BioXmark® submitted for FDA approval

4 April 2022


  •     The U.S. represents the world’s largest market for precision marking in cancer therapy


Nanovi informs that in March 2022, the company completed the submission of a De Novo classification request for BioXmark to the U.S. Food and Drug Administration (FDA) in order to achieve market authorization for the product in the U.S.. The submission follows communication between Nanovi and FDA, including a pre-submission meeting held in 2021.


BioXmark is a novel liquid soft tissue marker, developed by Nanovi to enhance target visibility in imaging and guide high precision radiation therapy for multiple cancer types. Nanovi obtained CE marking of BioXmark in 2020, and the product has since then been commercially available across all EU member states.


The U.S. has 2.56 million new cancer cases annually and is the world’s biggest cancer therapy market. For most solid cancers, radiation therapy in combination with surgery and/or chemotherapy is a first-line treatment option. In radiation therapy, precision is essential to effectively kill cancer cells and minimize radiation damage to surrounding healthy tissue and organs for optimal patient outcomes.


In a comment to the U.S. regulatory submission of BioXmark, Jesper Boysen, CEO of Nanovi, said:

The submission of our U.S. regulatory file on BioXmark is a significant milestone. BioXmark builds on a unique technology platform developed in collaboration with the Technical University of Denmark and – as a liquid fiducial marker – has demonstrated clinical performance to potentially open new opportunities in high precision radiation therapy. . We now look forward to our continued interactions with the FDA.”


Click here to download the news release in pdf format.