SpineGuard announced today that it has received regulatory clearance to market its Classic PediGuard products in China.
“This regulatory clearance is the result of a diligent collaborative process with General Care International (GCI),” said Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. “It is a major milestone for SpineGuard and further validates the value of our DSG™ (Dynamic Surgical Guidance)-based PediGuard device for making spine surgery safer.”
The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection.
Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.