MONROE TOWNSHIP, N.J., OXFORD, UK, & MALVERN, Pa. June 21, 2023 − Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, and PETNET Solutions Inc, A Siemens Healthineers Company, today announced the commercial availability of POSLUMA® (flotufolastat F 18) in the United States. POSLUMA (formerly referred to as to as 18F-rhPSMA-7.3) is an optimized, high-affinity radiohybrid (rh) Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent. It 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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA was approved by the U.S. Food and Drug Administration on May 25, 2023.

POSLUMA is now commercially available through multiple radiopharmacies of PETNET Solutions, the primary manufacturer and commercial distributor for Blue Earth Diagnostics in the United States. By the end of June 2023, commercial production across the country will be underway at the 31 PETNET radiopharmacies Blue Earth Diagnostics included in its New Drug Application for POSLUMA, marking a record number of sites authorized for the manufacturing of a radiopharmaceutical upon its initial FDA approval. Additional PETNET sites are expected to manufacture POSLUMA before the end of the summer.

“We are pleased to make POSLUMA widely available across the United States for use in men with newly diagnosed or suspected recurrence of prostate cancer, and hope that this will make a real difference to physicians and their patients,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics Ltd. “Our product introduction plan for POSLUMA includes practical education programs for physicians and staff at imaging centers to educate them on the appropriate use of POSLUMA, including image acquisition and reader training programs to help ensure the best information is available to inform patient care. In addition, we are actively communicating with Medicare carriers, Medicare Advantage Plans, private insurers and radiology benefit managers to help them understand the utility and value of POSLUMA, so that they will cover these procedures appropriately.”
Dr. Gauden continued, “It is an ongoing pleasure to continue working with PETNET Solutions. We have a long-standing, productive relationship based on our seven-year success with Axumin® (fluciclovine F 18). Our companies share a passion for PET molecular imaging, and for providing imaging tools to help inform the management of patients across the prostate cancer care continuum.”

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