U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA®

MONROE TOWNSHIP, NJ, and OXFORD, UK, May 30, 2023 -Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval for its optimized, high‐affinity radiohybrid (rh) Prostate‐Specific Membrane Antigen (PSMA)‐targeted PET imaging agent, POSLUMA® (flotufolastat F 18) injection (formerly referred to as ¹⁸F‐rhPSMA‐7.3). POSLUMA 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.

It is the first and only FDA‐approved, PSMA‐targeted imaging agent developed with proprietary radiohybrid (rh) technology. POSLUMA will be commercially available in early June 2023, through certain radiopharmacies in the national radiopharmacy network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. It will become increasingly available nationally in coming months.

“With the FDA approval of POSLUMA, we realize our goal of providing an important product that will be widely available across the United States to help inform the management and treatment of patients across the prostate cancer care continuum,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “This event marks a major milestone in the expansion of Blue Earth Diagnostics’ robust prostate cancer portfolio. POSLUMA was developed to assist physicians in the detection and localization of prostate cancer. It represents a new class of purposely engineered, high‐affinity PSMAtargeted radiopharmaceuticals based on novel radiohybrid technology, which may offer diagnostic imaging and therapeutic potential. All of us at Blue Earth Diagnostics want to express our sincere gratitude to the many patients, physicians, clinical trial sites and collaborators who have worked closely with us to progress POSLUMA.”

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