PainChek informed the ASX in a statement on Wednesday morning that the US Food and Drug Administration (FDA) had granted its smart device-based pain assessment and monitoring application a De Novo classification, a regulatory pathway to market for novel medical devices.

As the company explained:

This is a major milestone as (the) PainChek Adult App becomes the first and only regulated medical device available to assess pain (for) people who cannot reliably verbalise within the US nursing home and long-term care market. With its FDA De Novo grant, PainChek is recognised as a unique medical device, with no regulated competitive product, addressing critical unmet needs in pain management, especially within the substantial US aged care market.

PainChek said the initial addressable market in US aged care comprised more than three million long-term care beds and represented a commercial opportunity worth more than US$100 million ($152 million).

Other markets to open up

The company said the development also streamlined the pathway for rapid regulatory clearances in additional market segments, including home care and hospitals, "which are estimated to take the total US aged care market opportunity to $582 million".

PainChek is strongly positioned for immediate commercial rollout in the US, bolstered by strategic partnerships with leading healthcare software providers PointClickCare and Eldermark. Additionally, a reseller agreement with Eldermark is in place to accelerate market entry and sales growth.

The company said it was already active in business development in the US market via relationships with resellers and through direct channels, "and this will be accelerated following the FDA De Novo clearance''.

The company will also be presenting at aged care conferences in Las Vegas and Boston in the coming months.

PainChek Chief Executive Officer Philip Daffas said the De Novo clearance was a "transformative achievement'' for the company.

It validates our innovative technology and provides the foundation for accelerated US market growth, building off our established success in Australia and the momentum we've recently achieved in the UK.

The clearance was based on data from a two-year clinical trial in the US, and the company said it had patent protection across the world's major markets, including the US, the European Union, and China.

PainChek shares traded as high as 10.5 cents in early trade on Wednesday, up 31.2% on the previous day's close, before settling back to be just 1.3% higher at 8.1 cents.

Shareholders are sitting on healthy gains over the past 12 months, with the stock trading as low as 2.4 cents during that period.

PainChek was valued at $165.1 million at the close of trade on Tuesday.

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The Painchek share price hit a new 52-week high of 4.6 cents today. It has since slipped back to 4.3 cents at the close of trade.

The biotech stock's upward bolt today followed the same trajectory as two other micro-cap healthcare shares that charged higher this morning after releasing news updates.

ASX asks biotech to 'please explain' share price skyrocket

In its price query, the ASX referred to PainCheck's ascension from a closing price of 2.9 cents on 19 September to 4.5 cents at the time.

It also noted a "significant increase in the volume of PCK's securities traded on 20 September 2023 and today".

The ASX biotech responded by saying it knew of no reason for the stock's rapid rise.

The company confirmed it had no undisclosed news to declare.

Painchek said it was "possible that the market may be reacting to the recent issue of shares as part of the placement that was announced on 14 September 2023".

$3.55 million placement to fund product development

The ASX biotech stock has leapt 47% since announcing a successful $3.55 million capital raise among institutional, professional and sophisticated investors last Thursday.

Painchek will use the funding to continue developing its smartphone-based medical device application.

The company has an app called Painchek Universal, which allows patients who cannot self-report their level of pain to communicate this to their carers.

The app uses artificial intelligence and facial recognition to detect pain levels.

The company said it will use the placement funds for the following key purposes:

• Continue the international commercialisation of the Adult App in aged care and for the hospital and homecare sector
• Submit Adult App US FDA De Novo regulatory clearance application for US market entry with
• established US partners
• Commence commercialisation of the Infant App, including novel vocalisation technology
• Complete a core technology upgrade and obtain ISO27001 certification

The ASX biotech company issued an investor presentation for stockholders on 14 September.

The post Why did this ASX biotech stock explode 36% today? appeared first on The Motley Fool Australia.

The company's stock finished last Thursday's session trading at 4.5 cents. Since then, it has surged more than 44% despite no word having been released by the company.

At the time of writing, the PainChek share price is 6.5 cents, the same as it was at yesterday's close.

