Echo IQ is awaiting FDA approval for its AI-powered EchoSolv platform
\nEchoSolv utilises machine learning algorithms to detect aortic stenosis
\nStockhead reached out to Echo IQ\u2019s COO, Deon Strydom<\/p>\n
\u00a0<\/p>\n
When looking at a healthcare stock to buy, one of the signposts potential investors often look for is how close the company\u2019s products are to a US FDA approval.<\/p>\n
Companies with at least one product in the final stages of approval are obviously safer investments than those just beginning the investigative phases of development.<\/p>\n
Receiving an FDA approval can also have a significant impact on a biotech\u2019s stock price for several reasons \u2013 the most important one being the revenue generating opportunities it could bring.<\/p>\n
At the end of the day, the FDA is the ultimate gatekeeper for the US pharmaceutical market, which is by far the world\u2019s largest.<\/p>\n
One ASX company that\u2019s close to receiving such approval is Echo IQ (ASX:EIQ)<\/a><\/strong>, a $65m-market capped stock focusing on artificial intelligence (AI) and data science to improve detection of structural heart disease.<\/p>\n On Tuesday, EchoIQ \u00a0announced the lodgement of a formal FDA 501(k) application<\/strong> for its AI-powered EchoSolv <\/strong>platform to diagnose aortic stenosis.<\/strong><\/p>\n \u201cThe FDA will have 90 days to give us a response, but what\u2019s important to know is that we\u2019ve had what\u2019s called a Pre Sub Meeting with them. So there shouldn\u2019t be surprises from their perspective,\u201d said EchoIQ\u2019s COO, Deon Strydom.<\/strong><\/p>\n According to FDA guidelines, applicants under the 510(k) expedited process can anticipate a decision regarding clearance 90 days from the date of submission.<\/p>\n Assuming no requests for additional information are issued by the FDA, Echo IQ could receive clearance to market by as early as August.<\/p>\n \u00a0<\/p>\n Echo IQ\u2019s EchoSolv is a novel machine learning algorithm software developed by the company using its access to cardiac data covering millions of echocardiographic data points.<\/p>\n The decision support platform was built to provide physicians with a reliable tool to perform an accurate detection of aortic stenosis (AS), a condition that occurs in approximately 3% of the population aged over 65.<\/p>\n AS happens when there\u2019s an abnormal narrowing of the aortic valve, which slows down the flow of blood from the left ventricle to the rest of the body through the aorta.<\/p>\n This conditions forces the heart to put in extra effort to pump blood effectively. If left untreated, patients have a 50% chance of dying within 2 to 3 years.<\/p>\n The EchoSolv technology detects the condition by checking echo measurements (a measure of the heart\u2019s pumping chambers) of the patient, which can be completed in just 3 seconds.<\/p>\n Strydom explained that this rapid diagnosis is possible because Echo IQ\u2019s algorithm leverages data from the National Echo Database of Australia (NEDA)<\/strong>, which is the largest database of echocardiograms in the world.<\/p>\n \u201cWe have an exclusive agreement with NEDA to commercialise their data. This allowed us to train our algorithms on millions and millions of patient records and echoes, to help us diagnose structural heart disease within seconds,\u201d he said.<\/p>\n The current standard practice to detect AS is to use the echocardiogram device, which is practically a transducer that sends ultrasound waves through the chest toward the heart.<\/p>\n \u201cBut this device often misdiagnoses the condition, and the reason is because the condition is just so complex,\u201d Strydom told Stockhead<\/em>.<\/p>\n \u201cThe physicians have to try and get the exact right angles in order get these images of the heart, and it\u2019s a moving object so there\u2019s a lot of interdependencies from operating errors there.\u201d<\/p>\n EchoSolv helps to eliminate those operating errors by sending the echocardiogram data back to its algorithm, which are then analysed to give the correct diagnosis output.<\/p>\n \u201cSo EchoSolv is essentially a decision support too that tells a doctor if a patient is at risk of the condition,\u201d said Strydom.<\/p>\n \u201cWe\u2019re not saying that we\u2019re better than humans. This is a difficult and complex condition to diagnose, so humans will always be involved. We don\u2019t supersede them.<\/p>\n \u201cBut what we\u2019re able to do is augment what the physicians are doing, giving them more information so they can make a more informed decision.\u201d<\/p>\n \u00a0<\/p>\n Source: EchoIQ<\/strong><\/em><\/p>\n \u00a0<\/p>\n Now that the Echo IQ\u2019s product development around aortic stenosis is largely complete, the company is turning its attention to another condition, heart failure<\/strong>.<\/p>\n According to the Causes of Death report, which is released once a year, heart failure accounts for more than 18,500 (one in every 10) deaths annually here in Australia.