For what it's worth, I'm happy with today's announcement and email from the company for the following reasons:
- The company set guidance "Pivotal US FDA Remplir™ nerve repair status report due in Q1 CY24" and delivered "Orthocell Successfully Completes all Nerve Repair Surgeries in Remplir™ US Market Authorisation Study". This is important to me because it increases investor confidence in the company delivering on guidance projections.
- Reaffirmed study results during Q3 CY24 ~ which have the "potential to provide data demonstrating the impact and advantages of using Remplir over traditional nerve repair methods"
- Reaffirmed FDA submission during Q4 CY24 ~ "Orthocell remains on schedule to submit its US 510(K) market authorisation application by the end of the year"
- Reaffirmed FDA approval for Q1 CY25 (from November 2023 presentation) which was better than I was expecting after the study results were delayed from Q2 to Q3 CY24
- Provided additional information on the study design
- Implies an upcoming partnership and Remplir launch/sales in H1 2025 ~"Our commercialisation plans are well underway, which will allow for the speedy initiation of sales upon approval"
- Reaffirmed that this study is important for EU/UK product registration which is currently expected in Q4 CY25.
While we wait for the above to play out, hopefully the company can deliver on past revenue guidance to provide some excitement:
- Orthocell on the cusp of significant growth - Proactive Investors (1/11/23)
- Commercial-stage medical device company at revenue inflection point- JP Equity Investor Briefing (17/11/23)
- Scale up of manufacturing alongside the expected rapid growth in purchase orders from BioHorizons- JP Equity Investor Briefing (17/11/23)
- Successful market launch with revenue building momentum(AUS commercial launch of Remplir)-JP Equity Investor Briefing (17/11/23)
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- Ann: Part 1 Remplir US Market Authorisation Successfully Complete
Ann: Part 1 Remplir US Market Authorisation Successfully Complete, page-19
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