The FDA settlement confirms a solid safety and performance of the VCFIX® Espinal system, an innovative treatment for vertebral compression fractures of the US commercial pilots. Care care potential
The Hague, the Netherlands, September 17, 2025 / PRNewswire / -amber Implants, an innovative medical technology company that develops next generation implants for spinal injuries, announced today that it has received the authorization of the drug and food administration of the United States (FDA) for its VCFIX® spinal system. This authorization confirms the safety and performance of the device and represents a worldwide validation of its clinical value, providing immediate access to the world’s largest medtech market.
The VCFIX® spinal system is a vertebral increase system designed to treat a broad spectrum of vertebral compression fractures. This minimally invasive solution is used with bone cement and provides strong anterior and posterior column support. It integrates perfectly into existing surgical workflows, with the potential to improve spinal stabilization, reduce patient risk and shorten the procedure times, compared to current options.
The one -year monitoring data of the initial clinical trials of the VCFIX® Espinal System, announced in June 2025, demonstrated an immediate and sustained reduction in pain, a better column stability and a faster recovery, which underlines its potential for lasting functional benefits. Amber Implants is also working to mark CE in the EU, with the objective of a wide labeling that admits both the independent use of VCFIX® and integration with subsequent fixation systems.
Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, Said: “The Vcfix Spinal System is a groundbreaking vertebral augmentation solution with the potential to establish a new standard of care in vertebral fracture management, reinforcing amborcing ambor. Role As a Global Innovator in Spinal Fracture Solutions.
Every year, more than 9 million people worldwide suffer from vertebral compression fractures, even around 2 million in North America and Europe. In spite of this high prevalence, up to two thirds of the cases remain not diagnosed and not treated, leaving patients of advanced and fragile, often with osteoporosis, at risk of chronic pain, spinal deformity, disability and loss of independence. The current treatment options are limited: the kipoplasty is minimally invasive, but does not provide subsequent support for fractures, while the subsequent fixation is invasive, restricts the movement and prolongs the recovery with greater morbidity. The VCFIX® spinal system addresses these holes as a minimally invasive solution that uniquely admits the anterior and posterior columns, is perfectly integrated into existing surgical workflows and offers greater stability with less patient risk.
Dr. Mohammad Ahmadi, co -founder and director of Technology at Amber Implants, added: “We will begin our commercial launch of the United States with a pilot program in early 2026, accompanied by the expansion of the fundamental expansion test in the US.
Amber Implants is now a commercial stage company, which prepares for its launch in the United States in 2026. With the support of strong global patent protection and a growing portfolio, the company is on the way to capture a significant participation of the global € 2 billion+ vertebral fracture compression compression in the market of 2029. The approval of the FDA is recognized.
About amber implants
Amber Implants is a commercial technology company in commercial stage with operations in the Netherlands and the United States. Founded in 2018, the company develops next generation implants for spine lesions with the aim of improving the results of patients through a more natural healing and greater stability of the column. Its flagship product, the VCFIX® spinal system, offers a simpler, more efficient and safer approach to administer a wide range of spinal fractures.
Amber Implants is funded by the founders and investors of risk capital, with the participation of angels and non -dilutive government investors. In June 2025, the company reported one -year follow -up data for the VCFIX® Espinal System of its first human trial that shows significant improvements in the key clinical performance results, and the device received the authorization of FDA 510 (K) of the United States Food and Medicines Administration (FDA) in September 2025.
Amber implants of origin
