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  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Bowtie

    The market price of SSH is currently the plaything of speculators, and I am not about to speculate on where speculators might take the market price.

    You say, "While all of us may be excited and bullish about the technology". So you appear to agree with Bryce Willoughby and me that the efficacy of the technology is not in question.

    The one question I have always had, the one risk I have always seen, is that the uptake of the technology might be slow.

    Two reasons for that compared to HeartWare's LVAD -

    1. HTWR was entering a market already opened up by Thoratec. Once a patient elected to have an LVAD implanted it was just a question of whether to go with the incumbent THOR LVAD or the new much smaller HTWR LVAD. With SSH there is no comparable device approved and in use and SSH faces the task of opening up an entirely new market just as THOR did many years ago.

    2. THOR and HTWR's LVADs target a much sicker HF patient population where the HF patient reaches a point of no longer being able to defer a decision. SSH's patients still have the luxury of being able to take time to make a decision. The reports of the first UK HF patient to be implanted with a C-Pulse might encourage others to also make a decision to proceed. It is telling that the UK patient had a trigger to cause him to actually proceed - he needed to be able to get up and walk his daughter down the aisle.

    Now as regards Management, I agree that Dave Rosa is proceeding cautiously. If you have a Ming dynasty vase you don’t rush around risking breaking it. And Mr Rosa is doing all the right things as far as I am concerned. Successful completion of feasibility trial, successful development of the FIM and proven in animal trials and on target to be ready to replace the PIL model when it achieves PMA; recruitment of outstanding staff to ensure the product quality and enrollments are in good hands; and cash raised at an opportune time with sufficient cash to carry through these present difficult times. All of the foregoing gives me confidence that difficulties will be overcome and this product will achieve PMA in a timely manner.

    Even with slow uptake the upside is immense. Let me explain –

    The current share price is $5.43.
    But let us suppose shares were bought in the next month at $10 per share.

    Since we are agreed that the efficacy of the technology is low risk then the question is when that technology will achieve sufficient levels of uptake or PMA that it might be valued at a similar level to say HTWR market cap of ~$1.35 billion.

    Let us assume that it takes 3 years for SSH to achieve a market cap of $1.35 billion and during that time it doubles its shares on issue raising additional capital.

    On those assumptions the share price in 3 years would be $40, a quadrupling of the assumed $10 share price at entry (of course $40 is over 7 times the current share price).

    Now let us be pessimistic -
    Let us assume that it takes 6 years for SSH to achieve PMA and a market cap of $1.35 billion and during that time it quadruples its shares on issue raising additional capital.

    On those assumptions the share price in 6 years would be $20, a doubling of the assumed $10 share price at entry (and of course $20 is nearly 4 times the current share price).

    If I were to say anything I would just suggest to Joseph he might put his SSH shares in the bottom drawer, stop watching the gyrations in SSH share price, and open up the bottom drawer in 3 or 6 years time.

    Kind regards, Robert

    PS to save criticism for being too conservative let us suppose -

    Enrollments are accelerated and the FDA agrees to an interim review and market cap in 12 months is $1.35 billion.

    Shares on issue increase by 5M shares to 21.88M shares during that 12 months.

    On that basis the share price would increase to over $60 and you have better than a "10 bagger" based on current share price.
    Aug 21 03:59 AM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Luke

    The target market for NYHA Class IV heart failure (NYSE:HF) in the US and EU is around 250,000 patients and is strongly contested by Thoratec (NASDAQ:THOR) and HeartWare (NASDAQ:HTWR).

    Many patients only accept an LVAD when they are told death is imminent without it.

    Following the publicity surrounding the UK patient on the heart transplant waiting list, the lower risk C-Pulse might gain increasing acceptance as a bridge to transplant (NYSE:BTT) for later stage patients than previously anticipated.

    Mr Simon, the heart transplant surgeon, appears to have been very surprised at just how effective the C-Pulse has proven in a patient who has 50% of his heart muscle dead.

    He apparently has lots of similar patients and it would not surprise to see him now doing more C-Pulse implants in these sicker HF patients.

    I have seen reports that total LVAD implants are expected to increase to ~15,000 per year in the next couple of years.

    A couple of thousand (less than 15%) of these late stage NYHA Class IV patients switching to C-Pulse would make Sunshine Heart quite profitable from those sales alone.

