Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming RSNA® 2022 Annual Meeting
2022-11-22 · Blue Earth Diagnostics · original blueearthdiagnostics.com ↗
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Deta iscuss additio onstrate that en with bioch performance e cancer at va tics’ collabora DA‐approved lood prostate Prostate Can PET‐guided Sa Sub‐group A vision of Nucl gy and Imagin ynote: Nuclea n® (Fluciclovi ing 2022 – Blue E mmercializatio xumin® (flucic Assembly an ails of selecte onal analyses t 18F‐fluciclov hemical recur of bone scint arious PSA lev ators are liste for PET imagi e‐specific ant ncer Patients alvage Radio Analysis of a R ear Medicine ng Sciences, E ar Medicine/ ine F 18) at U Earth Diagnos on of innovat clovine F 18) a d Annual Me ed oral and po from EMPIRE ine PET/CT‐gu rrence of pros tigraphy with vels. Details o ed below. ing in men w igen (PSA) lev After Conven therapy Strat Randomized e and Molecu Emory Univers Molecular Im Upcoming RSN tics, a Bracco ive PET at the upcom eting, to be h oster E‐1, the first uided radiatio state cancer. 18F‐fluciclovi of selected or ith suspected vels following ntional Imagi tified by Seru Control Trial lar Imaging, sity, Atlanta, maging (Prosta NA® o ming held on ne in al d g ing um Ga. ate 2 Title: Bone Scan versus F‐18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study Presenter: Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill. Session Type: Scientific Poster Session Session Title: Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion Presentation Time: 9:00 – 9:30 AM CT Location: Learning Center NMMI‐DPS, McCormick Place Session No.: T2‐SPNMMI‐1 Title: Impact of 18F‐fluciclovine PET/CT on Failure‐free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy Presenter: Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga. Session Type: Scientific Poster Session Session Title: Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion ‐ A Presentation Time: 12:15 – 12:45 PM CT Location: Learning Center NMMI‐DPS, McCormick Place Session No.: T5A‐SPNMMI‐2 Axumin® (fluciclovine F 18) presentations Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here. Indication and Important Safety Information About Axumin INDICATION Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient’s overall long‐term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1‐855‐AXUMIN1 (1‐855‐298‐6461) or contact FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. 3 Full Axumin prescribing information is available at https://www.axumin.com/prescribing‐ information.pdf. About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well‐differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro‐oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com. About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com. Contact: For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799‐7917 [email protected] For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0)1865 784186 [email protected] Media Sam Brown Inc. Mike Beyer (M) (312) 961‐2502 [email protected] # # #
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