Two weeks ago, we shared our regulatory milestone. FDA 510(k) clearance for our Spring Distraction System (SDS™). Today we close the loop on how we fund the momentum and what makes the next phase possible.
We have successfully closed a pre-Series A round with a group of informal investors. These investors are not just providing capital. They are betting on a shift in how the world treats Early-Onset Scoliosis. With their support and funding, we are moving from a Dutch innovation to a global standard and it enables three concrete milestones.
First. A controlled market introduction in the United States and Canada. In a limited number of high-profile children’s hospitals, with careful clinical adoption and structured onboarding. With a follow-on into New Zealand and Australia later this year.
Second. Europe. We continue our CE trajectory under the Orphan Device pathway, with a focus on speed without shortcuts. The goal is straightforward. Bring responsible access to SDS™ across Europe as soon as possible.
Third. The United Kingdom. We are preparing a dedicated regulatory route that supports stepwise introduction and high-quality real-world evidence collection, so we can expand access while staying rigorous on safety and performance.
Across all regions, we move with the same approach that got us here. Clear questions. Clear deliverables. Early alignment on what “complete” really means.
And we do it with the continued enthusiasm of our team members Dennis Magermans, René Castelein, Moyo Kruyt, David Catsburg, Nancy Lamerigts and our long-standing R&D and regulatory partner BAAT Medical. The same discipline. The same cadence.
Yes, these milestones drive significant value creation. They de-risk market entry, strengthen our evidence base, fuel regulatory pathways and accelerate adoption.
But the bigger point is simpler.
This funding helps us bring SDS™ to children with early onset scoliosis outside the Netherlands. Children who have been waiting for the rules of scoliosis treatment to change. Now we have the fuel to get there.