The Hydrix Ltd (ASX: HYD) share price is going gangbusters today, up a huge 70% to 27 cents at the time of writing after rising by as much as 77% in morning trade.
Below we take a look at the medical technologies company’s latest news.
What did Hydrix announce?
The Hydrix share price is soaring after the company reported Angel Medical Systems had advised it that the US Food and Drug Administration has approved its AngelMed Guardian System (AMSG3-E) for commercial release in the United States.
The implantable AngelMed Guardian device constantly monitors patients’ heart signals, alerting them of impending heart attacks. According to the release, it also warns against deadly silent heart attacks. The Guardian is now the world’s first FDA-approved implantable cardiac monitoring device.
Commenting on the approval, Hydrix executive chair Gavin Coote said:
This is a brilliant outcome for AngelMed and Hydrix. The Guardian is a game-changer in cardiac monitoring. It is the world’s only implantable device that can alert a person of an impending heart attack and has the potential to transform patient quality of life.
The FDA approval clears the way for Hydrix to complete regulatory submissions in Asia-Pacific markets commencing with Australia and Singapore.
AngelMed’s CEO, Brad Snow added, “We are excited to commercially launch within weeks in the USA and look forward to supporting Hydrix with its plans to expand our reach into the Asia Pacific market and partner with us to develop next generation device features.”
The company said that with the FDA approval in hand, it will now submit applications for regulatory approvals in Australia and Singapore. It expects the Australian TGA regulatory approval process to take between 6–12 months, while Singapore’s HSA regulatory approval process is forecast to take 9–12 months.
Hydrix share price snapshot
Over the past 12 months the Hydrix share price is up 194%, leaving the 28% gains posted by the All Ordinaries Index (ASX: XAO) well behind.
Year-to-date, however, the Hydrix share price is flat, with much of its 12-month gains having been achieved on a single day last August,