Guerbet LLC

ELUCIREM™ (gadopiclenol) Injection Safety Data Poster Presentation First Place "Image of the Year" Winner of Applied Radiology and Guerbet 'Elucirem | The Reveal Image Challenge' to be Announced PRINCETON, N.J., Nov. 27, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today its schedule of activities at the 2023 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting from November 26-30 in Chicago, IL. In addition to the Guerbet exhibit (booth #1711), the company will be presenting safety data in an abstract titled "Safety of gadopiclenol for magnetic resonance imaging (MRI): a pooled analysis of eight studies." The session number W3-STCE1, will be presented as a scientific session on Wednesday, November 29 at 10:00-10:30 a.m. CST. Additionally, the "Elucirem | The Reveal Image Challenge" "Image of the Year" winner will be announced and unveiled at the Guerbet booth at RSNA on Monday, November 27th at 11:00 a.m. CST. The challenge, which was developed in partnership with Applied Radiology, provided MR imaging professionals with an opportunity to reveal their MR imaging potential and to share their MRI images using Elucirem™ (gadopiclenol) injection. A series of winning images were selected each month starting in May 2023, having been evaluated by a review committee, including MRI thought leaders and educators, Applied Radiology board members and Guerbet associates. Winning images were featured on the Applied Radiology website and social media platforms. All winning images will be available for viewing at the Guerbet RSNA booth. Poster Presentations Spotlight at the RSNA Innovation Theater Jeffrey H Maki, MD, PhD, Professor of Radiology and Director of MRI at the University of Colorado in Denver will be presenting "Relaxation properties of GBCAs In Vitro, in human blood – their unique behavior might surprise you" at 1:00 p.m. CST on Monday, November 27th. This presentation, which will take place in the RSNA Innovation Theater Exhibitor Pavillion in the South Hall, is based on a study done to measure T1 and T2 relaxivity In Vitro, in human blood. Digital Solutions Featured at Booth #1711 In addition to showcasing diagnostic and interventional solutions, Guerbet will also feature its digital and AI software-based products that help to close the loop with the smart connectivity between monitoring and reporting. Products that will be featured include: Dose & Care®, a state-of-the-art digital solution for monitoring patient exposure to X-rays that is compatible with all types of ionizing modalities and collects data to provide a record of patient exposure Contrast & Care®, an injection data management solution that enables imaging centers to collect, archive, examine, and share injection data, including data on contrast products, adverse events, injector activity, information on estimated glomerular filtration rate, and other risk factors before a clinical exam Icobrain, a cloud-based AI solution designed to quantify disease specific brain structures on MR and CT Galileo, an educational web-based case review platform to help train radiology residents Myrian®, a universal image processing solution that can be integrated into all healthcare information systems Optistar™ Elite, a dual head contrast delivery system with an ultrasonic motor that makes it non-magnetic, built for long lasting performance and now has the new Fractional Dosing capabilities About Elucirem™ This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), gadopiclenol has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,2 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.3,4 Elucirem™ (Gadopiclenol) injection is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).1 Guerbet received FDA approval of Elucirem™ (NDA 216986) on September 21, 2022 after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.5 GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons thanks to interaction with gadolinium atoms. Gadopiclenol, the active drug substance of Elucirem™, has been designed to enable twice as much interaction, resulting in the highest relaxivity among all non-specific GBCAs.2 This allows use at half the conventional gadolinium dose to reveal high quality images. Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina. About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for over 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our revenue to research and development in four centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated 753 million euros in revenue in 2022. For more information, please visit . About Gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) in adult and pediatric patients aged 2 years and older. (refer to the approved USPI for full information). Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov Gadopiclenol is currently in the process of examination by the European Medicines Agency. ELUCIREM™ (gadopiclenol) injection Important Safety Information Indications and Usage ELUCIREM™ (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). Contraindications History of hypersensitivity reactions to ELUCIREM Warnings and Precautions Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease as well as patients with acute kidney injury. Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within minutes of GBCA administration and resolved with prompt emergency treatment. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM. Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Do not exceed the recommended dose. Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM. Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when Gadopiclenol MRI scans are interpreted without a companion non-contrast MRI scan. Adverse Reactions: In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW. ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase. Use in Specific Populations Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (NSF). Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. No dose adjustment of ELUCIREM is recommended for patients with renal impairment. ELUCIREM can be removed from the body by hemodialysis You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the full Prescribing Information, including the Medication Guide, for additional important safety information. 1Elucirem [package insert]. Princeton, NJ: Guerbet LLC; 2022 2 Robic, C., Port, M., Rousseaux, O., Louguet, S., Fretellier, N., Catoen, S., Factor, C., Le Greneur, S., Medina, C., Bourrinet, P., Raynal, I., Idée, J. M., & Corot, C. (2019). Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Investigative radiology, 54(8), 475–484. 3 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023;58(5):307-313. doi:10.1097/RLI.0000000000000944 4 Kuhl C, Csőszi T, Piskorski W, et al. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023; 308(1). doi:10.1148/radiol.222612 5 US FDA. Priority Review. Available at: . Accessed August 22, 2022 SOURCE Guerbet

ELUCIREM™ (gadopiclenol) Injection Safety Data Poster Presentation First Place "Image of the Year" Winner of Applied Radiology and Guerbet 'Elucirem | The Reveal Image Challenge' to be Announced PRINCETON, N.J., Nov. 2, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today its schedule of activities at the 2023 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting from November 26-30 in Chicago, IL. In addition to the Guerbet exhibit (booth #1711), the company will be presenting safety data in an abstract titled "Safety of gadopiclenol for magnetic resonance imaging (MRI): a pooled analysis of eight studies." The session number W3-STCE1, will be presented as a scientific session on Wednesday, November 29 at 10:00-10:30 a.m. CST. Additionally, the "Elucirem | The Reveal Image Challenge" "Image of the Year" winner will be announced and unveiled at the Guerbet booth at RSNA on Monday, November 27th at 11:00 a.m. CST. The challenge, which was developed in partnership with Applied Radiology, provided MR imaging professionals with an opportunity to reveal their MR imaging potential and to share their MRI images using Elucirem™ (gadopiclenol) injection. A series of winning images were selected each month starting in May 2023, having been evaluated by a review committee, including MRI thought leaders and educators, Applied Radiology board members and Guerbet associates. Winning images were featured on the Applied Radiology website and social media platforms. All winning images will be available for viewing at the Guerbet RSNA booth. Poster Presentations Spotlight at the RSNA Innovation Theater Jeffrey H Maki, MD, PhD, Professor of Radiology and Director of MRI at the University of Colorado in Denver will be presenting "Relaxation properties of GBCAs In Vitro, in human blood – their unique behavior might surprise you" at 1:00 p.m. CST on Monday, November 27th. This presentation, which will take place in the RSNA Innovation Theater Exhibitor Pavillion in the South Hall, is based on a study done to measure T1 and T2 relaxivity In Vitro, in human blood. Digital Solutions Featured at Booth #1711 In addition to showcasing diagnostic and interventional solutions, Guerbet will also feature its digital and AI software-based products that help to close the loop with the smart connectivity between monitoring and reporting. Products that will be featured include: Dose & Care®, a state-of-the-art digital solution for monitoring patient exposure to X-rays that is compatible with all types of ionizing modalities and collects data to provide a record of patient exposure Contrast & Care®, an injection data management solution that enables imaging centers to collect, archive, examine, and share injection data, including data on contrast products, adverse events, injector activity, information on estimated glomerular filtration rate, and other risk factors before a clinical exam Icobrain, a cloud-based AI solution designed to quantify disease specific brain structures on MR and CT Galileo, an educational web-based case review platform to help train radiology residents Myrian®, a universal image processing solution that can be integrated into all healthcare information systems Optistar™ Elite, a dual head contrast delivery system with an ultrasonic motor that makes it non-magnetic, built for long lasting performance and now has the new Fractional Dosing capabilities About Elucirem™ This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), gadopiclenol has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,2 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.3,4 Elucirem™ (Gadopiclenol) injection is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).1 Guerbet received FDA approval of Elucirem™ (NDA 216986) on September 21, 2022 after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.5 GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons thanks to interaction with gadolinium atoms. Gadopiclenol, the active drug substance of Elucirem™, has been designed to enable twice as much interaction, resulting in the highest relaxivity among all non-specific GBCAs.2 This allows use at half the conventional gadolinium dose to reveal high quality images. Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina. About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for over 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our revenue to research and development in four centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated 753 million euros in revenue in 2022. For more information, please visit . About Gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) in adult and pediatric patients aged 2 years and older. (refer to the approved USPI for full information). Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov Gadopiclenol is currently in the process of examination by the European Medicines Agency. ELUCIREM™ (gadopiclenol) injection Important Safety Information Indications and Usage ELUCIREM™ (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). Contraindications History of hypersensitivity reactions to ELUCIREM Warnings and Precautions Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease as well as patients with acute kidney injury. Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within minutes of GBCA administration and resolved with prompt emergency treatment. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM. Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Do not exceed the recommended dose. Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM. Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when Gadopiclenol MRI scans are interpreted without a companion non-contrast MRI scan. Adverse Reactions: In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW. ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase. Use in Specific Populations Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (NSF). Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. No dose adjustment of ELUCIREM is recommended for patients with renal impairment. ELUCIREM can be removed from the body by hemodialysis You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the full Prescribing Information, including the Medication Guide, for additional important safety information. 1Elucirem [package insert]. Princeton, NJ: Guerbet LLC; 2022 2 Robic, C., Port, M., Rousseaux, O., Louguet, S., Fretellier, N., Catoen, S., Factor, C., Le Greneur, S., Medina, C., Bourrinet, P., Raynal, I., Idée, J. M., & Corot, C. (2019). Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Investigative radiology, 54(8), 475–484. 3 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023;58(5):307-313. doi:10.1097/RLI.0000000000000944 4 Kuhl C, Csőszi T, Piskorski W, et al. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023; 308(1). doi:10.1148/radiol.222612 5 US FDA. Priority Review. Available at: . Accessed August 22, 2022 SOURCE Guerbet

--Leaders in Radiology Will Share Insights on VUEWAY® (gadopiclenol) solution for injection After the First Year of Use in the U.S.-- --Applied Radiology to Announce Expansion of the Bracco-Supported "Leaders on the Horizon" Program-- MONROE TOWNSHIP, N.J., Oct. 16, 2023 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a pioneer in diagnostic imaging, is showcasing its commitment to innovation and purpose-driven partnership at the Radiological Society of North America (RSNA) 2023 Annual Meeting, to be held November 26-30 in Chicago, Illinois. This year, Bracco's activities at RSNA are captured by the theme, "Unlocking the Invisible." Through this overarching vision, Bracco is demonstrating its dedication to maximizing diagnostic accuracy and resource efficiency with the aim of improving people's lives. Engagement Opportunities Hosted by Bracco at RSNA 2023: MR Symposium: Bracco presents "The Future is Now: The Novel GBCA Gadopiclenol." This symposium will feature insights from leaders in radiology on how they have implemented VUEWAY injection into their practice since its FDA approval last year, using half the gadolinium (0.05 mmol/kg) compared to other macrocyclic GBCAs with approved doses of 0.1 mmol/kg in approved indications in the U.S.i-v The event will take place on Monday, November 27 at McCormick Place S101AB, South Building, from 9:00 AM – 10:00 AM CST. Please see Indications and Important Safety Information below, including Boxed Warning. "I am delighted to participate in this Bracco-sponsored symposium, as it will be a great opportunity for anyone interested in learning more about gadopiclenol and our initial experience with it for abdominal MR imaging at the University of Wisconsin to date," said Perry J. Pickhardt, MD, Professor of Radiology and Chief of Gastrointestinal Imaging at the University of Wisconsin School of Medicine and Public Health. Max Wintermark, MD, Professor and Chair of Neuroradiology at The University of Texas MD Anderson Cancer Center, said, "I am excited to participate in the Round Table Symposium sponsored by Bracco Diagnostics Inc. This will be a great opportunity for anyone interested in learning more about gadopiclenol and what our experience has been at MD Anderson Cancer Center to date." Supporting the Future of Diagnostic Imaging: The Applied Radiology "Leaders on the Horizon" Residency Program, which is supported by Bracco through an unrestricted educational grant, is expanding globally and will now include all diagnostic imaging modalities. Through this program, scholarships are bestowed upon six radiology resident applicants whose submitted research papers (three clinical research papers and three clinical review articles) are selected for publication by Applied Radiology. These individuals will be honored at a special evening reception hosted by Applied Radiology during RSNA 2023. Additionally, Bracco is thrilled to be entering the fourth year of its 10-year commitment to donate $450,000 to the RSNA Research & Education (R&E) Foundation. Visit Bracco's Booth (#3300): Bracco's booth experience will highlight an array of product offerings and partnerships, including: Comprehensive Diagnostic Contrast Imaging and Delivery Solutions: Bracco remains the sole provider of such a comprehensive breadth of barium sulfate contrast agents following FDA mandates. The company's ongoing commitment to providing a full selection of contrast agents demonstrates its dedication to improving patient diagnostics. Subtle Medical Collaboration: Bracco and Subtle Medical have joined forces in a global collaboration, aiming to explore the integration of artificial intelligence-powered image acquisition, particularly in the context of MR imaging. "At this year's RSNA meeting, we are pleased to demonstrate our dedication to advancing the field of medical imaging through rigorous research and thoughtful, strategic partnership," said Cosimo DePinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics Inc. "Our goal, as it has always been, is to maximize diagnostic efficiency and effectiveness across the full spectrum of imaging procedures, enabling healthcare providers to provide the highest level of care to their patients." Connect with Bracco on LinkedIn and follow #BraccoImaging for more RSNA news. Indications VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine and surrounding tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). IMPORTANT SAFETY INFORMATION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindications VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY. Warnings Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration. Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible. Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Ensure catheter and venous patency before injecting as extravasation may occur, and cause tissue irritation. VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan. The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information for VUEWAY, including BOXED WARNING on Nephrogenic Systemic Fibrosis. Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616. VUEWAY is a registered trademark of Bracco Imaging S.p.A. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit . i. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022. ii. DOTAREM® (gadoterate meglumine) Injection full Prescribing Information. Princeton, NJ: Guerbet LLC; October 2019. iii. GADAVIST® (gadobutrol) Injection full Prescribing Information and Patient Medication Guide. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2022. iv. ProHance® (Gadoteridol) Injection, 279.3 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022. v. CLARISCAN™ (gadoterate meglumine) injection for intravenous use full Prescribing Information. Chicago IL: GE Healthcare; November 2020. SOURCE Bracco Imaging