CHF Solutions, Inc (CHFS)

[Tommy]

$SSH - The Future For Sunshine Heart Just Got Brighter

Ohttp://seekingalpha.com/article/1754472-the-future-for-sunshine-heart-just-got-brighter?source=email_rt_article_readmore

In a recent interview, Mr. Dave Rosa, CEO of Sunshine Heart (SSH), raised the prospect of a further market opportunity for C-Pulse for treating angina.

My first impression was that these angina sufferers were just a segment of the existing CHF population that C-Pulse was designed to treat. So my thoughts were this would facilitate greater penetration by C-Pulse of this CHF market rather than a new market opportunity.

After conducting some further research, I came to understand that angina is not classed as heart disease. Sufferers of angina might also have coronary diseases, and they are susceptible to suffering heart attacks, and also to developing heart failure. But angina by itself is a condition and not a disease.

Below, I firstly provide some information on the condition known as angina, followed by a description of the C-Pulse attributes that suggest it might be invaluable in treating angina.

Angina:

An extract of a description of the angina condition per this PharmQD article is provided below -

Angina is a symptom of a heart condition known as myocardial ischemia. Simply put, angina occurs when the coronary arteries cannot supply the heart with enough oxygen-rich blood to meet its needs. The symptoms of angina are usually chest pain or pressure and most often appear when the heart requires more oxygen than usual, such as during exercise or a period of stress. Angina symptoms disappear after the patient rests or takes nitroglycerin. This type of angina is known as stable angina. Unlike a heart attack, angina does not cause permanent damage to the heart muscle, but it is a warning symptom of a temporary lack of oxygen to the heart tissue that should be carefully investigated by a physician to determine its cause and treatment.

C-Pulse:

In my recent article, "Sunshine Heart's C-Pulse: The 'Platinum' Standard", I described in some detail how C-Pulse can cause additional oxygenated blood flow to the heart tissue in a most beneficial way.

That seems to be exactly what might be needed when an angina attack occurs and there is a temporary lack of oxygen to the heart tissue as described above. Mr Rosa said in the abovementioned interview that C-Pulse can increase blood flow to the heart by up to 67%.

It is understandable why physicians have been asking Mr Rosa about making C-pulse available as a therapy for treating the angina condition.

Size of the angina population:

While angina sufferers could also have heart failure, the statistics indicate that the majority would not be a part of the CHF population that Sunshine Heart C-Pulse currently addresses. This opens up a whole new market opportunity that, in size, potentially eclipses the current C-Pulse market opportunity.

To understand just how significant the angina market could be to C-Pulse, I provide below an extract from this article:

As of 2010 angina due to ischemic heart disease affects approximately 112 million people (1.6% of the population) being slightly more common in men than women (1.7% to 1.5%).[45]

In the United States 10.2 million are estimated to experience angina with approximately 500,000 new cases occurring each year.[2][46] Angina is more often the presenting symptom of coronary artery disease in women than in men. The prevalence of angina rises with increasing age, with a mean age of onset of 62.3 years.[47] After five years post-onset, 4.8% of individuals with angina subsequently died from coronary heart disease. Men with angina were found to have an increased risk of subsequent acute myocardial infarction and coronary heart disease related death than women. Similar figures apply in the remainder of the Western world. All forms of coronary heart disease are much less-common in the Third World, as its risk factors are much more common in Western and Westernized countries; it could therefore be termed a disease of affluence. The adoption of a rich, Westernized diet and subsequent increase of smoking, obesity and other risk factors, has led to an increase in angina and related diseases in countries such as China.

And also from this National Center for Biotechnology Information (NCBI) publication:

According to the latest American Heart Association (AHA) Statistics 2010,11 overall prevalence of angina is 4.6% in the USA, affecting 10,200,000 persons, compared with a total number of 17,600,000 patients with coronary artery disease (CAD). Angina therefore afflicts 58% of patients with CAD.11 Approximately 500,000 new cases are reported yearly, and prevalence rises rapidly with increasing age. While anginal attacks are considered reversible short term, they are by no means benign, with significant morbidity and mortality.13,14 New-onset angina, defined as beginning within 2-3 months prior to presentation, has a poor prognosis,13,15 with about 10% of patients experiencing a nonfatal myocardial infarction or coronary death during the next year.16 While much of the data has been collected in men, it is now recognized that in women too, angina is not benign, with a 19% mortality rate within 4.5 years.17

Fully implantable is required for C-Pulse to be adopted for angina therapy

In the words of Mr. Rosa (from PropThink interview):

I didn't believe patients would come in, have a surgery, have a drive line coming out for a condition that's really intermittent.

So if you have a fully implantable system with nothing going through the skin, it's more or less like a pacemaker in a model where the pacemaker gets put in. And when your heart goes out of rhythm, it functions.

