CAScination’s next step into the US market

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03.02.2016

CAScination has obtained FDA clearance for its navigation solution for interventional radiological treatments. Thanks to the FDA clearance, CAScination can provide solutions for the entire treatment range - from percutaneous interventions to surgical tumor removal - to customers in the US. CAS-One IR supports reliable, minimally invasive tumor ablation therapy.

CAScination AG, a Swiss medical device company, announces FDA 510(k) clearance of its unique, stereotactic navigation system for percutaneous interventions. Being a pioneer in surgical navigation for soft organs, CAS-One IR guides surgical instruments for effective tumor removal while sparing healthy tissue. The CAS-One IR device (CE marked since 2012) is routinely used in leading European cancer centers and has improved treatment for hundreds of patients.

CAScination's highly efficient stereotactic navigation system with unique single marker patient tracking offers guidance for a wide range of biopsy and ablation devices. It provides interventional radiologists with an intuitive tool to plan and carry out complex needle placements in various  organs. Accurate needle placement is enabled by a precise micromechanical aiming device. Innovative FotoFinish treatment verification software allows for immediate treatment outcome validation and documentation. CAS-One IR enables complex interventions where challenging tumor location and proximity to structures at risk demand a sophisticated interventional approach.

With FDA 510(k) clearance CAScination's CAS-One IR can be deployed in the US where over 80'000 patients are diagnosed with primary and secondary liver cancer each year.

Matthias Peterhans, co-founder and CEO of CAScination, states: "We have demonstrated in Europe that CAS-One Liver and CAS-One IR can improve the standard of care and enable new treatments for patients affected by cancer. As a next step, we are pleased to finally provide our complete solution portfolio to customers and patients in the US".

About CAScination
CAScination is a privately held medical device company founded in 2009 as a spin-off from the ARTORG Center for Biomedical Engineering research of the University of Bern in Switzerland. The company specializes in surgical navigation technology for soft organs and currently provides a portfolio of navigation solutions for surgical and radiological cancer treatments. Its products CAS-One Liver and CAS-One IR are CE marked and FDA cleared and currently in use in European hospitals. The company has won several awards including the CTI Swiss Medtech Award 2013, and has been nominated as a finalist of the Swiss Economic Award 2015.

(SK)

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