THE HAGUE, Netherlands, Jan. 19, 2022 /PRNewswire/ — Amber Implants, an modern medical know-how firm creating subsequent technology spinal implants for spinal accidents, right now pronounces the profitable closing of its US$10 million Collection A Financing in 2021. The spherical was co-led by the founders and current enterprise capital buyers, with participation from angel buyers and non-dilutive authorities funding.
Proceeds from the financing will probably be used to advance the Firm’s revolutionary vertebral physique augmentation system, VCFix®, by way of all preclinical verification and validation assessments, ISO 13485 certification, regulatory actions, and an early feasibility scientific research and a pilot and pivotal scientific trial.
In September 2021, Amber Implants was granted Breakthrough Gadget Designation for its VCFix® spinal system by the US Food and Drug Administration (FDA), which allows direct and interactive communications with the US FDA and precedence evaluate. Amber Implants will even have extra flexibility on the subject of scientific research, a devoted workforce for reviewing the appliance, and reimbursement by way of Medicare for 4 years.
Dr. Banafsheh Sajadi, Founder & Chief Government Officer of Amber Implants, stated: “We welcome the assist of our high-quality buyers to advance our lead product into scientific improvement. This funding allows us to totally validate the scientific efficiency of VCFix® spinal system each in Europe and the US – following receipt of the Breakthrough Gadget Designation. We’re excited to take an extra step in direction of bettering the standard of life for sufferers with vertebral fractures with our proprietary VCFix®.”
Dr. Peter Krekel, of Blue Sparrows MedTech Fund, stated: “We’re excited to reaffirm our dedication to Amber Implants’ journey by collaborating on this new funding spherical. The Firm has proven spectacular progress within the run-up to their first in-human scientific trials commencing. VCFix® is no doubt a ground-breaking technological development for the spinal market and we very a lot look ahead to seeing the optimistic influence it will probably have.”
Yearly, over 4 million folks undergo from vertebral fractures, which trigger extreme again ache, restricted mobility, and elevated charge of mortality amongst an already weak aged inhabitants of sufferers. Present therapies for spinal bone fractures contain injection of artificial polymeric cement into the fracture to stabilize it and relieve the ache. Nonetheless, 50% of sufferers who obtain this remedy undergo from problems associated to this operation.
Amber Implants VCFix® spinal system is the primary resolution to deal with broad sorts of vertebral fractures with out the necessity for utilizing PMMA bone cement and goals to considerably enhance affected person outcomes by offering extra pure bone therapeutic and stability, providing a neater, extra environment friendly and safer remedy for a broader kind of fractures to sufferers.
Amber Implants Dr. Banafsheh Sajadi, CEO E-mail: firstname.lastname@example.org
Amber Implants is a medical know-how start-up situated in the Netherlands and United States. Based in 2018, the Firm has developed the following technology of spinal implants for Vertebral Compression Fractures (VCF), and is focussed on bettering affected person outcomes by way of implants that present extra pure therapeutic and stability. Amber Implants goals to create extra distinctive options for spinal and different orthopaedic issues in future.
VCFix® spinal system is the primary resolution to deal with broad sorts of vertebral fractures with skill for use with out bone cement. Via its 3D-printed perforated construction, VCFix® implant goals to stimulate bone ingrowth, offering a extra pure therapeutic course of. It’s optimized for mechanical energy, most fracture discount and anatomical restoration. VCFix® implant gives pedicle anchorage for higher stability, higher distribution of hundreds on the center and posterior columns of the backbone and in addition the chance for posterior fixation for extra unstable fractures. The VCFix® spinal system is supplied with a user-friendly single-use sterile surgical package for excellent traceability and diminished dangers of an infection. VCFix® would be the new technology and a neater, extra environment friendly and safer remedy for sufferers with vertebral fractures.
For extra data, please contact Data@amberimplants.com