PRESS RELEASE
Life Molecular Imaging Expands Neuraceq® (florbetaben F-18 injection) Production in Decatur, IL
Unlocking access across the Midwest, bringing Neuraceq® to more patients
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]]>Boston, October 7, 2025 – Life Molecular Imaging (LMI), a Lantheus company, and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that Neuraceq® is now available from SOFIE’s radiopharmaceutical manufacturing site in Decatur, Illinois. The first doses were produced on September 23rd, 2025.
Neuraceq® is an FDA-approved radioactive diagnostic drug indicated for the detection of amyloid plaques in the brain of adult patients with cognitive impairment symptomology who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
By expanding into this new geography, Neuraceq® is now available to more patients, physicians, and imaging centers across Illinois and the greater Midwest.
“Expanding access to Neuraceq® ensures that physicians and patients navigating the evaluation of Alzheimer’s disease have the advanced diagnostic support they need. As demand for amyloid PET imaging grows alongside anti-amyloid therapies and improved reimbursement pathways, the availability of Neuraceq® from Decatur, IL, marks a key milestone in broadening service across the Midwest and beyond. This achievement reflects our commitment to improving patient care, supporting healthcare providers, and delivering answers to individuals and families facing the challenges of cognitive decline,” said Colleen Ruby, US Country Head and Chief Operating Officer, Americas and APAC of LMI, a Lantheus company.
“Expanding the SOFIE network is about more than just growth. Our Decatur, IL location represents a pivotal investment in the Midwest, enabling us to bring radiopharmaceuticals like Neuraceq® closer to communities, reducing wait times, and improving patient care across the region,” said William Crisp, Vice President of Operations.
About Neuraceq® (florbetaben 18F)
Indications and Use
NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Risk for Image Misinterpretation and other Errors: NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
- Radiation Risk: NEURACEQ, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration in the full prescribing information].
ADVERSE REACTIONS:
The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/application site erythema (1.7%), and injection site irritation (1.1%).
For more information please visit: Neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI), a Lantheus company, is dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com.
About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.
Contacts
Investor Relations: Mark Kinarney
Vice President, Investor Relations
978-671-8842
[email protected]
Media: Melissa Downs
Executive Director, External Communications
646-975-2533
[email protected]
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]]>The post Life Molecular Imaging Expands Neuraceq® (florbetaben F-18 injection) Production in Southern California appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging Expands Neuraceq® (florbetaben F-18 injection) Production in Southern California
Unlocking a new geography, making Neuraceq® available to more patients
Boston – August 19, 2025 – Life Molecular Imaging (LMI), a Lantheus company, dedicated to developing and offering novel PET radiopharmaceuticals, has expanded its manufacturing and distribution network for Neuraceq® (florbetaben F-18 injection) in Southern California. This expansion increases access to the broader Southern California area, including San Diego, extending availability of Neuraceq® to imaging centers, physicians, and patients with cognitive impairment. The first dose from a newly-equipped site in Los Angeles was provided on August 13, 2025.
Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs.
This expansion reflects LMI’s ongoing commitment to advancing diagnostic access and improving outcomes for patients affected by Alzheimer’s disease in California.
“At LMI, we are focused on expanding geographical access to Neuraceq® for patients and physicians involved in the evaluation of Alzheimer’s disease. As the adoption of anti-amyloid therapies continues to grow, the demand for reliable amyloid PET imaging is increasing in parallel. Launching Neuraceq® from Los Angeles is a key milestone in meeting this rising demand. It reflects our ongoing dedication to delivering timely, high-quality diagnostic solutions that align with the evolving needs of neurologists and patients,” said Colleen Ruby, US Country Head and Chief Operating Officer, Americas and APAC of LMI, a Lantheus company.
About Neuraceq® (florbetaben 18F)
Indications and Use
NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Risk for Image Misinterpretation and other Errors: NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
- Radiation Risk: NEURACEQ, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration in the full prescribing information].
ADVERSE REACTIONS:
The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/application site erythema (1.7%), and injection site irritation (1.1%).
For more information please visit: Neuraceq.com.
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI), a Lantheus company, is dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com.
About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.
Contacts
Investor Relations: Mark Kinarney
Vice President, Investor Relations
978-671-8842
[email protected]
Media: Melissa Downs
Executive Director, External Communications
646-975-2533
[email protected]
The post Life Molecular Imaging Expands Neuraceq® (florbetaben F-18 injection) Production in Southern California appeared first on Life Molecular Imaging.
