"With this approval, Lymphoseek is now the only FDA-approved diagnostic agent with a label for guiding sentinel lymph node biopsy procedures and will be immediately available with the existing reimbursement codes for this expanded population of cancer patients," said Michael Goldberg M.D., Navidea Interim Chief Executive Officer. "Navidea intends to continue its investment in Lymphoseek to further expand its use in other types of cancer, where current alternatives are neither efficient nor effective. We believe Lymphoseek can play a critical role in the staging and treatment of cancer, with potential for additional procedural cost savings."

The expanded approval is supported by data from Navidea's NEO3-06 prospective Phase 3 study that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment, which is the current "gold standard." The findings indicate that Lymphoseek accurately identified SLNs in the trial subjects for assessment, and is likely to be predictive of overall node pathology status. Moreover, multiple level nodal dissections of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average would have led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing sentinel lymph node biopsy.


The FDA granted the Lymphoseek application Fast Track Designation in December 2013 and Priority Review in February 2014. Fast Track Designation and FDA Priority Review are awarded to drug applications to expedite review of drug candidates intended to treat serious or life-threatening conditions, that demonstrate the potential to address unmet medical needs and may offer a significant improvement in treatment over existing options. Navidea has an additional sNDA under review at the FDA to further expand the Lymphoseek label.

This second sNDA focuses on more flexible and extended utilization practices, and has been assigned a PDUFA date set for October 16, 2014.

Conference Call Details
Navidea will host a conference call with the investment community to discuss the sNDA scheduled for Monday, June 16, 2014 at 08:30 a.m. EDT. Investors and the public are invited to access the live webcast through the link below. Participants who would like to ask questions during the question and answer \ session following the presentation must participate by telephone also. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins. The webcast replay is expected to be available on our investor website, http://ir.navidea.com, approximately two to four hours after the live event.

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