Navigating Regulatory Pathways: Orthocell Moves Into New Markets

In this week’s podcast, we travel to Perth to talk to regenerative medicine company Orthocell about gaining TGA, EU and US FDA approval to market its CelGro collagen membrane for dental and jaw bone surgeries. CelGro is a collagen scaffold that supports tissue reconstruction and repair. Orthocell CEO Paul Anderson discusses the regulatory approach for markets in Australia, Europe and the United States, and the setup of their dedicated and licenced GMP manufacturing facility in Perth. He shares some words of advice for medtech and medical device entrepreneurs too. This is a must-listen to episode for SMEs and start-ups keen to learn more about commercialising regenerative medicines!