Nanovi earns CE mark approval for BioXmark®, its novel liquid fiducial marker
3 March 2020
BioXmark is a unique device to enhance target visibility on medical imaging that empowers healthcare professionals to deliver high precision radiation therapy across cancer indications
Nanovi, a Danish medical device company specialized in the development and manufacturing of liquid fiducial markers, informs that it has been granted European regulatory approval to CE mark BioXmark®, its first product for human use. BioXmark® is a liquid fiducial marker intended for use to mark soft tissue within the body for enhanced visibility on medical imaging and enable high precision radiation therapy. The CE mark is a symbol to certify product conformity to patient and user safety requirements as well as to medical device performance standards under the EU Medical Device Directive.
BioXmark® offers the following features and benefits:
— Liquid formulation for a fast and easy customizable implantation
— Sticky, iodine-based soft marker for adaptivity to surrounding tissue, positional stability and visibility on relevant imaging modalities, including MRI
— Non-metallic for a low level of artifacts and low dose perturbation, offering compatibility with photon and proton radiation therapies
The unique features and benefits of BioXmark® open new opportunities to accurately mark targets within the body for enhanced visibility on medical imaging. This empowers healthcare professionals to deliver high precision radiation therapy across multiple cancer indications.
In connection with the CE marking of BioXmark, Jesper Boysen, CEO of Nanovi commented:
“The CE marking of BioXmark® gives cancer clinics across Europe access to a new tool to support high
precision radiation therapy across multiple cancer indications. Potentially, the use of our new liquid marker can both benefit patients and save costs in healthcare. For Nanovi, the CE marking of our first product is an essential achievement on our path towards building a full scale operational medical
Following the CE marking, Nanovi has started commercialization activities for BioXmark® in Europe. This includes presentation of the product at ESTRO 2020, the European Society for Therapeutic Radiology and Oncology’s annual congress, taking place on 3-7 April 2020 in Vienna, Austria. At ESTRO, there will also be presentations of results from two clinical studies of BioXmark®, both conducted by leading university clinics in the Netherlands. One study was conducted by the Amsterdam Medical Center, AMC, in rectal cancer patients receiving radiation therapy, and the other was conducted by the Maastro Clinic in bladder cancer patients receiving radiation therapy.
For more information, please contact:
Jesper Boysen, CEO of Nanovi
Phone: +45 24 65 60 33