AUS
NZ
UK
CA
USA
IND
Highlights
- GE HealthCare completes Phase I trial for innovative manganese-based MRI contrast agent.
- New contrast agent shows promising safety profile, potentially reducing environmental impact.
- GE HealthCare celebrates 150 years of innovation in Norway while advancing patient care.
GE HealthCare (Nasdaq:GEHC) has announced the successful completion of its Phase I clinical development program for a groundbreaking manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. The results of this first-in-human study, presented at the 2024 bi-annual Contrast Media Research symposium in Oslo, Norway, indicated that the manganese-based agent was well tolerated, with no serious adverse events, dose-limiting toxicities, or clinically relevant findings reported. These findings pave the way for further clinical development and potential market introduction.
Traditionally, MRI contrast agents have been gadolinium-based, which help enhance the visualization of abnormal structures or lesions, thereby aiding in the differentiation between healthy and pathological tissue. The new manganese-based agent not only demonstrates comparable relaxivity to gadolinium-based agents—meaning it can enhance signal intensity effectively—but is also expected to deliver similar diagnostic capabilities. Importantly, manganese is a naturally occurring element that is efficiently eliminated from the body, potentially offering a safer alternative to gadolinium. This innovation is particularly significant amid growing concerns over gadolinium retention in patients and its environmental impact after excretion.
Dr. Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics segment, expressed optimism about the Phase I results. He stated, “These are encouraging findings for this manganese-based contrast agent, and we look forward to completing the next steps in the clinical development process. This is part of our pipeline of products aimed at improving patient outcomes across care pathways.”
Dr. Robert J. McDonald, a radiologist at Mayo Clinic and a board member of the Contrast Media Safety Committee for the American College of Radiology, highlighted the potential benefits of the manganese-based agent. He noted, “This contrast agent could offer reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents, while providing comparable imaging capabilities and potentially lower environmental impact.”
The Phase I trial was conducted at the clinical research unit at Oslo University Hospital, Rikshospitalet, Norway, with partial funding from the Norwegian Research Council. GE HealthCare operates two contrast media facilities in Norway: one in Oslo, where the manganese-based agent was developed, is celebrating its 150th anniversary, and the other in Lindesnes has been producing active pharmaceutical ingredients for 50 years.
Kevin O’Neill, President and CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, remarked on the significance of these milestones, stating, “The Phase I results are a reminder of Norway’s heritage of innovation that has shaped the field of diagnostic imaging, improving patient outcomes worldwide. We aim to offer more choices to radiologists, delivering a broad portfolio that can enable personalized care and address unmet patient needs.”
With GE HealthCare’s Pharmaceutical Diagnostics unit leading the market in imaging agents used in 120 million procedures annually—equivalent to four patient procedures every second—this new manganese-based contrast agent represents a promising step forward in enhancing diagnostic imaging while potentially improving patient safety and environmental outcomes.
