Since securing the exclusive distribution rights to the AngelMed Guardian device, the only FDA approved implantable heart attack warning system, Hydrix (ASX: HYD) has now successfully implanted the device in four patients in Singapore.
Implanted over a 3-day period, patients were selected based on their previous medical history to ensure they would benefit from the AngelMed Guardian. Procedures were overseen by leading cardiologist Dr Leslie Lam and Angel Medical Systems staff in the United States.
“The AngelMed Guardian implants are a significant milestone for Hydrix and AngelMed,” said Hydrix Chairman, Gavin Coote.
“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.”
The four patients in Singapore will meet with Dr Lam in two weeks which will give the devices time to gather sufficient data on the patients’ baseline heart signal. This data will then enable Hydrix Medical engineers to customise alert signals allowing artificial intelligence to enable the device, warning of acute coronary syndrome events, including salient heart attacks.
While the AngelMed Guardian is approved for commercialisation in the United States, it has yet to be signed off in Australia by the Therapeutic Goods Association. However, Hydrix Medical is hoping to reach regulatory arrangements under the TGA’s Special Access Scheme. If regulatory requirements can be met, Hydrix is aiming to commence implants in Australia before the end of 2020.
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, where they hold exclusive distribution rights for 7-years.
If Hydrix Medical is able to secure just a 1% market share, they expect this to translate into over $35 million in annual AngelMed Guardian revenues for Hydrix.
“We are very pleased with the success of these first Asia Pacific implants and excited about the large potential market opportunity,” said Angel Medical Systems Founder and Chairman, Dr David Fischell.
“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.”
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