Australian-Singaporean regenerative medicine company Osteopore (ASX:OSX) has signed an exclusive five-year distribution agreement with Medsite Equipamentos e Produtos Para Saude.
Osteopore is a global leader in 3D-printed biomimetic and bioresorbable implants.
Under the agreement, Medsite will manage the regulatory filings in Brazil, a process expected to take approximately two years to complete.
To enhance commercial adoption, Medsite will work with Zeiki Medical Produtos Medicos.
Established in 2006 under CEO and founder Cristina Seixas, the Rio de Janeiro-based Zeiki supports around 2,000 surgeries annually.
The agreement spans an initial five-year term, coinciding with a projected 24-month regulatory period to complete Anvisa product registration requirements.
Osteopore CEO Dr Yujing Lim said, “The decision to enter the Brazilian craniofacial market is a strategic one as it leverages the strength of US FDA and European Union CE Mark regulatory approvals. We are looking forward to introducing our craniofacial solutions to more patients in need."
“With the right partner, the Brazilian market represents a significant market opportunity. With our initial Brazilian engagement, we were strongly encouraged by the enthusiastic response of the Brazilian craniofacial surgical community,” said Dr Lim.