Many medical device manufacturers have found themselves caught in a trap where they have received NUB status 1 and/or 4 but the hospitals were rejected during the negotiation with the insurance companies.
Through our joint work with Dr Martin Braun we have now found a way to resolve this.
It requires the ability to demonstrate good comparative effectiveness. If you only have single arm studies, we have the ability for many diseases to extend your data with another cohort to demonstrate comparative effectiveness through our real world evidence (RWE) services.
With Dr Braun, we are also able to help you develop the initial NUB application or to refine your historical NUB application for better success.
If you are interested in this please choose a time for a call with our CEO, Mattias Kyhlstedt: https://calendly.com/mattias-kyhlstedt