#United States #The Hague #Amber Implants #VCFix #spinal system

Amber Implants Secures FDA Clearance for VCFix® Spinal System

Amber Implants, an innovative medical technology company focused on developing advanced implants for spinal injuries, has recently announced a significant milestone. The company has received clearance from the US Food and Drug Administration (FDA) for its VCFix® Spinal System. This approval not only confirms the device's safety and efficacy but also marks its entry into the extensive MedTech market of the United States, which is known globally for its rigorous standards and credibility.

The VCFix® Spinal System is a sophisticated vertebral augmentation system designed specifically to address a wide range of vertebral compression fractures (VCFs). This system employs a minimally invasive approach involving the use of bone cement that provides robust anterior and posterior support. A significant feature of VCFix is its ability to integrate smoothly into existing surgical protocols. This innovative solution aims to enhance spinal stabilization while minimizing patient risks and reducing procedural durations compared to conventional methods.

Excitingly, initial data from one-year clinical trials of the VCFix® Spinal System has demonstrated promising results, revealing immediate and lasting reductions in pain along with improved spinal stability and accelerated recovery times. Such findings underscore the system's potential to become a new standard in the treatment of spinal fractures. Amber Implants is also progressing toward obtaining European CE marking, which would allow for broader utilization across the EU, including indications for standalone usage and compatibility with posterior fixation systems.

Dr. Banafsheh Sajadi, Co-Founder and CEO of Amber Implants, stated, "The VCFix® Spinal System represents a groundbreaking solution in vertebral augmentation, establishing a new benchmark in managing vertebral fractures. This approval positions Amber Implants as a leader in innovating spinal fracture solutions on a global scale. The US market, being the largest in MedTech, presents an invaluable opportunity for us to leverage a projected market size exceeding €800 million. This clearance sets the groundwork for our forthcoming commercial ventures."

It is notable that annually, over 9 million individuals worldwide experience vertebral compression fractures, with approximately 2 million occurring in North America and Europe alone. Alarmingly, about two-thirds of these cases remain undiagnosed and untreated, particularly endangering the elderly population, who are often affected by osteoporosis. The prevalent treatment options today are limited; kyphoplasty, while minimally invasive, fails to provide necessary posterior support, whereas traditional posterior fixation methods are more invasive, limit patient mobility, and involve longer recovery periods with increased morbidity risks. The VCFix® Spinal System stands out as a minimally invasive alternative that uniquely offers support for both anterior and posterior columns, promoting greater stability while lowering the associated risks for patients.

As quoted by Dr. Mohammad Ahmadi, Co-Founder and CTO of Amber Implants, "We are set to commence our US commercial launch with a pilot program in early 2026, paired with extending the ongoing EXPAND pivotal trial into the US market. Following this launch, we plan to enhance physician access to our product later in the same year. Concurrently, we are pursuing the EU label expansion for VCFix® to allow for standalone use in addition to integration with one-level fixation techniques."

Amber Implants is now positioned as a commercial-stage company gearing up for its US launch in 2026. With solid global patent protections and a robust pipeline, the company aims to capture a significant proportion of the global €2 billion+ vertebral compression fracture market by 2029. The recent FDA clearance not only accelerates adoption and revenue growth for Amber Implants but also acts as an avenue for entry into other international markets that recognize FDA approvals.

About Amber Implants

Founded in 2018, Amber Implants is a commercial-stage medical technology enterprise with operations in the Netherlands and the US. The company is dedicated to developing next-generation spinal injury implants that prioritize improving clinical outcomes through enhanced spinal stability and facilitating more natural healing processes. Its flagship offering, the VCFix® Spinal System, is tailored for efficiently managing a diverse array of spinal fractures, thereby ensuring safer patient care.

Supported by a blend of founder investments and venture capital, along with backing from angel investors and governmental funding, Amber Implants is poised for robust growth with a vision for advancing patient treatment in the realm of spinal health. In June 2025, the company revealed encouraging one-year follow-up data from initial human trials, culminating in the esteemed FDA's 510(k) clearance for the VCFix® Spinal System in September 2025.