@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

Investor presentation webinar gives some possible revenue and answers some of the questions regarding progress.

Anticipated reimbursement for Aortic Stenosis is US$68 of which EIQ gets 25% at ~90+% margin. US $8.5M ARR @10% market share (conservative 5M number of Echocardiograms only Medicare, total could be closer to 35M). In contrast the same market share for Heart Failure is $264 @25% or $42M as the penalties for hospitals are much higher if the patient returns to hospital following missed diagnosis or insufficient treatment.

Reimbursement allows EIQ to clip the ticket rather than charging the medical centre.

$4M cash burn in last 12 months. Stated that HF approval not needed to be a successful company. AS treatment in UK only @10% so large market expansion potential for device/ drug treatment.

HF FDA approval expected in the next 12 months. Reimbursement should follow shortly after.

Licensing discussions ongoing with device manufacturers, pharmaceutical firms and hardware producers. Expected to peak post approval and reimbursement.

Accepted that initial push on missed diagnoses had not been well received and so now focusing more on improved workflow and practitioner assist. Although the algorithm is black box they are trying to show how the numerical data generated leads to the decision to provide greater transparency.

Claiming competitors AI solutions were about improving the image rather than aiding the decision but pretty vague.

Suggesting that once a partner top US hospital is using the product, liability concern issues will drive wider adoption.

Following the study results announcement EIQ went into a trading halt for a CR. Despite earlier statements about options providing sufficient funding I had taken a small $1K position in RL assuming that a raise was coming and hoping to take part. However $7.1M was raised only from institutional investors @15c. "Several new institutional investors introduced to the register."

$4.65M for commercialisation, $1M for product development, $0.45M for FDA and trial costs and $1M for working capital.

47.4M new shares issued a dilution of 9% @5.4% to 5day VWAP so at least not heavily discounted. SP currently @16.7 so in the money.

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.

EIQ FDA submission 2024.pdf

90 days till the results of the FDA submission approximately. Will be waiting patiently for this one!

Nessy

held

EIQ letter.pdf

So the former CEO did buy before a market sensitive announcement about completion of the US Reader Study, but he had no knowledge of the upcoming announcement. It was his cultural fit that the company wasnt happy with. Does one say the appointment was not well researched enough or he was a very good actor and his real personality wasnt evident until he was a few months in to the job. Hopefully the latter and the board made a good swift decision before too much harm was done. Time will tell.

Nessy

held

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

SP had dropped significantly and I have topped up in SM @ 10c. This announcement gives a bit clearer timeline to FDA approval leading to a 25% jump. Good to see CEO buying on market.

EIQ announces that it has completed its US Reader Study. The results from the Reader Study are now undergoing final statistical analysis and are expected to form part of the Company’s FDA 510(k) application, which will be submitted in April 2024. The FDA currently publicises its timeframe for decision response as being 90 days from lodgement of final application. Echo IQ Chief Executive Officer Kimber Rothwell said: “Completion of our US Reader Study is a key step towards securing final FDA clearance for our cardiology decision-support technology and is an important milestone in Echo IQ’s commercial development.” The Company also advises that its Chief Executive Officer, Kimber Rothwell has purchased 500,000 Echo IQ (ASX:EIQ) shares on-market.

Some developments here. First cash flows coming in from sales - extremely small, but a starting point. With R&D refund they only have 2 quarters before they will probably need to do a capital raise. There is a new product aiming at determining heart failure earlier and more readily. FDA approval papers to be submitted very soon (hopefully). My main interest lies in how big the potential market is and the reimbursement possible in the US. This is an educated "bet" on where this may go and I will follow the hopefully increasing cash flows with interest.

EIQ quarterly Q2 2024.pdf

EIQ quarterly cash flow Q2 2024.pdf

Nessy

disc: held in SM and RL

Looks to be a well credentialed appointment to help direct a promising product to market.

EIQ CEO appt.pdf

Nessy

Disc: held IRL & SM

No revenue for this quarter and a cash burn of $1.7M. Next quarter has $500K options already exercised (remainder CY24, 145M outstanding ranging from 4c to 30c) and $650K R+D rebate. Should see some small revenue start next quarter but with $3.3M cash a raise is looking probable. Significant revenue likely following FDA approval early CY24. IP protection noted in quarterly report as a priority.

Pathway to FDA on-track, with reader study underway and final clearance anticipated Q4CY2023 /Q1CY2024

Echo IQ and EchoSolv(TM) will also be featured by Hydrix Medical at the Cardiac Society of Australia and New Zealand Conferenced in Auckland, New Zealand in August 2023. Echo IQ's Chief Medical Advisor will also be speaking at this important regional conference.

Increased operating expenses, reflecting an emphasis on sales and marketing activities, are starting to yield positive commercial impact, as reflected by the new partnerships and contracts announced . The Echo IQ Board of Directors was enhanced with the appointment of Simon Tolhurst, an experienced lawyer with expertise in competition law and mergers and acquisitions.

Commissioned broker report with a valuation of $0.59 gives a good detailed overview of the company and investment thesis.

Based on our modelling of revenues and expenses, we see EIQ achieving breakeven at the EBITDA line in FY25.

Financing EIQ’s first product EchoSolv™ was launched in December 2022. Growing the business in the near term is dependent on cash from revenue which is currently generated solely by EchoSolv™. As such, and until the product is generating sufficient income, the company will be reliant on access to external funding. 

Intellectual property EIQ is using a broad single patent approach across all conditions related to structural heart disease to protect its intellectual property. Its Australian provisional patent application (2022901868) is called ‘Systems and Methods for AI-assisted Echocardiography’. Intellectual property risk, notwithstanding the granting of the patent, could be offset by gaining a first-mover advantage, which – given the multifaceted commercialisation activity to date and lack of direct competition in imaging – seems within reach.

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.