MA-GE-HEALTHCARE
13.9.2022 14:06:34 CEST | Business Wire | Press release
GE Healthcare and Lantheus Holdings Inc (NASDAQ: LNTH) have announced that the recent Phase III clinical trial of their investigational radiotracer, [18F]flurpiridaz, has met its co-primary endpoints of exceeding a 60 percent threshold for both sensitivity and specificity for detecting Coronary Artery Disease (CAD). The findings, shared at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida, U.S., also demonstrate [18F]flurpiridaz Positron Emission Tomography (PET) has higher diagnostic efficacy and image quality in patients with suspected CAD, compared with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the predominant procedure used in nuclear cardiology today. SPECT MPI represents approximately 6 million procedures per year in the U.Si.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220913005138/en/
The Phase III Open-Label Study, which involved over 600 patients across sites in the U.S., Europe and Canada assessed the diagnostic efficacy of [18F]flurpiridaz in detecting CAD, the most common form of heart diseaseii and the leading cause of death globallyiii, with invasive coronary angiography as a standard of truth. More than 120 million people are affected by CAD globally each yeariv and in the U.S. alone, approximately 20 million adults have CAD, with nearly 383,000 deaths recorded in 2020v.
If approved, this investigational agent would offer the advantages of 18F, with broad available distribution and a half-life of almost two hours, removing the need for it to be manufactured in the immediate vicinity of the imaging department. This longer half-life could also make Flurpiridaz (18F) Injection suitable for exercise stress testing, which is not feasible with existing cardiac PET radiotracers.
Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke's Hospital, Missouri, US, shared: “These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [18F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.”
Dr. Francois Tranquart, MD, PhD, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, said: “The positive Phase III trial results are a key step towards future approval of Flurpiridaz (18F) Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease. This is another example of GE Healthcare investing in our portfolio of Molecular Imaging products to help improve diagnostic accuracy and patient outcomes.”
GE Healthcare has led the funding and development of [18F]flurpiridaz, and, if the imaging agent is approved, will have global commercialization rights. Lantheus has collaborated on the development and will also collaborate on potential commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales.
GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Its Molecular Imaging portfolio combines an innovative pipeline with established proprietary products across cardiology, neurology and oncology.
About GE Healthcare:
GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.
About Lantheus
With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
###
i Data on File: AMR Market Guide 2021.
ii WHO Factsheet 2020. Cardiovascular diseases (CVDs). 11 June 2021.
iii Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.
iv Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.
v Centers for Disease Control and Prevention. Heart Disease Facts. Accessed July 15 2022.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220913005138/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Barilla Opens Global Call for Startups Through Good Food Makers 202625.5.2026 11:47:00 CEST | Press release
The program has involved over 1,100 startups across 50+ countries, delivering 26 pilot projects. Barilla Group has opened applications for the 2026 edition of Good Food Makers, its global open innovation program designed to co-develop and test new innovative solutions with startups and innovators inside real industrial environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521973445/en/ Since its launch in 2019, the program has involved more than 1,100 startups from over 50 countries, leading to 26 pilot projects, with over 20 projects currently active thanks to the solutions developed by the program’s alumni. This highlights the program’s role as a concrete platform for industrial scalable innovation. The 2026 edition comes at a pivotal moment for the company, following the launch of BITE (Barilla Innovation & Technology Experience), the new innovation center dedicated to developing the next generation of food prod
JEOL: Sales Launch of the Laser SEM System “LazEdge”25.5.2026 10:16:00 CEST | Press release
JEOL Ltd. (President & CEO: Izumi Oi) has developed the “LazEdge”, an SEM system equipped with a laser processing system, and begins sales on May 25, 2026. Cross-section preparation instruments such as the focused ion beam system (FIB system), are widely used in science and technology fields across research institutes, universities, and industries. In recent years, demand is increasing for a system that can process large-areas at a high speed, while achieving high-quality of the processed surface. “LazEdge” is an instrument integrating JEOL’s SEM with the laser technology proprietary of Hamamatsu Photonics K.K., and enables laser processing inside the specimen chamber of the electron microscope. This system enables high-quality cross-section specimens produced through high-speed, large-area processing to be transferred seamlessly to subsequent analyses, such as SEM observation, elemental analysis, and crystal orientation analysis, without exposure to the external environment. As a resu
TFG-001, A Novel 3D Neural Microtissue Cell Therapy, Demonstrates Superior Functionality and Reinnervation for Parkinson’s Disease25.5.2026 08:00:00 CEST | Press release
TreeFrog Therapeutics, a regenerative medicine biotech company developing next-generation cell therapies, today announced that it will present new preclinical data on TFG-001 at the 7th World Parkinson’s Conference. TFG-001, a 3D neural microtissue cell therapy, demonstrated rapid dopamine release and extensive graft-derived reinnervation across multiple advanced translational Parkinson’s disease models—supporting its potential as a best-in-class candidate. The critical need for reinnervation in Parkinson's disease In Parkinson's disease, an estimated 60–80% of dopaminergic neurons are already lost before motor symptoms even appear. The nigrostriatal pathway degenerates, destroying the essential wiring that connects dopamine-producing neurons to movement control. While chemical dopamine replacements (like levodopa) can manage symptoms, they cannot restore the spatial precision, feedback loops, or dynamic regulation of a healthy brain network. To achieve true functional restoration, it
Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release
A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom