Long-term success on Wall Street is all about getting ahead of the story everyone else will be chasing months or even weeks down the road. That’s why Endra Life Sciences Inc. (NASDAQ-NDRA) has my attention now.

Look at NDRA today and it’s more potential than powerhouse. The company doesn’t even make room for revenue on its quarterly pre-revenue reports yet. It hasn’t sold anything. The profitability that institutional investors demand is probably years away.

On paper, all it has to back up its $15 million market cap is $3 million in cash, miscellaneous other assets and a whole lot of talent and ideas. Big ideas. Many patents were collected over the last five years, 5 others overseas and dozens of others around the world.

Those ideas and the talent to turn them into commercial reality are the important thing about NDRA right now. All in all, they’re why the analysts who know this little company best say it will be worth $5.00 to $6.00 under the right conditions.

The firm with the most bearish take on NDRA just raised its target to $2.75 and left the door open to additional upgrades beyond. That’s pretty big talk for a stock that was trading at $0.65 at the time . . . and even now, after a blockbuster 65% run, remains within sight of a lowly $1.

THE BILLION-DOLLAR OPPORTUNITY

What have the analysts figured out that the market can’t see? Putting the dots together starts with four simple letters: N A S H.

It stands for Non-Alcoholic Steato Hepatitis. It means fat builds up in the liver (steatosis) and starts causing inflammation. In effect, it’s a form of self-inflicted hepatitis. In extreme cases, scarring and cirrhosis follow. It resembles alcoholic liver disease, only without the liquor.

And it’s a silent health epidemic that we know affects 20 million Americans and probably up to 80 million more people carry the fatty markers without knowing. Do the math and it kills more people than coronavirus . . . but because it’s progressive, the longer you have it, the worse your odds get.

NASH is now the top reason people need liver transplants today. Bigger than hepatitis. It can even cause cancer. While there’s no cure right now, Big Pharma has already spent BILLIONS ($1 billion from Gilead alone, and even then, that drug failed) trying to ring that bell. There are literally dozens of hopeful drugs in the clinic now. Most will fizzle out on the road but those that finally make it all the way to FDA approval will share a $35 billion sales jackpot.

Is it any wonder Wall Street goes nuts on the faintest whiff of progress toward a NASH cure? But if you’re curious about where tiny little NDRA fits into the story and how it hopes to compete with just about every ambitious drug company around, stop wondering.

NDRA isn’t racing the giants to a cure. That’s a fool’s game. Instead, management did a little reading between the lines and realized that they can help by coming up with better ways to detect NASH in its early stages.

Detection is essential. And it’s difficult. “Early detection is one of the biggest challenges” because by the time you notice the symptoms, you’re really sick.

Right now there are really only two ways to test for NASH: 1) a liver biopsy and 2) a full MRI to peek inside the body. The biopsy is invasive and uncomfortable. The MRI is expensive and relies on increasingly irreplaceable helium to run the magnets.

Between Option A and Option B, there’s no easy way to screen for who has NASH and who doesn’t. When you’re looking at a silent and lethal epidemic, it’s a good idea to run as many tests as you can . . . tens of millions just to identify all the people who have the condition now.

So NDRA came up with Option C. and differentiate fat from lean tissues.

THE NDRA ALTERNATIVE

Because fat is the problem, recognizing it on the scanner is all it takes. You’ve got NASH or you don’t. Follow-up tests can gauge progress or remission once those new drugs hit the market, telling doctors when to prescribe a pill or how to evaluate its effects.

NDRA’s system is proprietary. Only their machines know how to decode the waves and find the fat. The procedure doesn’t require gigantic magnets or rare helium. The machine costs 1/50 of an MRI suite.

And hospitals don’t have to buy an all-new imaging suite to run the test. This system TAEUS sits next to the existing ultrasound and plugs right in. 

Say there are 20,000 radiology labs in the developed world that do ultrasound screens now. NDRA can ultimately gross $1 billion selling them each a $50,000 TAEUS unit. That’s not a bad windfall at all for a company that’s currently valued at $15 million, right? For little NDRA to trade at even 1X that “base addressable market” opportunity, it would need to unlock truly massive upside . . . which would in turn give shareholders who got in early plenty to cheer.

From there, the accounting really adds up. The system can also map temperature in the body to help guide laser- and heat-based surgical procedures. It can track blood flow down to the microscopic level. Ultimately TAEUS has the potential to spot blockages to diagnose and assist treatment of a wide range of conditions. And throughout, NDRA has made sure to keep building in ways to sell disposable equipment and charge licensing fees to people who have already built the machine.

