
ConcertAI Announce Strategic Agreement with Bayer to Accelerate Clinical Development in Precision Oncology
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ConcertAI announced a multi-year agreement with Bayer to leverage ConcertAI's Translational360™ -- powered by Guardant Health liquid biopsy genomic data -- and AI SaaS solutions, which use artificial intelligence and machine learning (AI/ML)-derived insights to accelerate clinical development in precision oncology.
The agreement will fully leverage ConcertAI's newly launched Translational360™, an integrated research-grade longitudinal clinical molecular database that taps into the CancerLinQ network of de-identified cancer patient data from over 9 million records coming from all 50 states in the U.S.
Translational360™ combines clinical, genomic, transcriptomic, and whole-slide imaging (WSI) from comprehensive molecular testing for deep phenotypical and genomic insights. Transcriptomics is increasingly a foundation of biopharma translational sciences, allowing researchers to understand disease molecular mechanisms, basis of patient response, and inter-patient variability that's essential for developing new therapeutics. Too often, clinical trial results in early phases are ambiguous with idiosyncratic positive and negative responses. The integrated data solutions and advanced AI enable selection of programs with the highest likelihood of success and design trials informed by multi-modal, multi-genomic, and transcriptomic data and AI.
'This partnership furthers causal biological inferences, where multi-modal and multi-molecular data can be integrated with AI/ML-based approaches across discovery, translation, and development, accelerating oncology pipelines, allowing our biopharma partners to deliver better medicines faster," said Jeff Elton, Ph.D., CEO of ConcertAI. 'This partnership builds on a multi-year history of working together and is unique in offering both tissue and liquid biopsy molecular data, allowing insights into patterns of treatment response, acquisition of resistance, AI modeling of likely success and benefit, informing program priority and clinical study design.'
'Data play a critical role in providing a multi-dimensional understanding of a tumor, the clinical environment, and the patient's response to therapy,' said Helmy Eltoukhy, Chairman and co-CEO of Guardant Health. 'The real-world data can provide access to unprecedented insights into a patient's cancer journey, including a tumor's complex systemic interactions, to help users navigate critical decision points as they develop novel targeted therapies.'
'As cancer rates continue to rise, we're committed to advancing next-generation solutions that can speed up drug discovery and clinical development, enabling us to bring precision oncology treatments to patients faster,' said Sai Jasti, Head of Data Science and AI for Pharma R&D at Bayer. 'By combining ConcertAI's powerful data solutions with Bayer's scientific and AI expertise, we aim to enhance the use of real-world data and cutting-edge AI to boost R&D productivity and ultimately deliver transformative precision therapies to those who need them.'
"More AI-designed new molecular entities are progressing faster in first-in-human trials, which is a great milestone,' said Claudio D'Ambrosio, Ph.D., Chief Revenue Officer of ConcertAI. 'Our entire R&D process has been historically built on studying controlled cell lines and animal models that don't reflect the interspecies differences, the physiology, and the different biological barriers we have in humans. We are flipping this paradigm on its head. We need to start with human cancer genomes and phenotypes and 'reverse translate.' Unlike only a few years ago, we now have powerful human data.'
About ConcertAI:
ConcertAI is a leader in predictive and generative AI SaaS and multi-modal real-world data research solutions for healthcare and life sciences. Our mission is to accelerate insights and outcomes for patients through research-ready data, CARAai ™ technologies, and scientific expertise in partnership with over 46 leading biomedical innovators, 2,000 healthcare providers, and medical societies. TeraRecon ® provides advanced radiological image visualizations and clinical AI decision augmentation solutions for MRI and CT. CancerLinQ ® is an initiative of ConcertAI, empowering oncology providers with ASCO-aligned automated QOPI and ASCO Certified ® quality solutions and SmartLinQ™ analytic services. Headquartered in Cambridge, MA, ConcertAI has offices in Bangalore, Frankfurt, Philadelphia, Raleigh-Durham, and Tokyo. For more information, visit us at concertai.com.
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Business Wire
an hour 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
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Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges
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Business Wire
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Sidus Space Advances $120M Agreement with Lonestar, Selects Atomic-6 as Solar Array Partner for Cislunar Data Satellite Mission
CAPE CANAVERAL, Fla.--(BUSINESS WIRE)--Sidus Space (NASDAQ: SIDU), (the 'Company' or 'Sidus'), an innovative space and defense technology provider, today announced the next milestone under its expanded $120 million preliminary agreement with Lonestar Data Holdings Inc. to support the world's first lunar data centers. Atomic-6 has been selected to supply its Light Wing™ solar arrays which are expected to power Sidus' LizzieSat® satellites supporting Lonestar's cislunar data storage constellation. 'This collaboration marks a key advancement as we evolve LizzieSat® in executing our vision for lunar satellite services,' said Carol Craig, CEO of Sidus Space. Share The all-composite, redeployable Light Wing™ arrays deliver industry leading power-to-mass performance, contributing to mission assurance and overall efficiency. Atomic-6's solution was selected after a rigorous technical and commercial review to meet the demands of secure, redundant satellite operations in the harsh cislunar environment. Sidus' versatile LizzieSat® platform offers a scalable solution for complex missions beyond low Earth orbit, including future lunar operations. The Company's end-to-end capabilities, from design and integration to launch and operations, are being applied to support Lonestar's phased deployment of resilient cislunar data infrastructure. 'This collaboration marks a key advancement as we evolve LizzieSat® in executing our vision for lunar satellite services,' said Carol Craig, CEO of Sidus Space. 'We're proud to lead a commercial-first initiative that not only delivers data security solutions in cislunar space but also reinforces our LizzieSat® platform's adaptability and utility across deep space operations.' The constellation aims to deliver secure, tamper-resistant data storage, immune to threats such as natural disasters, geopolitical instability, and cyberattacks. The selection of Atomic-6 underscores the importance of high-efficiency power systems in enabling this next-generation architecture. Light Wing™ arrays delivers up to 200 watts per kilogram, four times more power than comparable systems, offering exceptional efficiency and reliability. 'We're excited to welcome Atomic-6 as a trusted partner in this ambitious program,' Craig added. 'Their innovative solar arrays enhance our ability to meet the unique demands of cislunar deployment.' This announcement follows Sidus Space's March 2025 execution of an extended and amended preliminary agreement with Lonestar. As program development accelerates, Sidus remains committed to advancing commercial applications in cislunar space and enabling next-generation services through its adaptable LizzieSat® platform. 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For more information, visit: About Atomic-6 Atomic-6 is leading the materials revolution by designing, engineering and manufacturing the finest composites in the world. The company leverages a proprietary manufacturing process that optimizes fiber-to-resin ratios, significantly reduces porosity, and expedites production cycle times across aerospace, hypersonics, and defense applications. Visit About Lonestar Data Holdings Lonestar Data Holdings is a pioneering data center infrastructure company that offers a groundbreaking approach to data storage and data security. Lonestar provides resilient data storage solutions, that are compliant with data-sovereignty requirements globally, and are designed to protect critical information from cyberattack, natural disasters, and nation-state threats. After making history with the world's first software-defined data operations on the Moon in 2024, the company continues to lead advancements in edge processing and data storage in lunar orbit, while maintaining a strong commitment to sustainability with solar-powered and carbon-neutral operations. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Sidus Space's Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Sidus Space, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.