And investors reacted by hitting the sell button.

While the All Ordinaries Index (ASX: XAO) is up 0.2% at the time of writing, both All Ords shares are in the red.

Here's what's happening.

ASX All Ords share crashes on CEO exit

Shares in medical device manufacturer Impedimed Ltd (ASX: IPD) are taking a beating today, down 11.1% to 12 cents apiece.

This comes after the medical device manufacturer announced the exit of both its CEO and CFO.

Saying that the changes were "needed to deliver robust execution and control costs", the board of the ASX All Ords share said that Rick Valencia will step down from his role as managing director and CEO, effective immediately.

Parmjot Bains will take up Valencia's leadership position in an interim capacity, likely on 8 January 2024.

In another major shakeup, Tim Cruickshank has stepped down as CFO and is currently discussing transition arrangements. Impedimed chair, McGregor Grant, will take over as CFO in an interim capacity and will be an executive chairman.

Which brings us to the second All Ords share shaking up its top-level management.

Changes afoot at Stockland

This morning, diversified property developer Stockland Corp Ltd (ASX: SGP) also announced changes to its leadership team.

Though investors look to be taking these changes in stride, with the All Ords share down a more modest 0.3% at the time of writing.

Stockland reported that Louise Mason, CEO commercial property, will be stepping down from her role in late December. Mason will stay on for the next month to help facilitate a smooth transition.

Tarun Gupta, Stockland CEO said, "Louise has made a significant contribution to Stockland over the last six years."

He added, "She has led the repositioning of the retail and workplace portfolios and the substantial growth of the logistics portfolio."

Other management changes at the All Ords share will see Andrew Whitson, CEO communities, take on the role of chief executive, development, with end-to-end responsibility for development and delivery across all asset classes.

And Kylie O'Connor will join Stockland on 27 November in the new role of CEO, investment management.

The post 2 ASX All Ords shares tumbling following leadership shakeups appeared first on The Motley Fool Australia.

The S&P/ASX 200 Health Care Index (ASX: XHJ) is down 8% over the past year.

By comparison, the market benchmark S&P/ASX 200 Index (ASX: XJO) is up 3.2%.

But as always, there are outliers.

Here are three ASX healthcare stocks going their own way and booking astounding share price growth.

Neuren Pharmaceuticals Ltd (ASX: NEU)

The Neuren Pharmaceuticals share price has leapt 130% over the past 12 months to $12.86 at the time of writing.

The key driver has been the approval of Daybue by the United States Food and Drug Administration (FDA).

Daybue is the first and only approved treatment for Rett syndrome.

The illness is a rare neurodevelopmental disorder affecting 6,000 to 9,000 people in the US.

The ASX healthcare stock rose 1.4% yesterday after the company released its FY23 half-year report.

The company revealed a total income of $64.4 million, with Daybue accounting for $62.9 million of that.

Neuren reported a net profit after tax (NPAT) of $47.8 million.

Impedimed Limited (ASX: IPD)

The Impedimed share price has risen 157% over the past 12 months to 17 cents at the time of writing.

The company makes medical devices to assess and monitor lymphoedema and heart failure. It also offers a cloud-based digital platform called SOZO to manage patient data.

Everything changed for the ASX healthcare stock on 27 March when the company announced the inclusion of bioimpedance spectroscopy (BIS) for the first time in United States medical guidelines.

The National Comprehensive Cancer Network (NCCN) released a new version of the NCCN Clinical Practice Guidelines in Oncology for Survivorship on 24 March.

NCCN Guidelines are the globally recognised standard for clinical direction and policy in cancer care.

The new version names bioimpedance spectroscopy as an objective measurement tool to identify early signs of lymphoedema.

The news sent the biotech share into the stratosphere, up 117% in one day of trading in what the CEO described as "a major validating moment".

The ASX healthcare stock has continued rising amid further milestones, including the first medical policy from a top-five national payor in the United States covering bioimpedance spectroscopy last month.

AVITA Medical Inc (ASX: AVH)

The Avita share price has rocketed 166% over the past 12 months to $5.00 at the time of writing.

The company makes treatments for severe skin burns. It is known worldwide for its revolutionary flagship product — a spray-on skin technique called Recell.

The ASX healthcare stock has been rising reasonably steadily over the past 12 months.

Among the milestones was the 8 June announcement that the FDA had approved its premarket approval (PMA) supplement for the use of Recell to treat full-thickness skin defects beyond burns.

The Avita share price soared 11% on the news. Management said the approval dramatically expanded the company's market opportunity by at least five times.

The approval means Recell will have an expanded indication and can be used for other medical problems.

These include wound injuries, surgical excisions as a result of issues like necrotising soft tissue infections, and skin resections caused by the removal of skin cancer, among other things.

Recell was first approved in the US for the treatment of severe burns in 2018.

The post 3 ASX healthcare stocks that have more than doubled in a year appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

Brainchip Holdings Ltd (ASX: BRN)

The Brainchip share price is down 2.5% to 38 cents. This appears to be profit-taking after a decent gain on Wednesday in response to a patent announcement. In addition, with the struggling semiconductor company due to release its next quarterly update in the near future, some investors may be concerned that it will be yet another dud quarter.

