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Avisa Diagnostics

Developing A Thermometer for the Lungs
The post Avisa Diagnostics appeared first on Investing News Network.

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This Avisa Diagnostics profile is part of a paid investor education campaign.*

Overview

The global healthcare industry continues to experience rapid growth. With an average annual growth rate of 7.3 percent since 2014, healthcare spending is expected to exceed $10 trillion by 2022. Healthcare spending in the US accounted for 17.7 percent of the entire GDP in 2019, with that figure expected to rise to nearly 20percent by 2028.

Segmentation is an important consideration when it comes to investing in healthcare companies. Respiratory diagnostics is one segment within the healthcare industry to keep on the watchlist, especially in the wake of the COVID-19 pandemic. Before COVID-19, a child dies of pneumonia every 39 seconds and the United Nations Children’s Fund (UNICEF) projected around 18 million more health workers are needed by 2030. Amid the pandemic,   pneumonia and other respiratory diseases become an even larger health concern. The respiratory disease diagnostics market alone is expected to be worth $6.7 billion by 2025.

Avisa Diagnostics (CSE:AVBT) is an innovative healthcare company specializing in respiratory disease diagnostics through its rapid, point-of-care Avisa BreathTest solution™. This simple, ultra-rapid breath test was designed to save time, money and lives, and has been dubbed a “thermometer for the lungs.”

The compelling new technology measures bacterial load in the lungs enabling better diagnoses, monitor therapy, and helping to mitigate the overuse of broad-spectrum antibiotics.

UN reports show that bacterial resistance is responsible for over 700,000 deaths worldwide and millions in healthcare costs. More targeted technologies, like the Avisa breath test, allow for specific diagnosis and prevent the unnecessary use of broad-spectrum antibiotics.

The technology also aids doctors in monitoring patients on ventilators. An estimated 1.7 million people are on ventilators in the US alone, and nearly half of all individuals on a ventilator get ventilator-associated pneumonia which can potentially be fatal. The Avisa breath test allows for unprecedented monitoring and has the potential to save thousands of lives.

In terms of early detection and the ability to allow physicians to rule in or out specific diagnoses, there is no comparable technology on the market today. Avisa BreathTest™ has the ability to quickly detect urease pathogens anywhere in the lung within 10 minutes, with AVISAR™, a point-of-care medical device that provides analysis in seconds.

Avisa is currently in the process of putting together their investigational new device exemption for the FDA. Pending approval, they will then be able to move into commercialization.

Any new technology is only as profitable as the team managing its release, and Avisa has put together a team with proven experience in key areas of diagnostics, clinical regulation and strategy, medical device design, as well as medical technology. This positions them well in the testing and commercialization of new medical technology.

As the Avisa breath test approaches clinical trials, it will be essential to have leaders experienced in developing strategic research trial operations and gathering the necessary evidence to take the device to market.

CEO David Joseph has over 40 years of experience in the commercialization of medtech and pharmaceuticals, co-founding four companies in the industry, which were successfully exited through IPOs and M&As.

VP of Clinical Development Barbara Bunger, Ph.D. has over 30 years of experience navigating clinical trials. He currently serves as the vice president at Clinical Development and Regulatory Services, LTD, a company providing scientific, clinical research and regulatory services to the biopharmaceutical and medical device industry.

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Avisa Diagnostics’ Company Highlights

  • Avisa Diagnostics is a clinical-stage medical device company developing the Avisa BreathTest™, a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens, detecting and monitoring bacterial load after the patient inhales or ingests its drug substrates via proprietary delivery systems.
  • The respiratory disease diagnostics market alone is expected to be worth $6.7 billion by 2025, and the Avisa BreathTest™ is a unique technology addressing a prevalent issue within this growing market.
  • 1.7 million people are on ventilators in the US alone, and nearly half of all individuals on a ventilator get ventilator-associated pneumonia, a potentially fatal condition. The Avisa breath test allows for unprecedented monitoring and has the potential to save thousands of lives.
  • Avisa is currently in the process of putting together their investigational new device exemption for the FDA. Pending approval, they will then be able to move into commercialization.
  • Avisa’s management team has decades of combined experience in the development and commercialization of medical technology, diagnostics and clinical regulation and strategy. Experience in these key industries put them in a strong position to move the Avisa BreathTest™ through clinical trials and into commercialization.

Avisa Diagnostics’ Breakthrough Technology

Avisa BreathTest™

The Avisa BreathTest™ is a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens. It works by detecting and monitoring bacterial load after the patient inhales or ingests its drug substrates via proprietary delivery systems.

Avisa has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results.

Pivotal trials are also planned in Post-COVID-19 bronchiectasis and ventilator-associated pneumonia and plans to submit Investigational Device Exemption applications to the U.S. FDA for these trials next year.

The breath test is a novel use of existing technology with a clinical proof-of-concept, which mitigates the risk when moving through clinical trials.

Avisa has sufficient funding to reach key value inflection points through product launch, as well as a smart business model developed by experienced leaders which will enable accelerated market entry.

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Avisa Diagnostics

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Avisa Diagnostics’ Management Team

David S. Joseph — President & CEO

David S. Joseph has over 40 years of experience commercializing medtech/pharma, including co-founding four companies with successful exits either through IPOs or M&As.

Joseph was the Co‐founder, President, CEO and Chairman of SITE Microsurgical Systems, which was acquired by Johnson & Johnson Corporation (NYSE:JNJ) in 1983. He was also co-founder, President, CEO and Chairman of Surgical Laser Technologies, which reached IPO in 1989 and was acquired by Photo Medix in 1992.

Joseph then moved on to Orthovita, an orthobiologics company which reached IPO in 2006 and was acquired by Stryker (NYSE:SYK) in 2012 for US $350 million.

Prior to his entrepreneurial career, Joseph accrued over 15 years of executive healthcare management experience.

David Karshmer — SVP, Product Development

David Karshmer has over 25 years of experience in medical device design, providing a solid foundation for heading up the design of Avisa’s new breath test device.

Karshmer is also a successful serial entrepreneur, Avisa being his 6th start-up. He also founded IDEO Healthcare practice.

Matt Kuller — CFO

Matt Kuller is an experienced chief financial officer with over 15 years of experience in investment and financial management.

Kuller has been the CFO at multiple venture-backed startups, so he understands the unique challenges of determining financial strategy for a startup company.

He also has experience in the venture capital industry himself, as well as investment banking, rounding out his comprehensive understanding of business finance.

Barbara Bunger, Ph.D. — VP, Clinical Development

Barbara Bunger has over 30 years of industry experience, boasting a highly successful track record in the development of clinical and regulatory strategy, global clinical research trial operations and the overall evidence generation planning required to support reimbursement and market adoption.

She is the Vice President of Clinical Development and Regulatory Services at Clinical Development and Regulatory Services, LTD., a company providing scientific, clinical research and regulatory services to the biopharmaceutical and medical device industry. She is also Worldwide Director for the Clinical Research and Corporate Clinical Development at Becton Dickinson.

Bunger has led clinical research and regulatory functions at several clinical and regulatory consulting firms as well as at medtech companies including Medtronic Spine & Biologics, SI-Bone, Philips Healthcare’s emerging business unit and Triangle Research and Regulatory Services.

Graham Timmins, Ph.D. — Chief Science Advisor

Graham Timmins, associate professor of medical chemistry at the University of New Mexico, is the chief scientific advisor on the Avisa BreathTest™ project.

Timmins is the author or co-author of over 50 scientific publications during the course of his academic career, and has been awarded multiple federal grants.

He is also the co-inventor of the Company’s patent portfolio.

*Disclaimer: This profile is sponsored by Avisa Diagnostics (CSE:AVBT). This profile provides information that was sourced by the Investing News Network (INN) and approved by Avisa Diagnostics, in order to help investors learn more about the company Avisa Diagnostics is a client of INN. The company’s campaign fees pay for INN to create and update this profile.

INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.

The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Avisa Diagnostics and seek advice from a qualified investment advisor.

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Analyst reviews Apple stock price target amid challenges

Here’s what could happen to Apple shares next.

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10 hours ago

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March 12, 2024

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They said it was bound to happen.

It was Jan. 11, 2024 when software giant Microsoft  (MSFT)  briefly passed Apple  (AAPL)  as the most valuable company in the world.

Microsoft's stock closed 0.5% higher, giving it a market valuation of $2.859 trillion. 

It rose as much as 2% during the session and the company was briefly worth $2.903 trillion. Apple closed 0.3% lower, giving the company a market capitalization of $2.886 trillion. 

"It was inevitable that Microsoft would overtake Apple since Microsoft is growing faster and has more to benefit from the generative AI revolution," D.A. Davidson analyst Gil Luria said at the time, according to Reuters.

The two tech titans have jostled for top spot over the years and Microsoft was ahead at last check, with a market cap of $3.085 trillion, compared with Apple's value of $2.684 trillion.

Analysts noted that Apple had been dealing with weakening demand, including for the iPhone, the company’s main source of revenue. 

Demand in China, a major market, has slumped as the country's economy makes a slow recovery from the pandemic and competition from Huawei.

Sales in China of Apple's iPhone fell by 24% in the first six weeks of 2024 compared with a year earlier, according to research firm Counterpoint, as the company contended with stiff competition from a resurgent Huawei "while getting squeezed in the middle on aggressive pricing from the likes of OPPO, vivo and Xiaomi," said senior Analyst Mengmeng Zhang.

“Although the iPhone 15 is a great device, it has no significant upgrades from the previous version, so consumers feel fine holding on to the older-generation iPhones for now," he said.

A man scrolling through Netflix on an Apple iPad Pro. Photo by Phil Barker/Future Publishing via Getty Images.

Future Publishing/Getty Images

Big plans for China

Counterpoint said that the first six weeks of 2023 saw abnormally high numbers with significant unit sales being deferred from December 2022 due to production issues.

Apple is planning to open its eighth store in Shanghai – and its 47th across China – on March 21.

Related: Tech News Now: OpenAI says Musk contract 'never existed', Xiaomi's EV, and more

The company also plans to expand its research centre in Shanghai to support all of its product lines and open a new lab in southern tech hub Shenzhen later this year, according to the South China Morning Post.

Meanwhile, over in Europe, Apple announced changes to comply with the European Union's Digital Markets Act (DMA), which went into effect last week, Reuters reported on March 12.

Beginning this spring, software developers operating in Europe will be able to distribute apps to EU customers directly from their own websites instead of through the App Store.

"To reflect the DMA’s changes, users in the EU can install apps from alternative app marketplaces in iOS 17.4 and later," Apple said on its website, referring to the software platform that runs iPhones and iPads. 

"Users will be able to download an alternative marketplace app from the marketplace developer’s website," the company said.

Apple has also said it will appeal a $2 billion EU antitrust fine for thwarting competition from Spotify  (SPOT)  and other music streaming rivals via restrictions on the App Store.

The company's shares have suffered amid all this upheaval, but some analysts still see good things in Apple's future.

Bank of America Securities confirmed its positive stance on Apple, maintaining a buy rating with a steady price target of $225, according to Investing.com. 

The firm's analysis highlighted Apple's pricing strategy evolution since the introduction of the first iPhone in 2007, with initial prices set at $499 for the 4GB model and $599 for the 8GB model.

BofA said that Apple has consistently launched new iPhone models, including the Pro/Pro Max versions, to target the premium market. 

Analyst says Apple selloff 'overdone'

Concurrently, prices for previous models are typically reduced by about $100 with each new release. 

This strategy, coupled with installment plans from Apple and carriers, has contributed to the iPhone's installed base reaching a record 1.2 billion in 2023, the firm said.