]]>The post Medical Director Cardiology appeared first on Life Molecular Imaging.
]]>Career Opportunity
Medical Director Cardiology
Life Molecular Imaging GmbH (LMI) is a German-based Research & Development (R&D) organization focused on developing PET imaging and radiotheranostics solutions for diseases with high unmet medical needs. Our vision is to build our position as an innovator and leading player in the Nuclear Medicine field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.
We are currently seeking to fill a full-time role situated in our head office in Berlin, Germany:
Medical Director Cardiology*
Main Tasks & Responsibilities:
- Execution of the overall strategy for LMI ́s pipeline in cardiovascular indication
- Oversee company sponsored clinical research in cardiovascular indications, including input
on study related documents - Supervision of medical and safety aspects of ongoing clinical trials
- Support launch strategies, life-cycle management, and expansion of indications for use
- Provide Support for medical publications
- Liaise with Health competent authorities to drug access (early access, compassionate use or
registry programs) - Maintaining awareness of internal and external developments (scientific, clinical,
competitive, and regulatory) that could impact the development plan - Attend relevant scientific meetings and conferences and support development of summaries
of key data, presentations or symposium - Implementation of applicable guidelines of the quality assurance system of Life Molecular
Imaging - Ensure compliance with applicable local and global laws, regulations, guidelines and
company policies and procedures
Skills:
- Strong teamwork skills required to work with a cross-functional team, but also ability to work independently
- Results oriented and driven by objectives: initiative, flexibility, good organizational, prioritization and time management skills
- Strong communication, presentation, and interpersonal skills, including good command of English (both written and spoken), to internal and external stakeholders
- Ability to travel as required
- MS Office skills, especially Word, Excel, and PowerPoint
Experience/ Education:
- Medical education and doctorate degree (MD, PhD)
- Specialization in Cardiology
- Understanding of PET imaging and other imaging modalities is of advantage
- Work experience of >5 years in a clinical environment
- Experience in drug development (clinical phases I-III)
- Ideally industry experience in Medical Affairs in the Cardiology space
If you want to become part of an entrepreneurial team, if you are prepared to assume a wide range of responsibilities, and if your background and personal experience fit this profile, we invite you to apply. Don’t forget to include a cover letter detailing your interest in this position and your past relevant work experience as well as a CV.
Dr. Andrew Stephens
Life Molecular Imaging GmbH Tegeler Str. 6-7
13353 Berlin
We are currently accepting applications and look forward to receiving yours.
*The person counts, not the gender! Life Molecular Imaging is committed to diversity, rejects discrimination, and does not think in categories such as gender, ethnic origin, religion, disability, age, or sexual identity. Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment.
The post Medical Director Cardiology appeared first on Life Molecular Imaging.
]]>The post Life Molecular Imaging Announce Successful First Production of NeuraCeq® (Florbetaben [18F]) in Solna, Sweden appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging Announce Successful First Production of NeuraCeq® (Florbetaben [18F]) in Solna, Sweden
Berlin, Germany and Solna, Sweden – July 9, 2025 – Life Molecular Imaging and Karolinska University Hospital announced the successful first productions of NeuraCeq® (Florbetaben [18F]) at Karolinska University Hospital´s radiopharmaceutical production site in Solna, Sweden. This achievement marks an important milestone in expanding the regional supply of NeuraCeq® and strengthening access to advanced PET imaging diagnostics in Sweden and the broader Nordic region.
The collaboration enables local availability of NeuraCeq®, a diagnostic radiopharmaceutical indicated for PET imaging of beta-amyloid neuritic plaques in the brain. NeuraCeq® supports clinicians in evaluating patients with cognitive impairment who are being assessed for Alzheimer’s disease and other causes of dementia.
“We are pleased to announce the successful start of NeuraCeq® production at Karolinska University Hospital, a world-class institution with extensive expertise in nuclear medicine and radiopharmaceutical production,” said Andrew Stephens, MD, PhD, Chief Medical Officer of Life Molecular Imaging. “This initiative reflects our shared commitment to improving patient access to molecular imaging agents that support early and accurate diagnosis of neurodegenerative diseases.”
With a growing global network of production and distribution partners, Life Molecular Imaging continues to expand the availability of NeuraCeq® to meet increasing clinical and research needs worldwide.
