LONDON, September 13, 2017 /PRNewswire/ --
Stroke and heart diseases cost the U.S. nearly $1 billion every day in medical costs and lost productivity, so when a small-cap biotech company finally starts releasing validation news for a medical device with the potential to detect blockage in the carotid arteries the leading cause of stroke-before it's too late-investors tend to listen. Biotechs and big pharma companies in focus include: Regeneron Pharmaceuticals (NYSE: REGN), Exact Sciences Corp. (NASDAQ: EXAS), Shire PLC (NASDAQ: SHPG), Caladrius Biosciences, Inc (NASDAQ: CLBS)
The little-known company is CVR Medical (CVM.V; CRRVF), and its potentially life-saving device is the Carotid Stenotic Scan (CSS) - a technology designed to detect stenosis within arteries, or Ischemia, which is the leading indicator of strokes.
There has never been a cost-effective way to screen for Ischemia, until now.
After a decade of painstaking development, CVR is now nearing the end of the long road to validation, and for investors who understand this industry, this is the critical juncture.
CVR Medical has been quietly developing this new technology for 10 years. Now it's released updated preliminary clinical trial results, and signed a significant manufacturing deal.
Striking Out at the Disease Debilitating the World
Demand, unfortunately, is a given.
Every four minutes in the United States, someone dies of a stroke every 4 minutes in the United States alone - and this little-known biotech company has developed a medical device that hopes to challenge that deadly statistic.
Every year, globally, some 15 million people suffer a stroke-6 million of them killed and 5 million rendered permanently disabled, according to the World Heart Foundation.
According to the CDC Foundation, which assists the Centers for Disease Control (CDC), nearly 800,000 Americans die each year from heart disease, stroke and other cardiovascular diseases-accounting for one in every three deaths from disease. In monetary terms, that means that one in every six U.S. healthcare dollars is spent on these diseases. Even more dire, by 2030, the Foundation says that annual direct medical costs associated with these diseases are projected to rise to more than $818 billion. In addition to that we can add another $275 billion in lost productivity costs.
So, when a biotech company offers a potential solution to detecting and therefore giving doctors a chance to prevent the second-leading cause of death in the world--and then releases positive preliminary clinical trial results, investors listen.
First, one way to look at the potential of the CSS is to think about what 3D seismic imagery did for reserve discoveries in the oil and gas industry. This is exactly what CVR's sensory system could do for the medical industry in terms of detecting critical stroke symptoms.
This is how it works:
CVR's Carotid Stenotic Scan (CSS) is a tool to detect and calculate the severity of stenosis within the Carotid Arteries, potentially offering patients and caregivers a device for early detection in a quick and repeatable manner.
The CSS makes a connection between fluid flow and subsonic frequencies to detect arterial disease or blockage. Blood flowing through the carotid arteries produces wave patterns which are shaped and altered by the presence of irregularities on the inner artery walls.
CVR's advanced technology captures these wave patterns and analyzes them mathematically with patented algorithms. After a brief test, the analysis is complete, offering a way to potentially identify those at risk of a stroke and arming the healthcare provider with the information necessary to prevent the deadly event.
Unlike other comparative modalities, the CSS was designed to function without the assistance of a certified technician. These three facts combine to create one of the potentially biggest and most lucrative phenomena in recent medical equipment market history.
Detecting the early signs of a stroke, before it's too late, is a major challenge for our medical establishments. Often diagnosis is wrong. Usually, they are expensive.
CVR Medical's device-in-development is targeted to cost an estimated $49,000 per unit for detecting Ischemia, again, the leading cause of stroke.
CT scans are the most common method of diagnosing a stroke, but usually after it's already happened, and even then, stroke is not always seen on CT scans. CT scans can predict risk of stroke in patients who have suffered transient ischemic attacks (TIA), or 'mini-strokes', but its costs anywhere from $825 to $4800 for a CT scan, depending on your doctor and your insurance. That's because CT scanners cost between $1 million and $2.5 million dollars each.
Coming in at the planned $49,000 per unit, compared to up to $2.5 million, CVR Medical's CSS makes market sense. But beyond that, the CT scan isn't enough for detection.
According to the Centers for Disease Control (CDC), early action is vital for survival, and only 38 percent of stroke sufferers even recognize they are having a stroke in time to receive effective emergency intervention.
Catalysts Lining Up for CSS
Now it's hoping to charge out of the gate and take significant market share once it manages to gain FDA market clearance. In the meantime, the catalysts are really lining up:
On 7 September, CVR released updated results from its preliminary clinical trial that showed forward progress for the medical device, which we've been watching closely for some time. You can view the results from Thomas Jefferson University HERE.
The updated results of the preliminary clinical trials released just now bring the benefits of this device that much closer. Not only could it potentially help prevent strokes through early detection, but there is a secondary benefit: if all goes according to plan, it makes testing cheap, affordable and accessible to all.
Clinical trials are huge milestones for pharmaceutical and medical device companies, and there is nothing more important than this. More fail than succeed when it comes to clinical trials, and the winners are big.
But smart investors in this segment aren't looking for early blockbuster potential; they're looking for solidity, efficacy and long-term market disrupting potential.
The company's debut medical device, the Carotid Stenotic Scan (CSS), has been quietly in development for 10 years. Instead of trying to lure in investors with early stage blockbuster talk the founders invested millions of dollars of their own money, it waited until development was real, and the long road to validation came visibly closer to the light at the end of the tunnel.
That's not the only new catalyst; however, as news flow for CVR picks up real momentum.
In late August, CVR announced that after years of development, it signed a letter of intent with Canon Virginia, Inc. (CVI ), a domestic manufacturing subsidiary of Canon U.S.A., Inc. The deal means that, assuming FDA approval, Canon will manufacture the CSS at its state-of-the-art facilities. It is currently preparing statement of work (SOW) which is the final contracts. It's a relationship that, according to CEO and President Peter Bakema, is highly important, not only for credibility, but also for scalability.
Other recent manufacturing deals have also poised CVR for success right out of the gate. In March, they announced a partnership with ADCO Circuits, which will be the exclusive provider of CSS custom circuit boards for its sensors.
They've also got $2 million in the bank and a number of warrants being exercised, so they're not expecting to have to raise any money until 2018.
In combination with the recently updated preliminary clinical results, growing clinical relationships and the move towards hoped-for FDA approval, the catalysts for CVR Medical are building, fast.
"You can't come out with a lot of changes while you are validating, so we are almost over that hurdle. We are nearly moving into pivotal trials, which puts us right at the door to file for FDA approval," Bakema told Oilprice.com.
CVR now has several clinical sites where they are initiating trials; they are in IRB (Internal Review Boards, which are necessary in order to engage a university or hospital in human clinical trials) and negotiations at several renowned universities and hospitals throughout the United States.
After a long development journey, CVR is now becoming well-known in the medical community. The potential for research is huge, and "The sky is the limit as far as the amount of news that could come out of clinical relationships we are building now," the CVR CEO told us.
A Market That Needs This Product
"Strokes will absolutely strain the healthcare system," says Bruce Ovbiagele, M.D., M.Sc., professor and chairman of the Department of Neurology at the Medical University of South Carolina, Charleston. Caring for survivors is expensive because stroke can cause long-term disability, he said. "Policy makers at all levels of governance should be aware of this looming crisis so that we can consider practical ways to avert it."
Against the backdrop of devastating stroke statistics, CVR is hoping to make a dramatic impact upon an industry starved for innovation and advancement.
There are 5,564 hospitals in the U.S. alone, in addition to the over 200,000 primary care physicians-many operating primary care practices, and a multitude of specialty clinics. If each relevant medical establishment purchased a single CSS device, CVR Medical would be looking at a multi-billion-dollar market opportunity at $49,000 each.
Globally, well, the potential is that much greater.
And this management team remains undaunted. They've demonstrated strategic vision by leveraging intellectual property, market and industry know-how and key strategic relationships. And they kept it all quiet until it was on a solid path to validation.
