OCC - Orthocell Limited

Orthocell Limited (OCC) appears to be threatening for a breakout to the upside and, as such, is a personal stock selection for the February stock competition here at ASF. Referring to the daily chart below, we have the share price closing above the 10 and 30 day MA's at the end of the final complete trading week of the January calendar month, whilst also closing above two recent opens which could potentially act as support/resistance areas from 6th January and 10th January ($1.53 and $1.495, respectively). A supportive DMI/ADX and RSI also assist a potentially bullish perspective from a technical analysis aspect.

Price continuing to hold strongly after rise to $1.50 in late Deceember '24.

Recent approval for Remplir in Singapore should pass on in the next few months to Thailand who recognize each others approvals. Both these countries are destination countries for medical procedures from people throughout South East Asia.

Then we wait for Remplir approval in America by mid-year.

access said:

Price continuing to hold strongly after rise to $1.50 in late Deceember '24.

Recent approval for Remplir in Singapore should pass on in the next few months to Thailand who recognize each others approvals. Both these countries are destination countries for medical procedures from people throughout South East Asia.

Then we wait for Remplir approval in America by mid-year.

Click to expand...

Closed at a record high today.

FDA approval for Remplir coming soon. To be followed by Smrtgraft approval by TGA in Australia.

Price still holding strong. Remplir approval could push it to $2 over the next 2 months.

On Friday, Orthocell (ASX:OCC) secured a major commercial milestone, receiving US FDA 510(k) clearance for its flagship nerve repair product, Remplir™, allowing immediate sales into the US market. Remplir is a collagen-based nerve wrap designed to assist surgeons in repairing and regenerating damaged peripheral nerves. This approval gives Orthocell access to the US$1.6bn US nerve repair market, which it sees as a significant commercial inflection point expected to drive the company towards breakeven and future profitability.

The company has prepared extensively for this moment, with a US executive team already in place, logistics infrastructure set up, and a production facility in Perth capable of manufacturing 100,000 units per year. Orthocell has no debt or royalty obligations on Remplir, so it retains full margins.

It plans to roll out its US commercial strategy using a mix of in-house leadership and regional distributor networks, targeting up to 12 partners within 6–12 months.

Remplir now having regular approval for use in a range of countries. Smrtgraft will be next big product to get approval.

Share price is being held back until end of quarter figures are released to verify the sales that people are expecting to be taking place.

A massive market for their products and all being manufactured in Australia.

Remplir has had first sales in America with a range of distributors already in place.

Striate and Remplir both now on the market. We now wait for approval of autologous chondrocytes (OrthoACI™) and tenocytes (OrthoATI™) for cartilage and tendon repair.

Markets for the latter two are expected to be larger than Remplir.

Nothing much changed from last month.

access said:

Nothing much changed from last month.

Click to expand...

$1.13

Data to support US sales roll out and EU + UK regulatory submissions
• Interim results from a new Remplir™ study demonstrated a compelling overall treatment success rate of 81.1% following nerve repair procedures.
• Real World Evidence patient data collected in the study confirmsOrthocell’s nerve repair product, Remplir, as the ideal medical device for connecting severed nerves, protecting damaged nerves, or
capping nerve ends after amputation.
• The data demonstrated:
o 81.2% of muscles innervated by repaired nerves achieved functional motor recovery.
o 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms.
o No post-treatment complications or adverse reactions to Remplir were reported in any patient.
o Results consistent with previously published clinical trial outcomes.
• The data confirms the superior and predictable outcomes that Remplir delivers and istestament to why over 200 surgeons across more than 165 hospitals (and growing) are now using the product.
• Study data will be an important addition to Orthocell’s medical education efforts in US salesroll out and provide supporting evidence for the EU + UK regulatory submission expected in Q4 CY25.
• Orthocell ultimately targeting a Total Addressable Market in selected jurisdictions in excess of US$3.5 billion.
• Internal resources remain focused on the Remplir rollout in the US$1.6 Billion U.S. market, with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. Initial US surgical cases continue to build.