ASX biotech stock Echo IQ Ltd (ASX: EIQ) is off to the races today.
Shares in the company, which develops AI products to treat cardiovascular disease, closed on Friday trading for 24 cents. Shares entered a trading halt on Monday at the company's request and resumed trading on the ASX today.
In morning trade on Wednesday, shares just leapt to 30 cents, up 25.0%.
At time of writing, shares have given back some of those gains to be swapping hands for 29 cents apiece, up 20.8%.
For some context, the All Ordinaries Index (ASX: XAO) is up by 0.4% at this time.
Here's what sending the ASX biotech soaring today.
ASX biotech stock lifts off on FDA green light
The Echo IQ share price is surging after the company announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-enabled solution EchoSolv AS.
EchoSolv AS is designed to automatically highlight patients with significant risk of Aortic Stenosis, a form of heart valve disease.
Investors are bidding up the ASX biotech stock as EchoSolv AS can now be marketed to and used by healthcare professionals in the US as a decision support aid to detect severe Aortic Stenosis.
EIQ said it is already in advanced discussions with a range of US healthcare providers around the potential uptake of EchoSolv AS as the company said it will now turn its attention to commercialising its products in the world's top economy.
Following EIQ's recent capital raise, management said the company is well funded to advance multiple near-term commercialisation opportunities.
Commenting on the FDA clearance sending the ASX biotech stock soaring today, EIQ executive chair Andrew Grover said, "FDA clearance is major milestone for Echo IQ and provides the foundation to deliver a material value uplift for our shareholders."
Grover continued:
The company now has the ability to commercialise its technology in the world's largest and most well-regulated market, for a condition which is widespread and chronically underdiagnosed. EchoSolv AS shows significant improvements in the detection of severe Aortic Stenosis when compared to current clinical practice….
FDA clearance also provides another catalyst to secure reimbursement codes, which have the potential to provide Echo IQ with a fee on a per use basis from large insurance groups. This is anticipated to underpin future revenues in the US market.
New US-based CEO
In a separate release, the ASX biotech stock reported on the appointment of a new CEO.
Dustin Haines will take the helm on 10 January. He will be based in the US to lead the company's growth strategy, starting with commercialisation in the US market.
Haines has a 25-year career in the biotechnology and pharmaceutical sectors. Most recently he served as vice president of Gilead Sciences, Asia, Middle East, Turkey and Russia.
Commenting on the new CEO appointment, Grover said, "To have secured someone of Dustin's calibre to execute our stated commercialisation strategy highlights the considerable potential of the company's technology in the US market."
With today's intraday gains factored in, shares in the ASX biotech stock are up 71% in 2024.
