Key new technology

So what does the company do?

EchoIQ has developed a technology it calls EchoSolv HF, which is software which allows clinicians to identify patients with heart failure using data from echocardiograms.

The company last month said it had struck an agreement with the Mayo Clinic in the US, which paved the way for the technology to be rolled out once it was approved by the US Food and Drug Administration.

As the company said at the time, the agreement with the Mayo Clinic followed a collaboration between the two organisations.

The expanded agreement follows a validation study conducted through the Mayo Clinic Platform validation program. The study met its primary endpoint, with EchoSolv HF demonstrating a sensitivity of 99.5% in identifying patients with heart failure and a specificity of 91.1% in correctly identifying patients without heart failure. These results have not been reviewed or cleared by the FDA and are subject to the FDA's regulatory review process. Following this study, the Company lodged its market clearance application for EchoSolv HF with the FDA via the 510(k) premarket notification pathway. The Company advises that it is currently progressing through the FDA review process and will provide additional updates as developments materialise.

The company said the clearance had the potential to unlock a significant market opportunity, with heart failure a "substantial and growing burden on the US healthcare system''.

Share price upside remains

EchoIQ shares have appreciated substantially over the past year as the company has progressed its technology, improving from a low of 16.5 cents to be trading at a year-high of $1.25 today.

This is close to the Morgans target price of $1.30, but the analyst team at Morgans have flagged there's further significant upside possible following FDA approval.

As they said:

We initiate coverage with a Speculative Buy rating and $1.30 price target with potential upside to $1.68 on approval/reimbursement, underpinned by near‑term FDA clearance, reimbursement progression, and a credible pathway to US commercial scaling. We expect a positive outcome from the EchoSolv HF FDA 510(k), due imminently, which unlocks the large, structurally undiagnosed US cardiac market. Combined with attractive unit economics and clear patient and hospital benefits, we see a high probability of rapid US adoption and monetisation.

Echo IQ was valued at $759.9 million at the close of trade on Thursday.

The post This ASX health tech stock just hit a new record high. Could it go even higher? appeared first on The Motley Fool Australia.

Businesses with smaller market capitalisations could be compelling businesses to look at because they may have longer-term growth potential and the market hasn't priced in their long-term potential.

Fund managers from Wilson Asset Management (WAM) have picked out two businesses from the WAM Active Ltd (ASX: WAA) portfolio that could deliver good returns.

EchoIQ Ltd (ASX: EIQ)

WAM describes Echo IQ as an Australian medical technology company focused on improving decision-making in cardiology by using artificial intelligence (AI) to detect structural heart disease from echocardiograms.

The fund manager noted that the company received US Food and Drug Administration (FDA) approval for severe aortic stenosis, with additional FDA clearance for heart failure detection expected in the near term.

WAM pointed out that the EchoIQ share price rose by 47% in March after an announcement of an expanded resale and distribution agreement with the Mayo Clinic for EchoSolv HF. The fund manager said that the agreement provides "meaningful clinical validation and materially de-risks the FDA pathway".

The investment team expects further FDA clearance for the ASX share in the coming weeks, which would significantly expand EchoIQ's US addressable market and support early revenue generation.

WAM concluded:

We believe additional hospital signings and strategic partnership discussions with multiple Australian and US-based parties remain key near-term catalysts for further share price re-ratings.

Forrestania Resources Ltd (ASX: FRS)

The other ASX share that WAM highlighted from the WAM Active portfolio was Forrestania Resources, a Perth-based mineral exploration company targeting gold, lithium, nickel, and copper deposits, primarily in Western Australia's Eastern Goldfields, Forrestania, and Southern Cross greenstone belts.

WAM noted that the Forrestania Resources share price declined in March amid a 10% decline for the gold price.

The wider mining sector saw weakness during the month amid forced liquidations and broader macroeconomic volatility, including rising Treasury yields and a stronger Australian dollar.

WAM said it still owns this ASX share in its portfolio because it views recent events as "macro-driven dislocations, rather than a deterioration" of its investment thesis.

The fund manager decided to increase its stake in the ASX share during the March sell-off.

WAM's investment team concluded its thoughts on the business with the following:

Forrestania Resources remains a compelling, undiscovered gold opportunity on the ASX, led by David Geraghty, who spent 21 years at Mineral Resources Ltd (ASX: MIN) and played a key role in its success. With minimal institutional coverage and broker sponsorship, we see potential for a share price re-rating as near-term catalysts emerge.

The post 2 undervalued ASX shares to buy that experts think could deliver strong returns appeared first on The Motley Fool Australia.