Let's take a closer look at what's been happening with PainChek's stock lately.

A quick refresher

PainChek develops and markets its PainChek app.

The app uses artificial intelligence, facial recognition, and smart phone technology to assess pain levels of people who can't verbalise or self-report their pain.  

What's happening with the PainChek share price?

It's been a crazy couple of days for PainChek on the ASX.

More than 23 million of its shares have swapped hands since Friday's open. For context, the average day over the last 4 weeks has seen around 3.1 million PainChek securities traded.

Additionally, the PainChek share price soared 35.5% on Friday and another 6.5% yesterday.

It was in the green again earlier today amid the release of a 'please explain' issued by the ASX. In response, the company said it was as confused as anyone else about the change in trading behaviour.

Making the increased price and volume more head-scratching, is the fact the company hasn't released any price-sensitive news to the market in more than a month.

In fact, the last time the ASX heard price-sensitive news from PainChek was in October when it updated the market on its performance over the September quarter.

Though, it published its non-price-sensitive annual general meeting investor update earlier today.

At its current share price, PainChek has a market capitalisation of around $74 million.

The post What the heck is going on with the PainChek (ASX:PCK) share price? appeared first on The Motley Fool Australia.

As a result of the clearances, PainChek can market its pain sensing app for babies in Australia, Europe, the United Kingdom, Canada, Singapore, and New Zealand.

PainChek also announced its successful Infant Face-Only study is being peer-reviewed for publication. The study determined the app could successfully analyse a baby's facial expressions and evaluate if they're in pain.

Let's take a closer look at the latest news from Painchek.  

PainChek Infant

Painchek has announced that it's received a number of regulatory approvals needed market its PainChek Infant app.

The company now plans to launch its infant app in a number of countries. It will focus particularly on the hospital and home care markets.

PainChek says that its app can help healthcare professionals, parents, and carers to evaluate if a non-verbal child is in pain. Additionally, the app will help gauge how much pain the child is in.

According to PainChek, there are around 400 million pre-verbal children globally. Moreover, one quarter is born to first-time parents. Furthermore, PainChek stated this gives it a large market entry point.

The company also said that, while clinicians have access to paper-based pain measuring tools for infants, they are rarely used. Additionally, it claimed that high levels of exposure to pained infants can sometimes lead to medical professionals dismissing babies' pain signals.

PainChek plans to continue expanding its app's abilities. Currently, it is working to broaden the age range of children whose pain can be assessed. It will do so by conducting further research and clinical studies. It is also currently conducting a study at Melbourne's Royal Children's Hospital.

PainChek already has an app available that uses facial expressions to sense pain in non-verbal adults.

Commentary from management

PainChek's CEO Philip Daffas commented on the PainChek Infant app's approval, saying:

We're delighted to achieve this regulatory milestone ahead of schedule and continue to expand PainChek's global markets. The PainChek Infant App is unique in that it completes a microfacial analysis through a 3 second video assessment and provides the carer with an instant result in relation to the infant's pain severity level…

Having established the initial PainChek Adult App and the business model in aged care, this broad portfolio of offerings provides the foundation for our global market entry into the larger home care and the hospital markets.

PainChek share price snapshot

The PainChek share price needs the good news as it battles a tough 2021 on the ASX.

Currently, the PainChek share price is down 12.5% year to date. It's also fallen 56% since this time last year.

The company has a market capitalisation of around $73 million, with approximately 1.1 billion shares outstanding.

The post The PainChek (ASX:PCK) share price is rising on its latest announcement appeared first on The Motley Fool Australia.

At the time of writing, the mobile medical app developer's shares are up 13% to 7.8 cents per share.

What did Painchek announce?

The Painchek share price is moving after it provided an update this morning noting the company had received CE Mark and Therapeutic Goods Administration (TGA) clearance for its expanded Universal Pain Assessment Solution, or 'Universal' application.

According to the release, these clearances will allow the app to be marketed and sold across Europe, the UK, Australia, Canada, Singapore, and New Zealand.

