Karolinska Development AB issued the following announcement on Aug. 28.
Karolinska Development's portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface to improve osseointegration has now been 510(k) approved by the FDA.
Promimic develops and markets products within nano-materials for innovative surface treatments and has developed the HAnano Surface that speeds up and improves the anchoring of implants in bone. The EVOL SI Sacroiliac Joint Fusion System, which uses the HAnano Surface as an implant surface modification, has been developed in collaboration with the North Carolina-based company Cutting Edge Spine.
Promimic established its US operations two years ago and is now entering the orthopedic market with multiple OEM partners.
“The first FDA approval for a spinal implant that uses Promimics innovative surface treatment represents a major breakthrough on the US orthopedic market for Promimic", comments Viktor Drvota, CEO of Karolinska Development.