84 press releases in English indexed under medical devices.
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Berlin, Germany, June 17, 2026 – Bayer today announced the completion of the acquisition of Perfuse Therapeutics, Inc. As a result, Perfuse Therapeutics will now be fully integrated into Bayer. As announced previously, Bayer now holds the full rights pertaining to PER-001 intravitreal implant, a first in class, sustained release small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR). This acquisition strengthens Bayer’s pharmaceutical pipeline and strategically fits with Bayer’s strong footprint and expertise in ophthalmology. Under the terms of the agreement, Bayer paid an upfront payment of USD 300 million. The transaction carries a total potential value of up to USD 2.45 billion, comprising of the upfront payment and additional success-based milestone payments. For Bayer, BofA Securities acted as exclusive financial advisor and Baker McKenzie acted as legal counsel. For Perfuse, Centerview Partners LLC acted as exclusive financial advisor and Goodwin Procter LLP acted as legal counsel. About Perfuse Therapeutics Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. About Bayer' Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contact for media inquiries: Lisa Varrelmann, phone: +49 1746466492 Email: lisa.varrelmann@bayer.com Contact for investor inquiries:' Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com' www.bayer.com/de/investoren/ir-team
Not intended for U.S. and UK Media Bayer’s low-dose MRI contrast agent gadoquatrane approved in U.S. Gadoquatrane from Bayer receives FDA approval for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions / Gadoquatrane becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight, corresponding to 0.04 mmol Gd/kg body weight / Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight / Gadoquatrane received its first approval in Japan in March 2026, further submissions to health authorities worldwide are ongoing to secure marketing authorization in additional markets Berlin, June 15, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved gadoquatrane, a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) under the brand name Ambelvist™. The product is indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. Gadoquatrane is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). With this approval, gadoquatrane becomes the lowest dose mGBCA in the U.S. It has a recommended dose of 0.01 mmol/kg actual body weight (which corresponds to 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol dosed at 0.05 mmol Gd/kg body weight. There is a rising need for medical imaging, driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases. Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body and can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. For some adults and children with chronic diseases or conditions that require close, long-term monitoring – such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer – regular, repeat administrations may be required. “I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities, USA, and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.” “Bayer is a leader in radiology and has played a pioneering role in MRI contrast agent development, having launched the first gadolinium-based contrast agent in 1988,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “With gadoquatrane – a next generation high-relaxivity, low-dose MRI contrast agent demonstrating high stability – we continue driving advances for patients and their treating physicians. Reducing patients’ lifetime exposure to gadolinium is an important consideration and reflects the growing clinical guidance to use the lowest gadolinium dose necessary to adequately image patients.” Gadoquatrane received its first approval in Japan in March 2026, and Bayer has submitted applications for marketing authorization in additional markets around the world, including the EU and China, with more to follow. Key Clinical Trial Findings The FDA’s approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of gadoquatrane in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. Key findings demonstrated: · Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in gadoquatrane compared with only pre-contrast MRI images. · Visualization scores and number of lesions identified per blinded independent reader for gadoquatrane dosed at 0.01 mmol/kg body weight (which corresponds to 0.04 mmol Gd/kg body weight) were similar to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight. · Use in children is supported by evidence from adequate and well-controlled studies of gadoquatrane in adults, with additional pharmacokinetic and safety data from the pediatric study, including 93 patients aged 28 days to less than 18 years who received one 0.01mmol/kg dose and underwent MRI of any body region. About gadoquatrane Gadoquatrane is Bayer’s extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity. The compound has been approved under the brand name Ambelvist™ in Japan in March 2026 and in the U.S. in June 2026. It has not been approved in any other jurisdiction. Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world. About MRI MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. MRI contrast agents commonly contain gadolinium. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide. Cumulatively, since 1988, more than 900 million GBCA doses have been delivered globally. About Radiology at Bayer Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Global contact for media inquiries: Victoria Vigener, phone +49 151 23438911 Email: victoria.vigener@bayer.com US contact for media inquiries: Elaine Colon, phone +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com www.bayer.com/de/investoren/ir-team
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Berlin, Germany and San Francisco, California USA, May 6, 2026 – Bayer and Perfuse Therapeutics Inc. today announced an agreement under which Bayer will fully acquire Perfuse Therapeutics, a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. With this acquisition, Bayer will hold the full rights pertaining to PER-001, a small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR). This represents one of the first potential treatments for Glaucoma and DR being studied for its ability to improve the visual field for Glaucoma patients and to improve contrast sensitivity and reduce ischemia in DR patients. “We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer Pharmaceuticals. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.” “I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators," said Sevgi Gurkan, MD, Founder and CEO of Perfuse Therapeutics, Inc. "Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.” Glaucoma is a progressive optic neuropathy that causes the loss of retinal ganglion cells, resulting in loss of visual fields. It is the leading cause of irreversible vision loss1 affecting ~76-80 million people worldwide (2020) and is projected to affect ~112 million people by 2040 due to population aging.2 Despite its prevalence, there are no approved treatments today, preventing disease progression and blindness independently from the saturated approach of lowering intraocular pressure. There is a high unmet medical need for neuroprotective treatments for patients with Glaucoma. Diabetic Retinopathy (DR) is a microvascular complication of diabetes that damages retinal capillaries, causing ischemia, leakage, and neovascularization affecting about 146 million people globally today. This includes about 25 percent of adults with diabetes and is projected to increase to 160 million people by 2045. Currently, 25 million people have vision‑threatening DR and 1.3 million people are blind.3 Under the terms of the agreement, the transaction carries a total potential value of up to USD 2.45 billion, comprising a USD 300 million upfront payment and additional development, regulatory, and commercial milestone payments based on success criteria. For Bayer, BofA Securities is acting as exclusive financial advisor and Baker McKenzie is acting as legal counsel. For Perfuse, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel. The acquisition is subject to and will become effective after receiving the necessary antitrust clearances and Perfuse stockholder approvals. About PER-001 PER-001 is an investigational small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Endothelin is the most potent vasoconstrictor in the human body and is upregulated in glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. Endothelin is involved in inflammation and cell death through its receptors expressed in retinal vascular and neuroretinal cells. The PER-001 intravitreal implant is a bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of PER-001, allowing for a convenient dosing regimen. About Perfuse Therapeutics Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. For more information, visit www.perfusetherapeutics.com and LinkedIn. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. 1 Vision Loss Expert Group of the Global Burden of Disease, 2024, Eye ² Sarkis et al., 2025, Frontiers in Med ³ WHO, 2019, World report on vision Executive Summary Bayer Global Media Contact: Lisa Varrelmann, phone +49 1746466492 Email: lisa.varrelmann@bayer.com Contact for investor inquiries: Bayer Investor Relations Team, phone +49 214 30-72704 Email: ir@bayer.com www.bayer.com/de/investoren/ir-team Perfuse Therapeutics Media Contact: Perfuse Therapeutics Team Email: info@perfusetherapeutics.com Perfuse Therapeutics investor inquiries: Perfuse Therapeutics Team Email: info@perfusetherapeutics.com
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