Open thread Jan. 15, 2015 Dan Crawford | January 15, 2016 8:30 am Tags: open thread Comments (2) | Digg Facebook Twitter |
Quip of the GOP debate:
“The Republicans haven’t got a single candidate who could survive a Willie Wonka factory tour.” -David Waldman
They don’t even have a single Charlie! (Sorry JEB!)
Up until now a spectacular argument for government taking over all drug and medical device research has been the example of Sovaldi: the Hepatitis C cure. We all know the story.
Now, for the first time ever, all three million Hep C sufferers can clean the virus from their system — for only $300 billion dollars ($100,000 each) with 84 pills that costs $1 each to manufacture.
Seems the gov did the original (read: risky) research but once the researchers smelled money (er, uh, a cure) the law allowed them to continue with private funds and then make as much profit out of it as can be bled.
Hep C — PS: 30% more likely to come down with Parkinson’s — and who knows what else. Jingle, jingle, jingle goes the cash register.
Now we have a story supporting gov research from the opposite angle — if you ask me anyway.
Until now, heart failure has been progressive and surely terminal. In 2012 a trial or an innovative medical device in England with 20 patients ended with 25% cured and everyone else improved. It involved a balloon like cuff wrapped around the upper aorta that aided pumping — and apparently allowed the less strained organs to heal.
Now, a much bigger trial on two continents is being arranged (hopefully) but may potentially fall apart for lack of private funding.
Link to very long — what I can only call a — prospectus below
[cut and paste]
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.
Heart Failure condition overview
HF (Heart Failure) is a terrible disease , but unfortunately is very common. It is currently poorly treated, and is one of few diseases that increase in mortality YoY. More than 7 million HF patients exist in the US, with more than 800,000 new HF cases every year. The number of HF patients is expected to exceed 10 million by 2030. The HF increase in prevalence is driven by the epidemics of obesity, diabetes, and high blood pressure. Additionally, 7-10% of the aging population above 65 years old suffer from HF.
The outcomes of HF are very poor: 5 year mortality rate is higher than 60% – worse than many types of cancer. There are 1 million hospitalizations per year due to HF in the US. HF accounts from more hospitalization-days than any other disease. HF is the number 1 cause for readmission within 30 days – higher than 20% re-admission rates. The current annual cost of HF to the US economy is a huge $31B, with annual cost projected to reach $70B by 2030.
Figure 1 shows the poor outcomes of patient hospitalizations due to heart failure, as reflected by high mortality rates at 30 days, 12 months, and 5 years, and high rate of hospital readmissions. Figure 2 shows the poor and deteriorating median survival time after every HF hospitalization. Kidney failure accounts for more than 50% of mortality, as the kidneys heavily depend on sufficient blood pressure, and blood flow for their operation, which is obviously affected by HF.
PS. The insertion procedure is minimally invasive and there is no risk of clots as with other pumping aids, the whole device being outside the bloodstream.