GE HealthCare enhances cardiac diagnostics with innovative molecular imaging solutions showcased at SNMMI 2025
CHICAGO--(BUSINESS WIRE)--GE HealthCare's commitment to advancing precision care in cardiology through innovative molecular imaging solutions is on full display at this week's Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting in New Orleans, Louisiana.
'Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,' shares Marcelo Fernando DiCarli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular
Share
As cardiovascular disease (CVD) continues to rise globally, i the need for advanced diagnostic technologies becomes increasingly critical. GE HealthCare's molecular imaging technologies – including positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography-computed tomography (SPECT/CT) – and radiopharmaceuticals – namely its Flyrcado™ (flurpiridaz F 18) injection – play a crucial role in cardiac care by providing detailed insights into biological processes beyond conventional imaging.
These advanced imaging techniques enable early diagnosis, precise assessment of myocardial perfusion and ischemia, and evaluation of infiltrative cardiomyopathies. By identifying specific pathologic processes, molecular imaging helps tailor treatments to individual patients, with the aim to enhance the effectiveness of therapies and improving prognosis. Additionally, it allows for monitoring treatment responses and disease progression, ultimately helping contribute to better patient outcomes. ii
'Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,' shares Marcelo Fernando DiCarli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular Imaging Program, Departments of Radiology and Medicine, Brigham and Women's Hospital. 'For the first time in nearly 20 years, we have a new PET myocardial perfusion tracer that brings the latest imaging technology within reach for patients across the U.S. The image quality is exceptional, and its use has the potential to reduce unnecessary invasive procedures by improving diagnostic confidence. I've found it to be a valuable addition to our clinical practice, enabling more personalized treatment strategies and better patient outcomes. The excitement across the cardiology community is evident as we enter a new era in precision cardiac care.'
GE HealthCare's Flyrcado injection, a first-of-its-kind F 18-unit dose PET myocardial perfusion imaging (MPI) agent for patients with known or suspected coronary artery disease (CAD), helps clinicians deliver higher diagnostic efficacy compared to SPECT MPI, the predominant procedure used in nuclear cardiology today.
Recently launched in select U.S. markets, Flyrcado's availability aligns with its receipt of CMS pass-through status, effective April 1, which includes a drug-specific HCPCS billing code to support efficient coding and Medicare coverage. In addition, Flyrcado is now covered by all seven Medicare Administrative Contractors (MACs) at either invoice price or better, depending on the site of care. More than 50% of commercially insured beneficiaries are now covered under updated national and regional cardiac PET policies that include Flyrcado as a covered benefit—marking significant progress in expanding access beyond the hospital outpatient setting. Further expansion is expected in the second half of the year as additional payors complete their policy reviews. To support this evolving access landscape, GE HealthCare has launched the Flyrcado Support Center (800-729-0701) to assist customers with benefits investigations, coding, coverage, and claims submissions.
'With coverage now in place for all traditional Medicare beneficiaries, along with updated PET coverage policies in place for more than half of the nation's commercially insured beneficiaries, millions of Americans—many at risk for or living with coronary artery disease, the leading cause of death in the U.S.—will have greater access to this innovative technology,' said Eric Ruedinger, Vice President and General Manager of GE HealthCare's Pharmaceutical Diagnostics division for the U.S. and Canada. 'Flyrcado represents a significant advancement in cardiac care over SPECT imaging, offering clinicians a new, highly effective diagnostic tool to support more timely and personalized care for patients with known or suspected coronary artery disease.'
Flyrcado can be imaged with a range of PET/CT systems, including GE HealthCare's Omni Legend, offering clinicians flexibility in integrating this innovative tracer into their existing imaging workflows. With Flyrcado, clinicians have the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, providing a highly effective protocol for evaluating ischemia in patients.
Beyond Flyrcado, Omni Legend enables exceptional cardiac diagnostics, accommodating a range of tracers – including fast decay and emerging tracers. Representing a scalable PET/CT platform designed to evolve with healthcare system needs across care areas with shorter scan times and lower doses, iii it continues to gain in popularity, representing the company's fastest-ever-selling PET/CT. iv
GE HealthCare is also proud to provide its StarGuide and Aurora SPECT/CT systems, designed to capture gamma rays emitted by radioactive tracers. Both systems offer exceptional image quality and scan time efficiency, supporting clinicians in making confident diagnoses. These features make SPECT/CT a valuable tool in cardiac care, providing comprehensive views of both physiological and structural aspects of diseases.
