Orthocell Ltd (ASX: OCC) is an Australian medical technology company focused on developing and commercialising innovative regenerative medicine treatments. 

Over the last 12 months its share price has skyrocketed, up more than 260% in that span.

For context, S&P/ASX 200 Health Care (ASX: XHJ) is down 3% over that same period.

Yesterday, Orthocell shares entered a trading halt at a share price of $1.47.

Why was it seeking FDA approval?

Orthocell produces a range of products and regenerative medicine for a variety of bone and soft tissue injuries.

One such product is its Remplir product, which is used for peripheral nerve reconstruction.

Remplir was set to gain US FDA 510(k) regulatory clearance to commercially distribute Remplir into the US market.

It announced in February of this year it was expecting approval from the regulator in late March or early April 2025.

So why is this important?

This approval would give the company the chance to commercially distribute Remplir into the critical US$1.6 billion US market

What caused the trading halt?

Yesterday, Orthocell shares were placed on a trading halt. 

In a media release via the ASX, the company stated: 

Orthocell Limited requests that its securities be listed into an immediate trading halt. The company provides the following information in relation to this request: 

The trading halt is requested pending an announcement by the Company regarding the results of the US FDA 510(k) clearance application to commence commercial distribution in the US market. 

The Company requested the trading halt remain in place until an announcement and the opening of trading on Monday, 7 April 2025. 

What does this mean for Orthocell shares?

Given the timeline and the current trading halt, it is highly possible that Orthocell has received the FDA's decision and is preparing to announce the outcome. 

If the FDA has granted 510(k) clearance, Orthocell will be authorised to commence commercial distribution of Remplir in the U.S. 

This would mean access to the substantial U.S. nerve repair market. 

If the clearance was not granted, the company may need to address the FDA's concerns before proceeding.

Following a trading halt, If the halted stock resumes trading with good news, such as FDA approval (in Orthocell's case), investor demand usually drives up the share price.

Investors should keep an eye out for further announcements which, based on the media release, could come as early as today.