- Hydrix’s (HYD) share price soars after Angel Medical Systems advised the US FDA approved its upgraded AngelMed Guardian system for commercial release in the US
- The AngelMed Guardian is the world’s only FDA-approved, implantable heart monitoring device, which alerts patients of an impending Acute Coronary Syndrome (ACS) event, like heart attacks
- The company says receiving the FDA approval is a key milestone ahead of submitting applications for regulatory approvals in Australia and Singapore
- Hydrix has also begun the Medical Services Advisory Committee application process in Australia to establish a surgical code for the reimbursement of fees pertaining to implant procedures
- Hydrix last traded at 15.5 cents on June 25
Hydrix’s (HYD) share price has soared after Angel Medical Systems advised the US FDA approved its upgraded AngelMed Guardian system for commercial release in the US.
The AngelMed Guardian is the world’s only FDA-approved, implantable heart monitoring device, which alerts patients of an impending Acute Coronary Syndrome (ACS) event, like heart attacks.
The device can identify ACS symptoms and alerts a patient to seek medical help. The quicker a heart attack is recognised and treated, the greater the chance of recovery by the patient.
Cardiovascular disease is said to afflict 14 per cent of the global population. On average, the probability of death from an initial heart attack is one in ten, with the probability doubling to one in five for subsequent attacks.
The company says receiving the FDA approval is a key milestone ahead of submitting applications for regulatory approvals in Australia and Singapore. The Australian TGA regulatory approval process is anticipated to take six to twelve months, while the Singapore HSA regulatory approval process can also take up to twelve months.
The company says a one per cent market share in countries that Hydrix is targeting has the potential to generate $35 million in annual sales revenue for the company.
Hydrix has also begun the Medical Services Advisory Committee application process in Australia to establish a surgical code for the reimbursement of fees pertaining to implant procedures.
Additionally, the company will begin the Prostheses List Advisory Committee process to establish a device reimbursement code for the device following submission of the TGA application.
Hydrix last traded at 15.5 cents on June 25.