Latest 4C showed no revenue but did give a timeline for resubmission of the CPT III reimbursement code. Pushes expected revenue to 4Q?

$18M in the bank with a cash burn of $6.5M in the last 12 months. Will be interesting to see the 1Q of CY26 to get an indication of when cash flow positive may occur. Possible re-rate on FDA clearance and CPT reimbursement code before then but expecting the SP to be pretty static until then.

"There are three CPT Editorial Panel Cycles per year and Echo IQ completed resubmission prior to the deadline of 11 June 2025, allowing the Company to present its application in September 2025 for a potential code receipt shortly thereafter."

Still predicting H2 25 FDA clearance for HF on the back of the Mayo Clinic validation study.

"Separately to this, negotiations with large device manufacturers, global pharmaceutical companies and other hospital groups continued to advance pleasingly.”  Strange wording, very vague.

OUTLOOK

Completion of the Company’s validation study for EchoSolv HF in collaboration with the Mayo Clinic Platform and finalising requirements for FDA submission and subsequent clearance

Convert its growing pipeline of US hospital groups, pharmaceutical companies and device manufacturers to increase uptake of EchoSolv AS in the US

Commencement of integration opportunities with SARC MedIQ’s large network of US hospital groups, healthcare organisations and other large multi-clinic sites

Advance preparations and presentation to CMS and progress work towards a Category III CPT code and designated CPT code for EchoSolv AS allowing for reimbursement for US users

I like the deal today.

Not sure of the revenue and how this works, however happy to have exposure to over 300 healthcare facilities and 1500 physicians.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02966379-2A1607958&v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6

Hold IRL

A good example of how information can become available about small companies before it should. On the 19th a post on HC reported that the AMA had rejected EIQ's request for a CAT 3 reimbursement code. The SP went in to freefall with speculation and ended the day -25%. Many posters queried the initial post asking why the company had not released the information if it was true. A trading halt ensued and then the embarrassing response from the company today.

"Yes. Echo IQ Limited (EIQ) became aware of information concerning it on 19 May 2025 that had not been announced to the market.

The Company filed an application with the Current Procedural Technology (CPT) Editorial Panel of the American Medical Association for a Category III CPT code for reimbursement for reporting noninvasive evaluation of aortic stenosis derived from augmentative analysis of measurements obtained from an echocardiogram (EchoSolv AS). This will create a specific code for the use of Echosolv AS as a new or emerging technology.

On 17 May 2025 at 1:00AM AEST, the Company was notified via a letter from the CPT Editorial Panel rejecting this request, noting that two of the general criteria for Category I and Category III codes were not met.

The letter was sent to Dane Brescacin, the Company’s Vice President of Regulatory Affairs, who was unwell over the weekend and was not at work on Monday, 19 May 2025.

Andrew Grover, Executive Chair, called Dane Brescacin at approximately 1:00pm AEST on Monday, 19 May 2025 given concerns regarding the Company’s trading to check if there was any explanation for the increased volume and decreased share price.

Mr Brescacin then checked his emails and a trading halt request was sent to the ASX immediately.

The letter confirms that the Company can submit a new code change application addressing the deficiencies identified by the Panel. This application must be submitted by 11 June 2025 in order to be considered at the September 2025 Panel meeting. The Company intends to submit this application. The Company understands it is not uncommon for applications to be rejected initially, and it is confident it can strengthen its application to be able to meet the criteria in the second application submission to the CPT Editorial Panel of the American Medical Association. The Company is now progressing revisions to its submission, which will account for all feedback and guidance provided to date to ensure greater alignment to the AMA’s criteria. Resubmission is expected to occur prior to the next deadline of 11 June 2025, which will allow the Company to present its application in September 2025 for a potential code receipt shortly thereafter.

This post on HC was useful in explaining the process:

"For the Miscellaneous Reimbursement code, approval rates for reimbursement claims range from 20% to 40% - relatively low compared to Category III and Category I codes. This is because miscellaneous codes are generally less standardised, require more rigorous justification for use, and often involve case-by-case approval processes by insurers. Material revenue uplift is expected upon achieving a dedicated Category III CPT code.

Category III CPT codes are assigned to new and emerging technologies and typically receive higher reimbursement approval rates from insurers, usually between 40-60%. Echo IQ has filed an application for a Category III CPT code with the Centers for Medicare & Medicaid Services (CMS) and anticipates receiving approval by mid-2025. This code will streamline the reimbursement process, boosting both institutional adoption rates and overall revenue generation as healthcare providers experience greater confidence and predictability in reimbursement claims.

