Amber Implants is a The Hague-based medical technology company that develops next-generation spinal implants for spinal injuries. It closed its US$10m Series B Financing.
The founders led the round, along with existing venture capital investors. Angel investors and non-dilutive funding were also included.
The company plans to use the funds for its vertebral body augmentation technology, VCFix(r), which will include all preclinical validation and validation tests, ISO 13485 certificate, regulatory activities, an early feasibility study, and a pivotal and pilot clinical trial.
Amber Implants was founded in 2018 by Dr. Banafsheh Sajadi (Chairman), and is a medical tech startup in the Netherlands and United States. It has developed spinal implants to support Vertebral Compression Fractures, or VCF, and is focused upon improving patient outcomes with implants that are more natural in healing and stable.
The company received Breakthrough Device Designation (US Food and Drug Administration) in September 2021 for its VCFix(r), spinal system. This allows direct and interactive communication with the FDA and priority review. Amber Implants will have greater flexibility in clinical studies and a dedicated team to review the application. Medicare reimbursements are also available for four years.