Blue Earth Diagnostics Highlights Upcoming Presentation of Additional Results from Investigational Phase 3 SPOTLIGHT Study of PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer

− Results to be presented at American Urological Association’s 2023 Annual Meeting (AUA2023) –

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 the presentation of additional results from its completed Phase 3 SPOTLIGHT trial of ¹⁸F-rhPSMA-7.3 in recurrent prostate cancer, among a subgroup of patients who had undergone primary treatment with radiation therapy only. The results will be presented at the upcoming American Urological Association’s 2023 Annual Meeting (AUA2023), being held in Chicago, Ill., from April 28 to May 1, 2023. ¹⁸F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of ¹⁸F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Currently, ¹⁸F-rhPSMA-7.3 is investigational and has not received regulatory approval.

Details of the presentation are listed below.

Blue Earth Diagnostics invites participants at AUA2023 to attend the presentation above and to learn more about the Company at Booth 645. For full session details and scientific presentation listings, please see the AUA online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
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 ¹⁸F for PET imaging, or with isotopes such as ¹⁷⁷Lu or ²²⁵Ac for therapeutic use – creating a true theranostic technology. The radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics GmbH in 2018, followed by acquisition of exclusive rights to therapeutic applications in 2020. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of ¹⁸F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease, and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. rhPSMA compounds are investigational and have not received regulatory approval.

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.

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan
Vice President, Corporate Communications
(M) (781) 799-7917
priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley
Associate Director Marketing and Communications
Tel: +44 (0)1865 784186
clare.gidley@blueearthdx.com

Media
Sam Brown Inc.
Mike Beyer
(M) (312) 961-2502
mikebeyer@sambrown.com