Huh??? You consider THIS a "favorable" comment for c-pulse:
"The patient lived almost 7 months after the implantation of the device and died of septic complications secondary to gas line infection."
The poor guy managed to live ALMOST 7 months before the c-pulse KILLED HIM courtesy of a driveline infection that lead to SEPSIS????
Gee, I bet you'd find happiness in watching an orphanage burn as well, huh?
No, "The bottom line..." is that SSH has NOT demonstrated that c-pulse has ANY effect on cardiac function -- PERIOD. CONSEQUENTLY, "non-blood contact" is MOOT! If the device doesn't do ANYTHING, then no one will use it -- PERIOD! Get it? Maybe try thinking along the lines of trying to sell a refrigerator to an Eskimo because it has an icemaker!
Whoopee! I doubt that anyone reading that will look up Milano's "conflicts of interest." Regardless, who pays Abraham HIS consulting "fees" -- why none other than Sunshine Heart! How about THAT!
In fact, you might want to worry since Abraham also collects consulting fees from Cardiokinetic for its "umbrella" device which -- oddly enough -- may represent significant competition for c-pulse! Nothing beats playing both ends against the middle for a little extra dough, huh?
Yeah! Did you look up DRIO?! I loved that one!! Not long after I posted about it, it dropped over NINETY NINE PER CENT over the course of a week! It was a BEAUTIFUL thing!!!
What difference does "no blood contact" make if the device doesn't work in the first place? Presumably, no one will use it if it doesn't do anything to enhance mortality/morbidity REGARDLESS of "no blood contact."
That was my point -- IABP use has decreased by something along the lines of 70-80% in the past 15 years as it becomes more generally accepted that IABP contributes little if anything to improve patient mortality/morbidity.
Hmmmmmmm...no, it isn't. Back when it was invented, IABP was becoming increasingly popular, so it seemed reasonable to pursue a "para-aortic" balloon pump. Since then research has revealed that an IABP doesn't appear to do much if anything to improve survival or really much of ANYTHING for that matter. It's use has steadily declined to the point where now it is used only in the most drastic of cardiogenic shock cases.
Indeed, note that SHH itself has offered practically NO evidence that the c-pulse actually has ANY effect on actual cardiac performance in class III patients. Even in their "poster-boy" from England, his cardiac index was UNCHANGED before and after the c-pulse!
So, no, the thing is NOT a "positive innovation"! It's just a stupid excuse to con naive investors out of their money in order to enrich management and stockbrokers.
Well, for a hint, I suggest you look at the chart of what it did after its IPO in Australia about a DECADE ago. In fact, search a little and you might be able to find a few of the original investors on some Australian stock boards. I bet they have some great stories to tell!
"SSH through all these investment conferences and medical conferences has perhaps reached 10% of Cardiologist with info about the C-Pulse..."????
WOW!! They've been working on the stupid thing for FIFTEEN YEARS and they've actually managed to reach TEN PER CENT of the cardiologists??? I am SOOOOOOOOO "impressed! How about everyone stand and give SSH a big round of "slow clapping"! At that rate, they ought to reach ALL the cardiologists in about a HUNDRED YEARS!!!
And to think, after FIFTEEN YEARS they actually got Dr. Milano to write an editorial about it in the JACC heart journal! ! And what did she have to say:
"The most encouraging outcome was that none of the 20 patients experienced a stroke."???
Oh, hot dang! I think I'm having palpitations! NO ONE had a stroke is the "most encouraging thing"??? Yessir, patients'll be ringing SSH's phones off the wall after reading THAT!
And what else:
"Unfortunately, 1 patient experienced a procedure- and device-related death from a mediastinal infection. Furthermore, disappointingly 40% of patients experienced drive line exit site infection. Patients who survived with the device to a 12-month follow-up time point did experience a modest increase in 6-min walk distances..."
Well, dang, lady! Don't get TOO "optimistic" already! We got a scam to sell here, don't you understand?!!!
Oh, come on now:
"While the result...could be discounted as unexciting..."
