Is Avita Medical in Trouble?

A Quick Update on Avita Medical (NYSE: RCEL)

Avita Medical's Regulatory Review Faces an Obstacle

Earlier this week, Avita Medical (RCEL) disclosed that its latest innovation, the “ReCell Go”, is undergoing closer scrutiny by the U.S. Food and Drug Administration (FDA). The product is aimed to revolutionize medical procedures by automating sample preparations, this third-generation device promises both efficiency for medical staff and lucrative revenue growth for the company.

However, in a surprising turn, the FDA has called for additional data, stalling the regulatory review for a period that could extend to six months. This essentially delays the expedited timeline granted by the Breakthrough Device designation, potentially pushing the ReCell Go's launch to mid-2024, instead of its initial early 2024 release.

For investors tracking Avita, this new timeline isn't far from the company's original projection of a second-half launch in 2024. BUT, Wall Street's reaction has been palpable. With Avita's shares taking a significant hit, there's rising speculation on whether the FDA might call for a clinical trial for ReCell Go (which I don’t believe will happen but needs to be noted).

Diving Deeper into ReCell Go's Regulatory Pathway