Amber Implants Completes Enrolment of First-In-Human Clinical Trial of its VCFix® Spinal System

Amber Implants Completes Enrolment of First-In-Human Clinical Trial of its VCFix® Spinal System

The Hague, Netherlands, 11 June 2024: Amber Implants (‘Amber’ or ‘the Company’), an innovative medical technology company developing next-generation implants for spinal injuries, today announces that it has completed enrolment of its first-in-human clinical trial with its innovative VCFix® Spinal System. The VCFix® Spinal System is the first device that does not rely on bone cement for the treatment of vertebral compression fractures.

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) and assessed the safety and efficacy of the VCFix® Spinal System for patients suffering from osteoporotic vertebral compression fractures. The device was primarily used in stand-alone configuration without bone cement.

The study enrolled 10 patients, all of whom suffered from severe disabling pain with Disability Ratings of 70% and higher. Following the procedure, typically lasting less than 20 minutes, all the patients saw maximal pain reduction with Disability Ratings reduced to 10% or less and they were able to walk freely without disability at discharge.

The short-term efficacy data, as well as the performance of the device, has shown promising results and will be further assessed in the continuation of this trial. Prof. Dr. Med. Robert Pflugmacher said:  “VCFix represents a remarkable innovation, significantly improving the reconstruction of fractured vertebrae”. “This technology has proven to be user-friendly and has yielded exceptional short-term outcomes for our patients”, added Dr. Med. Ardeshir Ardeshiri.

The Company will soon begin the pivotal clinical trial for the same intended use (i.e., standalone and with and without cement) as well as test the device with a posterior fixation method for high-energy traumatic fractures. Amber is preparing for these pivotal trials in a broader European setting before the end of the year and is building towards Food and Drug Administration (‘FDA’) clearance for its first indication in early 2025.

Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants said: “Short-term efficacy data from the study is very promising, with results even exceeding our expectations. Patients have experienced significant pain relief and regained the ability to walk without discomfort. VCFix® has the potential to be a disruptive technology for the millions of patients who suffer from vertebral fractures each year. We are now focused on preparing for pivotal trials in Europe to bring the benefits of this technology to the many more patients who would otherwise suffer from the high rate of complications associated with other treatment options available.”

Per year, over 8.6 million people suffer from different types of vertebral fractures. These fractures cause severe back pain, limited mobility, disability, and an increased rate of mortality. Currently, vertebral compression fractures are managed through the injection of Polymethyl Methacrylate (PMMA) bone cement into the affected vertebra and/or with multi-level posterior fixation. This can lead to side effects in up to two-thirds of patients, post-treatment.

The VCFix® Spinal System is designed to restore the spine and provide maximum stability to the affected spinal segments. VCFix® offers an innovative strategy for managing a wide range of vertebral fractures, with and without cement and with and without posterior fixation. It can be used for a broad range of indications, from osteoporotic low-energy fractures to traumatic high-energy fractures, and would therefore be a disruptive technology for this patient population.

The VCFix® Spinal System has received a breakthrough designation from the FDA.

CAUTION: This device is exclusively for clinical investigation and no substantiated clinical benefits have been established.