Amber Implants announced the closing of a USD$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 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. A first-In-human clinical trial is expected to commence in early 2022 in Europe and the U.S.
In September 2021, Amber Implants was granted FDA's Breakthrough Device Designation for the VCFix spinal system.
Amber Implants' VCFix spinal system is reportedly the first solution to treat broad types of vertebral fractures without the need for using PMMA bone cement. The device is designed 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.
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®."
Source: Amber Implants