About NeuraCeq®*
NeuraCeq® (Florbetaben [18F]) is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. NeuraCeq® should be used in conjunction with a clinical evaluation.
A negative scan indicates sparse or no density of cortical β-amyloid plaques. A positive scan indicates moderate to frequent density.
NeuraCeq® should be used in conjunction with a clinical evaluation.
Most Common Adverse Reactions:
The overall safety profile of NeuraCeq® is based on data from 1,295 administrations of NeuraCeq® to 1,077 subjects and 12 subjects who received vehicle. The most common adverse reactions were injection/application site erythema, and injection site pain.
*Source: EU NeuraCeq® Prescribing Information, Revision 11/2023
About Life Molecular Imaging (LMI)
Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com. LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit https://www.lifehealthcare.co.za/news-and-info-hub/latest-news/life-healthcare-proposed-disposal-of-lmi/.
About Karolinska University Hospital
Karolinska University Hospital is one of Europe’s leading university hospitals, renowned for its advanced clinical care, research, and education. The hospital is closely integrated with Karolinska Institutet and is a major center for innovation in the fields of neuroscience, cancer and precision medicine.
For media queries
Brittany Hahn
Marketing Communications Manager
Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
The post Life Molecular Imaging Announce Successful First Production of NeuraCeq® (Florbetaben [18F]) in Solna, Sweden appeared first on Life Molecular Imaging.
]]>The post FDA Expands Indications for Neuraceq®, an Amyloid PET Imaging Agent, to Enhance Diagnosis and Care of Patients with Alzheimer’s Disease appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
FDA Expands Indications for Neuraceq®, an Amyloid PET Imaging Agent, to Enhance Diagnosis and Care of Patients with Alzheimer’s Disease
New indication added for selection of patients for amyloid-directed therapies
Quantitative image analysis added
Previous limitations of use removed
BOSTON, June 30th, 2025 – Life Molecular Imaging, Ltd. (LMI) announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Neuraceq® (florbetaben F18 injection), expanding its indication for selecting patients for amyloid-targeting therapies, as described in the prescribing information of the therapeutic products, and including the utilization of quantitative analysis for positron emission tomography (PET) scans.
Key updates to the Neuraceq® label include:
- Expanded clinical indication to include use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies.
- Utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation.
- Broader use for monitoring of therapy and following progression to Alzheimer’s disease (AD).
Amyloid, a naturally occurring protein, can accumulate into harmful plaques in the brain, thereby causing AD. Neuraceq® binds selectively to these plaques, enabling detection via PET imaging. This capability assists clinicians in determining whether or not AD is contributing to a patient’s cognitive symptoms, when combined with other diagnostic evaluations. This aligns with the prescribing information of FDA approved amyloid-targeting therapeutic products. The clinical studies section now includes that amyloid PET scans have been utilized in certain clinical trials to evaluate reductions in amyloid plaque following treatment with amyloid-targeting therapies.
“This FDA action is a major advancement in Alzheimer’s diagnostics,” said Andrew Stephens, Chief Medical Officer at Life Molecular Imaging. “Updating the Neuraceq® label to reflect the revised Appropriate Use Criteria for amyloid PET1 enhances clinicians’ ability to support patient decision making and identify individuals who may benefit from amyloid-targeting treatment – ultimately contributing to improved patient outcomes.”
The safety profile of Neuraceq® has been confirmed to remain unchanged with the new indication.
Neuraceq® PET imaging is widely covered under Medicare and many private insurance plans, although policy specifics can vary. Clinicians and patients are encouraged to verify individual coverage details.
About Neuraceq® (florbetaben F 18 injection)
Indication (approved by FDA on 23 June 2025)
Neuraceq® is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
- Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
- Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors may occur in the estimation of brain amyloid beta neuritic plaque density during Neuraceq® image interpretation. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a Neuraceq® scan.
Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal.
Radiation Risk
Neuraceq® contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
Common Adverse Reactions
The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of pain (3.4%), erythema (1.7%), and irritation (1.1%).
Please see the Full Prescribing Information for Neuraceq® at Neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com. LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit https://www.lifehealthcare.co.za/news-and-info-hub/latest-news/life-healthcare-proposed-disposal-of-lmi/.