More Tech Stocks:

Apple has effectively shifted its sales mix toward higher-value units despite experiencing slower unit sales, BofA said.

This trend is expected to persist and could help mitigate potential unit sales weaknesses, particularly in China. 

BofA also noted Apple's dominance in the high-end market, maintaining a market share of over 90% in the $1,000 and above price band for the past three years.

The firm also cited the anticipation of a multi-year iPhone cycle propelled by next-generation AI technology, robust services growth, and the potential for margin expansion.

On Monday, Evercore ISI analysts said they believed that the sell-off in the iPhone maker’s shares may be “overdone.”

The firm said that investors' growing preference for AI-focused stocks like Nvidia  (NVDA)  has led to a reallocation of funds away from Apple. 

In addition, Evercore said concerns over weakening demand in China, where Apple may be losing market share in the smartphone segment, have affected investor sentiment.

And then ongoing regulatory issues continue to have an impact on investor confidence in the world's second-biggest company.

“We think the sell-off is rather overdone, while we suspect there is strong valuation support at current levels to down 10%, there are three distinct drivers that could unlock upside on the stock from here – a) Cap allocation, b) AI inferencing, and c) Risk-off/defensive shift," the firm said in a research note.

Related: Veteran fund manager picks favorite stocks for 2024

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Major typhoid fever surveillance study in sub-Saharan Africa indicates need for the introduction of typhoid conjugate vaccines in endemic countries

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high…

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There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

Credit: IVI

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

 

The findings from this 4-year study, the Severe Typhoid in Africa (SETA) program, offers new typhoid fever burden estimates from six countries: Burkina Faso, Democratic Republic of the Congo (DRC), Ethiopia, Ghana, Madagascar, and Nigeria, with four countries recording more than 100 cases for every 100,000 person-years of observation, which is considered a high burden. The highest incidence of typhoid was found in DRC with 315 cases per 100,000 people while children between 2-14 years of age were shown to be at highest risk across all 25 study sites.

 

There are an estimated 12.5 to 16.3 million cases of typhoid every year with 140,000 deaths. However, with generic symptoms such as fever, fatigue, and abdominal pain, and the need for blood culture sampling to make a definitive diagnosis, it is difficult for governments to capture the true burden of typhoid in their countries.

 

“Our goal through SETA was to address these gaps in typhoid disease burden data,” said lead author Dr. Florian Marks, Deputy Director General of the International Vaccine Institute (IVI). “Our estimates indicate that introduction of TCV in endemic settings would go to lengths in protecting communities, especially school-aged children, against this potentially deadly—but preventable—disease.”

 

In addition to disease incidence, this study also showed that the emergence of antimicrobial resistance (AMR) in Salmonella Typhi, the bacteria that causes typhoid fever, has led to more reliance beyond the traditional first line of antibiotic treatment. If left untreated, severe cases of the disease can lead to intestinal perforation and even death. This suggests that prevention through vaccination may play a critical role in not only protecting against typhoid fever but reducing the spread of drug-resistant strains of the bacteria.

 

There are two TCVs prequalified by the World Health Organization (WHO) and available through Gavi, the Vaccine Alliance. In February 2024, IVI and SK bioscience announced that a third TCV, SKYTyphoid™, also achieved WHO PQ, paving the way for public procurement and increasing the global supply.

 

Alongside the SETA disease burden study, IVI has been working with colleagues in three African countries to show the real-world impact of TCV vaccination. These studies include a cluster-randomized trial in Agogo, Ghana and two effectiveness studies following mass vaccination in Kisantu, DRC and Imerintsiatosika, Madagascar.

 

Dr. Birkneh Tilahun Tadesse, Associate Director General at IVI and Head of the Real-World Evidence Department, explains, “Through these vaccine effectiveness studies, we aim to show the full public health value of TCV in settings that are directly impacted by a high burden of typhoid fever.” He adds, “Our final objective of course is to eliminate typhoid or to at least reduce the burden to low incidence levels, and that’s what we are attempting in Fiji with an island-wide vaccination campaign.”

