The All Ordinaries Index (ASX: XAO) is up 0.4% in late morning trade on Monday, with one ASX healthcare stock doing plenty of the heavy lifting.
The high-flying company in question is Silicon Valley-based EBR Systems Inc (ASX: EBR), which is focused on treating cardiac rhythm disease.
EBR Systems shares closed on Friday trading at $1.365. At the time of writing, they are 7.8% higher at $1.47 after leaping to an intraday high of $1.52, up 11.4%.
As you can see on the chart below, that sees the ASX healthcare stock up a very, well, healthy 138% over the past 12 months.
Here's what's spurring investor interest today.
ASX healthcare stock leaps on FDA update
Investors are bidding up the EBR Systems share price after the company, developing the world's only wireless cardiac pacing device for heart failure (WiSE System), announced that the US Food and Drug Administration (FDA) has scheduled the manufacturing Pre-Approval Inspection (PAI) to commence next week, on 14 January.
The ASX healthcare stock had previously anticipated that the PAI would start this week. However, management noted that the one-week delay won't impact the expected FDA regulatory approval timing, which was said to remain on track for the first quarter of calendar year 2025.
Commercial launch is then projected to take place later this year.
According to the release, the PAI's purpose is to confirm that EBR's manufacturing procedures comply with US quality system regulations and ensure that EBR can consistently produce devices that meet these approved specifications.
EBR reiterated that the FDA has previously said that the onsite Biomedical Monitoring (BIMO) audit is unlikely to be a requirement prior to final approval.
The Breakthrough Device designation for the WiSE System enables EBR to receive prioritised review and interactive communication with the FDA until the review process is completed.
The ASX healthcare stock initially released details of the FDA's review process on 30 September.
At the time, EBR Systems CEO John McCutcheon said:
We are delighted that our PMA application has progressed to substantive review by the FDA, effectively moving into the final stages of our regulatory timeline. The FDA moved quickly through this step, which could have taken up to 45 days.
This significant milestone brings us even closer to US commercialisation and to making available our life-changing WiSE technology to heart failure patients in need.
That announcement came shortly after the ASX healthcare stock secured $50 million in new funding. The company noted this provided it with a "cash runway" to get it through the FDA approval process, adding that the funds would also support it through early commercialisation and revenue growth.
