Navidea Biopharmaceuticals Announces the Regulatory Approval of Lymphoaim in India

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the regulatory approval of Lymphoaim (“Lymphoseek” in the rest of the world; Tc99m tilmanocept) by the Central Drugs Standard Control Organisation, India.

Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Sayre Therapeutics will lead Lymphoaim commercialization efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specializes in innovative treatment and medical device commercialization in South Asia.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted that Lymphoaim has received regulatory approval in India and will be available to patients in need.” Dr. Rosol continued, “This will also bring a new revenue stream to the Company to help us advance other pipeline products.”

Mr. Shukrit Sudhir Chimote, Chief Executive Officer for Sayre, said, “Lymphoaim, a radioactive diagnostic agent, would benefit surgeons in guiding sentinel lymph node biopsies. This product fits well with Sayre’s mission of providing novel treatment solutions, and will certainly help boost our presence in the surgical oncology segment.”

About Sayre Therapeutics

Sayre Therapeutics Private Ltd. is South Asia’s integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

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