Could This Endure The Biggest Biotech Breakthrough Of The Year?
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Title : Could This Endure The Biggest Biotech Breakthrough Of The Year?
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CVR’s Carotid Stenotic Scan (CSS) is a tool to observe blockage inside the Carotid Arteries, potentially offering patients together with caregivers a device for early on detection inwards a quick together with repeatable manner.
By. Ian Jenkins
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FORWARD-LOOKING STATEMENT. Statements inwards this communication which are non purely historical are forward-looking statements together with include statements regarding beliefs, plans, intent, predictions or other statements of time to come tense. Forward-looking statements inwards this press release include that CVR’s engineering scientific discipline tin successfully last deployed for early on detection of stroke; that CVR’s engineering scientific discipline may have got a major touching on on the medical device industry; that CVR tin sign a definitive manufacturing understanding to give it state-of-the-art manufacturing capabilities with Canon Virginia, Inc together with immediate scalability; that CVR’s device offering a way to seat those at peril of a stroke together with arming the healthcare provider with the information to foreclose it; that the device ca last used without the assistance of a certified technician; that this could potentially last 1 of the most lucrative phenomena inwards recent medical equipment marketplace history; that the device makes testing cheap, affordable together with accessible to all; that the CSS device tin last sold profitably at $49,000 per unit; that CVR is moving to pivotal trials together with with that volition last closer to FDA approval; that CVR’s clinical relationships have got cracking potential; that the manufacturing together with sales costs are expected to last less than one-half the sale proceeds; that CVR is non expecting to have got to enhance whatever coin until 2018; together with that CVR have got intellectual protection on our technology. Actual events or results may differ materially from those projected inwards whatever of such statements due to diverse factors, including the risks together with uncertainties inherent inwards medical device development, which include, without limitation, the potential failure of device candidates to advance through clinical studies or demonstrate security together with efficacy inwards clinical testing; CVR’s might to retain fundamental employees; its might to finance development; together with its might to satisfy the rigorous regulatory requirements for novel medical devices. Good results inwards little trials together with with express cases does non necessarily atomic number 82 to the same skillful results for large numbers or inwards the full general public. Our costs may last higher than expected together with CVR may bespeak to growth the expected sales toll of its device and/or enhance additional funds from the sale of equity prior to 2018. Competitors may develop amend or cheaper alternatives to CVR’s products. Having intellectual belongings rights does non guarantee that they may non last successfully challenged, or that nosotros may last infringing on the intellectual belongings of others. CVR may non last able to come upwards to in conclusion agreements with expected contract partners, it may non last able to commercialize its products together with fifty-fifty if it does, it may non realize whatever profit. The potential marketplace may last much smaller than expected. Readers are cautioned non to seat undue reliance on these forward-looking statements, which speak only equally of the appointment hereof. All forward-looking statements are qualified inwards their entirety yesteryear this cautionary contestation together with nosotros undertake no obligation to revise or update this information to reverberate events or circumstances later on today’s date. Readers should also refer to the peril factors disclosure outlined inwards CVR’s periodic reports filed from time-to-time with the securities regulators.
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Title : Could This Endure The Biggest Biotech Breakthrough Of The Year?
Could This Endure The Biggest Biotech Breakthrough Of The Year?
Advertorial
By Ian Jenkins
Someone dies of a stroke every 4 minutes inwards the United States. Globally, fifteen 1 G one thousand people endure a stroke every year. It’s debilitating physically together with financially—but 1 little-known society has developed a medical device that hopes to challenge that deadly statistic.
It’s been quietly developing this novel engineering scientific discipline for 10 years. Now it’s released updated preliminary clinical trial results, together with signed a manufacturing bargain which could brand a meaning touching on inwards the medical device industry.
After a decade of painstaking development, we’re right away nearing the halt of the long route to validation, together with for investors who sympathise this industry, this could last the critical juncture.
The little-known society is
CVR Medical (TSX:CVM.V; OTC:CRRVF), together with its potentially life-saving device is the Carotid Stenotic Scan (CSS)--a engineering scientific discipline designed to observe stenosis inside arteries, or Ischemia, which is the leading indicator of strokes. Of the fifteen 1 G one thousand people who endure stroke every year, some half dozen 1 G one thousand are killed, piece v 1 G one thousand are rendered permanently disabled, according to the World Heart Foundation.