Four ASX shares that are rising more than most today are listed below. Here's why they are climbing:

BHP Group Ltd (ASX: BHP)

The BHP Group share price is up 3% to $48.56. This follows a rise in copper and iron ore prices overnight after the US postponed military strikes on Iran. It isn't just BHP that is rising on Tuesday. A good number of mining shares are pushing higher, which has driven the S&P/ASX 200 Resources index 2.3% higher at the time of writing.

EchoIQ Ltd (ASX: EIQ)

The EchoIQ share price is up 19% to 73 cents. This morning, this healthcare technology company announced that its EchoSolv HF technology would be deployed via the Mayo Clinic Platform – Solutions Studio Program. This will enable Mayo Hospitals and 80 external partner hospitals to participate. The company's CEO, Dustin Haines, said: "The expansion of our agreement with Mayo Clinic is one of the more strategically important milestones in the Company's history. A more equitable arrangement with one of the most respected hospital systems in the US, as we move closer to FDA clearance and commercial deployment, leaves us well positioned for the months ahead."

Life360 Inc (ASX: 360)

The Life360 share price is up 3% to $19.32. Investors have been buying the family safety technology company's shares following another rise by its Nasdaq listed shares overnight. Despite this, Life360 shares are still down 40% since the start of the year amid broad weakness in the tech sector. Last week, Morgan Stanley put an overweight rating and $30.00 price target on its shares. This implies potential upside of 55% for investors over the next 12 months.

Qantas Airways Ltd (ASX: QAN)

The Qantas Airways share price is up almost 3% to $8.37. This has been driven by a pullback in oil prices overnight amid optimism that the US and Iran could soon commence peace talks. Given that fuel is one of Qantas' largest operating expenses, any relief in oil prices will be good news for future profitability. Last week, Macquarie Group Ltd (ASX: MQG) put an outperform rating and $11.60 price target on Qantas' shares. This suggests that upside of almost 40% is possible from current levels.

The post Why BHP, EchoIQ, Life360, and Qantas shares are racing higher today appeared first on The Motley Fool Australia.

Echo IQ said in a statement to the ASX on Tuesday that its EchoSolv HF technology would be deployed via the Mayo Clinic Platform – Solutions Studio Program, enabling Mayo Hospitals and 80 external partner hospitals to participate.

Regulatory hurdles remain

The EchoSolv software is currently going through the Food & Drug Administration (FDA) clearance process, after the company lodged a market clearance application for the technology in December.

Echo IQ said further re the agreement.

The expanded agreement follows a validation study conducted through the Mayo Clinic Platform validation program. The study met its primary endpoint, with EchoSolv HF demonstrating a sensitivity of 99.5% in identifying patients with heart failure and a specificity of 91.1% in correctly identifying patients without heart failure. These results have not been reviewed or cleared by the FDA and are subject to the FDA's regulatory review process.  

The company said it would keep shareholders advised as to the progress through the FDA clearance process.

The company said:

Clearance has the potential to unlock a significant market opportunity for Echo IQ. Heart failure represents a substantial and growing burden on the US healthcare system, with about 6.7 million Americans currently living with the condition and an estimated 2 million more patients remaining undiagnosed. Upwards of 16 million echocardiograms are performed in the US per annum, with around 8 million studies containing heart failure-relevant findings, representing approximately 50% of all echocardiographic exams.

Confident for the future

Echo IQ Chief Executive Officer Dustin Haines said the Mayo agreement was "one of the more strategically important milestones in the company's History''.

He added:

A more equitable arrangement with one of the most respected hospital systems in the US, as we move closer to FDA clearance and commercial deployment, leaves us well positioned for the months ahead. This milestone reflects the strength of the EchoSolv HF clinical utility and the growing commercial value of the solution, while the revised agreement provides a scalable pathway to market through the Mayo Clinic Platform. This may give us access to Mayo's hospital network and a broader ecosystem of healthcare providers seeking validated AI solutions.

Mr Haines said while the FDA application was still under review, the company remains confident in its submission.

The ASX biotech's shares were 13.8% higher in early trade at 70 cents. The shares have more than doubled in value over the past three months.

The company was valued at $405 million at the close of trade on Monday.

The post Which ASX biotech's shares are rocketing higher on big US news? appeared first on The Motley Fool Australia.

The two names in this article that WAM highlighted were among the top 20 holdings of the WAM Active Ltd (ASX: WAA) portfolio, a listed investment company (LIC) that seeks to identify mispricing opportunities in the Australian market.

Let's look at why the following businesses appealed to WAM.

Forrestania Resources Ltd (ASX: FRS)

The first business WAM mentioned was Forrestania Resources, a Perth-based resource exploration company that's targeting gold, lithium, nickel and copper deposits. It's searching for these resources largely in Western Australia's Eastern Goldfields, Forrestania and Southern Cross greenstone belts.

