstract Acute pyelonephritis might be complicated by the formation of renal and perirenal abscesses and very rarely by renal vein thrombosis (RVT), which is a life-threatening condition. We report a case of 35-year-old female with no significant past medical history, who presented a week history of fever, hematuria, flank pain, and lower urinary tract symptoms. Physical examination showed a shivering young woman with fever 39°C of temperature, left flank pain and tenderness was observed on palpation. Laboratory test results showed elevated CRP level at 210 mg/L, white blood cell count at 23000/mm3 with 14000/mm3 neutrophil. Urinalysis showed pyuria, bacteriuria and nitrites presence. Urine cultures grew Escherichia coli and blood cultures were sterile. Unfortunately, after 2 days of antibiotic therapy the patient flank pain worsened, and further imaging evaluation with Abdominal CT scan showed extensive thrombosis of the left renal vein and its branches protruding to the inferior vena cava. The patient improved after intravenous antibiotics and anticoagulation treatment. At 1-month follow-up, the patient was asymptomatic. At 3 months follow-up, CECT showed complete resolution of the IVCT and attenuated renal vein with atrophic small kidney. In conclusion, renal venous thrombosis secondary to acute pyelonephritis is very rare. It is very important to treat it rapidly because it can lead to pulmonary embolism, thrombosis of the inferior vena cava or renal failure, thus jeopardizing the patient's vital and functional prognosis. For full Article visit https://lnkd.in/gQEWAk4e

Join Cerus at the Society for the Advancement of Patient Blood Management, Inc. (SABM) 2024 Annual Meeting at the Hyatt Regency Phoenix in Phoenix, AZ, September 12 – 14, 2024! Be sure to attend Cerus’ Industry Workshop, “Protecting the Blood Supply with Pathogen Reduction: Current and Future Perspectives”, on September 12 at 3:00 p.m. The workshop features Nina Mufti, PhD discussing recent findings on the ReCePI trial, a Phase III trial evaluating the use of pathogen reduced red cell components in cardiovascular surgery patients¹ and Andrea McGonigle M.D. presenting on UCLA’s experience with Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT® Fibrinogen Complex (IFC), in postpartum hemorrhage. Register here: https://ow.ly/ksJ150SV6BN Please visit us at Booth #17 in the Exhibition Hall to learn more! Find out why hospitals are using INTERCEPT treated blood components: https://ow.ly/y2Pq50SV6BM #INTERCEPT #pathogeninactivation #JOINTHEMOVEMENT #IFC #bloodsafety #patientbloodmanagement 1. The INTERCEPT Red Blood Cell system is in clinical development. (ClinicalTrials.gov ID NCT03459287). INTERCEPT Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex: INDICATIONS FOR USE •Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. •Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available. •Second-line therapy for von Willebrand disease (vWD). •Control of uremic bleeding after other treatment modalities have failed. Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII. CONTRAINDICATIONS Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered. ©2024 Cerus Corporation. Cerus, INTERCEPT, and the Cerus logo are registered trademarks of Cerus Corporation. MKT-EN 00685-55 v1.0

Join Cerus at the Society for the Advancement of Patient Blood Management, Inc. (SABM) 2024 Annual Meeting at the Hyatt Regency Phoenix in Phoenix, AZ, September 12–14, 2024! Be sure to attend Cerus’ Industry Workshop, “Protecting the Blood Supply with Pathogen Reduction: Current and Future Perspectives”, on September 12 at 3:00 p.m. The workshop features Nina Mufti, PhD discussing recent findings on the ReCePI trial, a Phase III trial evaluating the use of pathogen reduced red cell components in cardiovascular surgery patients¹ and Andrea McGonigle M.D. presenting on UCLA’s experience with Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT® Fibrinogen Complex (IFC), in postpartum hemorrhage. Register here: https://ow.ly/ksJ150SV6BN Please visit us at Booth #17 in the Exhibition Hall to learn more! Find out why hospitals are using INTERCEPT treated blood components: https://ow.ly/y2Pq50SV6BM #INTERCEPT #pathogeninactivation #JOINTHEMOVEMENT #IFC #bloodsafety #patientbloodmanagement 1. The INTERCEPT Red Blood Cell system is in clinical development. (ClinicalTrials.gov ID NCT03459287). INTERCEPT Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex: INDICATIONS FOR USE •Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. • Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available. • Second-line therapy for von Willebrand disease (vWD). • Control of uremic bleeding after other treatment modalities have failed. Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII. CONTRAINDICATIONS Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered. ©2024 Cerus Corporation. Cerus, INTERCEPT, and the Cerus logo are registered trademarks of Cerus Corporation. MKT-EN 00685-55 v1.0

