First AngelMed Guardian implants in Asia-Pacific for Hydrix Medical

Key Highlights:

• First AngelMed Guardian patient implants in Asia Pacific for Hydrix Medical
• The four implants were carried out under the guidance of leading Cardiologist Dr Leslie Lam
• This significant milestone provides a foundation for future implants under early access schemes in Singapore and Australia

Hydrix Limited (ASX: HYD, ‘Hydrix’ or the ‘Company’) is pleased to announce its first supply and implant of the AngelMed Guardian device.

Four implants were performed over a 3-day period last week in Singapore and recipients have since been discharged from hospital. Each implant procedure was supported by a Hydrix Medical field clinical engineer in Singapore with real-time remote support from Angel Medical Systems staff in the USA.

The successful implants follow Hydrix’s announcement on 13 March 2020 that it had acquired an exclusive seven-year distribution agreement for eight Asia Pacific countries to distribute the AngelMed Guardian device, the world’s first FDA approved implantable heart attack warning system.

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.”

Speaking from New Jersey, Dr David Fischell, founder and Chairman of Angel Medical Systems commented “We are very pleased with the success of these first Asia Pacific implants and excited about the large potential market opportunity. It has been a global team effort in getting to this point and I’d like to acknowledge Dr Lam’s medical team and the teams from Hydrix and AngelMed for their hard work and dedication.”

Paul Kelly, Hydrix Medical – General Manager said: “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.”

Commenting further: “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.”

In terms of next clinical steps, these implanted devices will gather data over a two-week period to establish each patient’s baseline heart signal. Each patient will then meet with Dr. Lam and a Hydrix Medical field clinical engineer to calibrate and customise the device’s alarm configuration. The device will use Artificial Intelligence and machine learning algorithms to continuously monitor these patient’s heart signal to warn of an acute coronary syndrome event, including silent heart attacks.

Hydrix Medical is exploring opportunities with key stakeholders in Australia for implants under TGA’s Special Access Scheme. 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.

An estimated 500,000 people annually suffer from an acute coronary syndrome event in the top four Asia Pacific countries that Hydrix Medical is initially targeting. For context, a 1% market share could translate into over $35 million in annual AngelMed Guardian revenues for Hydrix.

This announcement is authorised for release by the Board of Directors of Hydrix Limited.

-ENDS-

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About Hydrix Limited

Hydrix Limited (ASX: HYD) is a powerful product innovation company. Hydrix’ purpose is to enhance the health, safety, and wellbeing of 1 billion lives. The company leverages its powerful product innovation capability across Hydrix Services design and engineering to create products which transform markets; Hydrix Ventures to pick winning investments in high potential innovative products; and Hydrix Medical to create new product revenue streams bringing cardiovascular technologies to market.