04 March 2021
Pictured: Orthocell CEO Paul Anderson with the MTPConnect Communications Coordinator Shannan Osrin and Director Stakeholder Engagement WA Dr Tracey Wilkinson in the MTPConnect podcast studio.
In a recent podcast episode, we spoke to Perth-based regenerative medicine company Orthocell about its recent US FDA, EMA and Australian (TGA) market approval for their collagen membrane dental implant.
Orthocell CEO Paul Anderson told our podcast how his team successfully navigated the complex reimbursement and regulatory pathways to break into those markets.
“We’ve been diligently working away at all the different aspects that enable you to get reimbursement, registration and indeed use it in humans and it’s been a collective effort of a multidisciplinary team and a healthy dose of tenacity,” Paul says.
“[This] is really showing the market that we have the capacity and the capability to not only manufacture world-class niche products but also to deliver them into a regulatory market, such as the FDA, the TGA and the European market as well.
“There are different requirements for each of those markets and it’s important for any company to have a strong internal understanding of what those regulatory pathways are and the differences, but it is also really important that you engage regulatory experts that can help to map out the development pathway.
“Often we see in younger companies that they miss out on grasping the start to the finish type approach, so not only do you have to engage with your clinician to make sure you have products that are relevant you also need to engage with international experts from a regulatory perspective to make sure your product development pathways are relevant to each and every one of those regulatory environments.”
Recently, Orthocell’s CelGro Dental product (recently renamed Striate +) was included on the Australian Prostheses List, a major milestone for the 10-year old company and positive news for patients looking to have dental bone and soft tissue repair procedures.
To find out more about Orthocell’s move into international markets, listen to the full podcast interview here.