    That is without even taking into account its target market of 5.3M in NYHA Class III and ambulatory Class IV. On top of that there is the potential angina market of ~2million patients with the fully implantable.

    As Bryce Willoughby says, we know the C-Pulse works. That is not in question.

    And, if it takes a while for C-Pulse uptake to gain traction, the potential prize for waiting is immense.

    Regards, Robert
    Aug 20 06:56 AM | 2 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Luke
    I think the enrollment criteria might exclude HF patients on the heart transplant list from participating in the US Pivotal trial.
    Obviously the EU trial does not have these constraints.
    C-Pulse is essentially intended as a destination therapy (DT) or a bridge to recovery (BTR).
    However, if a HF patient can be bridged to transplant with a C-Pulse that is a far preferable course than implanting an LVAD.
    Implanting an LVAD as a BTT has the following risks –
    Blood clots, stroke, bleeding, and increased risk of rejection of a subsequently transplanted heart.
    For some HF patients, the implant of an LVAD as a bridge to transplant (NYSE:BTT) causes elevated levels of antibodies.
    Elevated levels of antibodies increase the risk of rejection of a transplanted heart.
    That has to be a major concern.
    Implanting and removal of an LVAD is also quite an assault on the heart muscle with sizeable chunks of the heart muscle cut out.
    Rather than LVADs progressing into NYHA Class III HF therapy it is becoming increasingly more likely that C-Pulse will progress further into NYHA Class IV HF therapy (as well as into NYHA Class II for angina treatment).
    The move by C-Pulse further into NYHA Class IV might be aided by complementary therapies such as Celladon’s Mydicar (if Mydicar Phase 2b trial shows similar efficacy in correcting SERCA2a deficiency as indicated by its CUPID trial).
    But I repeat what I said in the article above, that Mydicar does not in my opinion (based on the CUPID trial results) seem likely to reverse HF as a standalone therapy (just a further increase in slowing of progression), while C-Pulse has shown ability to reverse HF in its feasibility trial with 25% becoming asymptomatic for HF.
    Aug 19 07:14 PM | 2 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Silly34

    Good to hear from you.

    I have a couple of minor non-urgent ops that I have been putting off for 2 years. If I continue to defer they could eventually become urgent. So I guess you could say I have a case of denial/self protection. On the other hand if I were advised I urgently needed a triple bypass I would go ahead immediately.

    It will be an education process for earlier stage HF patients to understand that when they are advised they need a C-Pulse they need to view it like a necessary triple bypass and act immediately.

    I am sure that education will require a lot of effort and will take time.

    Aug 17 08:22 AM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Bear Crusher

    Thank you for adding to the debate about potential technical risks/issues for Sunshine Heart C-Pulse.

    Similar issues have been raised in the past, including matters of calcification of the aorta and possible damage to the aorta from the C-Pulse action. Those issues have been addressed and adequately answered by Dave Rosa and his team and they have become non-issues. That is good, from my point of view, as I no longer need to be concerned about those issues as the concerns have been answered and resolved.

    I am sure other followers of this stock would feel the same way.

    Now, as for the potential for issues/problems with the TET system as raised by you.

    We do have some feedback on this. It has been reported that in the chronic animal trial there was no issue with overheating in surrounding tissue in the animal trial.

    You are saying, notwithstanding there was no overheating issue in the animal trials, there could be a problem when placed in humans due to movements that might affect the alignment of the TET coils.

    Neither you nor I, nor anyone else at this point in time, can categorically say this will or will not happen.

    Let us agree it is a potentially unresolved concern.

    I see it as a minor concern because Sunshine Heart could conceivably switch to the Witricity TET technology if Minnetronix cannot come up with a satisfactory TET system. You do agree that Witricity TET technology is not subject to overheating if the coils are not properly aligned?

    As to when the fully implantable (FIM) system will become available to humans -

    I believe you can be absolutely sure that neither Dave Rosa nor Kimberly Olesen will allow a new as yet untested in humans FIM system to be used in the Pivotal trial. Sunshine Heart has a perfectly capable existing C-Pulse PIL system that has shown outstanding efficacy in its Feasibility trial with drastically reduced re-hospitalizations and at least 5 "super responders" (25% of trial enrollees).