 

As more countries in typhoid endemic countries, namely in sub-Saharan Africa and South Asia, consider TCV in national immunization programs, these data will help inform evidence-based policy decisions around typhoid prevention and control.

 

###

 

About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO) and developed a new-generation typhoid conjugate vaccine that is recently pre-qualified by WHO.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, a Country Office in Austria, and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.

 

CONTACT

Aerie Em, Global Communications & Advocacy Manager
+82 2 881 1386 | aerie.em@ivi.int

Journal

The Lancet Global Health

Method of Research

Observational study

Subject of Research

People

Article Title

Incidence of typhoid fever in Burkina Faso, Democratic Republic of the Congo, Ethiopia, Ghana, Madagascar, and Nigeria (the Severe Typhoid in Africa programme): a population-based study

Article Publication Date

12-Mar-2024

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US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

Earlier today, CNBC’s…

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US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever... And Debt Explodes

Earlier today, CNBC's Brian Sullivan took a horse dose of Red Pills when, about six months after our readers, he learned that the US is issuing $1 trillion in debt every 100 days, which prompted him to rage tweet, (or rageX, not sure what the proper term is here) the following:

We’ve added 60% to national debt since 2018. Germany - a country with major economic woes - added ‘just’ 32%.   

Maybe it will never matter.   Maybe MMT is real.   Maybe we just cancel or inflate it out. Maybe career real estate borrowers or career politicians aren’t the answer.

I have no idea.  Only time will tell.   But it’s going to be fascinating to watch it play out.

He is right: it will be fascinating, and the latest budget deficit data simply confirmed that the day of reckoning will come very soon, certainly sooner than the two years that One River's Eric Peters predicted this weekend for the coming "US debt sustainability crisis."

According to the US Treasury, in February, the US collected $271 billion in various tax receipts, and spent $567 billion, more than double what it collected.

The two charts below show the divergence in US tax receipts which have flatlined (on a trailing 6M basis) since the covid pandemic in 2020 (with occasional stimmy-driven surges)...

... and spending which is about 50% higher compared to where it was in 2020.

The end result is that in February, the budget deficit rose to $296.3 billion, up 12.9% from a year prior, and the second highest February deficit on record.

And the punchline: on a cumulative basis, the budget deficit in fiscal 2024 which began on October 1, 2023 is now $828 billion, the second largest cumulative deficit through February on record, surpassed only by the peak covid year of 2021.

But wait there's more: because in a world where the US is spending more than twice what it is collecting, the endgame is clear: debt collapse, and while it won't be tomorrow, or the week after, it is coming... and it's also why the US is now selling $1 trillion in debt every 100 days just to keep operating (and absorbing all those millions of illegal immigrants who will keep voting democrat to preserve the socialist system of the US, so beloved by the Soros clan).

And it gets even worse, because we are now in the ponzi finance stage of the Minsky cycle, with total interest on the debt annualizing well above $1 trillion, and rising every day

... having already surpassed total US defense spending and soon to surpass total health spending and, finally all social security spending, the largest spending category of all, which means that US debt will now rise exponentially higher until the inevitable moment when the US dollar loses its reserve status and it all comes crashing down.

We conclude with another observation by CNBC's Brian Sullivan, who quotes an email by a DC strategist...

.. which lays out the proposed Biden budget as follows:

The budget deficit will growth another $16 TRILLION over next 10 years. Thats *with* the proposed massive tax hikes.

Without them the deficit will grow $19 trillion.

That's why you will hear the "deficit is being reduced by $3 trillion" over the decade.

No family budget or business could exist with this kind of math.

Of course, in the long run, neither can the US... and since neither party will ever cut the spending which everyone by now is so addicted to, the best anyone can do is start planning for the endgame.

Tyler Durden Tue, 03/12/2024 - 18:40

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