Navidea Biopharmaceuticals Participates in Symposium Focused on Sentinel Lymph Node Biopsy at the International Symposium on

  Navidea Biopharmaceuticals Participates in Symposium Focused on Sentinel
  Lymph Node Biopsy at the International Symposium on Metastasis in Head and
  Neck Cancer

Business Wire

DUBLIN, Ohio -- February 5, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced that it
recently participated in a focused panel session at the 6th International
Symposium on Metastasis in Head and Neck Cancer held in Marburg, Germany.
Lymphoseek^® (technetium Tc 99m tilmanocept) Injection and initial clinical
experience data from one site participating in the Lymphoseek head and neck
cancer clinical trial, NEO3-06, were discussed during a satellite symposium
focused on Sentinel Lymph Node (SLN) biopsy in Head and Neck Cancer. In this
session, presentations were made by a panel of head and neck specialists which
included Lymphoseek-related presentations from Navidea’s Chief Medical
Officer, Cornelia Reininger, MD, PhD and Francisco J. Civantos, MD, FACS, Head
& Neck / Skull Base Surgery, University of Miami. Lymphoseek is a
receptor-targeted, small-molecule, investigational radiopharmaceutical used in
lymphatic mapping procedures.

“It was enlightening for the delegates to understand more about sentinel node
localization and the specific function of Lymphoseek. Following significant
panel and expert discussion, it was agreed that sentinel node localization has
a vital role in head and neck cancers and should be applied in routine
clinical care,” Prof. John Buscombe, Head of the Department of Nuclear
Medicine at Cambridge University Hospitals, Cambridge, UK commented. “However,
current radioactive colloids often display variable performance and the
limitation of being of human or animal origin. These data appear to indicate
that lymphatic mapping procedures can be improved using an agent such as
Lymphoseek which shows more accurate localization of the sentinel node or
nodes and will lead to less aggressive surgery, more accurate staging of
disease and fewer side effects.”

Professsor Buscombe acted as moderator for the session and described the
history and technique of sentinel node localization and demonstrated that the
technique was safe for the surgeons, their assistants and the pathologists.
Dr. Reininger provided a summary of Lymphoseek’s performance advantages in
lymphatic mapping of solid tumor cancers. Data demonstrated Lymphoseek’s rapid
clearance from the injection site but stability in the sentinel node for up to
24 hours and reinforced its ability to accurately identify and map SLNs that
can facilitate accurate staging and may potentially decrease some patients’
extent of surgery, thus reducing possible serious morbidity. Professor
Civantos spoke of the University of Miami’s initial clinical experience with
Lymphoseek. Results to date have demonstrated its utility, diagnostic
predictive value and safety in patients, both preoperatively in
lymphoscintigraphy and for intraoperative localization.

“In the current standard of care with head and neck tumors, it is not uncommon
to remove as many as 60 regional lymph nodes during bilateral neck dissection
because of the likelihood that patients may have hidden cancer in the lymph
nodes. Sentinel node biopsy allows for a much less invasive and more precise
evaluation with reduced surgical side effects” said Dr. Civantos. “Our initial
clinical experience with Lymphoseek suggested a high level of accuracy in the
identification and mapping of SLNs that may significantly improve the
precision and practicality of the procedure. We believe that Lymphoseek may
also have special utility to improve localization in certain tumor types such
as those found on the floor of the mouth. I fully expect the final results of
the multi-institutional trial, when completed, will confirm these

“The study of head and neck cancer is part of Navidea’s worldwide strategy to
expand the utilization of Lymphoseek into multiple cancer types beyond breast
cancer and melanoma and to assist physicians and patients in improving the
accuracy of cancer diagnosis and staging,” said Dr. Reininger. “We believe
that there are many unmet needs in the lymphatic mapping of other solid tumor
cancers where the procedure may be highly useful, but for which a suitable
agent has not yet been developed. Lymphoseek targets key predictive lymph
nodes through its specifically-designed, receptor-based mechanism and can fill
that need and enhance diagnostic accuracy.”

The satellite symposium, Sentinel Lymph Node (SLN) Biopsy in Head and Neck
Cancer, was jointly sponsored with SurgicEye GmbH, Munich, Germany.

About Lymphoseek^®

Lymphoseek^® (technetium Tc 99m tilmanocept) Injection is a novel,
receptor-targeted, small-molecule, investigational radiopharmaceutical used in
lymphatic mapping procedures that are performed to help stage cancers such as
breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes
that drain from a primary tumor, which have the highest probability of
harboring cancer.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumor
metastases are identified and biopsied to determine if cancer has spread
beyond the primary tumor. Accurate staging of cancer is critical, as it guides
therapy decisions and determines patient prognosis and risk of recurrence.
According to the American Cancer Society, approximately 229,000 new cases of
breast cancer, 76,000 new cases of melanoma and 67,000 new cases of head and
neck cancers are expected to be diagnosed in the United States in 2012.

About Lymphatic Mapping

Lymphatic mapping is a procedure designed to guide lymph node dissection and
biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often
accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure
routinely performed pre-operatively to provide guidance on the location of
lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes
draining the area around a tumor are identified and biopsied to determine if
cancer has spread to the lymph nodes. These nodes, commonly referred to as
“Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant
cells. Lymphatic Mapping provides an accurate staging procedure that can help
ensure optimal surgical and therapeutic choices, including the avoidance of
the morbidity of a complete lymph node dissection for patients in whom the
Sentinel Lymph Nodes were found to be free of cancer.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of precision
diagnostics and radiopharmaceutical agents. Navidea is actively developing
four radiopharmaceutical agent platforms – Lymphoseek^®, NAV4694, NAV5001 and
RIGScan^TM – to help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making and, ultimately,
patient care. Navidea’s strategy is to deliver superior growth and shareholder
return by bringing to market novel radiopharmaceutical agents and advancing
the Company’s pipeline through selective acquisitions, global partnering and
commercialization efforts. For more information, please visit

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Navidea Biopharmaceuticals, Inc.
Brent Larson, 614-822-2330
Sr. VP & CFO
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