Led by Chairman, CEO and President Peter Bakema, with an impressive 30-year track record in business development, since its inception, CVR has brought on respected medical professionals in the industry. COO and Executive VP Tony Robinson has been with CVR for 8 years and has extensive domestic and global healthcare experience, while Dr. W. Douglas Weaver, a member of the BOD Scientific Advisory Board, is the former president of the American College of Cardiology and the former VP and System Medical Director of Heart and Vascular Services at Henry Ford Health System. His over 330 publications related to drug and device discovery have been some of the most influential in our time.
CVR has already invested $23 million into the research and development of their CSS technology, and right now they're at that critical juncture where the path to potential FDA approval is at least visible.
This is a small-cap, so shares are still priced as a small-cap, but once they enter pivotal trials the window of opportunity may have closed significantly. When and if the CSS clears pivotal trials and is followed by a full clinical report, FDA submission is the next step, and then, if successful market clearance and delivery.
Because the expected all-in manufacturing and sales costs are less than half the expected sale proceeds of each CSS device, the company is expecting a very quick and lucrative head start.
In CVR, we're looking at two catalysts in an industry that's all about validation; major demand for a critical medical need; and economics that make real market sense. With arrangements in place for device and components manufacturing already lined up, CVR looks set to benefit greatly on the first sign of positive clinical reports.
Other Biotech and Pharmaceutical companies to watch in the near term:
Teva Pharmaceutical Industries: If Teva isn't already on your investment radar then it certainly should be. While it is a broad play that encapsulates not only biotech but all aspects of pharmaceuticals, it is impossible to ignore the 18 percent jump that this giant saw on Monday the 11th.
This 18.98-billion-dollar market cap company has just hired Karl Schultz as its new CEO and President, a 30 year veteran of the industry who is sure to provide some serious upside. If there is one person you want overseeing your company during a sector boom - it is Karl Schultz
Regeneron Pharmaceuticals (NYSE: REGN): This biopharmaceutical company's shares are at over $490 as of 3 September 2017. And while they haven't broken past their 52-week high of $543.55, and are trading just above their 52-week-low, technical indicators show an uptrend.
Regeneron discovers, invents, develops and brings to market drugs for a number of diseases already, and they have a huge pipeline of medicines for everything from rheumatoid arthritis and asthma to pain, cancer and infectious diseases. Right now, they've got 16 products in clinical development.
Exact Sciences Corp. (NASDAQ: EXAS): is a molecular diagnostics company based in Marlborough, Massachusetts. The company's primary product is the FDA approved at-home DNA screening test. Exact Sciences is also developing other diagnostic tests for the early detection of lung, pancreatic, and esophageal cancers.
Exact Sciences has been in business for over 30 years, and is only growing in size and skill. The company has won a number of awards in the field including the InBusiness Madison 'Best Companies to Work For' and the 2016 10th Annual Prix Galien USA Award.
The company sports a $5.1-billion market cap and trades at a modest $42.79, making it an appealing choice for investors seeking to dip their toes into the medical waters.
Shire PLC (NASDAQ: SHPG): When it comes to biotech companies in the medical space, there is no bigger player than Shire. Specializing in rare diseases and specialized conditions, this 48.51-billion-dollar market cap giant sees consistently high volume and saw its stock price bounce in August following a tough first half of the year.
The biotech boom is sure to provide strong support to the veterans of the industry, and with very limited downside this is a safe way for investors to get in on this market trend. The technicals are looking good here and sentiment has clearly seen a positive shift of late.
Caladrius Biosciences, Inc (NASDAQ: CLBS), founded in New York, New York, is a company which has a solid mission objective which not only focuses on the patients saved by its groundbreaking developments, but also creating tremendous value for its investors. Leading the way in cellular therapies, Caladrius' primary focus is on patients who are suffering from imbalances in their immune system.
The company is also pioneering new technology including its patented T Regulatory Technology and its CD34 technologies which are cutting edge programs seeking to change the way some of the most dangerous illnesses are treated.
Caladrius, with its focus on technology and on its shareholders, is sure to make waves down the line and sharp investors are watching with a close eye.
By Paul Hope
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