Fluciclovine 18F

MONROE TOWNSHIP, N.J. & OXFORD, England--( BUSINESS WIRE )--Bracco and Blue Earth Diagnostics Ltd, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, welcomes proposed changes announced on July 10, 2024, by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (OPPS) Rule. The rule is designed to improve payments for diagnostic radiopharmaceuticals for U.S. Medicare patients, and has the potential to increase access to innovative radiopharmaceuticals that have lost, or will lose, their Transitional Pass-Through payment status. Blue Earth Diagnostics has been a pioneer in championing the discussions with CMS to secure this rule change. “ We are excited about this proposed CMS rule, which will increase patient access to advanced diagnostic imaging products to inform patient management, and, at the same time, enhance industry innovation and sustainability,” said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. “ Adoption of innovative radiopharmaceutical products, and importantly, patient access to these products, has been hampered for years by limitations of the CMS payment methodology,” added Terri Wilson, President, Blue Earth Diagnostics, Inc. “ In the case of Blue Earth Diagnostics, this new proposed rule will support our entire portfolio of diagnostic imaging agents. POSLUMA ® (flotufolastat F 18) will maintain its Pass-Through payment status for diagnostic imaging radiopharmaceutical reimbursement until September 30, 2026. Upon passage of the proposed rule, Axumin ® (fluciclovine F 18), which previously lost Pass-Through status in January 2020, will gain separate payment.” The proposed OPPS rule requires further refinement over a 60-day comment period. Blue Earth Diagnostics is looking forward to continued cooperation with CMS to determine necessary details to identify the new separate payment rates (which are proposed to differ from those under Transitional Pass-Through), build a model for future adjustments and ensure successful implementation of the rule. The final rule will be issued in early November 2024 and take effect January 1, 2025. 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 . Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA ® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full POSLUMA prescribing information is available at www.posluma.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 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. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com . This press release is for U.S. audiences only

MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)-- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced upcoming presentations by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 8 to 11, 2024, in Toronto, Canada. POSLUMA® (formerly referred to as 18F-rhPSMA-7.3) is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Axumin® is approved and indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. “We are pleased that our collaborators will be sharing important scientific information about POSLUMA, Axumin and investigational experience with 18F-flotufolastat with the imaging community at SNMMI,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “Two presentations relate to the use of POSLUMA and 18F-flotufolastat and the effects of urinary bladder activity on imaging quality. Results from a head-to-head study to be presented by Dr. Isabel Rauscher of the Technical University of Munich examine parameters of PET imaging between 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer, and a presentation by Dr. Ismaheel Lawal will discuss interim results from a study at Emory assessing PET imaging quality with and without the diuretic furosemide in patients with biochemical recurrence of prostate cancer (BCR). Dr. Nadine Mallak of Oregon Health and Science University will present interim results from an ongoing study of the use of Axumin in PSMA/PET-negative BCR patients, and Dr. Rauscher will also describe clinical experience with 18F-rhPSMA-7 and 18F-flotufolastat PET in salvage therapy planning for BCR.” Details of selected oral and poster presentations by Blue Earth Diagnostics collaborators are listed below. Presentations noted by “*” discuss results of experiences with an investigational agent for which the safety and efficacy have not been established by the FDA. POSLUMA (flotufolastat F 18), investigational 18F-flotufolastat and 18F-rhPSMA-7 DATE: Sunday, June 9, 2024 Title: Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial Presenter: Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga. Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241368 DATE: Sunday, June 9, 2024 Title: *Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat and 68Ga-PSMA-11-PET Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241424 DATE: Saturday, June 8, 2024 Title: *18F-rhPSMA-7 and 18F-flotufolastat PET-guided salvage radiotherapy in recurrent prostate cancer Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: Prostate Cancer: Focus on Imaging Session Type: Oral presentation Session Time: 3:30 – 4:45 PM ET Presentation: 3:35 – 3:45 PM ET Abstract ID.: 241112 Axumin (fluciclovine F 18) DATE: Sunday, June 9, 2024 Title: Role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT: interim results from a prospective trial Presenter: Nadine Mallak, MD, Associate Professor, Department of Diagnostic Radiology | Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Oregon Health and Science University, Portland, Ore. Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241835 Blue Earth Diagnostics invites participants at the 2024 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1639. The Company is hosting a Satellite Symposium, “Let’s Talk about POSLUMA®,” which will discuss the most recent innovations in PSMA-PET imaging for prostate cancer. It will feature invited speakers Sean Collins, MD, PhD, Professor, Georgetown University Hospital, and Elizabeth Hawk, MD, PhD, DABNM DABR, University of California San Diego, and be moderated by Todd Cohen, MD, VP of Medical Affairs, Blue Earth Diagnostics, Inc. The symposium will be held on Sunday, June 9, 2024, from 11:15 AM – 12:15 PM ET in the Toronto Convention Center, Room 701A, South Building – 700 Level. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about the Company’s clinical research. For full session details and scientific presentation lists, please see the SNMMI 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 . Full Axumin prescribing information is available at . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . 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: . 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 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. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . Axumin and POSLUMA are registered trademarks of Blue Earth Diagnostics Ltd. PP-rh-US-0492 This press release is for U.S. audiences only