References
1) Rabinovici et al. Updated appropriate use criteria for amyloid and tau PET: A report from the Alzheimer’s Association and Society for Nuclear Medicine and Molecular Imaging Workgroup. Alzheimers Dement. 2025 Jan;21(1):e14338. doi: 10.1002/alz.14338
For media queries
Brittany Hahn
Marketing Communications Manager
Life Molecular Imaging
Tel: +1.484.735.2840
[email protected]
The post FDA Expands Indications for Neuraceq®, an Amyloid PET Imaging Agent, to Enhance Diagnosis and Care of Patients with Alzheimer’s Disease appeared first on Life Molecular Imaging.
]]>The post Life Molecular Imaging announces presentation of new scientific data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2025 appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging announces presentation of new scientific data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2025
Research Presented Provides Further Insights into Amyloid and Tau PET Imaging
BERLIN, Germany, June 20 2025 – Life Molecular Imaging (LMI) announces today that new research results using its positron emission tomography (PET) imaging tracers will be presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in New Orleans (June 21-24, 2025), where groundbreaking research meets clinical innovation.
Research abstracts involving LMI compounds florbetaben F18 injection and/or PI-2620 presented at the SNMMI conference include the following presentations:
| Format | Schedule | Title | Presenting author | Details | |
|---|---|---|---|---|---|
| 1 | Presentation | Saturday, 21 Jun 2025 2:10 – 2:20 PM (Physics, Instrumentation & Data Sciences) | Pipeline Development for Cerebral Blood Flow and Binding Potential Quantification using a 20 min Dynamic 18F-Florbetaben PET Scan | Danny De Sarno | 231-232 (Convention Center) SS04: PIDSC: Data Analysis and Dosimetry In-Person & On-Demand |
| 2 | Presentation | Sunday, 22 Jun 2025 5:10 – 5:20 PM (Neurosciences) | The First Human Brain PET Scans using PHAROS Multi-functional High-Resolution Digital PET System with DOI and TOF Technology | Jae Sung Lee | 208-209 (Convention Center) IS_1 IS03: Kuhl-Lassen Award Session In-Person & On-Demand |
| 3 | Presentation | Monday, 23 Jun 2025 2:45 – 3:30 PM (Neurosciences) | Correlation of Early and Delayed [18F]FBB PET Imaging in Assessing Beta-Amyloid Deposition and Neurodegeneration in Alzheimer's Disease | Seo Young Kang | Hall B-C (Convention Center) MTA08: Neuroscience Science Pavilion In-Person Only |
| 4 | Presentation | Tuesday, 24 Jun 2025 8:30 – 9:15 AM (Physics, Instrumentation & Data Sciences) | Single-Session Triple-Tracer Brain PET Imaging Using Deep Learning | Yiyi Hu | Hall B-C (Convention Center) / MTA09 Science Pavilion MTA09: Physics, Instrumentation & Data Sciences In-Person Only |
| 5 | Presentation | Tuesday, 24 Jun 2025 8:50 – 9:00 AM (Neurosciences) | Amyloid PET Radiomics: Correlations with Clinical Features and Neurodegenerative Disease Types | Tomoaki Otani | 225-227 (Convention Center) SS_1 SS25: Clinical Neurosciences I In-Person & On-Demand |
| 6 | Presentation | Tuesday, 24 Jun 2025 1:00 – 1:45 PM (Physics, Instrumentation & Data Sciences) | An Integrated Solution for Precision PET Brain Imaging: Motion Corrected, Regularized, and MR-Guided | Matthew Spangler-Bickell | Hall B-C (Convention Center) MTA11: Physics, Instrumentation & Data Sciences Science Pavilion In-Person Only |
| 7 | Poster | June 21-24, 2025 | Comparison of Amyloid-PET Analysis Software Using 18F-florbetaben Brain PET/CT with Cognitive Impairment | Miju Cheon | Poster area |
| 8 | Poster | June 21-24, 2025 | Tau and Amyloid Biomarkers for Alzheimer’s Disease: A Dual-phase and Dual-modality PET Imaging Study with [18F]PI-2620 and [18F]florbetaben | Shichun Peng | Poster area |
| 9 | Poster | June 21-24, 2025 | Molecular Imaging for Cardiac Amyloidosis: Opportunities and Challenges | Aarti Pandey | Poster area |
| 10 | Poster | June 21-24, 2025 | Investigation of Cardiac Amyloid Deposits as a Cause of Cardiac Dysfunction in Persons with Alzheimer's Disease: The Prospective CACAO-PET Study | Stephan Settelmeier | Poster area |
| 11 | Poster | June 21-24, 2025 | Fully automated fast spatial normalization for multi-modality multi-tracer brain PET without MRI based on Cascaded Neural Networks | Cheng Tang | Poster area |
To learn more about the meeting, click here to visit the SNMMI Annual Meeting website: https://snmmi.org/AM/
To meet the LMI team, please visit booth #713 during SNMMI annual meeting in New Orleans.
About Neuraceq® (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.
Limitations of Use
- A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq® have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
Radiation Risk
Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Common Adverse Reactions
The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information please visit: Neuraceq.com
About PI-2620
Tau deposits, in conjunction with beta-amyloid plaques, represent the other pathological hallmark of Alzheimer’s disease, with tau deposits further playing an important role in other neurodegenerative diseases. PI-2620 is binding to 3R/4R and 4R tau deposits and is a next generation 18F-labeled investigational PET tracer with favorable properties and imaging characteristics. It was discovered in a research collaboration between Life Molecular Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company. Life Molecular Imaging has the exclusive, world-wide license for research, development and commercialization of tau PET tracers generated within the discovery program.
About Life Molecular Imaging (LMI)
Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com. LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit https://www.lifehealthcare.co.za/news-and-info-hub/latest-news/life-healthcare-proposed-disposal-of-lmi/.
For media queries
Brittany Hahn
Marketing Communications Manager
Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
The post Life Molecular Imaging announces presentation of new scientific data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2025 appeared first on Life Molecular Imaging.
]]>The post European Commission Grants Orphan Drug Designation to Florbetaben (18F) for Diagnosis of ATTR Amyloidosis appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
European Commission Grants Orphan Drug Designation to Florbetaben (18F) for Diagnosis of ATTR Amyloidosis
- Florbetaben (18F) has been granted Orphan drug designation for the diagnosis of ATTR amyloidosis
- Florbetaben (18F) previously received orphan drug designation as a diagnostic agent for the management of amyloid light chain (AL) amyloidosis in both the EU and US
- The efficacy of florbetaben (18F) in diagnosing cardiac amyloidosis is being evaluated in an ongoing multi-center Phase 3 study
BERLIN, Germany, June, 12, 2025 – Life Molecular Imaging GmbH (LMI) announces today that florbetaben (18F) has been granted orphan designation by the European Commission for the diagnosis of Transthyretin (ATTR) Amyloidosis.
Systemic amyloidosis is a rare group of complex diseases caused by protein misfolding and subsequent deposition in tissues, resulting in progressive organ damage. ATTR amyloidosis appears to be the most common form of amyloidosis, with incidence rates rising, likely due to prior underdiagnosis of the disease. Growing awareness of ATTR amyloidosis among cardiologists is improving recognition and diagnosis, allowing patients to access life-saving therapies.
Despite the observed rise in the prevalence and incidence of cardiac ATTR amyloidosis – and its high prevalence among patients with heart failure – the overall frequency in the general population remains below the threshold for orphan drug designation (five cases per ten thousand inhabitants of newly diagnosed patients). As a result, EMA granted orphan drug designation to florbetaben (18F) as a diagnostic agent for ATTR amyloidosis.
Florbetaben (18F) was initially developed and approved for the detection of neuritic amyloid plaques in the brains of patients with cognitive decline. Preliminary data suggest that florbetaben (18F) may also detect and quantify ATTR amyloid deposits in the heart and other organs using positron emission tomography (PET) imaging, thereby supporting diagnosis of the condition. The current multi-center Phase 3 trial (NCT05184088) aims to further validate florbetaben (18F)’s efficacy in the diagnosis of cardiac amyloidosis, including the ATTR subtype.
“The orphan drug designation for florbetaben (18F) will support our efforts to validate this tracer for the diagnosis of both AL and ATTR cardiac amyloidosis. With the approval of several new treatment options, especially for ATTR cardiac amyloidosis, fast and reliable diagnosis of the disease becomes even more important.” said Andrew Stephens, MD, PhD, Chief Medical Officer of LMI.