Impedimed Limited (ASX: IPD)

The Impedimed share price is down almost 9% to 21 cents. This may also be due to profit-taking after a strong gain by the medical device company's shares during yesterday's session. Impedimed shares jumped after it announced the first medical policy from a top-five national payor in the US covering bioimpedance spectroscopy.

Northern Star Resources Ltd (ASX: NST)

The Northern Star share price is down a further 6% to $11.79. Investors have been selling this gold miner's shares since the release of its quarterly update on Wednesday. In response to the update, analysts at UBS have downgraded Northern Star's shares to a sell rating with an $11.70 price target. UBS wasn't impressed with its guidance for FY 2024.

Telix Pharmaceuticals Ltd (ASX: TLX)

The Telix share price is down 13.5% to $10.52. This is despite the radiopharmaceutical company delivering strong top-line growth in the second quarter. Bell Potter was pleased with the company's performance but felt underwhelmed with the details provided. It said: "Today's update was relatively benign on commercial conditions (pricing, volume and mkt share)."

The post Why Brainchip, Impedimed, Northern Star, and Telix shares are falling today appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

Dusk Group Ltd (ASX: DSK)

The Dusk share price is down 16% to $1.27. Investors have been hitting the sell button after this specialist retailer released a disappointing trading update. Dusk revealed that it expects FY 2023 sales of $135 million to $137 million and EBIT of $16 million to $17 million. This compares to FY 2022's figures of $138.4 million and $26.5 million.

Impedimed Limited (ASX: IPD)

The Impedimed share price is down almost 12% to 13.7 cents. This has been driven by the announcement of a $20 million institutional placement. Impedimed intends to raise the funds at a 16.1% discount of 13 cents per share. Proceeds will be used to accelerate its Private Payor opportunity.

Nufarm Ltd (ASX: NUF)

The Nufarm share price is down 4.5% to $5.78. This may have been driven by profit taking after a strong gain yesterday following the release of its half-year results. In addition, Morgans gave its results a lukewarm reaction. It retained its hold rating with a lowered price target of $6.64.

Weebit Nano Ltd (ASX: WBT)

The Weebit Nano share price is down a further 2.5% to $5.59. Investors have been selling this meme stock this month amid rising short interest and its sky-high valuation on zero revenue. The Weebit Nano share price is now down by over a quarter since this time last week.

The post Why Dusk, Impedimed, Nufarm, and Weebit Nano shares are falling appeared first on The Motley Fool Australia.

In afternoon trade, the ASX biotech share is up 86% to 11 cents.

Why is this ASX biotech share rocketing higher?

Investors have been buying this ASX biotech share after it advised that the National Comprehensive Cancer Network (NCCN) has released a new version of the NCCN Clinical Practice Guidelines in Oncology for Survivorship.

According to the release, for the first time, these guidelines include bioimpedance spectroscopy (BIS).

Key points include:

• The NCCN Guidelines specifically name bioimpedance spectroscopy as an objective measurement tool to identify early signs of lymphoedema.
• The NCCN Guidelines now recommend regular screening for all cancer survivors at risk of lymphoedema.
• The recommendations made by the NCCN Survivorship Panel were Category 2A, which means that there was uniform NCCN consensus for this new recommendation.
• The inclusion of BIS in the NCCN Guidelines will help establish BIS as standard of care and accelerate adoption by Private Payors and Providers.

The release highlights that NCCN Guidelines are the globally recognised standard for clinical direction and policy in cancer care, with the goal of improving patient care and outcomes.

Why is this good news for ImpediMed?

This is good news for ImpediMed as it has the only FDA-cleared BIS technology for the assessment of lymphoedema.

The company's SOZO Digital Health Platform is broadly accepted and recognised for effective and accurate screening of lymphoedema.

The ASX biotech share's Managing Director & CEO, Richard Valencia, commented:

The recommendation in the NCCN Guidelines for the use of bioimpedance spectroscopy technology is a major validating moment for the Company. The authors of the NCCN Guidelines are world leaders in global cancer care driven by sound clinical evidence and patients' best interests. Their recommendations are highly influential for clinicians, patients, policymakers, and insurance companies.

We will take the information in these updated NCCN Guidelines and immediately integrate it into our reimbursement strategy to expand coverage of SOZO testing for lymphoedema. Our near-term focus remains leveraging our strong clinical evidence, market position, and now these guidelines to drive growth and adoption of our solution for breast cancer-related lymphoedema. Longer-term, these guidelines also support an opportunity to expand into other cancer types, broaden our footprint in oncology, and benefit even more patients.

The post Guess which ASX biotech share just rocketed 86% on 'a major validating moment' appeared first on The Motley Fool Australia.

Helia Group is the standout of these ASX All Ords shares after the company announced a big lift in earnings per share (EPS) and a sizeable combined interim and special dividend of 41 cents per share.

Let's take a look.

Helia Group Ltd (ASX: HLI)

Helia shareholders are throwing a party today after the company declared a combined 41-cent interim and special dividend and a 53% increase in undiluted earnings per share (EPS).

