Guerbet is a mid-sized corporation with the goal of becoming a prominent global player in the field of medical imaging. With a rich history of 90 years in the development of contrast media, the company is the sole pharmaceutical group worldwide that specializes in medical imaging. Through a network of subsidiaries and distributors, Guerbet has a presence in nearly 80 countries. The company provides an extensive array of products for CT scan, Cath Lab, Magnetic Resonance Imaging (MRI), and Interventional Radiology and Theranostic (IRT), as well as injectors and associated medical devices, all aimed at enhancing patients' diagnosis, prognosis, and overall well-being.

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Neoplasms

Small molecule drug

Contrast agent

Chemical drugs

Disease domain score

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Disease Domain	Count

Neoplasms	4
Nervous System Diseases	2
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	6
Contrast agent	4
Chemical drugs	1

Drugs associated with Guerbet SA

Gadopiclenol

Target-

Mechanism-

Active Org.

Bracco Imaging SpA [+2]

Originator Org.

Guerbet France SAS

Active Indication

Contrast agents [+7]

Inactive Indication

Blood brain barrier defect [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date21 Sep 2022

Gadoterate Meglumine

Target-

Mechanism

Magnetic resonance imaging enhancers

Active Org.

Guerbet SA [+2]

Originator Org.

Guerbet France SAS

Active Indication

Vascular Diseases [+2]

Inactive Indication

Central Nervous System Diseases [+4]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

Japan

First Approval Date22 Sep 2000

Ioxilan

Target-

Mechanism

Radiography enhancers

Active Org.-

Originator Org.

Guerbet SA

Active Indication

Vascular Diseases

Inactive Indication

Contrast agents

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date21 Dec 1995

Clinical Trials associated with Guerbet SA

NCT05954559

/ Not yet recruitingPhase 4IIT

High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment

Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be 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). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.

Start Date15 Jun 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT06127810

/ WithdrawnNot ApplicableIIT

A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)

The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection

Start Date30 Dec 2024

Sponsor / Collaborator

The Medical University of South Carolina

[+1]

CTRI/2024/10/075817

/ Not yet recruitingPhase 4

Active surveillance in India of the safety of Dotarem®, a gadolinium-based contrast agent. Post-marketing observational, surveillance study - NA

Start Date04 Nov 2024

Sponsor / Collaborator

Guerbet SA

100 Clinical Results associated with Guerbet SA

0 Patents (Medical) associated with Guerbet SA

269

Literatures (Medical) associated with Guerbet SA

01 Feb 2022·Investigative RadiologyQ1 · MEDICINE

Small Brain Lesion Enhancement and Gadolinium Deposition in the Rat Brain

Q1 · MEDICINE

Article

Author: Idee, Jean-Marc ; Robert, Philippe ; Factor, Cecile ; Corot, Claire ; Violas, Xavier ; Rasschaert, Marlene ; Catoen, Sarah ; Santus, Robin

ObjectivesThe aim of the set of studies was to compare gadopiclenol, a new high relaxivity gadolinium (Gd)–based contrast agent (GBCA) to gadobenate dimeglumine in terms of small brain lesion enhancement and Gd retention, including T1 enhancement in the cerebellum.Materials and MethodsIn a first study, T1 enhancement at 0.1 mmol/kg body weight (bw) of gadopiclenol or gadobenate dimeglumine was evaluated in a small brain lesions rat model at 2.35 T. The 2 GBCAs were injected in an alternated and cross-over manner separated by an interval of 4.4 ± 1.0 hours (minimum, 3.5 hours; maximum, 6.1 hours; n = 6). In a second study, the passage of the GBCAs into cerebrospinal fluid (CSF) was evaluated by measuring the fourth ventricle T1 enhancement in healthy rats at 4.7 T over 23 minutes after a single intravenous (IV) injection of 1.2 mmol/kg bw of gadopiclenol or gadobenate dimeglumine (n = 6/group). In a third study, Gd retention at 1 month was evaluated in healthy rats who had received 20 IV injections of 1 of the 2 GBCAs (0.6 mmol/kg bw) or a similar volume of saline (n = 10/group) over 5 weeks. T1 enhancement of the deep cerebellar nuclei (DCN) was assessed by T1-weighted magnetic resonance imaging at 2.35 T, performed before the injection and thereafter once a week up to 1 month after the last injection. Elemental Gd levels in central nervous system structures, in muscle and in plasma were determined by inductively coupled plasma mass spectrometry (ICP-MS) 1 month after the last injection.ResultsThe first study in a small brain lesion rat model showed a ≈2-fold higher number of enhanced voxels in lesions with gadopiclenol compared with gadobenate dimeglumine. T1 enhancement of the fourth ventricle was observed in the first minutes after a single IV injection of gadopiclenol or gadobenate dimeglumine (study 2), resulting, in the case of gadopiclenol, in transient enhancement during the injection period of the repeated administrations study (study 3). In terms of Gd retention, T1 enhancement of the DCN was noted in the gadobenate dimeglumine group during the month after the injection period. No such enhancement of the DCN was observed in the gadopiclenol group. Gadolinium concentrations 1 month after the injection period in the gadopiclenol group were slightly increased in plasma and lower by a factor of 2 to 3 in the CNS structures and muscles, compared with gadobenate dimeglumine.ConclusionsIn the small brain lesion rat model, gadopiclenol provides significantly higher enhancement of brain lesions compared with gadobentate dimeglumine at the same dose. After repeated IV injections, as expected for a macrocyclic GBCA, Gd retention is minimalized in the case of gadopiclenol compared with gadobenate dimeglumine, resulting in no T1 hypersignal in the DCN.

01 Dec 2021·Investigative RadiologyQ1 · MEDICINE

Safety and Gadolinium Distribution of the New High-Relaxivity Gadolinium Chelate Gadopiclenol in a Rat Model of Severe Renal Failure

Q1 · MEDICINE

Article

Author: Idee, Jean-Marc ; Bocanegra, Julien ; Factor, Cecile ; Seron, Aymeric ; Rasschaert, Marlene ; Robert, Philippe ; Corot, Claire ; Fretellier, Nathalie

ObjectiveThe aim of this study was to investigate the toxicological profile of gadopiclenol, a new high-relaxivity macrocyclic gadolinium-based contrast agent (GBCA), in renally impaired rats, in comparison with 2 other macrocyclic GBCAs, gadoterate meglumine and gadobutrol, and 1 linear and nonionic GBCA, gadodiamide.MethodsRenal failure was induced by adding 0.75% wt/wt adenine to the diet for 3 weeks. During the second week of adenine-enriched diet, the animals (n = 8/group × 5 groups) received 5 consecutive intravenous injections of GBCA at 2.5 mmol/kg per injection, resulting in a cumulative dose of 12.5 mmol/kg or saline followed by a 3-week treatment-free period after the last injection. The total (elemental) gadolinium (Gd) concentration in different tissues (brain, cerebellum, femoral epiphysis, liver, skin, heart, kidney, spleen, plasma, urine, and feces) was measured by inductively coupled plasma mass spectrometry. Transmission electron microscopy (and electron energy loss spectroscopy analysis of metallic deposits) was used to investigate the presence and localization of Gd deposits in the skin. Relaxometry was used to evaluate the presence of dissociated Gd in the skin, liver, and bone. Skin histopathology was performed to investigate the presence of nephrogenic systemic fibrosis–like lesions.ResultsGadodiamide administrations were associated with high morbidity-mortality but also with macroscopic and microscopic skin lesions in renally impaired rats. No such effects were observed with gadopiclenol, gadoterate, or gadobutrol. Overall, elemental Gd concentrations were significantly higher in gadodiamide-treated rats than in rats treated with the other GBCAs for all tissues except the liver (where no significant difference was found with gadopiclenol) and the kidney and the heart (where statistically similar Gd concentrations were observed for all GBCAs). No plasma biochemical abnormalities were observed with gadopiclenol or the control GBCAs. Histopathology revealed a normal skin structure in the rats treated with gadopiclenol, gadoterate, and gadobutrol, contrary to those treated with gadodiamide. No evidence of Gd deposits on collagen fibers and inclusions in fibroblasts was found with gadopiclenol and its macrocyclic controls, unlike with gadodiamide. Animals of all test groups had Gd-positive lysosomal inclusions in the dermal macrophages. However, the textures differed for the different products (speckled texture for gadodiamide and rough-textured appearance for the 2 tested macrocyclic GBCAs).ConclusionsNo evidence of biochemical toxicity or pathological abnormalities of the skin was observed, and similar to other macrocyclic GBCAs, gadoterate and gadobutrol, tissue retention of Gd was found to be low (except in the liver) in renally impaired rats treated with the new high-relaxivity GBCA gadopiclenol.

