-
510(k) clearance secured from FDA allows for EIQ’s AI-enabled solution, EchoSolv AS, to be marketed and sold in the USA
-
Clearance marks a major milestone and will allow for rapid commercial scale-up
-
EIQ is in advanced discussions with a range of US healthcare providers around the potential uptake of EchoSolv AS
-
Working alongside US consultancy to obtain reimbursement codes for the use of EchoSolv AS under insurance to scale up following FDA clearance
Sydney: AI and Medical Technology company Echo IQ Limited (“the Company”) (ASX:EIQ) has received 510(k) clearance from the US Food and Drug Administration (FDA) for EchoSolv AS, allowing for the solution to be marketed to and used by healthcare professionals in the USA as a decision support aid in the detection of severe Aortic Stenosis.
The clearance follows a formal submission in May 2024. Following detailed review, the FDA has determined that the Company demonstrated substantial equivalence to the predicate device cited in this submission, and has cleared it for marketing and use in the US.
Prior to securing FDA clearance, Echo IQ has been advancing discussions with a number of parties including large hospital groups, device manufacturers and pharmaceutical companies, on the commercial and clinical benefits of EchoSolv AS. As such, the Company is now exceptionally well placed to convert these negotiations into material agreements.
The Company will also scale up work alongside its US consultancy to obtain reimbursement codes for users of EchoSolv AS under insurance. This will create financial incentives for more widespread use of EchoSolv AS in US hospital settings on a fee-per-use basis.
Management commentary:
Executive Chair, Mr Andrew Grover said: “FDA clearance is a major milestone for Echo IQ and provides the foundation to deliver a material value uplift for our shareholders. The Company now has the ability to commercialize its technology in the world’s largest and most well-regulated market, for a condition which is widespread and chronically underdiagnosed.”
“EchoSolv AS shows significant improvements in the detection of severe Aortic Stenosis when compared to current clinical practice. Clearance follows an extensive R&D phase, which saw the solution rigorously tested in the US and Australia. The FDA’s decision further validates the hard work undertaken by the Company and the results which were demonstrated from these initiatives.”
"Following clearance, the Company is now aggressively focused on commercialization. Prior to the FDA’s decision, we have undertaken extensive discussions with a number of hospital groups in the US, as well as potential licensing opportunities with device manufacturers and pharmaceutical companies. We are now very well positioned to capitalize on these advanced negotiations and our well-established pipeline.”
“FDA clearance also provides another catalyst to secure reimbursement codes, which have the potential to provide Echo IQ with a fee on a per use basis from large insurance groups. This is anticipated to underpin future revenues in the US market.”
About Aortic Stenosis:
Aortic Stenosis is a form of heart valve disease, frequently caused by calcification of the aortic valve (commonly referred to as the gateway to the heart). Accurate and timely diagnosis of AS is challenging under current protocols, which means many sufferers are not receiving life extending and lifesaving treatments, such as valve replacement surgery. EchoSolv AS is designed to automatically highlight patients with significant risk of the disease in order to assist clinicians in decision-making for valve intervention and/or follow-up in a highly consistent, systematic and efficient manner.
About EchoSolv AS:
EchoSolv AS is a machine learning and AI-based decision support software specified for use as an adjunct to echocardiography for assessment of severe Aortic Stenosis. When used by an interpreting physician, EchoSolv AS provides information to facilitate rendering an accurate diagnosis of AS. EchoSolv AS includes both the algorithm-based Aortic Stenosis phenotype analysis and the application of recognized Aortic Stenosis clinical practice guidelines.
For more information o Echo IQ, a Cassling partner, and EchoSolv AS, click here.
Media Enquiries:
Philip Woolff, Chief Operating Officer
philip.woolff@echoiq.ai / marketing@echoiq.ai
+61 (0)490 030 620
Investor Enquiries:
Andrew Grover, Executive Chair
Andrew.grover@echoiq.ai / investor@echoiq.ai
Echo IQ uses the AI-powered technology in EchoSolv to enhance the diagnosis of structural heart disease. Their mission is to help improve the lives of people by supporting earlier, more accurate detection of a number of life-threatening but often treatable conditions. The Echo IQ platform applies innovative methodologies and a proprietary algorithm to produce risk assessments for patients using their echocardiographic measurements. They harness the power of AI to produce consistent outputs at speed, and without bias. Applied to the identification of aortic stenosis, for example, EchoSolv has been designed to identify patients at risk of mortality who might benefit from further clinical review. Echo IQ is proud to be applying leading-edge technologies, led by thought-leaders in cardiology, to deliver new solutions in cardiac care.
Comments