Additional solutions from GE HealthCare's MIM Software are also available to enable multi-modality viewing and fusion of cardiac images and offer integration pathways for cardiac analysis.
A devoted provider of cardiology solutions, GE HealthCare supports the continuum of care and personalized treatments for the world's largest hospitals to the smallest clinics and beyond the walls of the clinician's office. With a vast and diversified portfolio, GE HealthCare offers healthcare professionals a breadth of solutions from early detection and diagnosis, to planning, intervention, and monitoring to help clinicians deliver better patient outcomes in cardiology care today and for the future.
For more information on GE HealthCare's innovative portfolio of molecular solutions for cardiology, please visit gehealthcare.com. SNMMI show attendees are also encouraged stop by the company's booth (#638 and #1023) at New Orleans Ernest N. Morial Convention Center in New Orleans, Louisiana from June 21-24.
About GE HealthCare Technologies Inc.
GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™.
Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.
Forward-looking statements
This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as 'will,' 'expect,' 'may,' 'would,' 'could,' 'plan,' 'believe,' 'anticipate,' 'intend,' 'potential,' and similar expressions. These forward-looking statements may include, but are not limited to, statements about Flyrcado and GE HealthCare Technologies Inc.'s (the 'Company's') performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company's actual results to differ materially from those described in its forward-looking statements include, but are not limited to, uncertainties regarding the commercial success of Flyrcado, the Company's ability to receive pass-through status from the US Centers for Medicaid and Medicare, and decisions by regulatory authorities impacting labeling, manufacturing processes, safety, or other matters that could affect the availability or commercial potential of Flyrcado. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company's actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.
Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection
FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information
Indications and usage
FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.
Contraindications
None
Warnings and precautions
Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information.
Radiation risks: FLYRCADO 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 minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.
Adverse reactions
Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.
Use in specific populations
Pregnancy
There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure.
FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy.
Lactation
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration.
Pediatric Use
Safety and effectiveness of FLYRCADO in pediatric patients have not been established.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
2 hours ago
- Business Wire
Galatea Bio and Fabric Genomics Partner to Deliver Comprehensive Genetic Testing for Common Diseases
MIAMI & OAKLAND, Calif.--(BUSINESS WIRE)-- Galatea Bio and Fabric Genomics, a GeneDx company, announced today a strategic collaboration to enhance genetic testing by incorporating both rare pathogenic variant analysis and polygenic risk scoring (PRS) to assess genetic susceptibility to common diseases. 'By leveraging Fabric Genomics' high-quality clinical gene panel interpretation to support Galatea's polygenic risk score reporting, we are enabling more personalized assessments of an individual's risk for common diseases,' said Martin Reese. The initial offering will include an inherited cardiovascular gene panel based on American Heart Association (AHA) recommendations, with additional PRS for cardiovascular related traits, including coronary arterial disease, high low-density lipoprotein (LDL), elevated triglycerides, low high-density lipoprotein (HDL), atrial fibrillation, hypertension, type 2 diabetes and hypothyroidism. A follow-up offering will integrate hereditary cancer panels with PRS for breast, colorectal, and prostate cancers. 'Galatea Bio is committed to making common genetic risk prediction more accurate for all,' said Carlos Bustamante, Ph.D., CEO & Co-Founder, Galatea Bio. 'Through our collaboration with Fabric Genomics, we're working to capture both rare and common genetic contributions to disease risk—delivering meaningful insights to individuals across the US and around the world.' This collaboration integrates Fabric Genomics' platform for clinical reporting and its expertise in clinical gene panel curation with Galatea Bio's advanced PRS algorithms. By combining these capabilities, the partnership provides both rare variant and polygenic genetic risk reporting using the Broad Clinical Lab's (BCL) Blended Genome - Exome. A key component of this collaboration is the integration of Galatea Bio's newly released individually-adjusted PRS solution, StrataRisk™ PRS, which provides genetic risk for individuals of all ancestries. This is made possible through a novel, proprietary algorithm that leverages data from the Galatea Bio Global Biobank to calibrate PRS scores against similar individuals in genomic ancestry space, ensuring equitable risk assessment across diverse populations. 