About florbetaben (18F)
Neuraceq® (florbetaben (18F)) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. Neuraceq has been approved for routine clinical use in this indication by FDA, EMA and MHRA, and has local regulatory approval in other countries such as Canada, China, Japan, Korea, Switzerland, Taiwan. Florbetaben (18F) is currently under investigation as a targeted radiopharmaceutical for the detection of amyloid deposits in the heart and other organs of patients with cardiac and systemic amyloidosis of AL and ATTR type.
Most Common Adverse Reactions
In clinical trials including demented and non-demented subjects, the most frequently observed adverse drug reactions in 872 subjects with 1090 florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).
About Life Molecular Imaging (LMI)
Life Molecular Imaging GmbH, together with its affiliates in the UK and US (LMI) is a radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. To learn more about LMI, please visit https://life-mi.com. LMI, a member of the Life Healthcare group of companies, is being acquired by Lantheus Holdings, Inc. For more information about the pending acquisition, please visit https://www.lifehealthcare.co.za/news-and-info-hub/latest-news/life-healthcare-proposed-disposal-of-lmi/.
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
For scientific information
Iris Hardewig | Clinical Development| Life Molecular Imaging
Tel. +49 151 14569896 | [email protected]
UK-Neuraceq-25-00001
The post European Commission Grants Orphan Drug Designation to Florbetaben (18F) for Diagnosis of ATTR Amyloidosis appeared first on Life Molecular Imaging.
]]>The post Life Molecular Imaging and SOFIE announce Neuraceq® availability in Albany, NY appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging and SOFIE announce Neuraceq® availability in Albany, NY
Improved Neuraceq® supply capabilities to enhance patient access to amyloid PET.
Boston, May 20, 2025 – Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE‘s radiopharmaceutical manufacturing site located near Albany, NY. This agreement results in increased availability of Neuraceq® for imaging centers, physicians, and patients with cognitive impairment in New York, Massachusetts and Vermont among others in the Northeast. The first doses have been made available on May 19th, 2025.
Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases.
“At LMI, we are committed to broadening access to Neuraceq® availability for patients and physicians navigating the evaluation of Alzheimer’s disease, especially as new treatment options emerge. By expanding our manufacturing capabilities in Albany, NY, through our partnership with SOFIE, we’re better positioned to meet the increasing demand for amyloid PET imaging. This initiative reflects our continued dedication to advancing patient access and supporting the healthcare community in the evolving landscape of neurodegenerative care,” said Colleen Ruby, US Country Head, and Chief Operating Officer, Americas and APAC.
“SOFIE is proud to launch Neuraceq® manufacturing in Albany, NY marking a significant milestone in our mission to advance molecular imaging for Alzheimer’s disease. Our facility in Albany, NY bolsters our ability to meet growing demand for advanced Alzheimer’s diagnostics and highlights our commitment to support patients and healthcare providers in the Northeast”, said William Crisp, PharmD, BCNP SOFIE Vice President, Operations.
About Neuraceq® (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.
Limitations of Use
- A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq® have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
Radiation Risk
Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Common Adverse Reactions
The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information please visit: Neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/.
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
The post Life Molecular Imaging and SOFIE announce Neuraceq® availability in Albany, NY appeared first on Life Molecular Imaging.
]]>The post Life Molecular Imaging Secures Funding from the Alzheimer’s Drug Discovery Foundation (ADDF) to Further Investigate [18F]F-DED PET in Alzheimer’s Neuroinflammation appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging Secures Funding from the Alzheimer’s Drug Discovery Foundation (ADDF) to Further Investigate [18F]F-DED PET in Alzheimer’s Neuroinflammation
Joining forces to accelerate development and to create a potential new option for Neuroinflammation Imaging
Berlin/Boston, May, 14, 2025 – Life Molecular Imaging has received an investment from the Alzheimer’s Drug Discovery Foundation (ADDF) to advance significant research in Alzheimer’s disease (AD). The $2.16 million investment, spanning three years, will fuel the development of [18F]F‑DED, an investigational F18-labeled PET imaging agent designed to target monoamine oxidase B (MAO-B), a key enzyme linked to neuroinflammation.
This ambitious research initiative is a collaborative effort with two world-class institutions, including the University Hospital of Ludwig-Maximilian University (LMU; Munich, Germany) and the Barcelona Beta Brain Research Center (BBRC, Spain), with experts in neurology, nuclear medicine, psychiatry, and stroke and dementia research.