But in that location has been no cost-effective way to hide for Ischemia.
So, when a biotech society offers a potential solution to assist foreclose the second-leading travail of death inwards the world--and together with then releases positive preliminary clinical trial results, investors listen.
Now it’s hoping to accuse out of the gate together with pick out the marketplace yesteryear tempest 1 time it manages to gain FDA marketplace clearance.
In the meantime, the catalysts are truly lining up:
On vii September, CVR released updated results from its preliminary clinical trial that showed forrard progress for the medical device, which we’ve been watching closely for some time. You tin sentiment the results from Thomas Jefferson University HERE.
And a few weeks prior, they announced some other landmark achievement when they signed a missive of the alphabet of intent to manufacture the CSS. The bargain gives CVR state-of-the-art manufacturing capabilities with Canon Virginia, Inc (CVI). This would give CVR immediate scalability, together with also adds to its credibility: It’s not the first manufacturing bargain the society has sealed.
Our researchers are keeping a closed optic on CVR Medical Corp. because nosotros retrieve this is the turning point. Here’s why:
- It’s had ii fresh catalysts inwards iii weeks inwards an manufacture that is all close validation
- It’s developing a device that meets critical need inwards terms of helping to foreclose 1 of the most debilitating together with deadly diseases of our fourth dimension
- It’s developing a medical device that truly makes sense to the market
- It’s been doing it quietly, without blockbuster hype, together with instead painstakingly going for existent validation, making it the existent deal.
Here are v reasons to maintain a closed optic on CVR Medical (TSX:CVM.V; OTC:CRRVF) inwards the coming weeks together with months:
#1 Catalysts are Lining Up, together with News Flow is Gaining Momentum
First, 1 way to facial expression at the CSS is to retrieve close what 3D seismic imagery did for super quick discoveries inwards the stone oil together with gas industry. This is just what CVR’s sensory organization could do for the medical manufacture inwards terms of detecting critical stroke symptoms.
This is how it works:
CVR’s Carotid Stenotic Scan (CSS) is a tool to observe blockage inside the Carotid Arteries, potentially offering patients together with caregivers a device for early on detection inwards a quick together with repeatable manner.
The CSS makes a connection betwixt fluid flow together with depression frequency soundwaves to observe arterial illness or blockage. Blood flowing through the carotid arteries produces moving ridge patterns which are shaped together with altered yesteryear the presence of irregularities on the inner artery walls.
CVR’s advanced engineering scientific discipline captures these moving ridge patterns together with analyzes them mathematically with patented algorithms. After a brief test, the analysis is complete, offering a way to potentially seat those at peril of a stroke together with arming the healthcare provider with the information necessary to foreclose the deadly event.
Unlike other comparative modalities, the CSS was designed to component without the assistance of a certified technician. These iii facts combine to create 1 of the potentially biggest—and most lucrative--phenomena inwards recent medical equipment marketplace history.
The updated results of the preliminary clinical trials released only right away convey the benefits of this device that much closer. Not only could it potentially assist foreclose strokes through early on detection of arterial disease, but in that location is a secondary benefit: if all goes according to plan, it makes testing cheap, affordable together with accessible to all.
#2 CSS Makes Market Sense at $49,000 Per Unit
Detecting the early on signs of a stroke—before it’s equally good late—is a major challenge for our medical establishments. Often diagnoses are wrong. Usually, they are expensive.
CVR Medical’s (TSX:CVM.V; OTC:CRRVF) device, inwards piece of cake stage clinical trials, is expected to cost an estimated $49,000 per unit of measurement for detecting Ischemia, again—the leading indicator of stroke.
CT scans are the most common method of diagnosing a stroke—but unremarkably later on it’s already happened, together with fifty-fifty then, stroke is non ever seen on CT scans. CT scans tin predict peril of stroke inwards patients who have got suffered transient ischemic attacks (TIA), or ‘mini-strokes’, but its costs anywhere from $825 to $4800 for a CT scan, depending on your MD together with your insurance. That’s because CT scanners cost between $1 1 G one thousand together with $2.5 1 G one thousand dollars each.