<\/p>\n \u201cAnd in the US, heart failure is the single largest reason for hospitalisations, with 17% of the US healthcare outspend being spent on heart failure,\u201d said Strydom.<\/p>\n What\u2019s more, the CMS (Centers for Medicare and Medicaid Services)<\/strong> \u2013 the organisation that provides health coverage to more than 100 million Americans \u2013 penalises hospitals for patient readmissions.<\/p>\n \u201cSo if I go to the hospital in the US today, and I get readmitted within 30 days, the hospital has to pay a significant penalty to the CMS,\u201d Strydom says.<\/p>\n For heart failure, that rate of readmission is currently as high as 25%.<\/p>\n \u201cSo these hospitals want keep patients out of hospital, because there\u2019s a big financial incentive for them to do so,\u201d said Strydom, adding that a platform like EchoSolv could help them solve that problem.<\/p>\n The company is currently working on a new platform to tackle the health failure segment, and according to Strydom, the software should be all completed and wrapped up within 12 to 16 months if everything goes according to plan.<\/p>\n \u201cThis is absolutely going to significantly increase our addressable market,\u201d he said.<\/p>\n \u00a0<\/p>\n Strydom believes an FDA approval or feedback over the next 90 days could trigger a revaluation of EIQ\u2019s stock price.<\/p>\n \u201cWe know what happens to the stock prices of all those other companies once they\u2019ve got an FDA clearance,\u201d he said.<\/p>\n An FDA approval will also significantly de-risk the business for shareholders, he adds.<\/p>\n \u201cYou can see this in medical device companies like ImpediMed, 4DX, and Compumedics. And obviously, we all know the success story with Pro Medicus. The FDA approvals for them were seen as de-risking of their businesses.\u201d<\/p>\n Echo IQ\u2019s management also has skin in the game, with current CEO Andrew Grover being the largest shareholder of the company.<\/p>\n \u201cWe\u2019ve now started reimbursement discussions for aortic stenosis in the US, and our FDA filing will open a much much bigger market for us.<\/p>\n \u201cSo the opportunity really is now,\u201d said Strydom.<\/p>\n \u00a0<\/p>\n \u00a0<\/p>\n\n \ufeff<\/span><\/span>\u00a0<\/p>\n \u00a0<\/p>\n \u00a0<\/p>\n Anteris Tech (ASX:AVR)<\/a><\/strong><\/p>\n Anteris provides solutions to the challenges facing heart surgeons.<\/p>\n Anteris\u2019 DurAVR THV system is\u00a0also used to treat\u00a0severe aortic stenosis. It\u2019s also said to create a wider valve opening and better blood flow, and also requires fewer stitches.<\/p>\n The company has recently raised $23 million to prepare for the DurAVR transcatheter heart valve\u2019s FDA pivotal study, a key step to gain regulatory clearance for the US market.<\/p>\n \u00a0<\/p>\n Imricor Medical Systems (ASX:IMR)<\/a><\/strong><\/p>\n Imricor is said to have the world\u2019s first and only commercially available MRI (magnetic resonance imaging)-compatible cardiac ablation catheter.<\/p>\n Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway from sections of the heart.<\/p>\n The company recently announced that Dubrava University Hospital in Croatia has submitted its first order of Imricor catheters and other consumable devices.<\/p>\n \u00a0<\/p>\n USCOM (ASX:UCM)<\/a><\/strong><\/p>\n The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients.<\/p>\n Uscom markets the USCOM 1A advanced hemodynamic monitor, the BP+ and BP+ Reporter, and SpiroSonic digital ultrasonic spirometer series and the proprietary SpiroReporter software.<\/p>\n Uscom has abundant IP protection across the globe.<\/p>\n \u00a0<\/p>\n EBR Systems (ASX:EBR)<\/a><\/strong><\/p>\n EBR Systems, established in 2003 in Silicon Valley, has pioneered the WiSE Cardiac Resynchronization Therapy (CRT) system tech \u2013\u00a0 literally the size of a cooked rice grain \u2013 which employs proprietary wireless methods to provide pacing stimulation directly inside the heart\u2019s left ventricle.<\/p>\n WiSE holds the distinction of being the world\u2019s first pacing system within the heart for heart failure.<\/p>\n The company was described by early investor\u00a0 and well-known venture capitalist Mark Carnegie as having potential to \u201cbe as big as Cochlear\u201d when it made its IPO in 2021.<\/p>\n Read more about EBR Systems here: How big-hearted EBR Systems is pacing a multi-billion dollar cardiac market<\/a><\/strong><\/em><\/p>\n \u00a0<\/p>\n At Stockhead we tell it like it is. While EBR Systems is a Stockhead advertiser, it did not sponsor this article.\u00a0<\/em><\/p>\n \u00a0<\/p>\n <\/span><\/p>\n The post With FDA approval close, Echo IQ\u2019s AI platform is set to disrupt US heart disease market<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"How does EchoSolv work?<\/h2>\n
Big plans ahead<\/h2>\n
So what now?<\/h2>\n
Echo IQ share price today:<\/h2>\n
A few other heart related stocks on the ASX<\/h2>\n