WAM noted that the company is led by executive chair David Geraghty, who has spent 30 years in the resources sector, including 21 years at Mineral Resources Ltd (ASX: MIN), where he played a key role in its breakout success.

Last month, Forrestania Resources executed a binding purchase agreement with Westgold Resources Ltd (ASX: WGX) to monetise ore stockpiles of up to $38 million in gross revenue, with first funds expected in the third quarter of 2026.

The fund manager said the agreement effectively transitions the ASX small-cap share from a developer to a producer, which is typically a major valuation catalyst.

WAM noted that the Lake Johnston mill project is fully funded and, based on current resources, is expected to support several years of production at a low cost. At the current resource prices, this is expected to generate "significant free cash flow relative to the company's current market capitalisation of over $600 million".

The fund manager also noted that the company is assessing additional tenement opportunities, having flagged interest in the Edna Gold Mine, owned by Ramelius Resources Ltd (ASX: RMS).

EchoIQ Ltd (ASX: EIQ)

The other ASX small-cap share that WAM highlighted was EchoIQ, which the fund manager described as an Australian medical technology company focused on improving decision-making in cardiology. It operates an AI-driven software platform.

Its flagship EchoSolv platform harnesses proprietary AI to scan echocardiogram reports and dramatically improve detection of structural heart disease, starting with severe aortic stenosis (AS) and now expanding into heart failure (HF) and beyond.

In December, Echo IQ formally lodged its US Food and Drug Administration (FDA) submission for EchoSolv HF after a standout clinical validation study with Mayo Clinic, with a decision expected in March or April.

WAM said that clearance would significantly expand the ASX small-cap share's US addressable market, with heart failure as the leading cause of rehospitalisation and accounting for 17% of total US healthcare spending.

The fund manager said that industry sources confirm Echo IQ's technology is market-leading, positioning the company for rapid US penetration.

Strategic partnerships remain a near-term catalyst, according to WAM, with active interest from multiple parties, while there is also potential to improve existing reimbursement rates for severe aortic stenosis.

The post 2 exciting ASX small-cap shares this fund manager thinks are buys appeared first on The Motley Fool Australia.

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.

The post This biotech has lodged a key submission with US regulators appeared first on The Motley Fool Australia.

Shares in the company, which develops AI products to treat cardiovascular disease, closed on Friday trading for 24 cents. Shares entered a trading halt on Monday at the company's request and resumed trading on the ASX today.

In morning trade on Wednesday, shares just leapt to 30 cents, up 25.0%.

At time of writing, shares have given back some of those gains to be swapping hands for 29 cents apiece, up 20.8%.

For some context, the All Ordinaries Index (ASX: XAO) is up by 0.4% at this time.

Here's what sending the ASX biotech soaring today.

ASX biotech stock lifts off on FDA green light

The Echo IQ share price is surging after the company announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-enabled solution EchoSolv AS.

EchoSolv AS is designed to automatically highlight patients with significant risk of Aortic Stenosis, a form of heart valve disease.

Investors are bidding up the ASX biotech stock as EchoSolv AS can now be marketed to and used by healthcare professionals in the US as a decision support aid to detect severe Aortic Stenosis.

EIQ said it is already in advanced discussions with a range of US healthcare providers around the potential uptake of EchoSolv AS as the company said it will now turn its attention to commercialising its products in the world's top economy.

Following EIQ's recent capital raise, management said the company is well funded to advance multiple near-term commercialisation opportunities.

Commenting on the FDA clearance sending the ASX biotech stock soaring today, EIQ executive chair Andrew Grover said, "FDA clearance is major milestone for Echo IQ and provides the foundation to deliver a material value uplift for our shareholders."

Grover continued:

The company now has the ability to commercialise its technology in the world's largest and most well-regulated market, for a condition which is widespread and chronically underdiagnosed. EchoSolv AS shows significant improvements in the detection of severe Aortic Stenosis when compared to current clinical practice….

FDA clearance also provides another catalyst to secure reimbursement codes, which have the potential to provide Echo IQ with a fee on a per use basis from large insurance groups. This is anticipated to underpin future revenues in the US market.

New US-based CEO

In a separate release, the ASX biotech stock reported on the appointment of a new CEO.

Dustin Haines will take the helm on 10 January. He will be based in the US to lead the company's growth strategy, starting with commercialisation in the US market.

Haines has a 25-year career in the biotechnology and pharmaceutical sectors. Most recently he served as vice president of Gilead Sciences, Asia, Middle East, Turkey and Russia.

Commenting on the new CEO appointment, Grover said, "To have secured someone of Dustin's calibre to execute our stated commercialisation strategy highlights the considerable potential of the company's technology in the US market."

With today's intraday gains factored in, shares in the ASX biotech stock are up 71% in 2024.

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