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Navidea Biopharmaceuticals, Inc. is a biopharmaceutical firm dedicated to advancing and commercializing specialized agents for immunodiagnosis and innovative immunotherapeutics. The company operates across two distinct segments: Diagnostic Substances and Therapeutic Development Programs. Its core technology, the Manocept platform, is designed to target the CD206 mannose receptor, which is prominently found on activated macrophages. This platform enables a variety of diagnostic imaging techniques, including single photon emission computed tomography (SPECT), positron emission tomography (PET), gamma-scanning, and both intra-operative and optical-fluorescence detection methods. Beyond diagnostics, Manocept also facilitates the targeted delivery of therapeutic compounds to macrophages, addressing diseases characterized by immune system involvement and inflammation. Among its key pipeline assets, NAV3-31 has successfully completed Phase IIb clinical trials. These trials assessed the imaging repeatability, reproducibility, and stability, along with the effectiveness of Tc99m tilmanocept imaging in monitoring anti-tumor necrosis factor alpha therapy for patients with moderate to severe rheumatoid arthritis (RA). NAV3-35 is currently undergoing a Phase IIb clinical trial for RA imaging, while NAV3-33 is advancing through Phase III clinical trials, also for RA. Furthermore, NAV3-32 is participating in a Phase 2b trial specifically for RA-involved joints. The company is also exploring the utility of Tc99m tilmanocept in other therapeutic areas, such as cardiovascular conditions, Kaposi's sarcoma, tuberculosis, and various other immunotherapeutic applications. Originally established as Neoprobe Corporation, the company officially adopted the name Navidea Biopharmaceuticals, Inc. in January 2012. Founded in 1983, its corporate headquarters are situated in Dublin, Ohio. In a significant corporate development, Navidea Biopharmaceuticals, Inc. initiated voluntary reorganization proceedings under Chapter 11 with the U.S. Bankruptcy Court for the District of Delaware on October 1, 2025.
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