Junior biotechnology company Echo IQ Ltd (ASX: EIQ) has lodged a key submission with the US Food & Drug Administration (FDA), which will help pave the way for sales of its heart failure detection software.
The artificial intelligence and medical technology company said in a statement to the ASX on Monday that it had lodged a market clearance application for EchoSolv HF, its heart failure clinical decision support software, with the FDA.
Large market awaits
The submission also incorporated results from a clinical validation study conducted specifically to support the application, the company said.
The company went on to say:
The study, designed to validate the model's ability to detect heart failure on an independent dataset, showed EchoSolv HF met the primary endpoint with study data demonstrating sensitivity of 99.5% and specificity of 91.0% in the detection of heart failure across a dataset of 17,000 echocardiograms from Mayo Clinic Platform.
Echo IQ said the 510k submission was required for medical devices to demonstrate that they are "substantially equivalent" in safety and effectiveness to a legally marketed device.
Once substantial equivalence has been determined and FDA clearance has been issued, the company may market and distribute the device in the United States for the cleared indications for use. FDA clearance, if obtained, would unlock a significant addressable market opportunity for EchoSolv HF in the US healthcare sector, where heart failure is the leading cause of hospitalisation and accounts for 17% of US healthcare expenditure nationally.
FDA decision to come
Echo IQ Chief Executive Officer Dustin Haines said it was a significant milestone for the company.
The lodgement of the submission is a testament to the hard work and disciplined execution of Echo IQ's operations team alongside our key industry partners including Mayo Clinic. With the submission process complete, we will continue to work with our broad network of industry partners across both product development and distribution, ahead of an expected FDA decision in the coming months. The ongoing advancement of our healthcare technology suite positions the company for another momentum driven year ahead, leveraging our proprietary technology to deliver improved healthcare solutions, and we look forward to updating our investors on key progress initiatives early in the new year.
EchoiQ was valued at $178.8 million at the close of trade on Friday, with its shares last changing hands for 27.5 cents.
The stock has traded as high as 37 cents and as low as 16.5 cents over the past 12 months.