'By leveraging Fabric Genomics' high-quality clinical gene panel interpretation to support Galatea's polygenic risk score reporting, we are enabling more personalized assessments of an individual's risk for common diseases,' said Martin Reese, Ph.D., President of Fabric Genomics. 'This combined approach allows us to better explain patients' results with a more accurate risk profile.' Evaluating both rare genetic disease variants and polygenic risk scores can have several advantages over reporting either of these independently. Traditional single-gene or multi-gene panel testing focuses on high-penetrance rare mutations, which capture a subset of patients with an inherited single gene disease and often results in negative or uncertain results, leaving many patients' risk unexplained. PRS, which aggregates the cumulative effect of numerous common genetic variants, can provide refined risk stratification. 'This collaboration between Fabric Genomics and Galatea Bio is enabled by our clinical Blended Genome - Exome,' said Niall Lennon, Ph.D., Chief Scientific Officer, Broad Clinical Labs. 'This is exactly the kind of application we envisioned for this cost-effective approach—one that will provide a more comprehensive view of genetic susceptibility to important common diseases.' About Fabric Genomics Fabric Genomics, a GeneDx company, is democratizing genomics-driven precision medicine. The company provides institutions with end-to-end clinical sequencing solutions that include the Fabric Enterprise software platform, assay design and validation support and the clinical interpretation services needed to scale genetic testing. At the core of this platform is a suite of sophisticated AI algorithms and data knowledge systems that turn data into expert clinical insights. Headquartered in Oakland, California, Fabric Genomics supports clinical applications across a variety of use cases including rare disease, oncology, cardiovascular, neurological and women's health. To learn more, visit and follow us on X and LinkedIn. About GeneDx At GeneDx (Nasdaq: WGS), we believe that everyone deserves personalized, targeted medical care—and that it all begins with a genetic diagnosis. Fueled by one of the world's largest, rare disease data sets, our industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans, accelerate drug discovery and improve health system efficiencies. For more information, please visit and connect with us on LinkedIn, Facebook and Instagram. About Galatea Bio Galatea Bio is an innovative, venture-backed biotechnology company that strives to advance 'Precision Health at Scale for All.' Founded by pioneers in the fields of population genetics and bioinformatics, Galatea Bio leverages cutting-edge ancestry algorithms to scale the promise of precision health to global populations, while maintaining a strong commitment to ethical research. The company is headquartered in Miami Lakes, Florida. For more information, visit or follow us on X and LinkedIn. About the Broad Clinical Labs Broad Clinical Laboratories was founded in 2013 as a non-profit subsidiary of Broad Institute of MIT and Harvard to accelerate the world toward a better understanding, diagnosis and treatment of disease by pursuing projects, developing products and driving adoption of cutting edge genomics technologies and novel molecular assays. Broad Clinical Labs is a leader in translational genomics, having sequenced over 700,000 genomes in service of its mission to accelerate the understanding and diagnosis of human disease. Forward Looking Statements This press release may contain 'forward-looking statements' within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words 'believe,' 'project,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'strategy,' 'future,' 'opportunity,' 'plan,' 'may,' 'should,' 'will,' 'would,' 'will be,' 'will continue,' 'will likely result,' and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) our ability to implement business combinations, plans, goals and forecasts, and identify and realize additional opportunities, (ii) the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, (iii) the size and growth of the market in which we operate, (iv) our ability to pursue our new strategic direction, and (v) our ability to enhance our artificial intelligence tools that we use in our clinical interpretation platform. The foregoing list of factors is not exhaustive. A further list and description of risks, uncertainties and other matters can be found in the 'Risk Factors' section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and other documents filed by us from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and we assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. We do not give any assurance that we will achieve our expectations.
