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Amber Implants receives approval for First in Human study in Europe

The Hague, Netherlands, June 6, 2023 /OrthoSpineNews/ – Amber Implants has achieved a significant milestone by obtaining regulatory approval for our clinical study in Europe. This remarkable achievement brings us one step closer to revolutionising the treatment of vertebral compression fractures with our groundbreaking VCFix Spinal System. With this approval, we will begin treating the first patients, aiming to showcase the clinical safety and exceptional functionality of our innovative device.

We are thrilled to embark on this study which will allow us to push the boundaries of medical innovation and pave the way for a brighter future in the field of spinal healthcare.

About Amber Implants

Amber Implants is a medical technology start-up located in the Netherlands and United States. Founded in 2018, the Company has developed VCFix® Spinal System as the next generation of treatments for vertebral compression fractures, and is focused on improving patient outcomes through implants that provide more natural healing and stability. Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders in future. 

About VCFix®

The VCFix® Spinal System is the first solution able to treat a broad range of vertebral compression fractures (VCFs) without need for bone cement. With its unique design, the VCFix® implant can potentially stimulate bone ingrowth, providing a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. The VCFix® implant provides pedicle anchorage for better stability, better distribution of loads in the middle and posterior columns of the spine, as well the possibility for posterior fixation for more unstable fractures. The VCFix® Spinal System also includes a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection. VCFix® will be the new generation of treatment, providing an easier, more efficient and safer solution for patients with vertebral fractures.

CAUTION Investigational device only. Limited by Federal law to investigational use.

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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