The ASX All Ords share is soaring today, up 16.25% to $3.255 apiece at the time of writing.

The mortgage insurance provider released its 2022 annual report today. It revealed a statutory net profit after tax (NPAT) of $186.8 million, down 3.1% on the prior corresponding period (pcp), and an underlying NPAT of $288.4 million, up 21.3% pcp. Statutory NPAT was materially lower as a result of pre-tax unrealised mark-to-market investment losses of $140.3 million due to rising bond rates.

The separation from Genworth Financial Inc (NYSE: GNW) was completed on time and under budget in H2 FY22. The company noted that it retained all its customers in the changeover process.

Both the interim and special dividends will be fully franked and payable on 24 March.

Impedimed Limited (ASX: IPD)

This ASX All Ords share fell to an intraday low of 5.6 cents, down 3.45%, before rebounding to be flat for the day at 5.8 cents at the time of writing.

In its half-year results, the medical devices company announced a 10% increase in revenue to $5,655,000 and a net loss attributable to members of $10,815,000 — up 21% pcp.

Impedimed said the oncology division would be its primary focus for 2H FY23. The company noted a need to look at private payer reimbursement, expanding the sales platform in advance of reimbursement, and completing the SOZO II hardware development and submitting it for US Food and Drug Administration (FDA) clearance.

Weebit Nano Ltd (ASX: WBT)

This ASX All Ords share is up 5.24% to $6.935 at the time of writing.

The semiconductor technology company also released its half-year results today. It reported no revenue and a $22,276,150 loss due to research and development costs. This is up 3.5% pcp.

The company said it had "achieved several key technical and commercial milestones" during the half.

Weebit expects to achieve its first revenue later in 2023. The company says it is "well positioned to productise its ReRAM technology".

The post 3 ASX All Ords shares making moves today following earnings, one up 16% appeared first on The Motley Fool Australia.

Not even the release of earnings reports could stir up excitement for many ASX shares. In fact, in some cases, it had the opposite effect. For some companies, the results weren't sufficiently up to scratch to prevent shareholders from hitting the 'sell' button.

Here are three ASX All Ords shares that fell into the negative following their FY22 results today.

These ASX All Ords shares failed to impress

Impedimed Limited (ASX: IPD)

The market shaved 4.2% off the Impedimed share price on Monday to finish at 6.8 cents per share. It seems a 26% increase in revenue to $10.6 million in FY22 wasn't enough to satisfy shareholders. The medical device company derived $9.9 million of its total revenue from its SOZO platform.

Notably, Impedimed now has involvement with 16 of the top 25 integrated delivery networks. However, the focus might have been on the company's continuing cash burn.

In FY22, Impediment chewed through $15.7 million operationally. Although, $42.5 million was added to the balance sheet through the issuing of new shares.

Objective Corporation Limited (ASX: OCL)

Another ASX All Ords share to suffer at the hands of the market today was Objective Corporation. The software company revealed a solid result for the 12-month period, posting gains across all key financial metrics. Yet, the Objective share price was sold down 4.24% to $15.80 apiece.

The company put up a respectable 12% increase in revenue, reaching $106.5 million in FY22. Meanwhile, net profit after tax (NPAT) grew at an even faster pace, up 31% to $21 million. In addition, dividends lifted 22% to 11 cents per share.

Race Oncology Ltd (ASX: RAC)

Finally, Race Oncology makes up the red trifecta of ASX All Ords shares in this list. The $335 million oncology treatment developer failed to attract buyers on Monday despite remarkable top-line growth.

According to its results, Race notched up revenue by a staggering 186% compared to the prior year. In turn, the company generated $53.9 million of revenue from ordinary activities. However, this was paired with widening losses on the bottom line. Total losses expanded to $11.2 million for the 12-month period compared to $6.3 million in FY21.

The Race Oncology share price finished at $2.03, down 2.9% for the day.

The post 3 ASX All Ords shares tumbling lower following full-year results appeared first on The Motley Fool Australia.

At the time of writing, Impedimed shares are swapping hands for 16.5 cents, down 2.94%.

Impedimed completes placement

One catalyst for today's fall in the Impedimed share price could be investor concerns over an impending share dilution.

According to its release, Impedimed announced it has received firm commitments for its institutional placement to raise $35 million before costs. The company highlighted that it had strong support from existing and new institutional and sophisticated investors.

The offer will see approximately 229.5 million new ordinary shares issued at a price of 15.25 cents apiece. This represents a 10.3% discount to the last closing price of 17 cents on 22 October (before going into a trading halt).

Impedimed will use the proceeds to support an array of strategic initiatives to address growth. In particular, it will allocate the fund to:

• Product enhancement of the SOZO II digital health platform, including weight scales and improved electronics for renal and heart failure
• Data and software enhancements including corporate account development such as electronic health record integration and heart failure programs
• Development and commercialisation of renal failure application, including end stage renal disease clinical trial and US FDA clearance
• General working capital to achieve breakeven, including advance inventory purchases to assist in the transition to SOZO II

In addition, Impedimed will launch a non-underwritten share purchase plan (SPP) of $5 million which it will offer to eligible investors. The terms will be the same as the institutional placement.

