Synthetic Heart Valve Ushers in a Revolution in Heart Surgery – Strait Access Technologies

Interview with Professor Peter Zilla, CEO of Strait Access Technologies

When do you expect your products the deployment device, the synthetic heart valve and the mitral valve repair to be ready for market?

Our products will be ready for the market at different stages, where we are expecting the first product, the balloon, to be ready for the first world in early 2017. Our first valves will be ready second half of 2017.

Have these technologies started to attract significant international attention for other developing countries?

It was quite interesting because we were aiming only at developing countries because all the original ideas were based on solutions for the developing countries. As we are located in a relatively well known cardiac centre, we are exposed to many international colleagues.  During their visits to us, they realised that many of our technologies would bring significant improvements to their current first world products.

Can you explain to us, just to give some background understanding as to why rheumatic heart disease (RHD) is so common in un-resourced parts of the globe? Is it driven by the lack of access to antibiotics?

Absolutely true. It is linked to poverty and crowding. You need to have a certain density of people living together. A good example of this is when one hundred years ago in the American army when they discovered that if soldiers slept a certain distance from one another, rheumatic heart disease plummeted. So it is a matter of urban crowding and slums coupled with the lack of antibiotics. Not necessarily access because penicillin G is still very effective in the streptococci which causes the disease but more in the reliable distribution and access to it.

Our first valves will be ready second half of 2017.

We understand that so far the company has had very significant cash injections from the department of science and technology and Bidvest—that was for approximately 12 million rand and 18 million rand, respectively. Are you actively seeking further venture capital currently to develop, manufacture and market these devices?

It was actually twice that amount in the first two rounds and we are currently in the third round of seeking further funding.  We are close to signing all the funding contracts, so basically we can say it is as good as done.

So you are fully funded?

We are funded until every single product reaches the stage of first demand.

How much cash was needed to develop the procedure fully?

If we add it all up it was approximately 17 million US dollars.

We understand that what has also driven your impetus was that cardiac surgery techniques and technology were driven in the 60’s and 70’s initially by the very high death toll from RHD. Since that time the global burden of the disease has changed with the disease all but eradicated in the global north. Yet heart disease of all kinds is still highly specialized and still ferociously expensive to treat. I think it is about five thousand US dollars for a conventional heart valve or thirty thousand US dollars for a Trans catheter heart valve implant. These technologies are not niche. Why then was there no market impetus to develop cheaper poly urethane technologies such as the ones you have now pioneered?

If one looks at the total costs, even thirty thousand US dollars for the prosthesis alone is a fraction of what a heart operation costs. One has all the work ups from cardiology and geographies to the operation itself on the heart lung machine. So the prosthesis itself is a very small fraction of costs. Our whole drive was twofold. On the one hand to develop prosthesis which is cheaper and longer lasting but at the same time to cut out the expensive procedures preceding it.

If that’s the case couldn’t the Strait Access Technologies eventually become standard particularly given the far less invasive nature without the need for sophisticated infrastructure of traditional open heart surgery?

I believe the western world will always be dominated by lifestyle diseases even with changes to diet and better medications in the cardiac field. That is completely different to what we are aiming at. These are elderly people who generally have multiple diseases. Our patients with rheumatic heart disease are largely young and generally have one disease, namely that of the heart. If you are dealing in the first world with a seventy plus patient who suffers from a systemic disease and arterial sclerosis, it is a systemic disease which may affect the heart only but normally it affects the heart, the arteries to the brain and the arteries to the kidneys. So one is talking about strokes and multiple expressions of the disease in different organs and one will always have to pull them through the expensive system of the first world.

But there are less invasive aspects to your technology. There is no need to cut the ribcage open and the entire trauma associated with that.

Yes, but the technique of implanting heart valves via catheter is by now well established. The first world or at least central Europe has switched more than half of their heart valve operations from open heart surgery to Trans catheter implantation. They have all the equipment which is necessary and therefore our main benefit, namely of being able to implant valves under simple circumstances will not one hundred per cent be mirrored under the circumstance of the first world. However there are aspects to it such as the way we deploy it where the first world would also greatly benefit.

So a standard surgeon could perform the operation? You wouldn’t have to be a cardiac specialist?

That is for developing countries and the emerging economies but at the moment the first world  has enough cardiac surgeons and cardiologists who are available for these operations so one doesn’t  have to go into this fringe zone of medicine. 

The medical device industry overall is dominated by quite a small number of multinationals. If you do meet the need of developing countries wouldn’t the broader aim of Strait Access Technologies then be to bring these superior devices into the industrialized world as well? If it is so ground-breaking and so much cheaper and so much less invasive why can it not become the global standard?

We are firmly convinced that eventually it will. We can see from the response which we got from colleagues from the big first world centres it’s not only the aspect like the deployment devices but the synthetic valves themselves.

They clearly last longer, they are simpler to produce and they are appealing. We can see the surgeons anxiously waiting for them. We just aren’t rushing because first and foremost, the goal is to have them developed for emerging economies where they really depend on it and secondly it is a true paradigm shift and that means one must be very careful not to rush. One small mistake could then lead to a very long protracted period of waiting until you have the next opportunity again.

The ethos of the company initially was to do something that was benevolent altruistic as opposed to going after dollars.

Yes.

Would you ever look to actually licence your IP and your technology?

Yes, we are currently talking to Russia. They are very interested in our technologies and the model which we would follow is based on licencing it out.

South Africa has a long legacy of pioneering medical science. The first heart transplant was carried out in this very hospital. That is something that they are very proud of. Is Strait Access Technologies a worthy inheritor of that and a company that could potentially become another national champion?

Certainly, we have the 50th anniversary of the first heart transplant coming up next year and the motto is courage and innovation. I think that gives you the answer. The link is certainly there but it was a bit of a leap because South Africa doesn’t have a history of medical device development. The Western Cape offers itself with three universities in a very narrow space and no natural resources like the rest of the country. So it is a typical geographic position where other countries would also place their innovative developments. The Western Cape as I’m sure you have realised in the last two weeks is at the brink of getting into that space.

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