Coming inwards at the planned $49,000 per unit, compared to upwards to $2.5 million, CVR Medical’s CSS makes marketplace sense. But beyond that, the CT scan isn’t plenty for detection.
According to the Centers for Disease Control (CDC), early activity is vital for survival, together with only 38 pct of stroke sufferers fifty-fifty recognize they are having a stroke inwards fourth dimension to have effective emergency intervention.
#3 Urgent Need, Hungry Market
Few things are to a greater extent than urgent than an early on detection organization for a medical status that kills half dozen 1 G one thousand people a year. In the U.S. alone, 1 American dies from stroke every 4 minutes, together with right right away the U.S. decease toll from strokes stands at upwards of 130,000 each year. Annually, to a greater extent than than 795,000 Americans endure a stroke.
“Strokes volition absolutely strain the healthcare system,” says Bruce Ovbiagele, M.D., M.Sc., professor together with chairman of the Department of Neurology at the Medical University of South Carolina, Charleston. Caring for survivors is expensive because stroke tin travail long-term disability, he said. “Policy makers at all levels of governance should last aware of this looming crisis so that nosotros tin consider practical ways to avert it.”
Against the backdrop of these devastating statistics, CVR is hoping to brand a dramatic touching on upon an manufacture starved for conception together with advancement.
The CSS is a groundbreaking tool that tin assess Carotid Arterial wellness inwards a way that has never been available to a patient, healthcare provider, or the payor inwards our electrical current healthcare system.
There are 5,564 hospitals inwards the U.S. alone, inwards add-on to the over 200,000 principal tending physicians—many operating principal tending practices, together with a multitude of specialty clinics. If each relevant medical institution purchased a unmarried CSS device, CVR Medical would last looking at a multi-billion-dollar marketplace chance at $49,000 each.
The global market, then, is gargantuan—and CVR says it’s eyeing that equally well, eventually.
#4 Finally, a Solid, Sober Small-Cap Dream Team inwards the Medical Segment
Clinical trials are huge milestones for pharmaceutical together with medical device companies, together with in that location is zip to a greater extent than of import than this. More neglect than succeed when it comes to clinical trials, together with the winners are big.
Clinical trials are huge milestones for pharmaceutical together with medical device companies, together with in that location is zip to a greater extent than of import than this. More neglect than succeed when it comes to clinical trials, together with the winners are big.
But smart investors inwards this segment aren’t looking for early on blockbuster potential—they’re looking for solidity, efficacy together with long-term marketplace disrupting potential.
The company’s debut medical device, the Carotid Stenotic Scan (CSS), has been quietly inwards evolution for 10 years. Instead of trying to lure inwards investors with early on stage blockbuster talk, it waited until evolution was real, together with the long route to validation came visibly closer to the lite at the halt of the tunnel.
The get-go matter that comes to heed when yous encounter the squad behind CVR together with the evolution of this breakthrough engineering scientific discipline is an unheard-of modesty together with professionalism. This squad has demonstrated the strategic vision of a supergiant yesteryear leveraging intellectual property, marketplace together with manufacture know-how together with fundamental strategic relationships.
But what is most inviting inwards the tricky small-cap earth of pharmaceuticals together with medical devices is that this squad kept its CSS evolution tranquility until recently. There was no hype together with no pump. Now they are on the corporation path to existent validation. This lonely signals a sober solidity that makes a small-cap bet on a large-cap marketplace attractive.
Led yesteryear Chairman, CEO together with President Peter Bakema, with an impressive 30-year rail tape inwards describe of piece of employment organization development, since its inception, CVR (TSX:CVM.V; OTC:CRRVF) has brought on some of the most respected medical professionals inwards the industry.
- Tony Robinson, COO together with Executive Vice-President has been with CVR for 8 years together with has extensive domestic together with global healthcare experience.
- Michael Rhodes, VP of Quality Systems, is a one-time VP for Quality for HSBC together with Motorola. He has 20 years of sense inwards multiple markets.
- Dr. W. Douglas Weaver, a fellow member of the BOD Scientific Advisory Board, is the one-time president of the American College of Cardiology together with the one-time VP together with System Medical Director of Heart together with Vascular Services at Henry Ford Health System. His over 330 publications related to drug together with device uncovering have got been some of the most influential inwards our time.