The new 'Universal' Painchek app builds upon the company's existing pain monitoring technology to now allow all patients to be assessed. Previously the app was specifically for people with dementia.

With the latest approval, the company's market will substantially broaden. The total market for pain monitoring is far larger than the niche market solely serving people with dementia.

What the Universal app adds

Painchek's Universal app implements the widely established self-reporting standard known as the numeric rating scale (NRS). The company's existing technology caters to carers for assessing and managing pain levels for patients who cannot verbalise it. However, with the addition of NSR, carers will now also be able to better support those who can self-report.

Painchek CEO Philip Daffas commented on the approval:

Historically, PainChek and NRS have been separate pain assessment processes in terms of function and documentation, as we initially developed PainChek to be used in situations where patients could not reliably verbalise their pain.

We have now improved the process by incorporating the NRS into the PainChek app, combining the benefits of the two pain scales into one universal pain assessment and management solution.

The initial rollout of the Universal app is slated for Australia and the United Kingdom from April. After which, it will continue to be distributed to mainland Europe and other international markets.

Painchek share price checkup

Considering the 52-week range on the Painchek share price, it has been a wild year for Painchek shareholders. Before today, the share had been floating around its 52-week low of 6.2 cents. Whereas, in May last year, the share price hit a high of 18 cents. 

Despite the increased volatility, the shares have returned a meagre 4% to holders over the past 12 months. For comparison, the S&P/ASX 200 Index (ASX: XJO) has notched up a 28% gain before dividends. 

The post Why the Painchek (ASX:PCK) share price is charging 13% higher appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that stop them push higher are listed below. Here's why they are rising today:

Lake Resources N.L (ASX: LKE)

The Lake Resources share price is up 3% to 36 cents. Investors have been buying the lithium company's shares after it refreshed its flagship Kachi Lithium Brine Project Pre-Feasibility Study (PFS) based on revised lithium price estimates. It now estimates that the project has a net present value of US$1.6 billion (A$2.1 billion). This is almost double its previous estimates. Lake Resources made the move following discussions with potential off-takers and recent projections from Benchmark Mineral Intelligence.

PainChek Ltd (ASX: PCK)

The PainChek share price has jumped 10% to 7.6 cents. This morning PainChek released an update on its smart phone-based pain assessment and monitoring application. According to the release, the Universal Pain Assessment Solution has received CE Mark in Europe and Therapeutic Goods Administration clearance in Australia.

Z Energy Ltd (ASX: ZEL)

The Z Energy share price has risen over 4% to $2.72. Investors have been buying the New Zealand-based fuel retailer's shares after it announced that it has successfully renegotiated the covenant waivers with its banking syndicate. This will allow Z Energy to recommence distributions to shareholders, starting with an expected full year dividend in FY 2021.

Zip Co Ltd (ASX: Z1P)

The Zip share price is pushing 2% higher to $8.92 despite there being no news out of the buy now pay later provider. However, investors may believe its shares are good value based on a note out of Citi yesterday. Although its analysts have retained their neutral rating, their price target of $11.35 is notably higher than where its shares trade at today.

The post Why Lake Resources, PainChek, Z Energy, & Zip shares are rising today appeared first on The Motley Fool Australia.

The share price increase came off the back of the company half-year report announced to the market yesterday. Let's take a look.

Why did the Painchek share price rise today?

Shares in the small-cap rose as revenue jumped 40% to $2.08 million for the half-year ending 30 December 2020.

However, this does not fully represent how the company performed in the period. Looking deeper into the results, we can see that revenue from continuing operations fell 30% to $127,000. The majority of the group's revenue was made up of research and development (R&D) and government grants.

As such, the company reported a net loss from operations for the half-year of $1.35 million.

PainChek continued to deliver sales growth in Australian residential aged care (RAC). Sales growth in the period resulted in total global licenses covering 71,318 beds, a 123% growth year on year (YoY). Furthermore, domestic sales reflected more than 30% of the Australian RAC.

Moreover, the company now has 884 aged care clients, growing 133% on the previous corresponding period. Forward-looking revenue equates to more than $3 million in annualised recurring revenue.