The SPP closes on 11 November, with the issuance of the new shares set for 18 November.

Management commentary

Impedimed managing director and CEO, Richard Carreon, said:

We are very encouraged by the level of support investors have shown as we look to capitalise on the significant opportunity with the recently released PREVENT Trial results. Following the completion of the capital raising, we are now in a fully funded position to accelerate sales in Oncology, while still investing in our other key focus areas of Renal Failure and Heart Failure.

About the Impedimed share price

Despite today's falls, Impedimed shares have gained around 90% in the past 12 months. However, the company's share price is around 15% off its 52-week high of 19 cents reached on 19 October.

Based on valuation grounds, Impedimed presides a market capitalisation of around $247 million, with almost 1.5 billion shares outstanding.

The post Impedimed (ASX:IPD) share price dips following capital raising update appeared first on The Motley Fool Australia.

Impedimed's shares were halted from trade yesterday while the company undergoes a capital raise.

If the company doesn't announce the results of the capital raise today, its shares are expected to be defrosted tomorrow.

The Impedimed share price is currently frozen at Friday's closing price of 17 cents.

 Let's take a closer look at what the medical software company's been up to lately.

Why is the Impedimed share price frozen?

Right now, the Impedimed share price is undergoing its second trading halt in as many weeks.

The company released its shares from the freezer last Tuesday when it announced the results of a successful trial.

The results were from Imedimed's PIVIOT clinical trial. They showed the company's L-Dex technology could help lower the rate of progression of chronic disease in patients with early detection of cancer-related lymphoedema.

Impressively, the Impedimed share price surged 20% on the trial's results.

So far, the company hasn't stated how it's planning to spend its current capital raising.

However, as of 30 June 2021, Impedimed had around $19.7 million of cash in its wallet and no debt.

Additionally, the last time Impedimed underwent a capital raise was more than 18 months ago.

Then, the company raised around $18.2 million through an entitlement offer. Yet, that was short of its $24.9 million goal.

The raised capital was to fund the commercialisation and reimbursement of the company's lymphoedema application in the United States, the commercialisation of its heart failure application, and the development and commercialisation of a renal failure application.

It would also fund data and software enhancements, clinical trials, and provide general working capital.

The entitlement offer saw institutional investors able to buy 13 new Impedimed shares for every 10 shares already held for 3.75 cents apiece. Participants also got 1 free option for every new share purchased.

The institutional entitlement offer raised around $10 million and saw 266.2 million new shares and an equal amount of new options handed to investors.

The retail component of the entitlement offer boasted the same ratios. It raised around $8.2 million, selling 218.6 million new shares and giving away the same number of new options.  

The post What's going on with the Impedimed (ASX:IPD) share price? appeared first on The Motley Fool Australia.

Impedimed shares are again on the move after coming out of a trading halt that was requested before the start of trade today.

Here's what we know.

What was announced?

The company announced positive readouts from its recently completed PREVENT pivotal trial involving cancer-related lymphoedema patients across the US and Australia.

It's the end of a 6-year journey for the PREVENT trial which has been examining the effectiveness of Impedimed's L-Dex technology in reducing the onset of chronic lymphoedema.

The aim of the study was to determine if early intervention in patients with lymphoedema using "bioimpedance spectroscopy (BIS)" resulted in a lower rate of disease progression. It was compared to using a tape measure to detect the presence of excess fluid.

The study findings indicate that in patients with early detection using L-Dex, the protocol "resulted in a lower rate of progression to chronic disease than patients with early detection from volume measures using a tape measure".

This, it claims, is a result that is statistically significant. The study collected data from 1,200 patients followed for up to three years across 13 hospitals in both countries.

The results showed that in patients using L-Dex with early detection lymphoedema, the intervention resulted in a 7.9% rate of chronic lymphoedema compared to 19.2% in the tape measure group.

This represents an absolute reduction of 11.3% and a relative reduction of 59%.

In addition to these findings, "92% of patients with early detection cancer-related lymphoedema using L-Dex and intervention did not progress [to the chronic stages]".

What did Impedimed conclude from its results?

The company surmised that its methodology "should be a standard approach for prospective breast cancer-related lymphoedema (BCRL) surveillance".

It also states its process is more specific in detecting lymphoedema than a tape measure "as it had fewer triggers and longer times to intervention trigger", based on the data.

In conclusion, the company said that when compared to a tape measure, the BIS screening method results in a more precise identification of patients more likely to benefit from early compression intervention.

For reference, lymphoedema is often managed using compression garments to mobilise the excess extracellular fluid.

Speaking on the announcement, Impedimed CEO Richard Carreon said the results were "significant not just for Impedimed, but for cancer patients at risk of lymphoedema".

Touching more on the results, Carreon added:

This study is consistent with the previous studies showing regular monitoring with L-Dex and simple intervention substantially reduce the risk of developing cancer-related lymphoedema. What differentiates this study is, for the first time, we have a level I randomised controlled trial of sufficient size and duration to result in a statistically significant difference between the outcomes using L-Dex and Tape Measure.