Together, they are on a trajectory that plans to convey a long-sought-after solution to helping observe the peril of ischemic stroke to the marketplace inwards an affordable together with accessible way. Their latest intelligence also comes at a really critical fourth dimension on our nation’s—and indeed, the world’s—healthcare story.
And now, next the release of updated preliminary clinical results from Thomas Jefferson University, Bakema is create to speak out.
“You can’t come upwards out with a lot of changes piece yous are validating, so nosotros are almost over that hurdle. We are nearly moving into pivotal trials, which puts us right at the door for FDA approval,” he stated inwards a recent interview.
CVR right away has several clinical sites where they are initiating trials at ii of the leading query hospitals inwards the country. Doctors at both are “excited close getting CSS inwards there, together with nosotros have got many other sites interested inwards conducting addional trials” says Bakema.
After a long evolution journey, CVR is right away becoming well-known inwards the medical community. The potential for query is huge, together with “the heaven is the bound equally far equally the amount of intelligence that could come upwards out of clinical relationships nosotros are edifice now,” the CVR CEO told us.
#5 Still Priced Like Early Stage Company
CVR (TSX:CVM.V; OTC:CRRVF) has already invested US$23 1 G one thousand into the query together with evolution of their breakthrough CSS technology, together with right right away they’re at that critical juncture where the path to potential FDA blessing is at to the lowest degree visible.
CVR (TSX:CVM.V; OTC:CRRVF) has already invested US$23 1 G one thousand into the query together with evolution of their breakthrough CSS technology, together with right right away they’re at that critical juncture where the path to potential FDA blessing is at to the lowest degree visible.
This is a small-cap, so shares are notwithstanding priced equally a small-cap, but 1 time they travel inwards pivotal trials the window of chance may have got closed significantly. When together with if the CSS clears pivotal trials together with is followed yesteryear a total clinical report, FDA submission is the adjacent step, together with then—if successful—market clearance together with delivery.
Because the expected all-in manufacturing together with sales costs are less than one-half the sale proceeds, the society is expecting a really quick together with lucrative caput start. The squad has already lined upwards manufacturing together with components, so 1 time the clinical reports are in, together with the FDA hurdle is cleared, sales together with profits could start quickly.
They’ve also got $2 1 G one thousand inwards the banking concern together with a number of warrants existence exercised.
A fundamental indicator of where this is going came inwards August, when CVR announced that later on years of development, it signed a missive of the alphabet of intent with Canon Virginia, Inc. (CVI), a domestic manufacturing subsidiary of Canon U.S.A., Inc. The deal, when fully executed, way that Cannon volition manufacture the CSS at its state-of-the-art facilities. It’s a human relationship that, according to Bakema, is highly important, non only for credibility, but also for scalability together with reduced cost of entry to market.
Other recent manufacturing deals have got also poised CVR for success right out of the gate. In March, they announced a partnership with ADCO Circuits, which volition last the exclusive provider of CSS custom circuit boards for its sensors.
In combination with the of late updated preliminary clinical results, growing clinical relationships together with the movement towards hoped-for FDA approval, the catalysts for CVR Medical (TSX:CVM.V; OTC:CRRVF) are building—fast.
The timing couldn’t last better, for investors—or for the millions of people falling victim to stroke around the earth every year.
By. Ian Jenkins
Sources:
http://www.nytimes.com/health/guides/disease/stroke-secondary-to-carotid-stenosis/print.html?mcubz=3
http://www.newsfilecorp.com/release/25684/CVR-Medical-Teams-with-Tech-Manufacturer-ADCO-Circuits#.Wa7VXK2ZO8U
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This communication is for amusement purposes only. Never invest purely based on our communication. Gains mentioned inwards our newsletter together with on our website may last based on end-of- twenty-four hours or intraday data. If nosotros ain whatever shares nosotros volition listing the information relevant to the stock together with number of shares here. We have got been compensated yesteryear CVR Medical Corp. to comport investor awareness advertising together with marketing for [TSX:CVM.V together with OTC:CRRVF]. Oilprice.com receives fiscal compensation to promote world companies. This compensation is a major conflict of involvement inwards our might to last unbiased. Therefore, this communication should last viewed equally a commercial promotion only. We have got non investigated the background of the company. The 3rd party, profiled company, or their affiliates may liquidate shares of the profiled society at or close the fourth dimension yous have this communication, which has the potential to wound percentage prices. Any non- compensated alerts are purely for the role of expanding our database for the do goodness of our time to come financially compensated investor awareness efforts. Frequently companies profiled inwards our alerts sense a large growth inwards book together with percentage toll during the course of educational activity of investor awareness marketing, which frequently halt equally shortly equally the investor awareness marketing ceases. The investor awareness marketing may last equally brief equally 1 day, later on which a large decrease inwards book together with percentage toll is probable to occur. Our emails may comprise forrard looking statements, which are non guaranteed to materialize due to a multifariousness of factors.