Remember, tens of millions of people in America alone (not even counting the rest of the world) probably have NASH and need to get a definitive diagnosis. Biopsies cost $1,500 apiece. An MRI scan is running close to double that . . . and that’s when the machines are actually working and slots are available! Even if the disposables only cost a few dollars per procedure, we’re looking at real money here.

All in all, management suspects there’s $18 billion to chase. At that point, the multiplier gets vast. Again, NASH is a big problem and big money: here’s a report suggesting that just selling the genetic markers that say you MIGHT get the disease is going to be worth $2 billion a year very soon. People with the markers will still need physical confirmation. That’s where NDRA comes in.

SOLVING THE BILLION-DOLLAR PUZZLE 

Of course it’s a long way from a $15 million stock with big dreams to the kind of company that can realistically conquer billion-dollar markets. NDRA today reflects reality on the ground today. However, management has done a lot of work paving the road from here to there.

To start, nothing ever happens in healthcare without regulatory approval. NDRA has already gotten clearance in Europe and is now looking to file its 510(k) medical device submission this summer, so the clock is ticking there. If you aren’t familiar with the 510(k) process, it’s a lot faster than what it takes to get a drug approved.

You really just need to prove safety and effectiveness. As long as your system doesn’t hurt people and actually provides the medical benefit you claim it does, the FDA tends to give you the green light to start selling. Historically it takes less than six months, so as long as NDRA makes its 2Q timeline, we can hope to hear back by the end of the year.

But maybe NDRA wants to wait and make sure the application is as strong as possible. A few months ago their research revealed a past FDA decision that might raise the odds of approval as long as they “do it that way.” Getting the data points in line has taken a little more time.

Meanwhile, the Europeans have already signed off on the device. That’s 5,500 hospitals or a $275 million revenue opportunity ($50,000 per TAEUS) that just opened up. Even if nothing happens on other regulatory fronts for months to come, NDRA is now free to start making money. And at this point, any slice of the initial $275 million market will feel mighty good.

Once you get the green light, you still need to convince the doctors they need to lobby hospitals to buy the equipment. NDRA has teamed up with the liver experts at the Medical College of Wisconsin while partnerships with the University of Pittsburgh Medical Center and Rocky Vista University do their share to spread the word. The more data that gets out into the journals, the easier the job gets.

A lot of doctors are probably eager for an efficient NASH testing system, so resistance is probably going to be mild at worst. When potential customers actively want to buy what you’re selling, all you have to do is give them a way to hand you the money.

And that’s the last big piece of the puzzle snapping into place. NDRA isn’t building a vast sales force to approach thousands of hospitals. That takes time and a whole lot of money. Instead, they’ve teamed up with GE Healthcare . . . which sells and supports the ultrasound machines that TAEUS plugs into.

If the ultrasound is the razor and TAEUS is the fancy new blade, NDRA has made a very powerful friend. GE is happy because the added functionality makes the ultrasound more relevant. NDRA gets to virtually “ride along” on the sales conversations. That’s what “facilitating introductions” means in that last link. Do you have an ultrasound machine? Did you buy it from GE? Have you heard that NDRA can leverage your existing machine to detect NASH?

THE BOTTOM LINE

Add it all up, NDRA has a solid shot at getting a lot of those hospitals to upgrade their existing ultrasound machines. Once they all do it, that’s billion-dollar potential, a real company maker.

Look at a company like Exact Sciences, which makes mail-in colon cancer tests. It took the last two years to book $1.3 billion in sales. This year it might do $1.2 billion as well. That once-obscure company is now worth close to $13 billion.

According to that math, NDRA only needs to sell a couple dozen TAEUS systems a year to justify its current market cap. The European hospitals can buy now. Even if NDRA hits 1% penetration of that market, we’re looking at a lot more than “a couple dozen” sales.

Remember, GE is helping. The data is flowing. Awareness around NASH isn’t fading. Doctors are waking up to the depth of the problem they’re facing as liver cancer and transplant numbers hit the red zone.

Day by day, those hospitals will get more receptive. And then “a couple dozen” will look small, at which point NDRA translates its potential into something a lot more substantial . . . and shareholders who saw the future in an obscure $15 million stock will be able to brag that they were early and right.

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