13 Apr 2021·2021 IEEE 18th International Symposium on Biomedical Imaging (ISBI)

Contrast-Enhanced Brain MRI Synthesis With Deep Learning: Key Input Modalities and Asymptotic Performance

Author: Marc-Michel Rohe ; Jean-Philippe Lamarque ; Samy Ammari ; Corinne Balleyguier ; Alexandre Bone ; Francois Nicolas ; Emilie Chouzenoux ; Mickael Elhaik ; Nathalie Lassau ; Philippe Robert

Contrast-enhanced medical images offer vital insights for the accurate diagnosis, characterization and treatment of tumors, and are routinely used worldwide. Acquiring such images requires to inject the patient intravenously with a gadolinium-based contrast agent (GBCA). Although GBCAs are considered safe, recent concerns about their accumulation in the body tilted the medical consensus towards a more parsimonious usage. Focusing on the case of brain magnetic resonance imaging, this paper proposes a deep learning method that synthesizes virtual contrast-enhanced T1 images as if they had been acquired after the injection of a standard 0.100mmol/kg dose of GBCA, taking as inputs complementary imaging modalities obtained either after a reduced injection at 0.025mmol/kg or without any GBCA involved. The method achieves a competitive structural similarity index of 94.2%. Its asymptotic performance is estimated, and the most important input modalities are identified.

News (Medical) associated with Guerbet SA

03 Feb 2025

·www.globenewswire.com

GUERBET : Implementation of a Liquidity Contract with NATIXIS ODDO BHF

Implementation of a Liquidity Contract with NATIXIS ODDO BHF Villepinte, 3 February 2025: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, ends its liquidity contract ongoing since 9 March 2022 and announces having appointed NATIXIS and ODDO BHF to implement a liquidity contract, starting on 3 February 2025, for a period of one year tacitly renewable. This contract complies with the decision of the Autorité des marchés financiers (AMF) n°2021-01 of June, 22 2021 related to the establishing of liquidity contracts on shares as accepted market practice and the standard contract of the Association française des marchés financiers (AMAFI). This contract with NATIXIS ODDO BHF aims at improving Company’s shares trading on the regulated market of Euronext Paris Before the termination, the following resources were allocated to the liquidity account: 10 996 shares340 083.86 euros The following resources have been allocated to the liquidity account: 10 996 shares340 083.86 euros The execution of the liquidity contract may be suspended upon occurrence of the following events or conditions: when all conditions provided in Article 5 of the AMF Decision n°2021-01 June 22, 2021 are met;if the share is listed outside the thresholds authorized by the Company’s Shareholders’ Meeting;upon the Company request. The liquidity contract may be terminated at any time and without prior notice by GUERBET, at any time by NATIXIS and/or ODDO BHF SCA subject to fifteen (15) calendar days' notice About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, in United States and Israël. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Contacts:GuerbetJérôme Estampes, Chief Financial Officer + 33 1 45 91 50 00 / jerome.estampes@guerbet.comChristine Allard, Head of Public Affairs and Communications: +33 6 30 11 57 82 / christine.allard@guerbet.com Seitosei.ActifinMarianne Py, Financial Communication + 33 1 80 48 25 31 / marianne.py@seitosei-actifin.comJennifer Jullia, Press +33 1 56 88 11 19 / jennifer.jullia@seitosei-actifin.com Attachment GUERBET - Implementation of a liquidity contract with NATIXIS ODDO BHF 03 02 2025