Ours (C-Pulse) could work the same way with the fully implantable. You put our pump in and when the patient begins to generate chest pain, there is an external power source that they could turn on and that would help get more blood through the coronaries.
So same kind of idea, same kind of concept (as a pacemaker) but it really opens us up to another large market by using this fully implantable design.

So, fully implantable C-Pulse is vital to opening up this market, just as I believe it is key to achieving large numbers of implants in the CHF market.

C-Pulse versus Nitrates for angina treatment

Present angina therapy cost and effectiveness -

Per NCBI publication referred to above:

The expense involved in controlling angina is considerable, approaching $1.1 million per capita as a lifetime cost in 2006 dollars for women.18 The estimated total direct and indirect cost of CAD for 2010 in the United States is about $177.1 billion. In weighing statistics, it should be emphasized that many millions of people with CAD remain undiagnosed, making the numbers, as striking as they are, actually conservative.

Based on angina afflicting 58% of patients with CAD (see above) the proportionate yearly cost of treating these patients would be over $100 billion.

The present use of nitrates for angina treatment is not a therapy that improves the heart condition.

Proposed C-Pulse therapy cost and effectiveness -

C-Pulse not only offers the opportunity for pain relief it also offers improvement in heart function and condition.

This improvement in heart function and condition might also improve the prognosis for angina sufferers. As referred to above, angina is associated with significant morbidity and mortality. About 10% of patients experience a nonfatal myocardial infarction or coronary death during the next year after first onset of angina.

Improvement in heart function and condition with C-Pulse might result in reduced hospitalizations and other cost savings as well as improving the quality of life for angina sufferers.

If with C-Pulse the total cost just stayed around ~100 billion then improvement in mortality and quality of life would still represent a considerable improvement over nitrate therapy. And $100 billion is a lot of C-Pulses.

Fully implantable C-Pulse

Sunshine Heart has already let contracts for a fully implantable pump design program with Cirtec Medical Systems, and entered into a collaboration with St. Paul-based Minnetronix for a transcutaneous energy transfer ("TET") system to power the fully implantable C-Pulse developed by Sunshine Heart.

The existing C-Pulse model has percutaneous leads similar to LVADs. Fully implantable is the "Holy Grail" for heart assist devices. It is something not yet achievable for Thoratec (THOR) and Heartware (HTWR) LVADs despite large R&D commitments over many years.

Below is a response on fully implantable I gave to a reader comment in respect of my above referenced article, "Sunshine Heart's C-Pulse: The 'Platinum' Standard":

Thanks for raising the subject of TET and fully implantable. Fully implantable is the game changer, the "holy grail".
A fully implantable C-Pulse system is, and always has been, the intention of Sunshine Heart right from conception. Initial company patents were based on this concept.

Feasibility of fully implantable C-Pulse was demonstrated in an animal trial in early 2012 (see here) -
• Completed animal feasibility 5/31 at Texas Heart with TET system
• Provided full support

Contracts were let earlier in 2013 for TET and pump for the fully implantable in humans model.

Animal trials are currently being conducted using these models developed for human implantation and both acute and chronic treatment trials are expected to be completed by year end.

The May 2012 fully implantable trial showed the system provided full support as for the non fully implantable. At this stage there is no reason to think the newly developed human fully implantable (FI) model will provide any lesser performance than the existing percutaneous interface lead (PIL) model.

What I am really interested to know is what the human clinical trial/s path will be for fully implantable.

If we were to undertake a critical path analysis the end point would be FDA approval for marketing the fully implantable device in the US. But even more critical would be the point of obtaining CE Mark in the EU. That could open the floodgates for early significant revenues and profits.

Now I would fervently hope that the FI model process will not follow sequentially after the PIL model process.

Surely at some stage the two must merge.

I can only imagine the C-Pulse cuff which is the critical design element for efficacy will remain unchanged.
The internal pump and the TET and the external batteries or other power source are pretty much just accessories to the main working part. Changing these might not be too different to THOR's changing to a newly designed pocket controller. Or to the many modifications to various aspects of the C-Pulse controls and other accessories progressively approved by the FDA.

The one significant safety issue in the Feasibility trial was 8 out of 20 patients with exit site infections. The FI would eliminate this one element of safety concern.

Financial implications of this new angina market

Clearly, if the size of the C-Pulse market is doubled that will potentially result in a doubling of profits from the C-Pulse system.

But it is better than that, because all of the start up costs and fixed overheads are already implicitly taken into account in valuing Sunshine Heart based on the existing CHF market opportunity.

This new angina market opportunity should only have to bear incremental costs associated with production and sale.

One would think that emergence and recognition of this new market should have had the effect of at least doubling the market value of Sunshine Heart stock. It would appear "Mr. Market" continues to slumber on as far as Sunshine Heart is concerned.

This additional market opportunity should at least allay any concerns that might exist as to the numbers of implants Sunshine Heart can achieve long term.