Looking ahead

PainChek aims to further develop its platform for use in new and larger healthcare market segments. The company said this was core to its business growth over the next 12 months.

In addition, the company has a number of products pending regulatory clearance. PainChek's business strategy includes the release of an app for assessing pain in young children.

Having recently completed the app development and clinical validation work, the company is projecting Australian (TGA) and European (CE) mark regulatory clearances in the second quarter of the calendar year 2021.

Promisingly, its children's app serves a potentially larger market than the adult app with a large hospital market and home care market opportunity.

The post Why the Painchek (ASX:PCK) share price is edging higher today appeared first on The Motley Fool Australia.

Shares in the small cap healthcare company were trading 4.2% higher at 7.4 cents on close of trade today.

What is driving the Painchek share price

In today's release, the company reported continued growth in its aged care and initial entry into the hospital, home care and disability markets during the quarter ended 31 December.

In its core aged care market segment, Painchek delivered sales growth of 7% from the prior quarter. And with its global licences covering 71,318 beds, year on year (YoY) growth is up 123%. The company reported its domestic sales now reflect more than 30% of Australia's domestic aged care market share.

As a result, Painchek now has 884 aged care clients, up 133% YoY, and the forward looking revenue equates to more than $3 million annualised recurring revenue.

However it was not all smooth sailing for the company, with several large provider agreements delayed as a result of COVID-19 disruptions. Paincheck said these discussions have since been resumed in January.

Management comments

Painchek CEO Philip Daffas welcomed the update, saying:

While 2020 was challenging for many businesses, we successfully continued to deliver with significant sales growth. This included pivoting to a fully digital sales and delivery model that met the immediate needs of our clients, as well as establishing a new cost-effective global go-to-market model.

About the company

PainChek develops and commercialises medical device applications. This is aimed specifically at automating intelligent pain assessment of individuals who are unable to communicate their pain with carers (such as people in aged care facilities).

In particular, the company is involved in the provision of pain management and better medication for residents living with dementia and other communication difficulties. Painchek has already obtained regulatory clearance in Australia and Europe.

The post Why the Painchek (ASX:PCK) share price lifted today appeared first on The Motley Fool Australia.

In morning trade the healthcare technology company's shares are down 3% to 9.2 cents.

What did PainChek announce?

Investors have been selling PainChek's shares despite it announcing a partnership with Ramsay Health Care Limited (ASX: RHC) and Edith Cowan University (ECU) for a research project.

According to the release, the research project will investigate ways of minimising or stopping the progression of frailty in hospital patients. It is expected that better pain management is key to achieving these outcomes.

This bodes well for PainChek, given that it has developed a smartphone-based pain assessment and monitoring application.

Management notes that this project marks the first commercial agreement with a hospital organisation entered into by PainChek.

And while the revenue associated with the project is not material, it feels it provides significant validation for its technology. It also allows the company to form a partnership with one of Australia's leading hospital and health service providers.

"An important step."

PainChek's CEO, Philip Daffas, was very pleased with the partnership and sees it as an important step for the company.

He commented: "Bringing PainChek into the local and global hospital market has been a longstanding goal of the company, and this marks an important step toward that goal. We expect that a successful outcome from this research will provide for excellent opportunities with groups such as Ramsay and provides us a high-quality case study we can demonstrate with other potential customers."

What is the project?

This project will examine how a nurse led volunteer program and better pain management could help improve outcomes for hospital patients who are frail.

The company notes that the evidence to support the association between pain and frailty continues to grow. Pain prevalence increases with increased age and so too does frailty.

As persistent pain can lead to functional disability, depression, or social isolation, it has been suggested that the burden of pain leaves older adults less capable to compensate. This increases the likelihood of frailty.

A consortium of 12 researchers from five Australian universities is investigating different ways of minimising or stopping the progression of frailty in hospital patients. This is through volunteer support interventions and optimal pain management facilitated by better pain assessment through the use of PainChek.

The post PainChek (ASX:PCK) share price lower despite Ramsay (ASX:RHC) partnership appeared first on The Motley Fool Australia.