Business Wire
4 hours ago
- Business Wire
GE HealthCare enhances cardiac diagnostics with innovative molecular imaging solutions showcased at SNMMI 2025
CHICAGO--(BUSINESS WIRE)--GE HealthCare's commitment to advancing precision care in cardiology through innovative molecular imaging solutions is on full display at this week's Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting in New Orleans, Louisiana. 'Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,' shares Marcelo Fernando DiCarli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular Share As cardiovascular disease (CVD) continues to rise globally, i the need for advanced diagnostic technologies becomes increasingly critical. GE HealthCare's molecular imaging technologies – including positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography-computed tomography (SPECT/CT) – and radiopharmaceuticals – namely its Flyrcado™ (flurpiridaz F 18) injection – play a crucial role in cardiac care by providing detailed insights into biological processes beyond conventional imaging. These advanced imaging techniques enable early diagnosis, precise assessment of myocardial perfusion and ischemia, and evaluation of infiltrative cardiomyopathies. By identifying specific pathologic processes, molecular imaging helps tailor treatments to individual patients, with the aim to enhance the effectiveness of therapies and improving prognosis. Additionally, it allows for monitoring treatment responses and disease progression, ultimately helping contribute to better patient outcomes. ii 'Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,' shares Marcelo Fernando DiCarli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular Imaging Program, Departments of Radiology and Medicine, Brigham and Women's Hospital. 'For the first time in nearly 20 years, we have a new PET myocardial perfusion tracer that brings the latest imaging technology within reach for patients across the U.S. The image quality is exceptional, and its use has the potential to reduce unnecessary invasive procedures by improving diagnostic confidence. I've found it to be a valuable addition to our clinical practice, enabling more personalized treatment strategies and better patient outcomes. The excitement across the cardiology community is evident as we enter a new era in precision cardiac care.' GE HealthCare's Flyrcado injection, a first-of-its-kind F 18-unit dose PET myocardial perfusion imaging (MPI) agent for patients with known or suspected coronary artery disease (CAD), helps clinicians deliver higher diagnostic efficacy compared to SPECT MPI, the predominant procedure used in nuclear cardiology today. Recently launched in select U.S. markets, Flyrcado's availability aligns with its receipt of CMS pass-through status, effective April 1, which includes a drug-specific HCPCS billing code to support efficient coding and Medicare coverage. In addition, Flyrcado is now covered by all seven Medicare Administrative Contractors (MACs) at either invoice price or better, depending on the site of care. More than 50% of commercially insured beneficiaries are now covered under updated national and regional cardiac PET policies that include Flyrcado as a covered benefit—marking significant progress in expanding access beyond the hospital outpatient setting. Further expansion is expected in the second half of the year as additional payors complete their policy reviews. To support this evolving access landscape, GE HealthCare has launched the Flyrcado Support Center (800-729-0701) to assist customers with benefits investigations, coding, coverage, and claims submissions. 'With coverage now in place for all traditional Medicare beneficiaries, along with updated PET coverage policies in place for more than half of the nation's commercially insured beneficiaries, millions of Americans—many at risk for or living with coronary artery disease, the leading cause of death in the U.S.—will have greater access to this innovative technology,' said Eric Ruedinger, Vice President and General Manager of GE HealthCare's Pharmaceutical Diagnostics division for the U.S. and Canada. 'Flyrcado represents a significant advancement in cardiac care over SPECT imaging, offering clinicians a new, highly effective diagnostic tool to support more timely and personalized care for patients with known or suspected coronary artery disease.' Flyrcado can be imaged with a range of PET/CT systems, including GE HealthCare's Omni Legend, offering clinicians flexibility in integrating this innovative tracer into their existing imaging workflows. With Flyrcado, clinicians have the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, providing a highly effective protocol for evaluating ischemia in patients. Beyond Flyrcado, Omni Legend enables exceptional cardiac diagnostics, accommodating a range of tracers – including fast decay and emerging tracers. Representing a scalable PET/CT platform designed to evolve with healthcare system needs across care areas with shorter scan times and lower doses, iii it continues to gain in popularity, representing the company's fastest-ever-selling PET/CT. iv GE HealthCare is also proud to provide its StarGuide and Aurora SPECT/CT systems, designed to capture gamma rays emitted by radioactive tracers. Both systems offer exceptional image quality and scan time efficiency, supporting clinicians in making confident diagnoses. These features