AstraZeneca (AZN) - The Next Big Biotech Breakthrough Could Just Be On The Horizon

A little-known, visionary biotech company is gearing up to release a potentially ground-breaking medical device that could help prevent strokes. It could help save six million lives a year—or a life every 4 minutes.

The unique new technology is the Carotid Stenotic Scan (CSS), by CVR Medical, and its futuristic system is designed to sense the leading indicator of strokes in only 2 minutes, and at a cost that will make it affordable and accessible to everyone.

CVR Medical (TSX:CVM.V ; OTC:CRRVF) is ready to burst out of the gate directly into a massive market. Here’s why:

- This is unprecedented: Pre-stroke intervention has never before been affordable and accessible

- It’s not invasive and preliminary tests demonstrate that in most cases it takes only 2 minutes

- The patented technology is positioned to own this huge market segment

- A CSS unit costs roughly $49,000, while current technology costs up to $2.5 million, making it economically out of reach

- Over 230,000 medical facilities in the U.S. alone could potentially want the device, and globally the demand could be huge

- The visionary team has invested $23 million in development and is expecting preliminary clinical results any day now

For the First Time in History: An Affordable Solution to a Multi-Billion-Dollar Problem

Stroke statistics are shocking: Globally, every year 15 million people suffer a stroke. In the U.S. alone, nearly 800,000 people suffer from a stroke annually.

Currently, one out of every 20 deaths in America is caused by stroke, making this one of the most pressing medical problems of our time.

Until now, there has been no cost-effective way to screen for the leading indicator of Ischemic strokes, which cost the U.S. government alone over 30 billion dollars a year in healthcare expenses.

CVR Medical (TSX:CVM.V ; OTC:CRRVF), the company behind this medical device, has been quietly developing the technology for 10 years—and now it’s ready for its life-changing debut.

The company reckons that its diagnostic tool could not only help the millions of lives affected by Ischemia, the leading cause of stroke, but could also significantly reduce the tragic debilitation some 5 million people suffer every year because of stroke.

CVR’s early detection technology does not depend on the user for accuracy and provides results in only 2 minutes.

When it takes only 2 minutes to detect the leading indicator of stroke with a device that costs only $49,000 compared to up to $2.5 million for current technology—the market potential is phenomenal.

CVR’s technology is positioned to own this market segment

A low-cost, low maintenance pre-stroke medical intervention could benefit the entire society. Ischemia detection technology could save the U.S. government up to $34 billion a year, which is how much the Centers for Disease Control (CDC) say strokes cost the U.S. annually.

According to the CDC, early action is urgent for survival, and only 38 percent of stroke sufferers even recognize they are having a stroke in time to receive effective emergency intervention.

Amid this urgency, the market is massive—and it’s hungry for a breakthrough.

In the U.S. alone, the market includes 234,615 primary care offices, specialist offices, hospitals and clinics—all of which would benefit from CVR’s ground-breaking, affordable, non-invasive and easy-to-use technology to help the millions of people who suffer from carotid artery disease, or Ischemia.

If these facilities bought just one CSS pre-stroke intervention system, we would be looking at billions in revenue. CVR expects to fully penetrate not only the domestic market, but the gargantuan global market.

Because the all-in costs are less than half the sale costs, the company is expecting a very quick and lucrative head start.

Brilliant Technology, Visionary Developers

CSS is a screening tool that is designed to detect and measure carotid arterial stenosis to identify patients at risk from Ischemic Stroke.

CSS technology makes a connection between fluid flow and sub-sonic 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 is designed to capture these wave patterns and analyze them mathematically with patented algorithms.

With a quiet modesty and professionalism rare in the biotech industry, the dream team behind the technology has not only developed something that could radically change how we deal with the number 2 cause of death in the U.S., but it’s also expertly leveraged intellectual property, market sentiment and strategic partnerships.

CVR Medical (TSX:CVM.V ; OTC:CRRVF) recently teamed up with Hitachi (NYSE:HIT), which will develop and create the processing unit to operate the Carotid Stenotic Scan device, enabling CVR Medical to be able to interpret the sub-sonic and infrasonic sound waves it collects in real time.

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 some of the most respected medical professionals in the industry.

- Tony Robinson, COO and Executive Vice-President has been with CVR for 8 years and has extensive domestic and global healthcare experience.  

- Michael Rhodes, VP of Quality Systems, is a former VP for Quality for HSBC and Motorola. He has 20 years of experience in multiple markets.

- 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.

Together, they are on a trajectory which will revolutionize healthcare by offering easily accessible, affordable early detection for a potentially massive market share at a very critical time in our healthcare story.

Like the X-ray, invented in 1895 and enriching medical investors with wild implications for clinical practice, CVR’s early stroke detection device is poised to spark changes far beyond the widespread implementation of the device itself. Indeed, the CSS is only the first phase of CVR’s plans to contribute in a very positive way to medical diagnostics.

Cashed-Up, Patented, and Ready to Take the Market by Storm

CVR (TSX:CVM.V ; OTC:CRRVF) has invested $23 million in this technology, with early stage clinical trials complete and now headed toward pivotal trials, eyeing the potential for immediate profitability once FDA market clearance is obtained.

This means there’s only a short window of opportunity between market and profitability.

The critical timeframe is now: The release of a preliminary clinical report is pending any day, and then the full clinical report will follow in 4-8 weeks. Once that happens, the next step is FDA submission, and if successful, delivery to the market.

The team has already lined up manufacturing and components, so once the clinical reports are in, and the FDA hurdle is cleared, it’s breakout time.

For biotech in general, 2017 will be the critical breakout year. For CVR Medical’s patented pre-stroke intervention system, it will be the debut of an amazing new technology that promises to capture the lion’s share of a multi-billion-dollar market that could hit out hard at one of the most pressing medical issues of our time.

And if all that wasn’t enough, we are seeing major gains this year by cellular immunotherapies, reporting 90 percent remission rates for acute lymphoblastic leukemia (ALL). This should go before the FDA this year and could trigger a wave of approvals for other blood cancers and lymphomas, and could eventually replace chemotherapy. Among many other positive developments in recent years, in December 2014, Amegen (NYSE:AMGN) won FDA approval for immunotherapy Blincyto, and large-cap AstraZeneca (NYSE:AZN) is also poised for major gains in redefining cancer treatment.

Liquid biopsies, or blood tests that uncover signs of actual DNA or cell-free circulating tumor DNA (ctDNA), could prove to be a revolutionary cancer test with annual sales forecast to be $10 billion. Cancer Genetics, Inc. (NASDAQ:CGIX) now has five programs to develop and validate multi-market liquid biopsy tests. And bioabsorbable stents, approved in the U.S. in July for the first time, have an amazing market potential approaching $2 billion in six years, with this year the critical juncture. Prominent North American players in this market include Abbott (NYSE:ABT) and Reva Medical Inc. (ASX:RVA).

It is a transformative time in the biotech industry, and CVR looks to be entering the market at just the right moment.

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