Cardiovascular technology promoter Hydrix (ASX: HYD) has confirmed its AngelMed Guardian implantable heart attack alerting device has been used for the first time in four separate surgical procedures at a Singapore hospital.
The surgeries were performed over three days last week on patients chosen based on their previous medical history and perceived benefits they would derive from the device.
Each procedure was supported by a Singapore-based Hydrix field clinical engineer with real-time remote support from Angel Medical Systems’ US-based staff.
The four recipients have been discharged from hospital and each AngelMed implant will gather data over a set period to establish patient baseline heart signals.
Each device will use artificial intelligence and machine learning algorithms to continuously monitor patient heart signals to warn of an acute coronary syndrome event, including silent heart attacks.
Hydrix executive chairman Gavin Coote said the implant surgeries were a milestone moment.
“This achievement demonstrates strong execution of our buy-build-invest strategy to create product revenue and earnings streams, and of equal importance, reflects progress in our aspiration to meaningfully improve a billion lives,” he said.
“We are very pleased with the success of these first Asia-Pacific implants and excited about the large potential market opportunity.”
Cardiac warning system
AngelMed Guardian is the world’s first US Food and Drug Administration-approved implantable monitor for the early warning of heart attacks and other suspicious cardiovascular activity.
Implanted like a single-chamber pacemaker, the device is designed to forewarn of an impending acute coronary syndrome (ACS) event caused by a partial or complete blockage of blood flow and oxygen to the heart, including episodes when there are no recognisable symptoms.
A vibrational alert and sound from the implant as well as a flashing LED light from a separate pager-like device create the alarm, prompting the patient to seek immediate medical help.
Research has demonstrated reducing ACS event time-delays from symptom onset to medical intervention can potentially reduce morbidity rates, heart muscle damage, hospital stay duration and associated medical costs.
Angel Medical Systems Inc invested approximately $243 million to develop the AngelMed Guardian device and fund clinical trials, which culminated in US FDA approval in 2018.
In March, Hydrix announced it had acquired an exclusive seven-year agreement to accelerate the distribution of AngelMed Guardian through the Asia-Pacific region.
Under the terms of the agreement, Hydrix completed an equity investment in AngelMed to gain distributor rights to markets in Singapore, Japan, Indonesia, Thailand, Hong Kong, Malaysia, New Zealand and Australia.
The company is also responsible for meeting an agreed number of product implants and securing full regulatory approval in a number of jurisdictions within pre-determined time periods.