Just thought of this last night so it may come out a bit fragmented:
5 million people (keep this number in mind) in this country (one in sixty-four) suffering with — what until now has always been — terminal heart failure. 2012 study with 20 very sick level III and level IV illness and one hospital stay — non-invasively received a balloon like insert around their upper aorta to assist heart pumping — at thisi stage of the technology, carrying a battery on a strap on the outside: 25% actually got cured and off the machinery, 60% permanently improved, the rest did not worsen. 20 patients.
Now a trial with 200 patients should be on the way to get FDA approval — could get early approval by next year if results good enough.
Trouble in our profit centered medical research ways: investors wont pony up the $20-30 million (note this number) required to complete the study — for fear that any patent may be too easy to work around.
This is sort of the opposite extreme situation with Gilead Sciences, Inc wanting $300 billion — $100,000 each 99% effective treatment for 3 million Hepatitis C patients for a drug course it costs Gilead $100 to manufacture.
My thinking: 5 million dying (for now) heart failure patients would gladly put up $6 apiece to fund the sure cure test. OTH, maybe state legislatures could pony up 10 cents a resident ($30 million divided by 320 million Americans); e.g., $1.3 million in Illinois to save 213,000 Illinois lives up front and many thousands more year after year.
Or possibly, heart failure patients could take the “Go Fund Me” approach.
Almost forgot: this C-pulse technology does not enter the blood stream — and therefore causes no problems with blood clots or strokes.
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Novel, implantable device ‘could slow, reverse heart failure’
Honor Whiteman Tuesday 7 October 2014 http://www.medicalnewstoday.com/articles/283566.php
Around 50% of people who develop heart failure die within 5 years of diagnosis. But could a novel, implantable heart device change this? In a clinical trial, the C-Pulse – a cuff that wraps around the aorta and pumps blood from the heart around the body – has proved effective in reversing heart failure, even in some patients with severe cases.
* * * * * * * * * * * * * * * * * * * *
Sunshine Heart develops the C-Pulse device for HF (Heart-Failure) patients. C-Pulse showed outstanding clinical results in the US feasibility study, and EU study, including improvement in HF condition, and recovery.
Heart Failure is poorly treated, resulting in 5 year mortality rate of 60%. C-Pulse targets a huge unmet market of 5.2 million patients in relatively progressed HF stages.
Slow enrollment in the US pivotal trial (the equivalent of an FDA phase III trial), and circumstantial pause and resumption of trial enrollment have lead to dwindling cash.
SSH share price fell rapidly, fueled by panic, tax purposes selling, inability to raise additional cash, fears of approaching bankruptcy, and a poison-pill mechanism preventing an otherwise likely take-over.
Sunshine Heart basically has no other option but pursuing a strategic move soon, that is explored in this article, and can result in substantial gains in the next 6 months.
* * * * * * * * * * * * * * * * * *
The market has turned very hostile toward high-risk small-cap med-tech companies, and Sunshine Heart (NASDAQ:SSH) has long struggled to deliver the sort of progress that would make it easy to argue that the market is being unfair. Although the company has resolved a clinical hold, enrollment rates have been an ongoing long-term disappointment and the company’s targets for reimbursed procedures have proven much too optimistic. With that, that company’s prospects for finishing its pivotal COUNTER HF trial, let alone advancing a better, fully implantable, version of its technology without exceptionally dilutive/expensive financing has basically vanished. The company’s C-Pulse device does seem to provide benefits and quality of life improvements to the majority of patients who get it, but …
Dennis,
You have hit on one of my major pet peeves, and that is our for-profit health care so-called ‘system’. From the drug manufacturers to the insurance companies, and more and more to the actual care providers, it seems everyone wants their pound of flesh.
This fight is not just about dollars, however. This goes to the heart of who we are as a people. This is a moral battle. Do we believe every life matters, and health care is a basic human right, or do we believe that the only ones who should be assured of life-saving treatments are those who can pay the freight?
I watched a segment on the news last night about a new biometric treatment for cancer that is having great success – using our own immune systems to block the cancer’s reproduction. I’m sure these treatments are outrageously expensive. But unlike flat screen TVs, the price seldom comes down later on. So who lives and who dies?
Little is said these days about how much research that drug companies build on was/is done on the public dime. Yes, the manufacturers have expenses in years of trials, no one is disputing that. But their argument is ‘Poor us, we have to bear the cost of developing and marketing these life-giving drugs, and you are such a bunch of ungrateful socialist whiners for denying us that right.”
So, maybe the NIH should quit doing basic research, or better yet, charge the $hit of drug companies for the rights and privileges of developing them further. I don’t believe (someone please correct me if I’m wrong), the NIH ever gets to patent anything THEY come up with. And their funding has been repeatedly cut by the very congress idiots who insist we suckers must pay whatever Big Pharma decides to charge.
Sandi,
In the case of Sovaldi (Hep C, 99% cure) the government paid for the initial, “risky” research. As soon as they smelled money the researchers sought out private funding so to enrich themselves if things turned out. The chief researcher make $446 million for himself — not a bad year or so’s pay.