The Impedimed share price has rallied 22% in the past week, extending its gains in the last month to over 50%.

The post The Impedimed (ASX:IPD) share price is up 10% on trial success appeared first on The Motley Fool Australia.

At the time of writing, Impedimed shares are up 9.52% to 11.5 cents.

What did Impedimed announce?

According to the release, Impedimed advised it has established its SOZO Heart Failure Program at Advocate Health Care's Heart Institute located in Chicago Illinois.

The program will be guided by Dr Ali Valika, MD, a specialist certified in Advanced Heart Failure and Transplant Cardiology.

Advocate Aurora Health comprises 26 hospitals and over 500 sites of patient care. The building in Illinois represents one of two premier, not-for-profit health systems in the United States. It's worth noting that 350 specialists perform more than 20,000 heart procedures each year, mostly in Illinois.

Dr Ali Valika aims to optimise fluid levels in heart failure patients both in clinic and after discharge.

ImpediMed stated that it was able to use its existing footprint within the Advocate Aurora Health system to move forward with the new program. The Advocate Aurora Health system currently has 10 SOZO devices under a Lymphoedema Prevention Program.

Impedimed managing director and CEO, Richard Carreon commented:

After the significant COVID-19 delays it is fantastic to initiate the SOZO heart failure program at such a highly respected/credentialed medical institution. We are looking forward to working with Dr. Valika and his team in advancing the use of SOZO and improving outcomes in the heart failure patients.

We are expecting other hospitals to initiate SOZO heart failure programs shortly, adding to the clinical and reimbursement evidence required to underpin widespread commercialisation.

Impedimed share price summary

Over the past 12 months, Impedimed shares have pushed almost 90% higher. However, year-to-date, its shares have fallen close to 10% for the 9 months.

Based on today's price, Impedimed commands a market capitalisation of roughly $171.9 million, with approximately 1.5 billion shares on issue.

The post Why the Impedimed (ASX:IPD) share price is rocketing 9% today appeared first on The Motley Fool Australia.

At the time of writing, shares in the healthcare company are trading for 13 cents each – up 4%. For context, the ASX All Ordinaries Index (ASX: XAO) is 0.25% higher.

Let's take a closer look at today's announcement.

Impedimed share price lifts with reduction in losses

• Revenue of $8.4 million – up 46.5% on the prior corresponding period (pcp). This includes a 64% growth in revenue from its SOZO software, which totalled $7.6 million.
• Loss from ordinary activities of $20.7 million, which is down 3% on the pcp.
• Net operating cash outflows for the period of $13.3 million. This is down from the $19.2 million outflow in the pcp.
• Nil dividend paid for the year, which is the same as FY20.

What happened in FY21 for Impedimed?

The Impedimed share price rocketed 13% in November when AstraZeneca plc (LSE: AZN) announced it was using SOZO for phase II clinical trials. The product was used for measuring fluid volumes in patients with chronic kidney disease.

Besides SOZO, Impedimed also announced news in relation to its 'Prevent' treatment and 'HF-Dex' system.

What did management say?

Impedimed CEO and Managing Director, Richard Carreon, said

Our transition to a connected digital health platform put the Company in a strong position to thrive during a very turbulent year. We have built a strong and resilient business, with quarter-over-quarter record results. Throughout the past year, our Company continued to prove its resilience, as we signed SOZO contracts in excess of $12.0 million, had a churn rate of just 1%, and a contract renewal rate of 100% throughout the entire financial year.

What's next for Impedimed?

Just in the last 2 days, Impedimed released 2 statements that were material to the Impedimed share price.

The first relates to designation of a product in the US and the second on an R&D tax rebate.

On the first matter, SOZO received "Breakthrough Device Designation" from the US Food and Drug Administration (FDA) for use in renal patients. The product will be used to measure fluids in patients undergoing dialysis. The company says the designation is the "perfect forum" to ultimately get FDA clearance.

On the second, the company received a $1.8 million research and development (R&D) from the Australian government. Last year the company received a $2.6 million refund.

Impedimed share price snapshot

Over the past 12 months, the Impedimed share price has increased 62.5%. Year-to-date, however, it is only up 8.33%. This is below the All Ords Index. Impedimed has a market capitalisation of about $187 million.

The post Impedimed (ASX:IPD) share price rises with 46% lift in revenues appeared first on The Motley Fool Australia.

The Impedimed share price has been seesawing between the opening price of 12 cents and its current price of 12.5 cents per share, up 4.1%.

Founded and headquartered in Brisbane with US and European operations, Impedimed is a medical technology company that uses bioimpedance spectroscopy (BIS) technology, specifically its SOZO test, to help predict potential heart failure and prevent edemas and hospital readmission.

Impedimed is marketing its SOZO technology to US hospitals as a way of diagnosing the potential risk of future fluid overload in heart failure patients before they're released.

What did Impedimed announce?

Impedimed advised today The American College of Cardiology (ACC) journal reported finding there was a strong clinical correlation between a heart failure patient's HF-Dex level exceeding 51% at the time of release from hospital, and subsequent hospital readmission.

Impedimed's SOZO technology tests the HF-Dex level (extracellular fluid to body water ratio) of a patient and the company believes this finding will eventually help promote the use of its SOZO tests in hospitals across the world. This is especially the case in the US, where hospitals must cover the cost of patient readmission if it occurs within the first 30 days of their release.

The conclusion from the abstract states that HF-Dex measurements near the time of hospital discharge may help identify individuals at higher risk for readmission and may benefit from closer follow-up to reduce the likelihood of readmission.

ACC journal author Annie Burns expanded on the risk of fluid overload in heart failure patients.

After a heart failure related hospital stay, patients may experience improvement in symptoms even though fluid overload persists. This analysis shows that SOZO with HF-Dex has the potential to identify patients with fluid overload, who are at higher risk of readmission at the time of hospital discharge and would benefit from closer follow-up.

Impedimed called this "a significant finding, as the cost of hospital readmissions is enormous, costing the US healthcare system an estimated $31 billion annually".

More background on SOZO technology

SOZO is used in around 700 locations globally, as a point-of-care assessment tool to guide clinical decision-making and "maximise patient health".

Using ImpediMed's bioimpedance spectroscopy (BIS) technology, SOZO measures and tracks information about the human body to aid clinicians. According to the company, results from the 30-second test are available immediately on the device and online.

Impedimed share price snapshot

The Impedimed share price is up more than 200% over the past 12 months but has declined by nearly four cents since 2021 began.

The post Impedimed (ASX:IPD) share price bounces on 'significant' hospital finding appeared first on The Motley Fool Australia.

The positive price movement came as the medical technology company announced it received Food and Drug Administration (FDA) clearance for a new heart monitoring device in the United States.

At the time of writing, shares in the company are up 8.7%, trading at 12.5 cents. By comparison, the S&P/ASX All Ordinaries Index (ASX: XAO) is 0.08% higher.

Let's take a closer look at today's news and what it means for the Impedimed share price.

Impedimed's new product

In a statement to the ASX, Impedimed advised it has received FDA 510(k) clearance for its SOZO device to include a heart failure index (HF-Dex) as a monitoring tool for patients living with heart failure.

The 510(k) clearance is a requirement for launching new medical products in the US.

Impedimed says the HF-Dex can measure fluid levels in people using a 30-second, non-invasive test. According to the company, the product presents the data in graphical format for a quick assessment and is most useful in conjunction with other clinical data.

In addition, the Impedimed said the product "has been demonstrated in peer-reviewed publications and abstracts accepted at internationally renowned cardiology conferences", such as the American College of Cardiology and the Heart Failure Society of America.

What did management say?

Commenting on the news, Impedimed CEO Richard Carreonsaid said:

We are very pleased with this expanded clearance for SOZO that includes our heart failure index. This is a major step forward in SOZO becoming the standard of care for the management of heart failure patients.

The use of HF- Dex will provide clinicians unparalleled insights into the extracellular fluid accumulation in heart failure patients that has not otherwise been readily available to them before.

Impedimed share price snapshot

Over the past 12 months, the Impedimed share price has increased 212%, although it's up just 4% year-to-date. Today's news regains the ground lost yesterday when the company's shares fell 11.5%.

Impedimed has a market capitalisation of $171.5 million.

The post The Impedimed (ASX:IPD) share price rocketed 13% today. Here's why appeared first on The Motley Fool Australia.

This came after the ASX medical technology company reported a significant uptick in the number of tests conducted with one of its leading medical devices.

What testing results did Impedimed report?

The Impedimed share price is surging after the company reported its customers had conducted more than 28,000 patient tests with its SOZO device in the second quarter of the 2021 financial year (Q2 FY21). That brings the total number of patient tests since SOZO's commercial launch in October 2017 to more than 200,000.

The company noted that the pace of testing is picking up speed, with 100,000 tests in the past 13 months compared to the 100,000 tests in the first 32 months. It forecasts the SOZO testing rate will continue to increase.

SOZO is an FDA cleared "non-invasive bioimpedance spectroscopy (BIS) device". According to the company, the device provides a "precise snapshot of fluid status and tissue composition in less than 30 seconds". Those results can then be posted directly online, enabling the information to be shared amongst medical professionals.

Management notes

Commenting on the testing numbers, Impedimed CEO Richard Carreon said:

This is a significant milestone for our company, but more importantly for the patients whose lives have been dramatically impacted by the reduction in lymphoedema rates from SOZO testing.

For the company, we are building a large dataset which will be very valuable in providing new insights into the course and care of a large number of chronic disease states.

Carreon added that COVID-19 had seen testing numbers fall in US cancer centres as the pandemic spread in late December and into January. With testing numbers having since improved, he expects testing numbers to pick up in March and that this trend "importantly, points to a strong recovery in patient testing heading into the fourth quarter".

Impedimed share price snapshot

Over the past full year, the Impedimed shares have gained 44%. That compares to a 10% gain on the All Ordinaries Index (ASX: XAO).