Financial StatementExecutive Change

13 Jan 2025

·www.globenewswire.com

Correction: GUERBET : Financial agenda for 2025

Financial agenda for 2025 Villepinte, 13 janvier 2025: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is announcing its financial agenda for 2025. Publications calendar 2024 ANNUAL REVENUE February 06, 2025, after trading 2024 ANNUAL RESULTS March 25, 2025, after trading 2025 1st QUARTER REVENUE April 24, 2025, after trading ANNUAL SHAREHOLDERS’ MEETING May 23, 2025 2025 2nd QUARTER REVENUE July 24, 2025, after trading 2025 FIRST HALF RESULTS September 22, 2025, after trading 2025 3rd QUARTER REVENUE October 23, 2025, after trading About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, in United States and Israël. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Contacts: Guerbet Jérôme Estampes, Chief Financial Officer + 33 1 45 91 50 00 / jerome.estampes@guerbet.com Christine Allard, Head of Public Affairs and Communications: +33 6 30 11 57 82 / christine.allard@guerbet.com Seitosei.Actifin Marianne Py, Financial Communication + 33 1 80 48 25 31 / marianne.py@seitosei-actifin.comJennifer Jullia, Press +33 1 56 88 11 19 / jennifer.jullia@seitosei-actifin.com Attachment GUERBET_Agenda financier 2025 EN

Financial Statement

13 Jan 2025

·www.argonmedical.com

Argon Medical Expands Oncology Product Offering with Acquisition of the SeQure® and DraKon™ Microcatheters

PLANO, Texas, January 14, 2025 /PRNewswire/ — Argon Medical, a leading provider of medical device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announces the acquisition of certain assets of Accurate Medical Therapeutics, Ltd., the manufacturer and distributor of the SeQure® and DraKon™ microcatheters, from Guerbet SA, a global leader in medical imaging. The addition of the SeQure and Drakon microcatheters to Argon’s portfolio extends the company’s oncology offering to include therapeutic devices and accessories. Argon is already well-established in diagnostic oncology through its vast portfolio of biopsy devices. Microcatheters such as SeQure and DraKon are commonly used by physicians to conduct interventional procedures in which therapeutic agents or devices are introduced into the small vessels delivering blood to a tumor or abnormality. As such, physicians often select a microcatheter for a procedure based on the catheter’s ability to navigate to the target and its compatibility with therapeutic agents or devices. Both the SeQure and Drakon catheters earned a strong reputation for being easy to navigate and broadly compatible. Further, SeQure is the only reflux control microcatheter designed to create a fluid barrier that directs the flow of therapeutic agents and devices toward the intended target. “A microcatheter can make or break a procedure,” said Dr. Neal Khurana, MD. “A well-designed microcatheter determines whether you achieve precise navigation, efficient delivery of embolic materials, and ultimately, optimal patient outcomes. The DraKon and SeQure microcatheters have become preferred tools in my practice due to their dependable trackability through tortuous vessels, the performance of their hydrophilic coating, and their ability to deliver contrast and embolics efficiently, even through the smallest catheter sizes.” Dr. Khurana is a leading interventional radiologist and co-founder of EmboPartners, a physician-run organization that specializes in minimally invasive vascular embolization procedures for improved patient care. “Adding the SeQure and DraKon microcatheters to our existing product portfolio marks an important first step in expanding the products we offer interventional oncologists beyond diagnostic procedures and into therapeutic delivery,” said George Leondis, President & CEO, Argon Medical. “As we do so, we also expand the ways in which we can improve the lives of patients and caregivers through the delivery of best-in-class medical devices and superior service, in alignment with our company mission.” Following the close of this acquisition, Argon will transition manufacturing of the SeQure and DraKon catheters to the company’s primary manufacturing facility in Athens, Texas. Once complete, Argon intends to re-commercialize both microcatheters in all markets where they were sold previously and evaluate new opportunities to supply these products to new markets.

AcquisitionDiagnostic Reagents

100 Deals associated with Guerbet SA

100 Translational Medicine associated with Guerbet SA

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Pipeline Snapshot as of 12 May 2025

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Iothalamate Meglumine	Peripheral Arterial Disease More	Approved
Gadoterate Meglumine	Contrast agents More	Approved
Sodium Chloride	Contrast agents More	Approved
Gadopiclenol	Diagnostic agents More	Approved
Ioversol	Contrast agents More	Approved

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