The European Union (EU) has granted CE mark to Alpha Orthopaedics' AT3 System, designed for relieving pain associated with tendinosis and fasciosis.
Using non-invasive ReleF technology, the device delivers RF energy and by its cooling effect generates temperature capable of triggering heat-shock proteins and other mediators of the wound healing response.
The company said the proteins and other mediators are needed to induce the reparatory process, which is believed to relieve the pain and enables the damaged structures to return to a normal state.
Alpha Orthopaedics president and CEO Diana Villegas said the CE mark comes at a perfect time after the successful completion of the company’s pivotal trial which objectively demonstrated ReleF’s mechanism of action, as well as its safety and effectiveness.
"Furthermore, the superiority of ReleF over Platelet Rich Plasma (PRP) shown in a side-by-side study over 18 months of follow-up, has poised Alpha Orthopaedics to enter the market with a great technology backed by solid pre-clinical and clinical demonstration of effectiveness," Villegas added.