The post Why the Impedimed (ASX:IPD) share price shot higher this morning appeared first on The Motley Fool Australia.

At the closing bell yesterday, the Impedimed share price finished the day flat at 13 cents.

What did Impedimed announce?

It will be interesting to see which way the Impedimed share price moves today following the latest news.

According to the release, Impedimed advised that all Prevent trial patients have completed their follow-up visits. All 10 participating sites are now closed and the data gathered from the trial is currently being compiled. The company highlighted that study investigators have commenced their work on a manuscript. The paper is due to be submitted for initial journal review before the end of next month.

The Prevent trial is an international study of 1,100 patients across the United States and Australia. In partnership with 10 medical centres, it is the largest randomised controlled study on patients at risk of lymphoedema. Recruits included breast cancer survivors who are at risk of developing secondary lymphoedema in their arms through their treatment. The trial was conducted over six and half years with patients followed up for three years.

Impedimed noted that the study aimed at understanding if detecting extracellular fluid build-up through a bioimpedance spectroscopy device would reduce the rate of lymphoedema progression, followed by early intervention. This was compared with using a measuring tape to identify extracellular fluid accumulation.

What did management say?

Impedimed managing director and CEO Mr Richard Carreon commented on finishing the trial:

We are pleased to reach this important milestone and expect the results to demonstrate improved outcomes when L-Dex is used to monitor patients at risk of lymphoedema. We believe the release of the results of the PREVENT trial, together with the recent meta-analysis results, will again further our case with both the NCCN and Private Payors.

How has the Impedimed share price performed?

The Impedimed share price reached a recent peak of 18.5 cents in November, before scuttling down to 13 cents.

The company's shares spent most of 2020 hovering below the 10-cent mark, however they have since gained traction. On current prices, Impedimed has a market capitalisation of $163 million.

The post Why the Impedimed (ASX:IPD) share price will be on watch today appeared first on The Motley Fool Australia.

What did Impedimed announce?

Impedimed is a medical device company that produces a family of FDA-approved devices. It has been listed on the ASX since 2007.

According to Impedimed, pharmaceutical giant AstraZeneca has selected its Sozo device for a phase 2 trial in order to measure fluid volume in patients with chronic kidney disease. The AstraZeneca study will use the Impedimed device to evaluate the efficacy, safety and tolerability of a combination of 2 AstraZeneca drugs.

The trial will begin in January 2021 and run for approximately 18 months. According to Impedimed, the study will generate $2 million in revenue. The total expected revenue from this trial and a previously announced AstraZeneca trial, in which it is also using Sozo, is $4.5 million. 

An additional 200 Sozo devices will be leased across 24 countries for the trial, bringing the total Sozo devices leased for AstraZeneca studies to 375.

Impedimed managing director and CEO Richard Carreon commented: "There are millions of people today living with chronic kidney disease, and we look forward to learning more about the impact this trial will have on improving patient care."

How has Impedimed performed recently?

In the first quarter of FY2021, Impedimed had revenue of $1.5 million, an increase of 11% on the prior corresponding period. Impedimed had $15.4 million cash on hand at 30 September 2020.

The Impedimed share price is up more than 187% since its 52-week low of 3.2 cents, however, it is down 38% since the beginning of the year. The Impedimed share price is down 34% since this time last year.

The post Here's why the Impedimed (ASX:IPD) share price shot up 13% today appeared first on The Motley Fool Australia.

Substantial shareholders are shareholders that hold 5% or more of a company's shares. These tend to be large investors, asset managers, and investment funds. These shareholders are obliged to update the market when they make any changes to their holdings.

As a result, I feel investors should look to use these notices to their advantage. After all, they show where the "smart money" is going.

Two notices that have caught my eye are summarised below:

ImpediMed Limited (ASX: IPD)

A notice reveals that Australian Ethical Investment Limited (ASX: AEF) has become a substantial holder of this medical software technology company this week. The ethical investment company has increased its holding to 27,759,024 shares, which gives it a 5.43% stake. ImpediMed is a medical software technology company that non-invasively measures, monitors, and manages fluid status and tissue composition using bioimpedance spectroscopy. Earlier this week it released an update and revealed total revenue of $1.5 million for the second quarter. This was a 63% increase on the prior corresponding period and puts it on track to achieve its guidance range of $7 million to $8.5 million for the full year. Its SOZO device was the main driver of growth during the quarter.

Reject Shop Ltd (ASX: TRS)

A change of interests of substantial holder notice reveals that Grahger Retail Securities has continued to add to its position in this discount retailer. Over the last few weeks Grahger Retail Securities has been on a buying spree. This continued between January 17 and January 23, with the investment company adding 333,358 shares for a total of ~$1.35 million. These purchases have lifted its stake up to 10.426%. This rampant buying has helped drive the Reject Shop share price up by 112% since the beginning of December. Once again, if these latest purchases are anything to go by, Grahger Retail Securities appears to believe its shares can still go higher from here.

The post Fund managers have been buying these ASX shares this week appeared first on The Motley Fool Australia.

