The Hague, Netherlands-based Amber Implants, a medical technology company developing spinal implants, announced on Wednesday that it has successfully closed its $10M (approx €8.8M) Series A financing in 2021.
The round was co-led by the founders and existing venture capital investors, with participation from angel investors and non-dilutive government funding.
The medtech company claims the funds will help advance its vertebral body augmentation system, VCFix, through all preclinical verification and validation tests, ISO 13485 certification, regulatory activities, early feasibility clinical study, and a pilot and pivotal clinical trial.
Dr. Banafsheh Sajadi, Founder and CEO of Amber Implants, says, “This funding enables us to fully validate the clinical performance of VCFix spinal system both in Europe and the US – following receipt of the Breakthrough Device Designation.”
Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
In September 2021, Amber Implants was granted Breakthrough Device Designation for its VCFix spinal system by the US Food and Drug Administration (FDA), which enables direct and interactive communications with the US FDA and priority review. The company will also have more flexibility with regards to clinical studies, a team for reviewing the application, and reimbursement through Medicare for four years.
Innovative and sustainable solutions to tackle spinal disorders
According to Amber Implants, over four million people suffer from vertebral fractures annually, which is a life-threatening disease and causes severe back pain, limited mobility, height loss, and an increased rate of mortality amongst the elderly population of patients.
Treatments available in the market today for spinal bone fractures require an injection of synthetic polymeric cement into the fracture to stabilise it and relieve the pain. However, 50 per cent of patients who receive this treatment suffer from complications related to this operation.
This is where Amber Implants wants to make a difference.
Founded in 2018 by Banafsheh Sajadi and Mohammad Ahmadi, the company claims that its VCFix spinal system is the first solution to treat broad types of vertebral fractures without the need for using PMMA bone cement.
The company aims to improve patient outcomes by providing natural bone healing and stability, offering an easier, efficient, and safer treatment for a broader type of fractures to patients.
Amber Implants says, “As a company, we are committed to improving the quality of life of the patient. Therefore we address unmet clinical needs. Our company prioritises the optimisation of the products and procedures for the patients’ well-being.” In the future, Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders.