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Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through…

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

We will update you on ELUT when more details emerge, subscribe to Microcapdaily to follow along!

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Picture by sasint from Pixabay

The post Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market first appeared on Micro Cap Daily.

The post Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market appeared first on Micro Cap Daily.

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Pharma industry reputation remains steady at a ‘new normal’ after Covid, Harris Poll finds

The pharma industry is hanging on to reputation gains notched during the Covid-19 pandemic. Positive perception of the pharma industry is steady at 45%…

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The pharma industry is hanging on to reputation gains notched during the Covid-19 pandemic. Positive perception of the pharma industry is steady at 45% of US respondents in 2023, according to the latest Harris Poll data. That’s exactly the same as the previous year.

Pharma’s highest point was in February 2021 — as Covid vaccines began to roll out — with a 62% positive US perception, and helping the industry land at an average 55% positive sentiment at the end of the year in Harris’ 2021 annual assessment of industries. The pharma industry’s reputation hit its most recent low at 32% in 2019, but it had hovered around 30% for more than a decade prior.

Rob Jekielek

“Pharma has sustained a lot of the gains, now basically one and half times higher than pre-Covid,” said Harris Poll managing director Rob Jekielek. “There is a question mark around how sustained it will be, but right now it feels like a new normal.”

The Harris survey spans 11 global markets and covers 13 industries. Pharma perception is even better abroad, with an average 58% of respondents notching favorable sentiments in 2023, just a slight slip from 60% in each of the two previous years.

Pharma’s solid global reputation puts it in the middle of the pack among international industries, ranking higher than government at 37% positive, insurance at 48%, financial services at 51% and health insurance at 52%. Pharma ranks just behind automotive (62%), manufacturing (63%) and consumer products (63%), although it lags behind leading industries like tech at 75% positive in the first spot, followed by grocery at 67%.

The bright spotlight on the pharma industry during Covid vaccine and drug development boosted its reputation, but Jekielek said there’s maybe an argument to be made that pharma is continuing to develop innovative drugs outside that spotlight.

“When you look at pharma reputation during Covid, you have clear sense of a very dynamic industry working very quickly and getting therapies and products to market. If you’re looking at things happening now, you could argue that pharma still probably doesn’t get enough credit for its advances, for example, in oncology treatments,” he said.

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Q4 Update: Delinquencies, Foreclosures and REO

Today, in the Calculated Risk Real Estate Newsletter: Q4 Update: Delinquencies, Foreclosures and REO
A brief excerpt: I’ve argued repeatedly that we would NOT see a surge in foreclosures that would significantly impact house prices (as happened followi…

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Today, in the Calculated Risk Real Estate Newsletter: Q4 Update: Delinquencies, Foreclosures and REO

A brief excerpt:
I’ve argued repeatedly that we would NOT see a surge in foreclosures that would significantly impact house prices (as happened following the housing bubble). The two key reasons are mortgage lending has been solid, and most homeowners have substantial equity in their homes..
...
And on mortgage rates, here is some data from the FHFA’s National Mortgage Database showing the distribution of interest rates on closed-end, fixed-rate 1-4 family mortgages outstanding at the end of each quarter since Q1 2013 through Q3 2023 (Q4 2023 data will be released in a two weeks).

This shows the surge in the percent of loans under 3%, and also under 4%, starting in early 2020 as mortgage rates declined sharply during the pandemic. Currently 22.6% of loans are under 3%, 59.4% are under 4%, and 78.7% are under 5%.

With substantial equity, and low mortgage rates (mostly at a fixed rates), few homeowners will have financial difficulties.
There is much more in the article. You can subscribe at https://calculatedrisk.substack.com/

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‘Bougie Broke’ – The Financial Reality Behind The Facade

‘Bougie Broke’ – The Financial Reality Behind The Facade

Authored by Michael Lebowitz via RealInvestmentAdvice.com,

Social media users claiming…

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'Bougie Broke' - The Financial Reality Behind The Facade

Authored by Michael Lebowitz via RealInvestmentAdvice.com,

Social media users claiming to be Bougie Broke share pictures of their fancy cars, high-fashion clothing, and selfies in exotic locations and expensive restaurants. Yet they complain about living paycheck to paycheck and lacking the means to support their lifestyle.

Bougie broke is like “keeping up with the Joneses,” spending beyond one’s means to impress others.

Bougie Broke gives us a glimpse into the financial condition of a growing number of consumers. Since personal consumption represents about two-thirds of economic activity, it’s worth diving into the Bougie Broke fad to appreciate if a large subset of the population can continue to consume at current rates.

The Wealth Divide Disclaimer

Forecasting personal consumption is always tricky, but it has become even more challenging in the post-pandemic era. To appreciate why we share a joke told by Mike Green.

Bill Gates and I walk into the bar…

Bartender: “Wow… a couple of billionaires on average!”

Bill Gates, Jeff Bezos, Elon Musk, Mark Zuckerberg, and other billionaires make us all much richer, on average. Unfortunately, we can’t use the average to pay our bills.

According to Wikipedia, Bill Gates is one of 756 billionaires living in the United States. Many of these billionaires became much wealthier due to the pandemic as their investment fortunes proliferated.

To appreciate the wealth divide, consider the graph below courtesy of Statista. 1% of the U.S. population holds 30% of the wealth. The wealthiest 10% of households have two-thirds of the wealth. The bottom half of the population accounts for less than 3% of the wealth.

The uber-wealthy grossly distorts consumption and savings data. And, with the sharp increase in their wealth over the past few years, the consumption and savings data are more distorted.

Furthermore, and critical to appreciate, the spending by the wealthy doesn’t fluctuate with the economy. Therefore, the spending of the lower wealth classes drives marginal changes in consumption. As such, the condition of the not-so-wealthy is most important for forecasting changes in consumption.

Revenge Spending

Deciphering personal data has also become more difficult because our spending habits have changed due to the pandemic.

A great example is revenge spending. Per the New York Times:

Ola Majekodunmi, the founder of All Things Money, a finance site for young adults, explained revenge spending as expenditures meant to make up for “lost time” after an event like the pandemic.

So, between the growing wealth divide and irregular spending habits, let’s quantify personal savings, debt usage, and real wages to appreciate better if Bougie Broke is a mass movement or a silly meme.

The Means To Consume 

Savings, debt, and wages are the three primary sources that give consumers the ability to consume.

Savings

The graph below shows the rollercoaster on which personal savings have been since the pandemic. The savings rate is hovering at the lowest rate since those seen before the 2008 recession. The total amount of personal savings is back to 2017 levels. But, on an inflation-adjusted basis, it’s at 10-year lows. On average, most consumers are drawing down their savings or less. Given that wages are increasing and unemployment is historically low, they must be consuming more.

Now, strip out the savings of the uber-wealthy, and it’s probable that the amount of personal savings for much of the population is negligible. A survey by Payroll.org estimates that 78% of Americans live paycheck to paycheck.

More on Insufficient Savings

The Fed’s latest, albeit old, Report on the Economic Well-Being of U.S. Households from June 2023 claims that over a third of households do not have enough savings to cover an unexpected $400 expense. We venture to guess that number has grown since then. To wit, the number of households with essentially no savings rose 5% from their prior report a year earlier.  

Relatively small, unexpected expenses, such as a car repair or a modest medical bill, can be a hardship for many families. When faced with a hypothetical expense of $400, 63 percent of all adults in 2022 said they would have covered it exclusively using cash, savings, or a credit card paid off at the next statement (referred to, altogether, as “cash or its equivalent”). The remainder said they would have paid by borrowing or selling something or said they would not have been able to cover the expense.

Debt

After periods where consumers drained their existing savings and/or devoted less of their paychecks to savings, they either slowed their consumption patterns or borrowed to keep them up. Currently, it seems like many are choosing the latter option. Consumer borrowing is accelerating at a quicker pace than it was before the pandemic. 

The first graph below shows outstanding credit card debt fell during the pandemic as the economy cratered. However, after multiple stimulus checks and broad-based economic recovery, consumer confidence rose, and with it, credit card balances surged.

The current trend is steeper than the pre-pandemic trend. Some may be a catch-up, but the current rate is unsustainable. Consequently, borrowing will likely slow down to its pre-pandemic trend or even below it as consumers deal with higher credit card balances and 20+% interest rates on the debt.

The second graph shows that since 2022, credit card balances have grown faster than our incomes. Like the first graph, the credit usage versus income trend is unsustainable, especially with current interest rates.

With many consumers maxing out their credit cards, is it any wonder buy-now-pay-later loans (BNPL) are increasing rapidly?

Insider Intelligence believes that 79 million Americans, or a quarter of those over 18 years old, use BNPL. Lending Tree claims that “nearly 1 in 3 consumers (31%) say they’re at least considering using a buy now, pay later (BNPL) loan this month.”More tellingaccording to their survey, only 52% of those asked are confident they can pay off their BNPL loan without missing a payment!

Wage Growth

Wages have been growing above trend since the pandemic. Since 2022, the average annual growth in compensation has been 6.28%. Higher incomes support more consumption, but higher prices reduce the amount of goods or services one can buy. Over the same period, real compensation has grown by less than half a percent annually. The average real compensation growth was 2.30% during the three years before the pandemic.

In other words, compensation is just keeping up with inflation instead of outpacing it and providing consumers with the ability to consume, save, or pay down debt.

It’s All About Employment

The unemployment rate is 3.9%, up slightly from recent lows but still among the lowest rates in the last seventy-five years.

The uptick in credit card usage, decline in savings, and the savings rate argue that consumers are slowly running out of room to keep consuming at their current pace.

However, the most significant means by which we consume is income. If the unemployment rate stays low, consumption may moderate. But, if the recent uptick in unemployment continues, a recession is extremely likely, as we have seen every time it turned higher.

It’s not just those losing jobs that consume less. Of greater impact is a loss of confidence by those employed when they see friends or neighbors being laid off.   

Accordingly, the labor market is probably the most important leading indicator of consumption and of the ability of the Bougie Broke to continue to be Bougie instead of flat-out broke!

Summary

There are always consumers living above their means. This is often harmless until their means decline or disappear. The Bougie Broke meme and the ability social media gives consumers to flaunt their “wealth” is a new medium for an age-old message.

Diving into the data, it argues that consumption will likely slow in the coming months. Such would allow some consumers to save and whittle down their debt. That situation would be healthy and unlikely to cause a recession.

The potential for the unemployment rate to continue higher is of much greater concern. The combination of a higher unemployment rate and strapped consumers could accentuate a recession.

Tyler Durden Wed, 03/13/2024 - 09:25

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