OrthoSera receives CE Marking for hypACT device to regenerate osteoarthritic bone
Patent and market authorization for human hyperacute serum product.
OrthoSera's proprietary serum technology is ready for human clinical use. Hyperacute serum, a variety of platelet rich plasma (PRP), has been shown to have superior effects compared to PRP in preclinical models of osteoarthritis and other degenerative diseases. OrthoSera has successfully applied for a US patent for the composition and the use of hyperacute serum in the regeneration of osteoarthritic bone.
To bring this technology to the bedside OrthoSera has developed the hypACT device isolating a specific serum derivative (SPRF) from the patient in a closed system, which is then applied during a same-day-procedure. This product has now received market authorization in Europe through a certification process by TÜV Rheinland.
"After the successful launch of BoneAlbumin as our first commercial product in the dental field late last year this is another important milestone for our company," comments Dr Zsombor Lacza, CEO of OrthoSera. "Following market authorization we are now making our autologous hypACT inject device available for clinical use to further build on the strong preclinical results of our hyperacute serum technology."
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