Amber Implants Announces Successful One-Year Follow-Up Data in First-in-Human Clinical Trial of VCFix® Spinal System

- One-year follow-up data from first-in-human trial shows significant improvements in key clinical performance outcomes 
- This data supports a strong safety profile for the VCFix® Spinal System for the treatment of vertebral compression fractures

THE HAGUE, Netherlands, June 3, 2025 /PRNewswire/ -- Amber Implants, an innovative medical technology company developing next-generation implants for spinal injuries, today announces the completion of the one-year follow-up for all patients enrolled in its first-in-human clinical trial of the VCFix® Spinal System. This milestone marks a significant step in demonstrating the safety of VCFix® for the treatment of vertebral compression fractures.

Notably, no device-related adverse events were reported in any patient at the one-year follow-up, underscoring the strong safety profile and promising clinical potential of VCFix®. In addition, significant improvements in key clinical performance outcomes were observed, regardless of cement augmentation. Patients, both with and without cement, experienced immediate and sustained reductions in pain levels, as assessed by the Numeric Pain Rating Scale (NPRS). By the 6-month follow-up, pain scores decreased by more than 8 points. Disability scores, assessed using the Oswestry Disability Index (ODI), also showed significant post-operative improvement, with an 84 point reduction from baseline to 6-months. These improvements were generally maintained throughout the one-year follow-up period, indicating lasting functional benefits.

Dr. Mohammad Ahmadi, Co-Founder and Chief Technology Officer of Amber Implants, said: "Behind every data point is a patient whose quality of life has been improved. These one-year results reinforce our mission to provide safer, more effective solutions for people suffering from painful spinal fractures. The encouraging data provides a solid foundation as we move towards our goal of bringing this innovative technology to many more patients across Europe and beyond."

Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, explained: "This milestone marks a critical inflection point for Amber Implants. With a clean safety profile and encouraging early clinical outcomes, we are well-positioned to advance VCFix® into the pivotal stage and unlock significant clinical and commercial value. Our vision is to establish a new standard of care in vertebral fracture management."

The trial was conducted at two centers in Germany with Prof. Dr. Med. Robert Pflugmacher (Orthopaedic surgeon, Kreiskrankenhaus Mechernich GmbH) and Dr. Med. Ardeshir Ardeshiri (Neurosurgeon, Wilhelmsburger Krankenhaus Groß-Sand Hamburg). "We are observing excellent clinical outcomes and a significant reduction in pain. This innovative technology shows great potential to become a new standard in the treatment of vertebral compression fractures." said Prof. Dr. Med. Robert Pflugmacher.

Amber Implants is now preparing to initiate its pivotal clinical trial across multiple sites in European countries, including the two centers that participated in this study. The upcoming study will evaluate the safety and efficacy of the VCFix® Spinal System in its stand-alone configuration (with or without bone cement), in a larger number of patients.

Each year, more than 8.6 million people suffer from various types of vertebral fractures, leading to severe back pain, limited mobility, disability, and increased mortality. Current treatments typically involve injecting Polymethyl Methacrylate (PMMA) bone cement into the affected vertebra and/or performing multi-level posterior fixation. These procedures lead to complications in up to two-thirds of patients.

The VCFix® Spinal System is designed to restore the fractured vertebra and stabilize affected spinal segments. Its innovative design supports the treatment of a wide range of vertebral fracture types – both with and without cement, and with or without posterior fixation. Its versatility makes it suitable for indications ranging from osteoporotic low-energy fractures to traumatic high-energy fractures. With a global vertebral compression fracture treatment market projected to exceed $2.5 billion by 2028, VCFix® is uniquely positioned to disrupt a field long reliant on traditional cement-based interventions.

VCFix® has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

CAUTION: This device is exclusively for clinical investigation. No substantiated clinical benefits have yet been established.

About Amber Implants

Amber Implants is a medical technology company with operations in the Netherlands and the United States. Founded in 2018, the Company develops novel spinal implants for vertebral compression fractures (VCFs) and is committed to improving patient outcomes through implants that promote more natural healing and enhanced spinal stability. Amber Implants is delivering a new generation of treatments for traumatic fractures, offering a simpler, more efficient, and safer approach for managing a broader range of spinal injuries.

In 2021, Amber closed a Series A Financing co-led by the founders and existing venture capital investors, with participation from angel investors and non-dilutive government funding. The VCFix® Spinal System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).