Amber Implants has announced the successful closing of its US$10 million Series A financing round, the funds of which will be used to boost the company’s vertebral body augmentation system, VCFix.
The financing round was co-led by the founders and existing venture capital investors, with participation from angel investors and non-dilutive government funding.
The proceeds will be used to advance Amber Implants’ VCFix spinal system, through preclinical verification and validation tests, ISO 13485 certification, regulatory activities, and an early feasibility clinical study, as well as 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.
The company says it will also have greater flexibility with regards to clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for four years.
Banafsheh Sajadi, founder and 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.”
Peter Krekel, of investor Blue Sparrows MedTech Fund, added: “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.”