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.
"...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."
"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!!!
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!
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?
The September presentation is available on EDGAR. At one point it says:"eliminating the driveline is not a new idea." Well, DUH! It then references the Lionheart LVAD as an example of TETS success! Not only that but it REPEATS the same slide, but this time with the comment "No serious TETS complications" in bright RED! He totally ignores that TETS have MULTIPLE SIGNIFICANT problems which is why no LVADs use them!
"Where will clinical implementation of TETS technology first find traction?"
Really? Gee, Rosa, apparently YOU thought it was going to find traction THREE YEARS ago when you said you were looking forward to using it on a patient in 2012!
Anyone else smelling smoke? The implication is that SSH will be the "first" to implement TETS but WHEN seems conveniently to have been overlooked!
Oh, and look! They did two more cows!! And one of them is named "Dolly" -- how quaint! And take my breath away but what they didn't demonstrate that the c-pulse was able to augment end diastolic pressure! in a cow! A healthy cow, no less!! Well, won't the future farmers of America be thrilled to know that if they need to augment end diastolic pressure in any of their herd, they'll be able call Sunshine Heart for service!
SSH is always good for a laugh! From a 2012 interview:
"Currently, infections are common in VAD patients because the device is powered by an external battery through a cable that runs through the skin. "Drive-line infection is the number-one problem with these devices, and I think it's a bigger problem than people realize," Dr William Cohn (Texas Heart Institute, Houston) told heartwire..."
"Number one problem"??? You don't say! Hey, don't you work with Sunshine Heart? Funny but, listening to them, why, you wouldn't think it was any problem at all! Think maybe y'all need a little "tete-a-tete" to help get your stories straight?
Cardiologists? What cardiologists? They were all cardiovascular surgeons, weren't they? If Dr. Abraham had been there, I would have attended since I'd love to know how he managed to collect six minute walking data on those THREE CORPSES!
...tsk, tsk! You're not keeping up with the program. SSH has been around fifteen or so YEARS now working on c-pulse. Of course, most of that was in Australia where IPO investors subsequently got to watch 90 plus per cent of their purchase price evaporate over the next decade or so. When SSH couldn't find any more suc...uhhhhhh...investors dum...uhhhhh...fearless enough to buy stock, they grabbed their passports and hightailed to the good ol'USA! Yessir, home of P.T. Barnum who wisely said uhhhhh....hmmmm...doggone it!...what was it he said?
Maybe they were the only ones willing to let Dr. Abraham six minute walk CORPSES in their hallways. Understandable, I think, given the general effect ZOMBIES have on most people.
...the TCT conference presentation? They initially announced it on September 11, and RE-announce it five DAYS later? Maybe a little "smoke and mirrors" play in order to take everyone's mind off SSH firing its CMO and why they didn't issue a press release any explanation.
Well, I dunno...I guess that means these insiders here don't have much confidence:
PETERS WILLIAM S, MATHIESEN JEFFREY S, ROSA DAVID A, OLESON KIMBERLY, KRIDNER DEBRA,
YEARICK JIM, BASSETT KEVIN
...since they look like they've done pretty much NOTHING but SELL. In fact, has ANY insider -- besides Mr. Brown -- EVER bought any stock DIRECTLY? Every acquisition I see listed says "option award."
The last time I looked, the FDA wouldn't accept number of sites as trial data. How many c-pulses has the company actually implanted in US trial patients so far.
Perhaps more significant is the CMO's evident firing -- judging from the wording of the 8-k -- for reasons the company apparently doesn't want to reveal -- as judged from the lack of any press release explaining what happened. It's even worse if he actually resigned since, obviously, with two trials going on, you'd have to conclude he didn't see a very bright future ahead.
Then there's the latest PR about "three equity awards under Sunshine Heart's New-Hire Equity Incentive Plan."
Even aside from wondering how many of these awards are required for "incentive" -- SSH reported similar awards earlier this year for apparently the same three people --," these "new hires" aren't all that new, having been employed around six months now. These people sure seem to be needing an awful lot of "incentive."
"no reason for this stock to remain in the cellar"??? Hmmmmm...I think I can offer a few. First, at end of last quarter, company had 1.9 million bucks and the burn rate was 3 million a quarter, which means right now they should be BROKE. They reported NO revenue as well as NO receivables -- so not only broke but ain't no money coming in. They got 1.8 million in payables, but how are they going to pay the bills? Most creditors won't take stock, you know? Finally, there's the "shock" of 54 million additional shares coming out of nowhere -- at least it probably was to most existing shareholders -- that didn't cost their shareholders a single dime because of an idiotic financing deal.Who would be stupid enough to buy stock in a company where management had screwed shareholders like that?
...HAW!!!...you might want to check out what happened to DRIO!...I called that one four or five months ago when it was trading north of a buck a share!...it closed at 5 CENTS a share Friday!!!...oh, man!...talk about a good laugh!...it dropped from 60 CENTS to a NICKEL in only a WEEK!!...man, no doubt the suck...uhhhhh...shareholders were like deer caught in the headlights!...you might want to go over to the DRIO message board and review the events -- ya'know, help prepare you for your own day of reckoning!...HAW!!!...
Is that all they they need to issue:
"Pursuant to the Exchange, all of the Warrants are being exchanged effective as of August 22, 2014 (and all such warrants are being terminated) in consideration of the issuance by the Company to the Warrant holders an aggregate of 54,030,950 shares of Common Stock (the “ Exchange Shares ”). The number of Exchange Shares issued to each Buyer was determined pursuant to a formula set forth in the Amendment and Exchange Agreements. Of the aggregate Exchange Shares, 49,660,465 were issued as of August 22, 2014 and the Company has reserved an additional 4,370,485 Exchange Shares for potential future issuance due to contractual limitations on ownership as agreed to with a Buyer. Following the Exchange, the Company has 75,158,770 shares of Common Stock outstanding."
Why, that's hardly a drop in the bucket!...HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW!!!!!
...about reimbursement for omidria in the 10-Q...it's too LONG to include all of it here, but the gist is:
"Obtaining reimbursement approval for any product from each government or third-party payor can be a time-consuming and costly process that will require the build-out of a sufficient staff or the engagement of third parties and could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our approved products to each payor. We can provide no assurances at this time regarding the cost-effectiveness and the amount, if any, or method of reimbursement for Omidria or any of our product candidates. Further, we can provide no assurance that the amounts, if any, reimbursed to surgical facilities for utilization of any of our surgery-related products, including Omidria, or product candidates or to surgeons for the administration and delivery of these products or product candidates will be considered adequate to justify the use of these products or product candidates."
...high-ho!...high-ho!... it's off to COA we go...HAW!...
...I've ever seen from gOMER was in the 10-Q:
"We expect our continued operating losses to result in an increase in the total amount of cash used in operations until at least the time that Omidria becomes cash flow positive, which may be in several years, if at all."
...HAW!!...yeah, would have been even MORE truthful if they had emphasized the "IF AT ALL"...HAW!...