Case Studies

Overview

Invicta Medical partnered with Psephos Biomedica to support the development and regulatory advancement of its innovative medical device - a brand new disruptive solution for patients suffering from obstructive sleep apnoea. With a focus on bringing new technology safely and efficiently to market, Invicta required expert guidance across both clinical and regulatory domains.

The Challenge

Developing a medical device in today’s landscape requires more than innovation—it demands a clear and robust pathway through regulatory frameworks.

Invicta needed to:

• Commence a proof-of-concept study in the UK utilising existing CE marked devices out of their current indication for use

• Ensure the study would be performed as an adjunct to normal patient treatment and without any long-term implantation

Without the right expertise, these challenges can slow progress and increase risk.

The Solution

Psephos Biomedica provided tailored support to guide Invicta through this process, including: