THE HAGUE, Netherlands, Jan. 19, 2022 /PRNewswire/ — Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today announces the successful closing of its US$10 million 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.
Proceeds from the financing will be used to advance the Company’s revolutionary vertebral body augmentation system, VCFix®, through all preclinical verification and validation tests, ISO 13485 certification, regulatory activities, and an early feasibility clinical study and a pilot and pivotal clinical trial.
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. Amber Implants will also have more flexibility with regards to clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for four years.
Dr. Banafsheh Sajadi, Founder & Chief Executive Officer of Amber Implants, said: “We welcome the support of our high-quality investors to advance our lead product into clinical development. 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. We are excited to take a further step towards improving the quality of life for patients with vertebral fractures with our proprietary VCFix®.”
Dr. Peter Krekel, of Blue Sparrows MedTech Fund, said: “We are excited to reaffirm our commitment to Amber Implants’ journey by participating in this new investment round. The Company has shown impressive progress in the run-up to their first in-human clinical trials commencing. VCFix® is without doubt a ground-breaking technological advancement for the spinal market and we very much look forward to seeing the positive impact it can have.”
Yearly, over four million people suffer from vertebral fractures, which cause severe back pain, limited mobility, and increased rate of mortality amongst an already vulnerable elderly population of patients. Current treatments for spinal bone fractures involve injection of synthetic polymeric cement into the fracture to stabilize it and relieve the pain. However, 50% of patients who receive this treatment suffer from complications related to this operation.
Amber Implants VCFix® spinal system is the first solution to treat broad types of vertebral fractures without the need for using PMMA bone cement and aims to significantly improve patient outcomes by providing more natural bone healing and stability, offering an easier, more efficient and safer treatment for a broader type of fractures to patients.
About Amber Implants
Amber Implants is a medical technology start-up located in the Netherlands and United States. Founded in 2018, the Company has developed the next generation of spinal implants for Vertebral Compression Fractures (VCF), and is focussed on improving patient outcomes through implants that provide more natural healing and stability. Amber Implants aims to create more unique solutions for spinal and other orthopaedic disorders in future.
VCFix® spinal system is the first solution to treat broad types of vertebral fractures with ability to be used without bone cement. Through its 3D-printed perforated structure, VCFix® implant aims to stimulate bone ingrowth, providing a more natural healing process. It is optimized for mechanical strength, maximum fracture reduction and anatomical restoration. VCFix® implant provides pedicle anchorage for better stability, better distribution of loads on the middle and posterior columns of the spine and also the possibility for posterior fixation for more unstable fractures. The VCFix® spinal system is provided with a user-friendly single-use sterile surgical kit for perfect traceability and reduced risks of infection. VCFix® will be the new generation and an easier, more efficient and safer treatment for patients with vertebral fractures.
For more information, please contact Info@amberimplants.com
SOURCE Amber Implants