The most substantial revenue enhancement is projected following the eventual receipt of a Category I CPT code. Category I codes signify widespread clinical acceptance and usage and typically result in the highest approval rates for reimbursement claims, generally between 80-100%. The achievement of a Category I CPT code not only enhances the reimbursement approval rate substantially but also typically increases the reimbursable amount, further improving Echo IQ's revenue potential."



Help me please, Strawpeople! Have a read of this - EIQ US listing.pdf

So, EIQ is going to be listed on the OTCQB market to facilitate access to US investors. Does this purely mean US investors can buy the current EIQ shares available in Australia during the US opening times? No dilution? Possible big changes in price as our market opens if there is strong buying/selling there? Would appreciate information from anyone and also whether people think this is a good move generally (and more specifically for a small AI health company).

Nessy

Disc: held

Interesting the run in EIQ of recent on no news. Up over 20% in the last couple of weeks, some reasonable volume too. Adam Dawes did give it a rev on Equity Mates on Feb 11, maybe has helped it on its way to almost all time highs. Funny that the description he gave of the company wasn't really what I would call totally accurate! Has this made EIQ a "popular" stock?? Or is there an announcement coming up??

Nessy

Held

Great interview as always Strawman.

COO Philip seemed to get a little vague when he was asked specific questions. For example:

i) In relation to the competitor company Icardio with the product Echocardio, whom received FDA approval in the same month as EchoIQ. When asked what this competitor approval meant for EchoIQ, he responded they were about “measurement”. How the two FDA approved software systems differed and why the EIQ product was superior was not well explained.

ii)       When asked the question in relation to progress of the Hydrix (HYD) 3 year agreement signed in April 2023 with EIQ to sell the “Echosolve” software in Australia NZ and Singapore, he was again vague. Philip talked about a pilot being extended out with Hendrix and these things taking time to get moving.  Well, the total operational revenue in FY 24 was only $44,500. This does not speak to a business or relationship that is firing.  In addition, you would think the recent FDA approval might have stirred some interest in the Australian market Philip could expand on.  

iii) Philip was asked about the announced (16/9/24) Icardio.ai collaboration with Abbott to develop artificial intelligence for Abbott’s imaging devices, the response was along the lines of: Well, this does not preclude Abbott from entering an agreement with EIQ. A fair enough statement as far as it goes, but not one that would encourage an investor to open their wallet.

Maybe Philip is not giving too much away because of the competition and the critical stage the company is at.  Fair enough too, and maybe I am being way too harsh.  

It would be great if there is a Strawman Cardio somewhere out there in the medical heartland (note the ingenious word pun), or someone knows one whom can give an objective opinion on EIQ’s software?  Because F*&^%ed if I know what to think.

@Strawman , great interview with Philip Woolff from EIQ. He strikes me as a man with great vision and a reasonably clear pathway to get where he thinks EIQ can go. It will be very interesting to see how the new American leader can start to commercialise their product in the new year. One question I have only just thought of that would have been worth asking is how long he thinks FDA approval would take for the heart failure side of the business - perhaps you can send him that and see if he replies. Once cash starts to flow it does seem like a favourable acquisition for a bigger US group, especially at its small valuation.

Nessie

disc: held

@Strawman , maybe you could reach out for another EIQ meeting. Lots of recent interest with the FDA approval. Hype in the stock price too, probably too much. Would be good to ask about how their research in to heart failure is going given it is potentially a bigger market.

Cheers,

Nessy

EIQ significantly derisked with FDA approval of AS diagnosis. Reimbursement codes next step and announcement of CEO should build momentum.

Highlights:

510(k) clearance secured from FDA allows for EIQ’s AI-enabled solution, EchoSolv AS to be marketed and sold in the USA

EIQ is in advanced discussions with a range of US healthcare providers around the potential uptake of EchoSolv AS – pipeline is well established with multiple groups

Ongoing liaison with device manufacturers and pharmaceutical companies advancing to broaden commercialisation pipeline

Work alongside US consultancy to obtain reimbursement codes for use of EchoSolv AS under insurance to scale up following FDA clearance

Company is well funded to advance multiple, near-term commercialisation opportunities

Advanced discussion with potential US based CEO with extensive healthcare, commercialisation and reimbursement experience.

“Following clearance, the Company is now aggressively focused on commercialisation."

Hot copper email sent out sharing a next investors article about EIQ. ("The Company has been engaged by EIQ to share our commentary on the progress of our Investment in EIQ over time").

Headline is that FDA approval could be any day now. The article does give a detailed run down on the company and outlines the risks. Their view is that it will take at least 12 months to ramp up sales. It does note that they have an investment in the company and include their investment memo.

Highlights of their thesis

"The data shows that the AI algorithm works.

