Bracco Diagnostics Showcases Innovation and Collaborative Vision at RSNA 2023 Annual Meeting

2023-10-16

--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 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 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 www.fda.gov/medwatch

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 www.bracco.com.

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