The 4DMedical Ltd (ASX: 4DX) share price is off to the races.
Again.
Shares in the S&P/ASX 300 Index (ASX: XKO) respiratory imaging technology company closed yesterday trading for $6.28. In earlier trade, shares leapt to $7.55, up 20.2%. After some likely profit-taking, in later morning trade, shares are changing hands for $6.85 apiece, up 9.1%.
For some context, the ASX 300 is down 0.3% at this same time.
Taking a step back, the 4DMedical share price is now up a jaw-dropping 2,074.6% over 12 months. That meteoric rise has been spurred by a series of international regulatory approvals for its CAT scan-based ventilation-perfusion software, CT:VQ.
Indeed, just one year ago, you could have bought the ASX 300 healthcare stock for a mere 31.5 cents. That would have turned an $8,000 investment into $173,968.
Boom!
Now, here's what's catching investor interest again today.
Image source: Getty Images
4DMedical share price surges on EU approval
The 4DMedical share price is leaping higher after the company announced that CT:VQ has received CE Mark certification for commercial use in the European Union.
The company noted that CE Mark certification enables it to immediately commence commercial engagement with healthcare providers across the EU. This sets up a pathway for clinical adoption and collaboration with major European hospital networks.
Investors will also have noted that the EU has a population of more than 450 million. And with the economic block already home to highly developed hospital-based imaging infrastructure, 4DMedical said the EU constitutes one of the largest global markets for advanced cardiothoracic imaging.
What else is impacting the 4DMedical share price today?
Atop the European Union's CE Mark certification, the company also announced an institutional capital raising.
4DMedical said it has received commitments from institutional investors for an $83 million private placement at an issue price of $5.90 per share.
That's a 6.1% discount to the 4DMedical share price at market close yesterday. But the company noted it represents a 12.3% premium to the 5-day volume average weighted price (VWAP).
The proceeds will be used, in part, to fund the commercial launch of CT:VQ across Europe and international markets.
What did management say?
Commenting on the EU green light and capital raise that sees the 4DMedical share price up sharply again today, CEO and founder Andreas Fouras said, "CE Mark certification for CT:VQ is a significant milestone that opens access to one of the world's largest and most sophisticated healthcare markets."
Fouras continued:
Combined with FDA clearance, 4DMedical now holds regulatory approval to rapidly commercialise CT:VQ across both the US and the EU. Since FDA clearance, rapid adoption by leading US institutions … reflects the level of excitement CT:VQ is generating in the United States.
This placement, timed alongside CE Mark certification, gives us the resources to carry that same momentum into Europe… With an estimated 400,000 nuclear VQ scans performed annually across the EU, and an extensive network of CT scanners, the European opportunity is substantial and immediate.