make SPECT/CT a valuable tool in cardiac care, providing comprehensive views of both physiological and structural aspects of diseases. Additional solutions from GE HealthCare's MIM Software are also available to enable multi-modality viewing and fusion of cardiac images and offer integration pathways for cardiac analysis. A devoted provider of cardiology solutions, GE HealthCare supports the continuum of care and personalized treatments for the world's largest hospitals to the smallest clinics and beyond the walls of the clinician's office. With a vast and diversified portfolio, GE HealthCare offers healthcare professionals a breadth of solutions from early detection and diagnosis, to planning, intervention, and monitoring to help clinicians deliver better patient outcomes in cardiology care today and for the future. For more information on GE HealthCare's innovative portfolio of molecular solutions for cardiology, please visit SNMMI show attendees are also encouraged stop by the company's booth (#638 and #1023) at New Orleans Ernest N. Morial Convention Center in New Orleans, Louisiana from June 21-24. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient's journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World's Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website for more information. Forward-looking statements This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as 'will,' 'expect,' 'may,' 'would,' 'could,' 'plan,' 'believe,' 'anticipate,' 'intend,' 'potential,' and similar expressions. These forward-looking statements may include, but are not limited to, statements about Flyrcado and GE HealthCare Technologies Inc.'s (the 'Company's') performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company's actual results to differ materially from those described in its forward-looking statements include, but are not limited to, uncertainties regarding the commercial success of Flyrcado, the Company's ability to receive pass-through status from the US Centers for Medicaid and Medicare, and decisions by regulatory authorities impacting labeling, manufacturing processes, safety, or other matters that could affect the availability or commercial potential of Flyrcado. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company's actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation. Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information Indications and usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information. Radiation risks: FLYRCADO 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 minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in specific populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established.
Business Upturn
4 hours ago
- Business Upturn
Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges
Sydney, Australia: As Live Biotherapeutic Products (LBPs) begin to transition from frontier science to clinical reality, Novotech, a leading global CRO and scientific advisory partner has published a new white paper examining the opportunities and challenges shaping this fast-evolving landscape of therapeutic class. This press release features multimedia. View the full release here: LBPs, which harness live microorganisms to restore or modulate human health, are being explored across a growing range of indications, from gastrointestinal and metabolic disorders to CNS and oncology. FDA approvals of Rebyota™ and Vowst™ have validated the category but for most biotech sponsors, the journey remains uncertain. According to Novotech's analysis, over 90% of LBP assets are still in early development stages, and nearly one-third of all trials from 2020 to 2025 have been withdrawn or suspended due to regulatory, manufacturing, or design complexities. Highlights from the report include: A growing pipeline of preclinical and Phase I–II LBP candidates, with notable concentration in Alzheimer's, IBD, diabetes, and NASH. Over 90 industry-sponsored trials launched since 2020, yet 32% have experienced discontinuation. North America and Europe leading in regulatory approvals and manufacturing activity, with rising interest from biotechs in Asia-Pacific. A projected CAGR of 38% for the LBP and microbiome CDMO market through 2030. The global market for LBPs and microbiome contract development and manufacturing organizations (CDMOs) was valued at USD 31.84 million in 2023. With growing investment in players like Vedanta Biosciences and MaaT Pharma, the LBP field is maturing but also becoming more competitive. Success will depend on smart trial design, global regulatory navigation, and efficient feasibility execution. Drawing on deep therapeutic expertise in microbiome-related studies and gastrointestinal, metabolic, and immunologic indications, Novotech supports sponsors from early development through global trial delivery. With operations spanning Asia-Pacific, North America, and Europe, Novotech is uniquely positioned to help biotech and small to mid-size pharma companies translate LBP potential into clinical success. Download the full white paper 'Why Live Biotherapeutics Matter to Emerging Biotech' here. For further information, please visit About Novotech Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase. With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results. For more information or to speak to an expert team member visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