It is anticipated that using [18F]F-DED PET imaging during this project has the potential to provide critical insights into both sporadic and genetically predisposed AD patients, bridging the gap on the contribution of neuroinflammation between early and late stages of the disease.
Until now, PET imaging of neuroinflammation has faced challenges due to genetic polymorphisms affecting ligand binding, leading to inconsistent results.
“This new research, supported by the prestigious ADDF funding, provides a unique opportunity to investigate the spatial and temporal dynamics of neuroinflammation and its association with established biomarkers,” said Andrew Stephens, Chief Medical Officer at LMI.
“Neuroinflammation could be a potential key driver in the spread of tau pathology to the cortex in Alzheimer’s disease. Leveraging PET imaging to explore its role presents a unique opportunity to deepen our understanding of disease progression”, added Matthias Brendel, Professor for Nuclear Medicine at LMU.
Gemma Salvadó Blasco, Group Leader of Neuroimaging Research BBRC, echoed this enthusiasm: “By combining data from diverse Alzheimer’s disease cohorts, we aim to unravel the complexities of disease progression. We’re thrilled to embark on this exciting journey.”
“PET-Imaging tools provide important insights into understanding Alzheimer’s disease and other neurodegenerative disorders and are integrated now into clinical care,” says Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. “New imaging tools exploring neuroinflammation may offer a non-invasive approach to visualize astrocyte activity alongside established biomarkers to further examine the relationship between inflammation and Alzheimer’s. If successful, this innovative approach will help deepen our understanding of the underlying disease.”
About
Neuroinflammation represents a key pathologic mechanism in many neurodegenerative diseases, including AD, movement disorders and multiple sclerosis. In the brain it can be mediated by reactive astrocytes (astrogliosis), which show increased activity of the enzyme monoamine oxidase B (MAO-B). The PET tracer [18F]F-DED is a deuterated deprenyl derivative that was designed to preferentially bind to areas with increased MAO-B activity (1,2).
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/.
About The Alzheimer’s Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer’s Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer’s disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer’s, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF’s leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer’s PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer’s drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: http://www.alzdiscovery.org/.
References
- Nag S, Fazio P, Lehmann L, et al. In Vivo and In Vitro Characterization of a Novel MAO-B Inhibitor Radioligand, 18F-Labeled Deuterated Fluorodeprenyl. J Nucl Med. 2016;57(2):315-320. doi:10.2967/jnumed.115.161083
- Ballweg A, Klaus C, Vogler L, et al. [18F]F-DED PET imaging of reactive astrogliosis in neurodegenerative diseases: preclinical proof of concept and first-in-human data. J Neuroinflammation. 2023;20(1):68. Published 2023 Mar 11. doi:10.1186/s12974-023-02749-2
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
For scientific information, please contact: Dr. Gérard N Bischof, PD | Scientific Project Manager | Life Molecular Imaging| [email protected]
The post Life Molecular Imaging Secures Funding from the Alzheimer’s Drug Discovery Foundation (ADDF) to Further Investigate [18F]F-DED PET in Alzheimer’s Neuroinflammation appeared first on Life Molecular Imaging.
]]>The post Life Molecular Imaging announces Neuraceq® availability at PharmaLogic Salt Lake City appeared first on Life Molecular Imaging.
]]>PRESS RELEASE
Life Molecular Imaging announces Neuraceq® availability at PharmaLogic Salt Lake City
Enhanced the supply capabilities of Neuraceq® to increase patient access to beta-amyloid PET imaging
Boston, April 24, 2025 – Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announce the expansion of their strategic partnership and licensing agreement to produce and distribute Neuraceq® from PharmaLogic’s PET radiopharmaceutical manufacturing facility located near Salt Lake City, Utah. The first commercial doses were made available on April 23, 2025.
Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases.
“Life Molecular Imaging is pleased to expand the availability of Neuraceq® to Salt Lake City, enhancing access for patients and imaging centers in this key region. This expansion reflects LMI’s commitment to ensuring broad accessibility to Neuraceq®, reinforcing our dedication to supporting a key step on the pathway to treatment,” said Colleen Ruby, US Country Head and Chief Operating Officer, Americas and APAC.
About Neuraceq (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.
Limitations of Use
- A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
Radiation Risk
Neuraceq, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information please visit: neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years’ experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
The post Life Molecular Imaging announces Neuraceq® availability at PharmaLogic Salt Lake City appeared first on Life Molecular Imaging.
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