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."
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.