Orthocell Ltd (ASX: OCC) share price is catching the eye of investors on Monday.
In late afternoon trade, the regenerative medicine company's shares are up over 10% to $1.37.
This means that Orthocell shares are now up approximately 250% since this time last year.
What is Orthocell?
Orthocell is a regenerative medicine company with a focus on regenerating mobility for patients by developing products for the repair of a variety of bone and soft tissue injuries.
Its portfolio includes the CelGro platform of collagen medical devices which facilitate tissue reconstruction and healing in a variety of dental and orthopaedic reconstructive applications.
Striate+ was the first product approved for dental GBR applications, and is distributed globally by BioHorizons Implant Systems Inc. It is cleared for use in the US, Canada, Australia, New Zealand, the UK, and Europe.
SmrtGraft is for tendon repair and is available in Australia under Special Access Scheme or participation in a clinical trial.
Finally, there is the very promising Remplir product, which is used for peripheral nerve reconstruction. It recently received approval in Australia, New Zealand and Singapore and is distributed exclusively by Device Technologies.
It is Remplir that has been getting investors excited recently and could explain why Orthocell shares are charging higher today.
The company recently noted that it remains on track to gain US FDA 510(k) regulatory clearance to commercially distribute Remplir into the critical US$1.6 billion US market. It is expecting approval from the regulator in late March or early April 2025. This means that it could be just weeks (or even days) away from being received.
This would be great news as management notes that Remplir has gained excellent sales traction since its Australian market launch in November 2022.
In fact, it has achieved three consecutive quarters of record revenue. There are now ~180 orthopaedic and plastic surgeons now using Remplir in peripheral nerve repair surgeries across Australia, New Zealand and Singapore.
What else is boosting Orthocell shares?
Also potentially giving the Orthocell share price a boost is its addition in the All Ordinaries index.
The company will be officially added to the index next Monday following the quarterly rebalance
This could have opened up the company to fund managers that have strict investment mandates preventing them from investing in companies outside the index. It could also mean that funds tracking the index are buying shares ahead of its inclusion.
