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.”

“As the main manufacturer and distributor of POSLUMA to imaging centers in the United States, PETNET Solutions is proud to continue our longstanding commercial relationship with Blue Earth Diagnostics, which began in 2015 when we became a commercial supplier of Axumin,” said Barry Scott, Head of PETNET Solutions Inc. “With our large national network of cyclotron-equipped radiopharmacies, we are well-positioned to provide broad access to POSLUMA, as well as a wide range of other novel PET biomarkers that facilitate precision medicine for healthcare providers across the country.”

Blue Earth Diagnostics and PETNET Solutions welcome visitors to the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Chicago, June 24-27, 2023, to visit their exhibit booths. Blue Earth Diagnostics is at Booth 6025 and PETNET Solutions is at Booth 6075.


About POSLUMA® (flotufolastat F 18)
POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent 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 therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. POSLUMA was approved by the U.S. Food and Drug Administration in May, 2023.


About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.