Imminent share price catalyst in potential aortic stenosis FDA approval.

Multi-billion dollar market target for “heart failure” diagnostics assistant.

Second catalyst for FDA approval on heart failure could be within 12 months.

Exclusive commercial access to the world's biggest heart data repository

Clear pathways to commercialisation in the USA - the biggest healthcare market in the world.

SaaS revenue model, potential to rapidly grow revenue and/or secure large licensing deals.

Cost savings, 3 seconds until results, removing bias"

Could provide some momentum to the SP.

Disc: held in SM and RL

EIQ announces positive study results for Heat Failure AI solution. FDA decision for Aortic Stenosis due soon and now pursuing approval for heart failure.

Highlights:

• Echo IQ recently completed two clinical studies to evaluate the performance of its Heart Failure AI system in detecting new onset heart failure:

o EIQ’s AI-alone detects 86% of heart failure cases (vs 46% detection observed in current standard clinical practice)

o Combination of AI and clinical evaluation increases diagnosis accuracy to 97% in high-risk individuals

• Heart failure is the leading cause of re-hospitalisation in the US, accounts for 17%(1) of all US healthcare expenditure and is a US$60bn market annually.

• Results were presented by invitation at Late Breaking Science sessions at the European Society of Cardiology (ESC) Congress 2024, the world’s largest and most renowned cardiology congress.

• Positive results form the basis for FDA application for EIQ’s AI solution as a diagnostic aid for the detection of heart failure.

• Groundbreaking results highlight EIQ’s potential ability to positively impact heart failure health economics – Reimbursement strategy being progressed.

• Significant commercial interest established and expected to scale in light of significance of results.

“The current status quo is not acceptable, since many patients with heart failure do not receive a clear diagnosis, and similarly other individuals at risk of heart failure may not be identified. The results of these studies demonstrate our ability to positively change the diagnostic landscape and to improve on current practices, with the goal of enhancing our patients lives.”

Proposed regulatory pathway and commercial opportunities: Following the presentation of these results at ESC Congress 2024, the Company remains well placed to advance its regulatory strategy with an application for US FDA clearance for its heart failure solution. Work is now underway toward a pre-submission meeting with the regulator, which will provide additional insight into its clearance pathway. Concurrently, Echo IQ has been engaging with a number of leading global pharmaceutical companies and device manufacturers, with both on-market and planned therapies for heart failure and associated conditions. These results are expected to advance these discussions ahead of potential commercial uplift with counterparties.

So the new CEO from end of Jan 2024 is now the former CEO...... Never like those sorts of announcements. I wonder if it was anything to do with him buying 500k shares on market just recently.

Nessy

disc - held

Further good results from second clinical trial with some comments in the announcement that suggests a marketing approach. Incorrect/inaccurate diagnosis leading to malpractice suits and an increase in recipients for device manufacturers. Trial was funded by one such company. Now to get the adoption and revenue going.

Echo IQ’s EchoSolv AI technology identified 72% more patients with severe aortic stenosis than human diagnosis alone

• Trial revealed that women were 66% less likely to have been accurately diagnosed than men using human-only assessment: EchoSolvTM resolves this discrimination

• Study was funded by Edwards Lifesciences (NYSE:EW)(Edwards Lifesciences Corp. engages in patient-focused medical innovations for heart disease and critical care monitoring. Its products are categorized into four main areas: Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, Surgical Structural Heart, and Critical Care)

• Clinical trials now completed at St. Vincent’s Hospitals and Beth Israel Deaconess Medical Center (USA) with more than 40,000 echocardiograms reviewed

• Trial results support rapid commercial deployment of EchoSolvTM in multiple sites and markets

In the United States, diagnostic errors affect an estimated 12 million adults each year. Furthermore, we know that 1 in 3 medical malpractice cases resulting in death or permanent disability are due to inaccurate or delayed diagnosis. EchoSolvTM has clearly demonstrated how valuable it can be in clinical practice and we are pleased to see a number of facilities in Australia and the US evaluating our technology.

Device manufacturers, such as replacement valve manufacturers, could potentially see an increase in suitable recipients for their proven therapies.

We look forward to sharing more news in the weeks ahead as Echo IQ starts to capitalise on these exciting results.”

Ultromics are in the same field received $33M in series B funding in 2021. Spun out of the University of Oxford and built-in partnership with the U.K.'s National Health Service (NHS). They already have partnerships with Mayo Clinic, Janssen, Microsoft Azure and the American society of echocardiography. FDA and CE Mark. Need to read more of the research to see where Echo IQ is going to have enough advantage to catch up in US / Euro market.

Ultromics receives FDA Clearance for its Breakthrough Device EchoGo® Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction.