ChatGPT want able to shed nuch than we already know @mikebrisy & @mmff even with constantly correcting and rephrasing the request. Hopefully good news awaits!!

From ChatGPT

On April 29, 2025, Orthocell Limited (ASX: OCC) entered a trading halt pending an announcement regarding a new regulatory approval for its Remplir™ nerve repair device. While the company has not yet disclosed the specific jurisdiction, this development aligns with Orthocell's ongoing global expansion strategy for Remplir. 

Following the U.S. FDA 510(k) clearance granted in early April 2025, Orthocell has been actively pursuing regulatory approvals in several key markets, including Canada, the United Kingdom, the European Union, Brazil, and Thailand. The company has also submitted an application for regulatory approval in Hong Kong, with a decision anticipated by early Q3 2025.  

Remplir is already approved and commercially available in Australia, New Zealand, and Singapore, where it has gained traction among approximately 180 orthopedic and plastic surgeons.  The device is a collagen wrap used in nerve repair surgeries to assist in the regeneration of damaged peripheral nerves.  

The trading halt is expected to remain in place until Orthocell releases the pending announcement or until the commencement of normal trading on May 1, 2025. Investors and stakeholders are advised to monitor official channels for the forthcoming update, which is anticipated to provide further details on the new regulatory approval and its implications for the company's global operations. 

Held on SM portfolio

OK thanks @lowway and @mmff. I’m guessing Canada approval. Early, but I can’t come up with anything else.

Good deduction @mikebrisy

CANADA IT IS!!!

Yes, turned out to be simple by a process of elimination, dear Watson.

What threw me, was that their timeline had approval for Q4 of CY 2025, so to come in 6 months ahead of that timeframe is pretty good.

Now before we get excited, Canada should be similar order of magnitude to Australia, where Remplir did $0.457m in the first full year, and $1.04m in the second. And, of course, that should also temper US expectations where even 10x those numbers isn't vast.

We're back to that game of surgeons having to make a change from existing standards of care to taking on a new treatment method. Some things I don't know in this speciality area include: how quickly will KOL experiences translate from Australia and Singpore to Canada and US. If they get their distributors lined up, we'll see some revenue figures at 1H FY26, and that might give an indication.

I guess what is encouraging is the pace of the global rollout and then how quickly they've put distributors in place.

The next big one is EU+UK. $OCC are showing regulatory submission in Q3 CY 2025 and approval in Q4 CY 2026. But I wonder whether management are being conservative with their timelines. For a medical device with existing approvals in jurisdictions like Australal, Canada and US FDA, 12 months should be ample based on what I've seen before.

So, good news, But still a long road ahead. I'm keep my position very small for now until I see more sales data, as I don't have a handle on the commercial risk-reward. No need to hurry.

Disc: Held in RL and SM