Which tells you how DESPERATE SSH to find SOMETHING that c-pulse can actually DO! So far, all they've demonstrated in the pivotal trial is that it would probably be very useful in euthanasia!
So now the "back and fill" starts with one of thr STUPIDEST ideas I ever heard of -- using the c-pulse to "massage" the pulmonary artery to see if it'll reduce pulmonary artery pressure in patients with pulmonary HTN. That HAS to be Rosa's idea! NOBODY else on this planet could come up with anything THAT dumb!
Well, the letter I referred to was publishedd in JACC: Heart Failure, vol 3, no. 4, of THIS year.
More importantly, it originated from the docs in Britain who are SUPPOSED to be handling the c-pulse candidates there. Doesn't look real good for your own team to start "dissing" your product, now, does it?
Has he ever had to replace a c-pulse with an LVAD?
...forming around my aorta. Say what:
"Adhesion formation after open-heart surgery is a well-documented, significant complication encountered during secondary procedures. Secondary procedures account for 15% to 20% of the approximately 450,000 open-heart surgeries performed annually in the United States and the 350,000 open-heart surgeries performed annually throughout the European Union. After virtually every open-heart procedure, extensive adhesions form between the epicardial surface of the heart and the inner surface of the sternum. These adhesions make sternal re-entry and accessing the heart a time-consuming and dangerous process in secondary procedures.
Sternal re-entry and dissection of post-operative cardiac adhesions expose the patient to critical risks, such as injury to the innominate vein and aorto-coronary bypass grafts.1 A 2% to 6% incidence of major vascular injury, often including the right ventricle, right atrium, or aorta has been reported.
Removing adhesions, while essential, is a tedious and risky process that can extend the length of cardiac procedures by 60 minutes or more, entailing greater risk to the patient due to prolonged exposure to anesthesia."
So you can imagine what it means if adhesions form between the aorta and the c-pulse. Imagine having someone hacking away at dense, fibrous scar tissue around your OWN aorta in order to remove the device and/or replace it with an LVAD -- not a very pretty image, is it?
I tried to provide a link but yahoo either blocks it outright or subsequently deletes it. You'll just have to google "Upgrade Ambulatory Extra-Aortic Counterpulsation to Full-Support LVAD." It's the very first thing that pops up on my screen.
Ross Swift was the much ballyhooed "first c-pulse in Britain" last year who so tearjerkingly got to walk down his daughter down the wedding aisle last year. Well, it appears that about four months after he got c-pulse, he got an LVAD -- which by the US trial would make him a FAIL. From the letter "Upgrade Ambulatory Extra-Aortic Counterpulsation to Full-Support LVAD" written by the docs handling the c-pulse "European" trial in Britain at the Royal Brompton & Harefield NHS Foundation Trust., it says, regarding a patient, that "...four months after c-pulse implantation in a patient with underlying history of ischemic heart disease...", he was UPGRADED to an LVAD!
Best I can tell, the dates fit and Mr. Swift is the ONLY known c-pulse recipient in Britain so far.
But even MORE interesting were their complaints of PROBLEMS with "dense adhesions...between the aortic wall and the c-pulse cuff..." when they tried to remove the c-pulse and place the LVAD. Unfortunately, I can't copy and paste the quite a bit more they had to say, but they sounded quite unhappy about it. That may explain why there haven't been any more c-pulse implants in Britain. They conclude by saying that it might be a good idea to avoid patients with "borderline left ventricular function" at risk of future LVAD placement. Unfortunately, that includes pretty much ALL class 3 patients and pretty much puts SSH's entire "customer Base" at risk. Now I'm understanding Rosa's sudden interest in pulmonary hypertension!
Probably because SSH takes SO LONG to do ANYTHING! I thought Rosa was going to release soome "good news" after he got back from Europe last week -- taking his time about taht too I suppose? Then there was the alleged PR expalining why they fired Oleson -- that seems to be a bit slow about coming as well.
Yeah, what, five YEARS ago now? And how many have they sold over there? ZERO? Why? You might find my previous post about Ross Swift "upgrading" to an LVAD interesting.
"...based on the personalities of a yahoo message board??"???? Are you kidding? With Rosa's IQ, he probably bases decisions on rock, paper, scissors that he plays with HIMSELF!
...clapping for SSH! They got "approval" which was NOT required to resume enrollment for a trial that did NOT require suspension to BEGIN WITH! Not only that a trial that they suspended in order to try and get something from the FDA that NO ONE has EVER tried to get before -- a "physician patient selection committee." A committee that they did NOT need in the first place, but also a committee essentially GUARANTEED NOT to receive approval from the FDA! And WHAT is missing from to day's announcement? Why, it looks like there is NO mention of a "physician patient selection committee"! How about that!
Money wasted, shareholder equity wasted, TIME wasted -- all for NOTHING! Well, on the bright side, during the entire suspension no doubt SSH management continued to collect their fat salaries, benefits, bonuses, and perks!
It has now been FOUR MONTHS since SSH cancelled its Cowen presentation because they realized they were going to have to suspend enrollment! Should we send a card? Order a cake maybe?
Wow! Just think! Figure 120 days at about 71,000 bucks a day comes to around 8.5 MILLION bucks! 8.5 MILLION BUCKS that SSH has flushed down the toilet waiting to resume a trial that did NOT need to be suspended in the FIRST PLACE! And ONLY because SSH wanted to try and sneak past the FDA a protocol change that the trial really DIDN'T NEED!
Of course, I think they don't want to re-start the trial PERIOD because they finally realize what a totally BOGUS medical device the c-pulse REALLY is!
In any case, come on! Altogether now! How about a LONG round of REALLY SLOW clapping for the CLOWNS that run SSH!!!
I knew it! Pat myself on the back, thank you! I forgot all about HPTX after I posted about its Andromeda takeover and only stumbled over the PR from last fall about Andromeda and its "diapep" being FRAUDULENT and HPTX being taken for 570 MILLION dollars and then writing off 55 MILLION dollars!
And now Horizon shareholders get to foot the bill for a pathetic, effectively one trick pony -- I'm sure they're grateful! Bright side is, likely Horizon will dump HPTX's idiot management!
"...the five pts were lost to the study due to calcium deposits in the ascending aorta"??? Really? And where did you find that? I didn't see it in the PR. And, let's face it, Dave's response was PRACTICALLY incomprehensible. I mean, I didn't hear the word "aorta" anywhere -- did you? And unless they are recruiting 80 plus year olds, 5 out of 7 with aortic calcifications is DEFINITELY strange.
In any case, did you sense that Dave answered the analyst's question in ANY respect?
Hey! Could be! But I'm STILL trying to find some justification for beleiving that "massaging" the pulmonary artery will somehow improve pulmonary hypertension. Have YOU found anything to support that "idea"? I mean, after all, if you're a shareholder, it's YOUR equity that Dave is flushing down the toilet IF it is, in fact, a REALLY stupid idea.
From the press release:
"Finally, in terms of expanded opportunities beyond congestive heart failure, the Company has initiated a research program with Dr. Mark Slaughter and the Jewish Hospital of Louisville, Kentucky for the treatment of Pulmonary Arterial Hypertension."
Pulmonary hypertension????? For added emphasis, imagine about two feet high: "??????????"
In the the conference call, Dave IMPLIED -- you might want to sit down at this point -- that they were planning on trying to use the c-pulse to MASSAGE the pulmonary artery! Cross my heart! He said there was reason to believe that "massaging" the pulmonary artery would reduce blood pressure within it. I am NOT making this up! I'm still researching it, but at this point, it is the single DUMBEST thing I have EVER heard of!
Helpful hint -- when a biotech gets in trouble on a trial, management often starts other "programs" that don't seem to have much to do with the company's original "mission." It helps distract investors from the "trouble" and provides an excuse for future trials and secondaries. Just something to keep in mind.
