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Navidea Biopharmaceuticals bags CDSCO approval for Lymphoaim in India

Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma

Navidea Biopharmaceuticals announced the regulatory approval of Lymphoaim by the Central Drugs Standard Control Organisation. 

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Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised 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 tumour, which have the highest probability of harbouring cancer.

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

Dr Michael Rosol, Chief Medical Officer, 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.”

Shukrit Sudhir Chimote, CEO, 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.”

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