Amber Implants Announces FDA Approval of VCFix, the First Bone Cement-Alternative Vertebral Augmentation System, and Files Prospectus for U.S. Commercial Launch

Amber ImplantsAnnouncing itsVertebral Augmentation Products---VCFixApproved by the FDA for marketing.VCFixIt is a vertebral augmentation system used to treat various types of vertebral compression fractures. This minimally invasive solution can be used alone or in conjunction with bone cement, providing robust anterior and posterior column support. Compared to existing solutions, it can be seamlessly integrated into current surgical procedures, potentially enhancing spinal stability, reducing patient risk, and shortening operation time.

Executive Evaluation

"The VCFix Spinal System is a groundbreaking vertebral augmentation solution that has the potential to establish a new standard for the treatment of vertebral fractures, reinforcing our company's position as a global innovator in spinal fracture solutions. As the world’s largest medical technology market, the United States not only represents a market potential exceeding 800 million euros (approximately 6.2 billion yuan), but also serves as an ideal platform for business growth. This approval lays a solid foundation for us to initiate commercial promotion."

---Banafsheh Sajadi  Amber ImplantsCo-founder and Chief ExecutiveXingguan

More than 9 million people worldwide suffer from vertebral compression fractures each year, with approximately 2 million cases in North America and Europe. Despite the high prevalence, nearly two-thirds of cases remain undiagnosed and undertreated, leaving elderly and frail patients with osteoporosis at risk of chronic pain, spinal deformities, functional impairments, and loss of self-care ability. Current treatment options have limitations: while vertebroplasty is minimally invasive, it cannot provide posterior column support for fractures; posterior fixation, on the other hand, provides support but involves greater trauma, restricts mobility, requires a longer recovery period, and has a higher incidence of complications.VCFixAs a minimally invasive solution, it uniquely supports both the anterior and posterior columns simultaneously, seamlessly integrating into existing surgical workflows to provide patients with enhanced stability at a lower risk.

Amber ImplantsPreparing for full commercialization in the U.S. market by 2026. Clinical study data released in April this year demonstrated excellent safety and efficacy.

• No device-related adverse events were reported in all patients during the one-year follow-up period, fully demonstrating the excellent safety and significant clinical potential of VCFix.
• Patients showed significant improvement regardless of whether cement augmentation was used.
• According to the Numeric Pain Rating Scale (NPRS), both patients with and without the use of bone cement experienced immediate and sustained pain relief. At the 6-month postoperative follow-up, the pain score decreased by more than 8 points. The dysfunction score assessed by the Oswestry Disability Index (ODI) also showed significant improvement, decreasing by 84 points from baseline to 6 months post-surgery. These improvements were consistently maintained throughout the one-year follow-up period, indicating lasting functional recovery for the patients.

• Induced Osteointegration

• Non-cemented implant

Based on its structural strength advantages,VCFixCan treat vertebral compression fractures without the need for bone cement. However, for severe unstable fractures,VCFixStill CompatibleBone cement injection for auxiliary fixation.

• Precision Reduction

VCFixOffering multiple specifications and models equipped with an adjustable angle expansion mechanism, precise fracture reduction and anatomical structure reconstruction are achieved through personalized adaptation.

• Strengthen Stability

VCFixAdopting pedicle anchoring technology to optimize the biomechanical load distribution between the vertebral body and the spine. For complex fracture cases, additional posterior fixation can be selected to enhance stability.

Amber Implants