Newsletter #5: Reaching beyond

Dear partners,

The first half of 2026 will remain a significant milestone in Movmedix’s history.

After several years of preparation, investment, and collective effort, we have obtained our first FDA 510(k) clearance for our ACJ solution designed for acromioclavicular joint reconstruction. This achievement represents far more than a regulatory approval: it opens the door to the world’s largest sports medicine market and validates the quality of the work accomplished by the entire Movmedix team.

This success perfectly reflects the evolution of our company. Over the past few years, we have built the foundations for sustainable growth: strengthening our teams, structuring our organization, investing in manufacturing capabilities, expanding internationally, and accelerating our innovation programs. Today, we are entering a new phase: the phase of execution.

Our business continues to grow across our established markets, maintaining a strong position in China while steadily expanding our presence in many regions worldwide, particularly throughout the APAC region. At the same time, the clearance of our first 510(k) marks the beginning of our journey in the United States, a strategic milestone for the future of Movmedix.

This momentum is also reflected in the progress of our product portfolio. While continuing to develop the LARS® ligament, which remains the foundation of our success, we are investing in the technologies that will shape the next generation of ligament augmentation and soft tissue repair solutions.

Our ambition is clear: to build a comprehensive portfolio that supports surgeons across an increasing number of sports medicine indications.

What makes me most proud today, is our teams’ ability to embrace these challenges while preserving what defines Movmedix’s DNA: agility, scientific rigor, close collaboration with surgeons, and a constant commitment to improving patient outcomes.

The second half of the year will be particularly important. The launch of our first commercial activities in the United States, the continuation of our international expansion with new regulatory approvals expected in key markets, the advancement of our clinical programs, and the development
of our next-generation products will all provide opportunities to further accelerate our growth and impact.

I would like to sincerely thank our employees, distributors, surgeon partners, and shareholder for their trust and commitment. This achievement is the result of a collective effort and a shared ambition.

Obtaining our first 510(k) is not the finish line. It is the beginning of a new chapter.

Thank you for being part of this journey.