    It has already been stated that once PMA is received for the PIL system then the process to gain follow on approval for an FIM should be relatively quick and straightforward.

    PMA for the PIL is obviously 2 to 3 years away. I for one am very happy to see refinement, miniaturization and ongoing testing of the FIM continue in that period. It might be that there will be a small in human trial in the EU or elsewhere to show safety in humans before seeking follow on approval on the back of the PIL PMA. The C-Pulse part that wraps around the aorta is the same for both PIL and FIM so operation and efficacy should be similar. This has already been shown to be the case in the animal trials.

    I believe that success will be achieved with the C-Pulse FIM in humans within one or two years. But let us keep a watching brief on this question you have raised of potential overheating of a TET system.

    I believe that Minnetronix and Sunshine Heart would not have entered into a collaborative arrangement unless there was some confidence a TET system that is suitable for purpose could be successfully delivered.

    But even if that were not the outcome of the collaboration, for reasons given above, I do not believe it would be an insurmountable problem as we know there is already a technology available that has already overcome the issue of overheating if coils are not aligned.

    So it is most likely that, just as for aortic calcification and possible wear on the aorta, this is a non-issue.
    And BC, I am very happy to discuss these issues but I do not wish to engage where there are wild unsubstantiated assertions about the credibility and intentions of third parties. I hope you understand that.
    Aug 15 12:55 AM | 4 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi conspiracy_theory

    Based on feasibility trial and EU experience, a review of the progress of patients after the half way point of 190 enrollments will show a significant proportion of the enrollees receiving C-Pulse have had a halting of progression or reversal of their HF symptoms and low re-hospitalization rates.

    Based on empirical data the control group will have progressively worsening HF and have a much higher rate of re-hospitalizations than those receiving the C-Pulse.

    Do you have any idea if and what action would then be taken by the FDA to allow the control group to immediately access C-Pulse in these circumstances?

    And would the same question be applicable if it was glaringly obvious even in the early stages of the trial that the C-Pulse recipients were doing so much better than the control group?

    Regards, Robert
    Aug 13 06:12 PM | 3 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Thanks Tim.

    And yes, there are some grains of interest worth discussion among all the chaff Bear Crusher throws around. I kind of regret if I have been a bit terse and less than kind to him in any of my answers.

    Kind regards, Robert
    Aug 13 07:10 AM | 2 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Bear Crusher

    Please get it right. Dave Rosa was talking about the "TET" system not the "test" system.

    I will attempt to explain the situation to you step by step.

    The pump is an entirely new device that has no prior approval from the FDA for implantation in humans.

    The pump has successfully undergone acute and chronic trials in animals (powered by the TET system).

    The pump is continuing to be bench tested for reliability for long term running.

    All of the foregoing is necessary before the FDA will approve implantation of a new device (the new pump) in a human patient.

    Is all that clear.

    Now to the TET system.

    TET systems have already been approved by FDA for use in humans, e.g., LionHeart and Abiomed devices.

    The TET system should not require another round of rigorous testing by Sunshine Heart to gain FDA approval to use it.

    The same would apply if Sunshine Heart were to implement a Pacemaker from Medtronic or other FDA approved device into their C-Pulse system. They might need to show the system as a whole operated satisfactorily and safely in an animal trial.

    Sunshine Heart would not expect to have to subject a bought in already FDA approved Pacemaker to bench testing for reliability and longevity. That would be quite ridiculous.

    And the same applies to an already FDA approved TET system.

    Got it.
    Aug 13 01:41 AM | 5 Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi arisberna

    I only look at market share price compared to what I believe the fundamental value of the stock is.

    I am the wrong person to ask about timing of market entry.

    If I could make any suggestion it would be to ask yourself, if you wait how much lower could the share price go and how much higher could it go?

    Aug 12 09:33 PM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi rootbeer,
    I do think the Celladon Mydicar is a promising therapy for helping to heal an injured and failing heart. But I also believe it addresses only one of many problems involved in a failing heart.

    Celladon say they believe they can overcome the problem of neutralizing antibodies existing in a large percentage of patients.

    I expect trials will determine how successful and safe this might be.

    Aug 12 09:27 PM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Conspiracy_Theory

    I agree that what you say is certainly an option for SSH to raise cash without dilution.

    It is pleasing to see the actual SSH cash burn of $6.5M a quarter less, and the remaining cash of $42M more, than in my estimates above.

    Furthermore, provided the share price is above $6.40 at the time, there are $7M in warrants due to be exercised in December this year.

    That means even if the cash burn increases to $7M a quarter there would be sufficient cash to last another 7 quarters through to 1st quarter 2016.

    That gives plenty of time to get enrollments up to speed and achieve early review by FDA and to progress the FIM before any need to license or go to the market for additional cash.

    Aug 12 09:17 PM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Rodney,
    I cannot disagree with your concerns. The decline in health with HF is gradual and there are periods when a patient can pick up before continuing towards inevitable disaster.

    Without a trigger to cause an immediate decision it is easy to put off the inevitable (the gentleman in UK who wanted to walk his daughter down the aisle had such a trigger and the result for him was very good).

    There was a good discussion in the conference call on this question of patient acceptance. Centers are being encouraged to revisit the question of C-Pulse with patients as many people understandably will wish to think extensively about it and discuss with friends and relatives before committing to surgery.

    In the longer term, I believe the surgery will eventually be more readily accepted by patients on the recommendation of their Cardiologist in much the same way as a triple bypass is offered as the only solution to a potentially life threatening situation.

    That will be when the C-Pulse has FDA approval and the Cardiologist will say with confidence, OMT is no longer controlling your disease and the approved standard of care in these circumstances is implant of a C-Pulse. The eventual availability of a fully implantable C-Pulse will reinforce that.

    And of course C-Pulse needs only 0.1% of its target market to be quite profitable and just 1% of its target market to be extremely profitable. See -

    Aug 12 09:00 PM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Brennan,
    Good to hear from you and thanks for the kind sentiments.
    Aug 12 01:23 AM | Likes Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi Tim'S

    I think there are compelling reasons why the large Bios, who are no longer achieving past growth rates, should be looking to sweep up SSH, even at this early stage.

    Even a few billion dollars would be a small share of their annual R&D budgets, some of which would be being expended on projects with less promise than C-Pulse.

    But there are several considerations, including matters of "face" and the psychology of the situation that possibly preclude a bid at this time.

    Firstly, those large companies might prefer to acquire a company like SSH at a later stage when they are already accretive to earnings for the takeover entity.

    Secondly, and more importantly, It would take a brave and bold executive from JNJ, BSX or others to recommend to their Board to pay a few billion for a micro cap with a market cap under $100M. Because I doubt the SSH Board and Management would let this "Golden Goose" go for less than this.

    Thirdly, SSH has made it fairly clear that they want to take this project forward by themselves. And they have "poison pill" arrangements in place to prevent a hostile takeover. At the right time and at the right price SSH could agree to enter into takeover discussions. With the share price where it is, I doubt now would be considered the right time.

    Fourthly, with SSH "not in play", there is no urgency for any larger players interested in SSH to take any action at this time. (I think that possibly also reflects in the current share price)

    Anyway, it is in SSH shareholder's interest to hold off until there are substantial runs on the board.

    In regard to the "psychology of the situation" -

    Take the case of the bidding war between JNJ and BSX for Guidant which was eventually won by BSX with a bid of $27.2Bn. That was for a pacemaker business and, unlike C-Pulse, pacemakers do nothing to heal the heart.

    Just the difference between the high and low bid was $5.7bn.

    That makes a total bid of $3-$4bn for C-Pulse very much in the realms of possibility even at present. It would just require one big player to see another securing a potential competitive advantage and then the bidding war would be on.

    Below is a link to an interesting study about the BSX/JNJ bidding war for Guidant titled, "When Winning Is Everything".

    I am looking forward to the day when the bidding war for C-Pulse begins.

    But the immediate issue is an acceleration in the pace of enrollments in the Pivotal trial.
    I hope to hear of positive progress tomorrow.

    Trust that is all helpful.

    Aug 12 01:22 AM | 1 Like Like |Link to Comment
  • Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy [View article]
    Hi tpim,
    Thanks for the comments. Hopefully a good announcement tomorrow. My focus like yours is longer term than tomorrow.
    Aug 12 12:09 AM | Likes Like |Link to Comment