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NOT AN INVESTMENT ADVISOR. The Company is non registered or licensed yesteryear whatever governing trunk inwards whatever jurisdiction to give investing advice or render investment recommendation. ALWAYS DO YOUR OWN RESEARCH together with consult with a licensed investment professional person earlier making an investment. This communication should non last used equally a ground for making whatever investment.
INDEMNIFICATION/RELEASE OF LIABILITY. By reading this communication, yous grip to the terms of this disclaimer, including, but non express to: releasing The Company, its affiliates, assigns together with successors from whatever together with all liability, damages, together with injury from the information contained inwards this communication. You farther warrant that yous are solely responsible for whatever fiscal outcome that may come upwards from your investment decisions.
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FORWARD-LOOKING STATEMENT. Statements inwards this communication which are non purely historical are forward-looking statements together with include statements regarding beliefs, plans, intent, predictions or other statements of time to come tense. Forward-looking statements inwards this press release include that CVR’s engineering scientific discipline tin successfully last deployed for early on detection of stroke; that CVR’s engineering scientific discipline may have got a major touching on on the medical device industry; that CVR tin sign a definitive manufacturing understanding to give it state-of-the-art manufacturing capabilities with Canon Virginia, Inc together with immediate scalability; that CVR’s device offering a way to seat those at peril of a stroke together with arming the healthcare provider with the information to foreclose it; that the device ca last used without the assistance of a certified technician; that this could potentially last 1 of the most lucrative phenomena inwards recent medical equipment marketplace history; that the device makes testing cheap, affordable together with accessible to all; that the CSS device tin last sold profitably at $49,000 per unit; that CVR is moving to pivotal trials together with with that volition last closer to FDA approval; that CVR’s clinical relationships have got cracking potential; that the manufacturing together with sales costs are expected to last less than one-half the sale proceeds; that CVR is non expecting to have got to enhance whatever coin until 2018; together with that CVR have got intellectual protection on our technology. Actual events or results may differ materially from those projected inwards whatever of such statements due to diverse factors, including the risks together with uncertainties inherent inwards medical device development, which include, without limitation, the potential failure of device candidates to advance through clinical studies or demonstrate security together with efficacy inwards clinical testing; CVR’s might to retain fundamental employees; its might to finance development; together with its might to satisfy the rigorous regulatory requirements for novel medical devices. Good results inwards little trials together with with express cases does non necessarily atomic number 82 to the same skillful results for large numbers or inwards the full general public. Our costs may last higher than expected together with CVR may bespeak to growth the expected sales toll of its device and/or enhance additional funds from the sale of equity prior to 2018. Competitors may develop amend or cheaper alternatives to CVR’s products. Having intellectual belongings rights does non guarantee that they may non last successfully challenged, or that nosotros may last infringing on the intellectual belongings of others. CVR may non last able to come upwards to in conclusion agreements with expected contract partners, it may non last able to commercialize its products together with fifty-fifty if it does, it may non realize whatever profit. The potential marketplace may last much smaller than expected. Readers are cautioned non to seat undue reliance on these forward-looking statements, which speak only equally of the appointment hereof. All forward-looking statements are qualified inwards their entirety yesteryear this cautionary contestation together with nosotros undertake no obligation to revise or update this information to reverberate events or circumstances later on today’s date. Readers should also refer to the peril factors disclosure outlined inwards CVR’s periodic reports filed from time-to-time with the securities regulators.
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