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.
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?
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?
Hey, thanks! I was going to copy and paste that in response to your post pumping c-pulse by telling everyone how it killed some poor guy courtesy of a driveline infection that led to sepsis! You saved me the hassle -- kudos!
But, aw heck, I just gotta a little:
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, 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!!!
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!
Me "miserable"??? Au contraire! After that post of yours about the guy that c-pulse KILLED courtesy of a driveline infection that lead to sepsis, I'm practically rolling on the floor laughing!
Which, granted, is kinda sick! But at least I'm not trying to pump SSH by broadcasting how effective it is at KILLING people!
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!
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!!!
"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!
Hey! I got an idea!! Maybe you should call SHH and get'em to include in the "presentation" that guy you "boasted" about earlier! You know! The one you pointed out that was killed by his c-pulse after he got septic from a driveline infection!!! No doubt a GREAT selling point! HAW!!! I swear, you and Rosa would make a great tag team!!! Be like Abbott and Costello!!! No, no!! Better yet! "STUPID and EVEN STUPIDER"!!!! HAW!!!
By the way, given the remarkable resemblance between your posts and those "bigsmart--whatchamaccallhim," is it fair to infer a touch of bipolar disorder or some other psychiatric ailment at work? HAW!
"...stockholders don't see block buster..."??? Yeah, and THEIR stockholders also don't have to "see" some dual personality MORON talking to himself all day long and pumping SSH by posting articles about how SSH's product KILLED a patient courtesy of sepsis caused by a c-pulse driveline infection! Aren't they LUCKY!!!
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!!!
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.
"FDA allows interim analysis"??? Who cares? Apparently, per Rosa, NO ONE is willing to pay for the implants and follow up care! NO implants means NO data which means NOTHING to "interim" analyze!
"German reimbursement..." is simply RENEWAL of the "German reimbursement" they ALREADY have. Given that there were NO implants in Germany or even all of Europe last quarter and that, per Rosa, there may not be ANY this quarter as well, "German reimbursement" is hardly anything to get excited about.
"1st quarter enrollment"???? Who CARES? The FDA certainly doesn't! On the other hand, how many IMPLANTS will have been done by then? In over a year and a half, there are only THREE verifiable implants and it appears that SSH paid or helped pay for those. But now NOBODY -- including SSH per Rosa -- is willing to accept responsibility for all the costs of implants and follow up care and Rosa even warned everyone that there may not be ANY implants this quarter for the US trial!
Given all that, I'd say SSH currently isn't worth a pile of fresh dog manure!
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.
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.
I happened to stumble over a clinical trial:
"A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)"
Lo and behold, what do I see but Dr. Abraham's name! Is he hedging his bets? After all, the "parachute" looks like it could be a c-pulse killer. Look at all the places participating in their trial -- something like 60 altogether!
And they're looking to recruit 580 patients! I guess that's going okay too -- at least I haven't seen any newspaper or Readers Digest ads (like some companies have been known to resort to).
And it looks like it's applicable to BOTH NYHA class II and class III patients -- a much larger available customer base! And 96% treatment success, too -- 32% maintain, 54% improve! That's GOOD, isn't it? Takes only an hour and a half to put in, three days in the hospital, and doesn't require boring into someone's chest of any holes for pump lines, etc, etc. Looking BETTER all the time! And look! P-values!! REAL p-values!!! Lots and lots of p-values! "Be still, my fluttering heart!" Almost all of which look statistically significant! Impressive, huh?
I dunno, but I'd be willing to bet Dr. Abraham won't need to six minute walk any CORPSES for THAT trial -- unlike for you know who!! Maybe that's why he signed up!
"...there is nothing to fear but Fear itself..."??? I hear Australians who bought SSH's initial IPO have rephrased it to say, "nothing to fear but fear itself AND losing the shirt off your back buying some worthless biotech stock."
At the end of the "update" about the fully implantable c-pulse -- the one Rosa said 3 YEARS ago was a year AHEAD of schedule and the one he was looking to the end of 2012 to put in a human -- it says:
"Lack of blood contact contact and non-obligatory feature make it the most likely candidate to leverage TETS in a mechanical circulatory assist device."
Huh? What exactly has blood contact and the "non-obligatory" have to do with anything about TETS? Geez, earlier they tried to argue that TETS worked fine in the Lionheart and that involved blood contact and was "obligatory," so how does NOT having those become an argument for TETS success in for c-pulse? Everyone else has tried to "leverage" TETS in LVADs with no success, what's so magical about c-pulse? Quick, quick! Look in the mirror! Look in the mirror!! That's it! Good! Just keep looking!
Funny, but I looked all over that SEC filing of the "update" and couldn't find hardly a THING about the US trial! I guess there wasn't anything worth updating for the US trial -- is that about the gist of it?
"Parachute Device's potential market is very small."??? Wow! Kinda sad to discover SSH's investor relations is so STUPID, huh? After all, the parachute trial is on 580 class III AND class II patients -- and I'd say that market is pretty substantial.
Then again, how STUPID is it to ask a company that wants to sell you its stock to give an opinion of its competitors. Oh, yeah -- "When that thing is approved, they're goin' to put us out of business in no time at all! Whatever you do, DON'T buy our stock!" Uh-huh! gotcha!
Consider Cardiokinetix actually has THREE YEAR data! Complete with p-values!!! EIGHTY EIGHT patients too.
Consider the the effect on NYHA class -- baseline 2.6 (the parachute is for class 2 and 3) decreasing to 1.7 at six months and staying around that for 3 YEARS! And a p less than 0.0001 -- showoffs!
Consider the data for "repeat HF hospitalization + death." Parachute cuts that in HALF! Oh, yeah!
Best of all, consider "parachute outcomes in perspective." Almost a 60% improvement over OMT alone! 50% better than OMT plus CRT!! And even 50% better than OMT plus CRT plus ICD!!! Smokin'!!
No! Of course, parachute ain't no threat at all! Probably doesn't matter anyway since, at the rate SSH is going, by the time they get c-pulse approved, there'll probably be cure for CHF!!!