Three small cap shares that posted strong gains today are listed below. Here's why they are on the rise:

The Amaysim Australia Ltd (ASX: AYS) share price rose 7% to $1.04 on Thursday. Investors have been flooding into the telco sector this week after TPG Telecom Ltd (ASX: TPM) revealed that it is looking into a merger with Vodafone Australia. The market appears to believe that the emergence of a third telco giant in the Australian market instead of a large number of smaller players will bring an end to the price war. Interestingly, Amaysim has been tipped as a potential takeover target for TPG Telecom and Vodafone in the past. Food for thought.

The Impedimed Limited (ASX: IPD) share price rocketed 28.5% higher to 45 cents today after the medical device company released the results for the PREVENT trial. According to the release, the authors from the PREVENT trial concluded that Impedimed's L-Dex is very sensitive in the assessment of sub-clinical lymphoedema in patients with a history of breast cancer. The paper also supports the recommendation for an aggressive measurement protocol consisting of an L-Dex assessment every three months. Whilst this is positive news, it is still early days and there's a long road ahead.

The Wellcom Group Limited (ASX: WLL) share price built on yesterday's strong gain with another push higher on Thursday. The production and content management company's shares climbed over 6% higher to $5.15 a day after reporting full year revenue of $108 million and net profit after tax of $11.7 million. This was a 9% and 10% increase, respectively, on FY 2017's result. Wellcom's solid result was driven partly by a number of new contracts wins including customers from Countdown (Woolworths NZ), News Corp, and SPC Ardmona.

The post These ASX small cap shares posted strong gains today appeared first on The Motley Fool Australia.

But if you're worried you've missed the boat on these big players, here are three smaller healthcare companies that could light up the market over the next few years. 

Shares in healthcare companies can be the foundation around which you can build a successful portfolio. Because these companies tend to exhibit defensive characteristics they can help protect your portfolio in a market crash, potentially reducing the volatility of your overall returns.

This is due to the social need healthcare companies provide. In an economic downturn, people will tend to reduce their spending on discretionary or luxury items long before they cut back on the amounts they spend on healthcare, meaning that these companies tend to remain profitable even at times when other companies are fighting to stay afloat. 

But the healthcare sector also offers unique growth opportunities. Because of the amount of technology, R&D and specialised knowledge and science that goes into developing medical products and services, the healthcare industry often presents stiff barriers to new competitors trying to enter the market.

Plus, the products and services offered by healthcare companies are generally highly differentiated – reducing the need for companies to compete with one another based solely on price. This essentially means that a company with an innovative new medical product or service, provided it has the cash available to develop and market it, can quickly become profitable. 

Just look at the performance of the big industry players over the last 12 months. The share price of CSL is up over 50%, ResMed Inc is up by almost the same amount, and Cochlear Limited (ASX: COH) has increased over 30%.  

Of course, this doesn't mean that every healthcare company is going to be a big success – plenty fail through lack of financing, advances in competing technologies, or poor clinical trial results.

But here are three smaller companies that might be worth the risk.     

Starpharma Holdings Limited (ASX: SPL) 

Starpharma is an Australian pharmaceutical company based out of Melbourne. The company specialises in a type of nanotechnology called dendrimers, which are man made synthetic compounds that have the ability to enhance existing pharmaceuticals or create entirely new products. 

Currently, Starpharma has two key product offerings: a women's health product called VivaGel which treats bacterial imbalances, and a drug delivery platform which aims to improve the efficacy of certain medicines. 

The company has been in the news recently as it entered into a licensing agreement with global pharmaceutical company Mundipharma. As part of the agreement, Mundipharma will market and sell VivaGel in 43 countries across Europe and Latin America. 

Impedimed Limited (ASX: IPD) 

Another Australian healthcare company worth looking into is Impedimed. It develops technology that can measure various properties about a patient's fluid levels and body composition, which can then be used in the diagnosis and treatment of serious conditions including lymphedema and heart disease. 

This company is a higher risk investment as its products still appear to be in the trial and testing phase, and total revenues for the most recent quarter ended June 30 were only $1.4 million. However, in a recent investor presentation, Impedimed stated the addressable market for its products in the US is more than US$2.8 billion annually.

Plus, the company is also following a subscription-based business model, which is attractive for investors as it locks in recurring revenues and reduces risk.   

Virtus Health Ltd (ASX: VRT) 

Virtus specialises in assisted reproductive services, and is the largest provider of in-vitro fertilisation services in Australia. It is also the market leader in Ireland. 

Just last week Virtus announced that it had acquired Danish fertility clinic Trianglen, signalling that it is keen to expand its footprint in Europe. The maximum consideration paid for the purchase, which depends on Trianglen meeting certain EBITDA targets set out in an earn-out agreement, is $43 million. It is forecast that the acquisition will increase Virtus' earnings per share by FY19. 

Foolish takeaway 

Not every healthcare or pharmaceutical company is going to be the next CSL Limited. But the three companies mentioned here are still great additions to your watch lists. While they still might be risky investments right now, they all have the potential to deliver real growth in the future. 

The post There 3 under-the-radar healthcare shares could make you rich appeared first on The Motley Fool Australia.