"Orthocell submitted the regulatory application for SmrtGraft to the TGA on June 10, 2024, as noted in multiple sources. The approval process duration can vary, typically taking several months to over a year, depending on the complexity of the medical device and the TGA’s review timeline.
For context, Orthocell’s Remplir product received TGA approval approximately 20 months after its application submission in July 2020.
Given Orthocell’s target for a 2025 launch, it seems likely that an announcement could occur in the second half of 2025, potentially between Q3 and Q4.
This estimate aligns with the company’s plans and recent presentations/investor communications, such as the April 2025 HealthInvest Summit presentation, indicating a strong focus on launching SmrtGraft in 2025.
The company’s confidence in this timeline, despite the elapsed 12 months since submission, suggests they may have received positive feedback from the TGA or anticipate a streamlined review. The market potential for SmrtGraft is significant, with an estimated addressable market of over US$1.2 billion annually, making timely approval crucial for revenue growth."
OCC Price at posting:
$1.23 Sentiment: None Disclosure: Held
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