Echo IQ (ASX:EIQ) Partners with Mayo Clinic Platform, Advances EchoSolv HF towards FDA Clearance
FDA Engagement
Echo IQ engaged positively with the US FDA regarding its EchoSolv HF clinical decision support solution, establishing a clear path towards regulatory clearance. The final validation study, a key regulatory requirement, is set to commence this quarter with FDA clearance anticipated in the second half of CY2025.
Collaboration with Mayo Clinic Platform
The Company secured a collaboration agreement with the Mayo Clinic Platform to advance the validation study for EchoSolv HF. This agreement includes the potential licence of EchoSolv HF to 30 Mayo Clinic Care Network sites using the group’s proprietary integration software system for three years.
Market Opportunity
Heart failure represents a significant market opportunity in the USA, with an estimated total addressable market of US$70 billion annually. Current challenges include only 50% of heart failure cases being accurately diagnosed, and heart failure accounting for 17% of US healthcare expenditure due to rehospitalisations.
Executive Comments
Chief Executive Officer, Mr Dustin Haines, said: “Our meeting with the FDA was very encouraging and has provided Echo IQ with a clear path towards regulatory clearance for EchoSolv HF. Alongside this, the collaboration agreement executed with the Mayo Clinic Platform, part of the Mayo Clinic, which is the top-ranked hospital in the nation, leaves the Company incredibly well positioned to advance its planned validation study, progress regulatory clearance and generate better patient health outcomes in a condition which is common throughout the US and leaves 50% of patients without clear diagnosis.
Given the previous work undertaken in Australia with EchoSolv HF, which highlighted the correct identification of up to 97% of heart failure cases, we are excited to commence our planned validation study for our innovative solution. I would like to take this opportunity to thank Mayo Clinic Platform for their collaboration. We look forward to working together to deliver improved patient outcomes at scale.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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