My Diabetes II cure, Bydureon, which ups my insulin flow and downs my sugar flow — and made me lose 50 pounds in the first 50 weeks w/o effort — was discovered in the saliva of a Gila monster by a VA researcher (the right hand man to a Noble winner) who is still probably working on salary. Doesn’t keep the drug company from charging $700/mo retail to the highest payers — for what cost them probably $20 to make.
Just a thought: maybe the government could just pay for all trials — that’s the big cost (billions?) I think. Nobody could say that would inhibit private innovation — encourage it for good motives anyway.
It doesn’t matter what we believe; it matter is we have the power to protect ourselves. I just ended a comment somewhere else with this — at the risk of being repetitive it’s about no longer discussing every issue (opportunity, education, whatever) IN THE CONTEXT of our society which is missing an economic organ that is as important as any other single component of democracy: high union density …
… AND THE SUPER-SIMPLE, SET-IT-AND-FORGET-IT cure.
Every other form of serious market muscling is a big felony (don’t even try to take a movie in the movies). Make something a felony backed auto by RICO that is not even a ticket now. Make union busting a felony. Progressive states start — just get out of the way — no longer the need for endless articles about how to deal with our pathologies IN THE CONTEXT of a labor union free market.
Just make union busting a felony and take the rest of the decade off while our problems fix them selves.
Which I initially thought would be a real hit to the user base – much harder to view privately etc. But commenter pointed out also creates much better environment for video ads. Ka Ching.
This is clearly an area where the NIH could take over the development work and expense.
And, yes, major drug companies have some serious profit margins. (But then again, this report says “Publishing – periodicals” has a higher profit margin. I find that hard to believe.) https://biz.yahoo.com/p/sum_qpmd.html
Finally, I agree that health care is a basic human right, but that means that the government should to protect your access to it, not that the government should pay for it. We have the right to keep and bear arms. That does not mean the government has to buy everyone an M-16 and an M-9.
Just thought of this last night so it may come out a bit fragmented:
5 million people (keep this number in mind) in this country (one in sixty-four) suffering with — what until now has always been — terminal heart failure. 2012 study with 20 very sick level III and level IV illness and one hospital stay — non-invasively received a balloon like insert around their upper aorta to assist heart pumping — at thisi stage of the technology, carrying a battery on a strap on the outside: 25% actually got cured and off the machinery, 60% permanently improved, the rest did not worsen. 20 patients.
Now a trial with 200 patients should be on the way to get FDA approval — could get early approval by next year if results good enough.
Trouble in our profit centered medical research ways: investors wont pony up the $20-30 million (note this number) required to complete the study — for fear that any patent may be too easy to work around.
This is sort of the opposite extreme situation with Gilead Sciences, Inc wanting $300 billion — $100,000 each 99% effective treatment for 3 million Hepatitis C patients for a drug course it costs Gilead $100 to manufacture.
My thinking: 5 million dying (for now) heart failure patients would gladly put up $6 apiece to fund the sure cure test. OTH, maybe state legislatures could pony up 10 cents a resident ($30 million divided by 320 million Americans); e.g., $1.3 million in Illinois to save 213,000 Illinois lives up front and many thousands more year after year.
Or possibly, heart failure patients could take the “Go Fund Me” approach.
Almost forgot: this C-pulse technology does not enter the blood stream — and therefore causes no problems with blood clots or strokes.
*********************************
*********************************
Novel, implantable device ‘could slow, reverse heart failure’
Honor Whiteman Tuesday 7 October 2014
http://www.medicalnewstoday.com/articles/283566.php
Around 50% of people who develop heart failure die within 5 years of diagnosis. But could a novel, implantable heart device change this? In a clinical trial, the C-Pulse – a cuff that wraps around the aorta and pumps blood from the heart around the body – has proved effective in reversing heart failure, even in some patients with severe cases.
* * * * * * * * * * * * * * * * * * * *
Sunshine Heart – A Speculative Biotech Play For Substantial Short-Term Gains
Doron Fael Jan.14.16 | About: Sunshine Heart, Inc. (SSH)
http://seekingalpha.com/article/3811136-sunshine-heart-speculative-biotech-play-substantial-short-term-gains
Sunshine Heart develops the C-Pulse device for HF (Heart-Failure) patients. C-Pulse showed outstanding clinical results in the US feasibility study, and EU study, including improvement in HF condition, and recovery.
Heart Failure is poorly treated, resulting in 5 year mortality rate of 60%. C-Pulse targets a huge unmet market of 5.2 million patients in relatively progressed HF stages.
Slow enrollment in the US pivotal trial (the equivalent of an FDA phase III trial), and circumstantial pause and resumption of trial enrollment have lead to dwindling cash.
SSH share price fell rapidly, fueled by panic, tax purposes selling, inability to raise additional cash, fears of approaching bankruptcy, and a poison-pill mechanism preventing an otherwise likely take-over.
Sunshine Heart basically has no other option but pursuing a strategic move soon, that is explored in this article, and can result in substantial gains in the next 6 months.
* * * * * * * * * * * * * * * * * *
Can Sunshine Heart Survive To See The Dawn?
Stephen Simpson, CFA
http://seekingalpha.com/article/3934666-can-sunshine-heart-survive-see-dawn?auth_param=17tckm:1bd3k0r:1333c28776918ba740d9bea4d932addc&dr=1
The market has turned very hostile toward high-risk small-cap med-tech companies, and Sunshine Heart (NASDAQ:SSH) has long struggled to deliver the sort of progress that would make it easy to argue that the market is being unfair. Although the company has resolved a clinical hold, enrollment rates have been an ongoing long-term disappointment and the company’s targets for reimbursed procedures have proven much too optimistic. With that, that company’s prospects for finishing its pivotal COUNTER HF trial, let alone advancing a better, fully implantable, version of its technology without exceptionally dilutive/expensive financing has basically vanished. The company’s C-Pulse device does seem to provide benefits and quality of life improvements to the majority of patients who get it, but …
Dennis,
You have hit on one of my major pet peeves, and that is our for-profit health care so-called ‘system’. From the drug manufacturers to the insurance companies, and more and more to the actual care providers, it seems everyone wants their pound of flesh.
This fight is not just about dollars, however. This goes to the heart of who we are as a people. This is a moral battle. Do we believe every life matters, and health care is a basic human right, or do we believe that the only ones who should be assured of life-saving treatments are those who can pay the freight?
I watched a segment on the news last night about a new biometric treatment for cancer that is having great success – using our own immune systems to block the cancer’s reproduction. I’m sure these treatments are outrageously expensive. But unlike flat screen TVs, the price seldom comes down later on. So who lives and who dies?
Little is said these days about how much research that drug companies build on was/is done on the public dime. Yes, the manufacturers have expenses in years of trials, no one is disputing that. But their argument is ‘Poor us, we have to bear the cost of developing and marketing these life-giving drugs, and you are such a bunch of ungrateful socialist whiners for denying us that right.”
So, maybe the NIH should quit doing basic research, or better yet, charge the $hit of drug companies for the rights and privileges of developing them further. I don’t believe (someone please correct me if I’m wrong), the NIH ever gets to patent anything THEY come up with. And their funding has been repeatedly cut by the very congress idiots who insist we suckers must pay whatever Big Pharma decides to charge.
Sandi,
In the case of Sovaldi (Hep C, 99% cure) the government paid for the initial, “risky” research. As soon as they smelled money the researchers sought out private funding so to enrich themselves if things turned out. The chief researcher make $446 million for himself — not a bad year or so’s pay.
My Diabetes II cure, Bydureon, which ups my insulin flow and downs my sugar flow — and made me lose 50 pounds in the first 50 weeks w/o effort — was discovered in the saliva of a Gila monster by a VA researcher (the right hand man to a Noble winner) who is still probably working on salary. Doesn’t keep the drug company from charging $700/mo retail to the highest payers — for what cost them probably $20 to make.
Just a thought: maybe the government could just pay for all trials — that’s the big cost (billions?) I think. Nobody could say that would inhibit private innovation — encourage it for good motives anyway.
It doesn’t matter what we believe; it matter is we have the power to protect ourselves. I just ended a comment somewhere else with this — at the risk of being repetitive it’s about no longer discussing every issue (opportunity, education, whatever) IN THE CONTEXT of our society which is missing an economic organ that is as important as any other single component of democracy: high union density …
… AND THE SUPER-SIMPLE, SET-IT-AND-FORGET-IT cure.
Every other form of serious market muscling is a big felony (don’t even try to take a movie in the movies). Make something a felony backed auto by RICO that is not even a ticket now. Make union busting a felony. Progressive states start — just get out of the way — no longer the need for endless articles about how to deal with our pathologies IN THE CONTEXT of a labor union free market.
Just make union busting a felony and take the rest of the decade off while our problems fix them selves.
This slashdot story says facebook will be all video no text within 5 years: https://tech.slashdot.org/story/16/06/15/1921217/executive-says-facebook-will-be-all-video-no-text-in-5-years
Which I initially thought would be a real hit to the user base – much harder to view privately etc. But commenter pointed out also creates much better environment for video ads. Ka Ching.
First, the government does patent its inventions. That includes the NIH.
https://techtransfer.cancer.gov/intellectualproperty/patents/nih-patent-policy
This is clearly an area where the NIH could take over the development work and expense.
And, yes, major drug companies have some serious profit margins. (But then again, this report says “Publishing – periodicals” has a higher profit margin. I find that hard to believe.)
https://biz.yahoo.com/p/sum_qpmd.html
Finally, I agree that health care is a basic human right, but that means that the government should to protect your access to it, not that the government should pay for it. We have the right to keep and bear arms. That does not mean the government has to buy everyone an M-16 and an M-9.