Say what, Dave:
"During an interruption in C-Pulse therapy, the CardioMems device recorded hemodynamic variability and an increase in heart failure symptoms while conversely improvement in the hemodynamic and heart failure conditions were improved with the C-Pulse therapy as measure by the CardioMems system."
"Cardiomems"??? When did Cardiomems enter the picture? Cardiomems is for measuring ambulatory pulmonary artery pressure. While PAP certainly increases in CHF, the increase is due to the inability of the LEFT side of the heart to dispose of sufficient quantities of blood coming from the right side. Consequently, why not SIMPLY measure cardiac output DIRECTLY and see what c-pulse does! I swear, they can't afford to pay for the implants and follow-up care of the c-pulse trial subjects but they can afford to put PAP monitors into patients and finance PAP research?
Perhaps more relevant, what happened to the "SphygmoCor" that SH boasted about earlier this year? They evidently thought enough of it to buy some from Atcor -- a publicly traded company in AUSTRALIA! Their last earnings report boasts of the "multi-unit sale to Sunshine Heart, the C-Pulse heart assist device manufacturer for patients with moderate to severe heart failure. This transaction followed an evaluation which confirmed the considerable benefit of adding SphygmoCor to assist C-Pulse programming and patient therapy optimisation."
But I don't see any mention in the PR or conference call about it. Well, I guess it's nice to know at least some AUSTRALIAN company is making money off SSH.
Leave it to Dave:
"We are also pleased to report that there have been zero exit site infections in the study to-date."
Well, Dave, ya'know, FIRST, they have to be ALIVE to get an infection! That "alive" part has been a bit of a challenge for SSH, hasn't it?
THEN they have to have had the c-pulse in LONG enough to get an infection. So, Dave, since 90 plus percent of divelines get infected by the end of one year, all you've managed to accomplish is reveal to all the world that so far not a single patient haslikely been in the experimental arm more than a year -- DESPITE the fact that the trial has been running for over TWO years now. Way to go, Dave!
From the conference call:
QUESTION: "...on OPTIONS HF trial in Europe, 14 enrolled now, can you just talk about...that...and how it can...accelerate the pace and then any download of clinical results, anytime throughout the backend of 2015 on those European patients that we should be expecting this year?"
Dave at his best:
"Yes, so when you look at Q1, we actually lost five patients to calcium. And I don’t believe that to-date we’ve had five patients in all the trials that we’ve been working on that we have lost due to calcium. So it was kind of an odd situation we were actually expecting to post higher numbers. I think the overall sense is that Europe is starting to pick up and what’s nice is we have some new additional centers that are coming on board. So I think we just need to keep pushing things forward at the sites.
I mean we have eight implanting centers but literally 15 sites that in total that are referring. So I do expect these numbers to increase overtime but we are definitely going to be very careful especially given the U.S. experience regarding the patients that we allow them to trail. We want to make sure that they meet criteria that there is not patients that are being in essence force into the trial because there is no other options. But patients are out there and Q1 we would have quite a bit more and it is not doing for the calcium issue."
Hey! Don't look at me! But this calcium thing is NEW. FIVE patients "lost" -- aka "died" -- due to calcium? Out of what 14 patients? That's just plain weird! Certainly not the kinda stuff that would encourage c-pulse volunteers. Is SSH planning on offering some MORE DETAILED explanation?
..." hiding something imo"??? Oh, come on! How could you possibly think such a thing? I mean, management has always been so forthcoming about things! For example, take the number of research centers they had to close in the insurance debacle. Hmmmmm...no, don't count that one! Well, how about when they announced the number of c-pulses that have actually been implanted during the pivotal trial? Hmmmmm...no, better skip that one. How about the announcement back in January that they were planning on selling a big wad of stock under the ATM agreement? Hmmmmmm...no, no, better punt that one too! Wait, I got it! How about when they explained why they FIRED their "CMO" last fall -- lemme just look here --- uhhhhh, no, better write that one off.
Well, give me a few minutes! I'm bound to come up with SOMETHING they've been forthright and honest about!