Patent and market authorization for human hyperacute serum product
Krems an der Donau, Austria, September 07, 2016 / B3C newswire / -- OrthoSera GmbH, an orthobiologics company developing serum-based solutions for musculoskeletal indications announces that its 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.
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In order 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 GmbH. "Following market authorization we are now making our autologous hypACT™ inject device available for clinical use in order to further build on the strong preclinical results of our hyperacute serum technology."
With headquarters in Krems/Austria and subsidiaries in the US and Hungary, OrthoSera GmbH is a commercial-stage regenerative medicine company. The serum-based approach to address various degenerative diseases like osteoarthritis is expected to become a game changer in the orthobiologics market. OrthoSera puts special emphasis on designing simple and affordable protocols allowing a wider patient population to benefit from their solutions. The first commercial product BoneAlbumin™, an innovative albumin-coated bone allograft, is currently marketed in Europe with a special focus on dental and orthopedic indications.
Dr. Marion Ettenauer
A-3500 Krems an der Donau
+43 664 77 883 16206