Thank you to everyone who attended Cerus’ Industry Workshop, “Protecting the Blood Supply with Pathogen Reduction: Current and Future Perspectives” and visited our booth at the Society for the Advancement of Patient Blood Management, Inc. (SABM) 2024 Annual Meeting! Special thanks to Nina Mufti, PhD for discussing recent findings on the ReCePI trial, a Phase III trial evaluating the use of pathogen reduced red cell components in cardiovascular surgery patients¹ and Andrea McGonigle M.D. for presenting on UCLA’s experience with Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT® Fibrinogen Complex (IFC), in postpartum hemorrhage. Learn more about pathogen reduced blood components: https://ow.ly/y2Pq50SV6BM #INTERCEPT #pathogeninactivation #JOINTHEMOVEMENT #IFC #bloodsafety #patientbloodmanagement 1. The INTERCEPT Red Blood Cell system is in clinical development. (ClinicalTrials.gov ID NCT03459287). INTENDED USE The INTERCEPT Blood System for Cryoprecipitation is intended to provide a functionally closed system for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex. Pathogen Reduced Cryoprecipitated Fibrinogen Complex is indicated for: •Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. • Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available. • Second-line therapy for von Willebrand disease (vWD). • Control of uremic bleeding after other treatment modalities have failed. Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII. CONTRAINDICATIONS Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered. © 2024 Cerus Corporation. Cerus, INTERCEPT, and the Cerus logo are registered trademarks of Cerus Corporation. MKT-EN 00685-75 v1.0

Blood Components in Blood banking and Blood transfusions Red Blood Cells (RBCs) - Function: Carry oxygen to tissues - Storage: 35-42 days at 2-6°C - Indications: Anemia, blood loss, surgery Plasma - Function: Transport proteins, clotting factors, and antibodies - Storage: Frozen (-18°C) for up to 1 year - Indications: Bleeding disorders, liver disease, shock Platelets - Function: Blood clotting - Storage: 5-7 days at 20-24°C with agitation - Indications: Low platelet count, bleeding disorders ✔ Cryoprecipitate - Function: Clotting factors (FVIII, FXIII, vWF) - Storage: Frozen (-18°C) for up to 1 year - Indications: Hemophilia A, von Willebrand disease ✔ Fresh Frozen Plasma (FFP) - Function: Clotting factors, antibodies - Storage: Frozen (-18°C) for up to 1 year - Indications: Bleeding disorders, liver disease Granulocytes - Function: Fight infection - Storage: 24 hours at 20-24°C - Indications: Severe infections, neutropenia Albumin - Function: Maintain blood volume, transport proteins - Storage: 2-30°C for up to 3 years - Indications: Shock, burns, liver disease ◆ Component Preparation - Whole blood is collected from donors and processed into components - Centrifugation separates blood into layers: plasma, buffy coat (platelets & WBCs), and RBCs - Components are then extracted, tested, and stored for transfusion ◆ Component Transfusion RBCs: Anemia, blood loss, surgery - Plasma: Bleeding disorders, liver disease, shock - Platelets: Low platelet count, bleeding disorders - Cryoprecipitate: Hemophilia A, von Willebrand disease - FFP: Bleeding disorders, liver disease - Granulocytes: Severe infections, neutropenia ✔ Blood Banking Benefits - Component therapy allows for targeted treatment - Reduced risk of transfusion-related complications - Improved patient outcomes - Efficient use of donated blood In conclusion, blood components are essential for treating various medical conditions. Understanding their functions, storage requirements, and indications is crucial for availabiity safe and effective transfusion practice. #MedicalLaboratoryTechnology #Microbiology #Phlebotomy #LaboratoryTesting #DiagnosticTesting #HealthcareProfessional #MedicalTesting #ClinicalLaboratory #BiomedicalScience #HealthcareIndustry #MedicalScience #LaboratoryMedicine #ClinicalMicrobiology #InfectionControl #PhlebotomyTechnician #MedicalLabTechnician #MicrobiologyLab #ClinicalLab #HealthcareCareer #MedicalCareer #ScienceCareer #COVID19Testing #Virology #Bacteriology #Parasitology #MolecularDiagnosis #GeneticTesting #Cytology #Histopathology #Immunology #Serology

While fibrinogen is generally recognized as a critical blood clotting factor that can decline quickly in the massive hemorrhage patient, logistical challenges often prevent its rapid administration. Earlier this month, the American Journal of Clinical Pathology published the experience of Dr. Sethapati et al. with the implementation of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT Fibrinogen Complex (IFC), at Stanford Health Care’s Blood Bank. The publication, which details the positive impact of this blood component on waste and turnaround time at a single site, can be found here: https://ow.ly/HBIp50SAsrU #massivehemorrhage #transfusion #fibrinogen #IFC #INTERCEPT #AJCP INTERCEPT Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex: INDICATIONS FOR USE • Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. • Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available. • Second-line therapy for von Willebrand disease (vWD). • Control of uremic bleeding after other treatment modalities have failed. Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII. CONTRAINDICATIONS Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex. For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered. MKT-EN 00685-56, v1.0