Australian company Hydrix (ASX:HYD) has announced the first supply and implant of its AngelMed Guardian device.
The device is the first FDA-approved implantable heart attack warning system.
The company said four implants were performed over a three-day period in Singapore and recipients have since been discharged from hospital.
Hydrix announced in March 2020 that it had acquired an exclusive seven-year distribution agreement for eight Asia Pacific countries to distribute the AngelMed Guardian device.
Gavin Coote, Hydrix executive chairman said, “The AngelMed Guardian implants are a significant milestone for Hydrix and AngelMed. 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.”
According to Hydrix Medical general manager Paul Kelly, “The patients selected for implant in Singapore were chosen based on their previous medical history and the benefit they would derive from the AngelMed Guardian. The success of the initial implants will provide a strong foundation to build upon.”
“Hydrix Medical supplied the devices on a commercial basis to Dr Leslie Lam whose patients were implanted at the Farrer Park Hospital Singapore under his GN-26 early access scheme permit,” added Mr Kelly.
The company said the implanted devices will gather data over a two-week period to establish each patient’s baseline heart signal. Each device's alarm configuration will then be calibrated and customised. The device will use Artificial Intelligence and machine learning algorithms to continuously monitor each patient’s heart signal to warn of an acute coronary syndrome event, including silent heart attacks.
Hydrix Medical said it is exploring opportunities with key stakeholders in Australia for implants under the TGA’s Special Access Scheme. It said subject to reaching commercial, medical and regulatory arrangements, and to COVID-19 disruptions, there is potential for implants in Australia in the December 2020 quarter.