Well, no sh__, sherlock!! I dunno, I reckon maybe SSH should just skip over talking to cardiologists altogether from now on!
Sorry but NO, the "the insurance issue has" NOT "been resolved" UNLESS Rosa has decided to that SSH will accept responsibility for ALL of the costs of implant and post-implant care. NO insurance company reimburses experimental devices -- that is a simple FACT. NO research hospital will pay for it. NO HOSPITAL -- teaching or otherwise -- can budget for something when it has NO IDEA what that something might eventually cost. They CANNOT sign "blank checks" made out to SSH so SSH can continue its trial! And SSH is no help since it ITSELF has CLEARLY declared it has NO IDEA how much patient care will cost.
Rosa HIMSELF said in the conference call that if SSH had to pay $200,000-250,000 or "uncapped" costs for every implant then SSH would NEVER be successful! And NOWHERE has SSH indicated that they have resolved the issue. They SAID they would ATTEMPT to "negotiate" but how can they "negotiate" when they have NO IDEA what the thing might eventually cost? Furthermore, they did NOT specify WHEN they MIGHT resolve the issue and, given the FIFTEEN YEARS they have messing with the thing already, I wouldn't be optimistic about ANYTHING in the future.
What's truly remarkable is how STUPID any company could be, attempting to do a trial dependent on insurance reimbursement of the costs! I have NEVER heard of such a thing! Every company prepares a budget ahead of time anticipating total costs and raises money BEFORE they start the trial! What kind of five star IDIOT starts ANY trial, much less a 400 patient "pivotal" trial -- HOPING that eventually somebody ELSE will pay for it?!!!
On top of all THAT, The FACT that there were NO implants in Europe last quarter and the FACT that Rosa HIMSELF said there MAY NOT be ANY implants ANYWHERE -- Europe or the US -- THIS quarter indicates CLEARLY that the trial -- for the time being -- is effectively DEAD.
"...material inducements to seven individuals entering into employment with the Company."??? Funny how after all the "big to-do" over hiring the "superstars earlier this year," they didn't bother to specify EXACTLY what these seven were supposed to be doing -- isn't it?
Even funnier is that they didn't offer any explanation as to HOW they expect to PAY for them! After all, Rosa made CLEAR in the conference call that the "pivotal" trial is now basically "DEAD in the water" thanks to Rosa's sudden realization over a YEAR and a HALF into the trial that insurance won't reimburse the stupid device and the research centers won't accept the costs and SSH could "NEVER be successful" if SSH has to pick up the tab!
Helpful hint -- not a DIME will come out of management's pockets!
Yeah, I bet there was someone posting something similar 12-14 YEARS ago, and 10-12 years ago, and 8-10 years ago, etc, etc, while SSH shareholders in Australia watched their EPIC spiral to a NINETY FIVE PER CENT LOSS! Holding on didn't help them much, now did it? Well, that is, unless they had sense enough to sell with the US IPO!
Well, given that, at present, SSH doesn't even know how it's going to pay for the trial since insurance companies are refusing, the trial centers are refusing, and even SSH itself is refusing, I'm inclined to believe that worrying about how much of the market they "might" capture is a bit PREMATURE -- wouldn't you agree?
As far as the EU, they've been approved there going on two years and how many did they implant last quarter -- ZERO! Got that, Z-E-R-OOOOOOOOOOO! So you might not want to count on the EU for saving this sorry SOS company.
"I don't understand why SSH accepted that number."??? I think they accepted it because the DIMWITS actually believed that third party reimbursers would pick up the costs! Well, as they say -- OOPS!
ALSO, that many patients meant that much more time for management to collect fat salaries, benefits, bonuses, and perks before having to close up shop and look for new scams to work!
"if this happens"??? Yeah, that's what SSH counts on suck...uhhhhhh...investors believing. Problem is that "this" never seems to "happen"! And right now, who cares about "interim analysis" when SSH can't even get insurance companies to pay for it and say they won't pay for it either! Kinda hard to run a trial when NO ONE is willing to pick up the tab!
