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Navidea Awarded SBIR Grant From The NIH For Development Of Radio-Immuno-Guided Surgery (RIGS) Agent Aimed At Detecting Metastatic Cancer

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the receipt of a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), National Institutes of Health (NIH), to fund the development of the Company's radio-immuno-guided surgery monoclonal antibody targeting agent for use in detecting metastatic sites in colorectal cancer. The SBIR grant has the potential for grant money up to a total of $1.5M over three years if fully funded. The first-year Phase I funding of $315,000, which has already been approved, is expected to enable Navidea to complete preclinical bridging activities using a RIGS tumor-antigen-targeted monoclonal antibody and prepare a standardization clinical trial protocol. Second and third year (Phase II) funding of up to $1.2M is contingent upon meeting certain Phase I success criteria, including Institutional Review Board (IRB) approval of the clinical trial protocol.

"We are pleased that NIH/NCI has recognized the potential value for Navidea’s RIGS agent to significantly benefit surgeons in effectively locating cancerous tissues during surgery and enabling their more thorough surgical removal for better patient outcomes. We appreciate NCI’s support as we complete these important preclinical studies and prepare for re-initiation of human clinical trials," said Mark Pykett, V.M.D., Ph.D., President and CEO of Navidea. "The development of our RIGS monoclonal antibody agent represents another clinical advancement of Navidea’s pipeline of innovative precision diagnostic products, including Lymphoseek ® and NAV4694, which target devastating oncologic and neurologic diseases."

About the RIGS Monoclonal Antibody Targeting Agent

The RIGS targeting agent is an investigational, tumor-specific, radio-labeled monoclonal antibody. It may be used during surgery to identify cancerous tissue undetectable by traditional diagnostic and intraoperative techniques. The RIGS monoclonal antibody agent may enable more effective surgeries caused by metastasized colorectal cancers leading to improved patient survival.

Before surgery, a cancer patient is injected with the RIGS targeting agent which circulates throughout the patient’s body and binds specifically to cancer cell antigens or receptors. Concentrations of the RIGS targeting agent within affected tissue are then detected using a gamma probe and direct the surgeon to targeted tissue for removal.

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