This milestone is the outcome of a collaborative regulatory journey.

SDS™️ is a growth-friendly implant for the treatment of early onset scoliosis (EOS). Earlier in our regulatory trajectory it received FDA Breakthrough Device Designation. Since the program was introduced in 2015 by the U.S. Food and Drug Administration (FDA), Breakthrough designation has been granted to only a tiny fraction of devices that ultimately go through the 510(k) pathway. In fact, fewer than 0.1 percent, emphasizing the value of SDS™️ in the need for a more effective treatment for the life-threatening and debilitating disease EOS.

What mattered most was what happened next.

Together with our R&D and regulatory partner BAAT Medical and the FDA team, we ran a structured process with focused regulatory sprints. Clear questions, clear deliverables, and early alignment on what a complete and high-quality dossier should look like. It was rigorous. It was constructive. It was human work, done with discipline.

Now the impact becomes real.

With FDA clearance, we will initiate a controlled release of SDS™️ in a limited number of high-profile children’s hospitals in the United States and Canada. This phased introduction is designed to support careful clinical adoption and to allow the first children outside the Netherlands to be treated with SDS™️.

In parallel, we are fully committed to scaling access responsibly. Next regions on our roadmap include Australia and New Zealand. Of course, Europe matters just as much. Our CE marking trajectory continues under the orphan pathway, with the goal to contribute to better early onset scoliosis care across Europe as soon as possible.

We built SDS™️ to reduce treatment burden during growth and to respect spine-physiology in children with EOS. FDA clearance is a major step. Worldwide SDS™️ access for children with EOS is the mission.