Echo IQ (ASX:EIQ) Requests FDA Meeting for Heart Failure Solution
FDA Meeting Request
Echo IQ (ASX:EIQ) has formally requested a pre-submission meeting with the US Food & Drug Administration (FDA) to discuss clearance for its heart failure clinical decision support solution, EchoSolv HF. This meeting aims to confirm the company’s FDA regulatory strategy and protocol for the expected US clinical validation study.
The pre-submission meeting is anticipated to occur during Q1 CY2025, with clearance for EchoSolv HF expected in H2 CY2025. This request follows two completed studies evaluating the solution’s performance, demonstrating that Echo IQ’s AI technology detected 86% of heart failure cases, compared to 46% in standard clinical practice.
Market Opportunity and Validation Study
Heart failure represents a significant market opportunity for Echo IQ, accounting for 17% of US healthcare expenditures and estimated at US$60 billion annually. The company is currently in advanced negotiations with several prominent US healthcare organisations to conduct the proposed validation study, which is set to commence next quarter.
This study will mark the final clinical requirement before a formal submission for FDA clearance. Management is optimistic about the potential of EchoSolv HF to enhance patient outcomes at scale.
Executive Insights
Incoming CEO Mr Dustin Haines stated, “This request marks an important step forward in the Company’s clinical development pathway for its innovative heart failure solution.” He added that the collaboration with FDA consultants and potential research partners is crucial for understanding the final clearance requirements.
Echo IQ Chair Andrew Grover expressed confidence in achieving FDA clearance, highlighting that the company has gained valuable insights from its previous clearance for EchoSolv AS. He noted that this development underscores Echo IQ’s operational progress and market potential of their technology in the US.
Motley Fool contributor Kiarra Jackson 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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