Over the past quarter, Skaaltec has made significant strides in advancing SmartVNS, our non-invasive neurostimulation system, and we would like to share some of the milestones we reached:
Working with our development partner Helbling and with user inputs from a clinical trial at cereneo, we finalized a product-level redesign of our wearables, featuring an intuitive and patient-friendly design. We updated the internal hardware to match the new form factor and performed EMC (electromagnetic compatibility) evaluation, getting one step closer in our regulatory journey towards medical device approval.
Technologically, we achieved a major breakthrough in building a fully-integrated SmartVNS system by embedding our tried-and-tested motion analysis and stimulation control algorithms. This permits standalone use of the system, streamlining the clinical workflow by removing the need for an external device for setup and control.
To complement our hardware, we developed a prototype web platform for therapists and a proof-of-concept IoT gateway for seamless data transfer and charging. The ongoing feasibility trial continues to provide valuable feedback from users, ensuring our solution is aligned with clinical needs. These achievements mark our steady progress towards market readiness and delivering impactful solutions for stroke recovery.