"Not much volume so you can't really read into the drop."??? You know, I bet if you went and reviewed the Australian message boards during the ten years SSH traded down there after its IPO, I bet someone posted something similar MULTIPLE times as the stock proceeded to lose over NINETY FIVE PER CENT of its value.
And as far as "coulda, woulda" etc, etc -- yeah, and Tinkerbell COULD take us all to Neverland and teach us how to fly, but I really don't think I WOULD bet on it.
Wow! That was so...soooooo..."illuminating"????? And how exactly does it relate to explaining SSH's problems with insurance companies refusing to reimburse the surgery, with cardiologists ignoring it , with patients refusing it, etc, etc, etc?
Wouldn't you just LOVE a "briefer" explanation of why SSH did NOT do a SINGLE, SOLITARY implant in Germany last quarter and why they may NOT do ANY implants ANYWHERE this quarter? SOME explanation a bit less "wordy" than the article you quoted?
Actually, I suspect that the typical bagholder usually CLAIMS to have made money "trading" the stock rather than admitting they were so dimwitted as to have actually bought the thing in the first place!
Oh, gee!! NOW you figure it out! And what were you saying back in June:
"I am a REAL MD and am very optimistic about this company, its legitimacy, and its recent market run-up in anticipation of the ADA meeting beginning tomorrow in San Francisco..."
And what did you ask me back then:
"...what kind of medical doctor are you? Are you a Fellow of the American College of Anything, other than bashing companies trying their best to advance medical science? Time will tell with Oramed, but you in my opinion are insulting and pathetic."
Actually I'm a "Fellow" of the American College of People With an IQ Greater Than 90" -- which OBVIOUSLY you're NOT! Excuse me while I GLOAT:
HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW!!!
What a joke! First, SSH management does a major "Houston we have a problem" at their conference call by admitting that "many" centers are refusing to implant c-pulse without guaranteed compensation for whatever insurance refuses to reimburse and by admitting that, evidently, ALL insurance is refusing to reimburse.
Then they turn around and MAGNIFY the issue by putting out a press release trying to blame "audio interruptions" for a "misunderstanding" and claiming things really aren't so bad!
There were NO "audio interruptions" when Rosa said reimbursement was a problem with "MANY" centers and when he indicated that some centers will have to be replaced. There was NO "audio interruption" when Rosa whined about the time and effort spent recruiting these sites, only to have the hospitals' FINANCE DEPARTMENTS -- HIS words exactly -- refuse to accept patients without guarantee of compensation.
Then the idiots say today, "Reimbursement challenges with private insurance companies are common in clinical studies in the United States for technologies that are not commercially approved." Well, DUHHHH!!! That's because NO insurance company reimburses ANY experimental device without subjecting it to an extensive pre-approval. If those idiots had simply read ANY insurance company medical policy manual they would have known that!
All that shows is what a dumba__ the author is! The author totally ignores that it does NOT matter what the incidence of LAD STEMI are in the general population. What DOES matter are the etiologies of the patients in class III and ambulatory class IV since both devices' clinical trials are aimed at those patients. IF all of those patients have LAD infarcts as a source of their CHF, then the parachute and c-pulse are competing for the same patients.
As far as class III non-ischemic patients, what's the incidence in class III/IV? I don't know. I couldn't find any data that breaks down the frequency of various etiologies in class III/IV.
However, I DO know that if "Its target market is likely around 15% to 30% of the target market...," then you have to wonder how it is that Cardiokinetix doesn't seem to have ANY problem collecting patients for its trials if it only has access to 15-30% of the SAME class III/IV patients as SSH is drawing from. SSH, on the other hand, is stuck having to run newspaper ads, Readers Digest ads, spamming CHF patients' email, and spending who knows how much on "superstars" and "hiring incentives," etc, etc. And even then, SSH has documented only ONE c-pulse implant in the US trial since the trial started OVER a YEAR ago.