Hearts are complicated things. Made up of various chambers, veins and arteries, the complexity of the organ has led to cardiology being right at the forefront of R&D in med tech for a number of years.
A number of companies have specialised in the Structural Heart space, which looks to treat abnormalities in the valves and vessels of the heart brought about either by congenital defects, or through wear and tear after ageing.
There are a number of these vessels and valves – some of which are significantly easier to treat than others. For example, the treatment of abnormalities within the aortic valve, known as TAVI (transcatheter aortic valve implantation) has been a hotbed of development and competition in the structural heart space for the last decade, partly because it is less complicated to repair than other valves, like the mitral.
Fundamentally, the anatomy of a mitral valve is much more complex than an aortic one. The mitral valve is a ‘dual flap’ which lies between the left atrium and ventricle. It’s clever because it manages blood flow between the atrium and ventricles, without allowing blood to flow backwards when the ventricle contracts.
This is different to the less complex aortic and pulmonary valves which manage the blood flow leaving the heart, which have been treated for a number of years.
The issue with the mitral valve is when it stops working, known as MR (mitral regurgitation) where the blood starts to go both ways through the valve. A relatively common problem (1 in 10 Americans over 75 are believed to have MR) which, up until recently, has been difficult to fix.
I’m not a cardiologist, so as far as explanations go I’ll leave it there, but basically when things go wrong with the mitral valve, which is pretty common, it’s tough to fix.
However, the attention that was turned to aortic valve repair a number of years ago has all of a sudden been directed towards mitral. It’s a really exciting area to be working in at the moment, and since the first Transcatheter Mitral Valve Repair (TMVR) device from Abbott hit the market in 2013, momentum has been building to today – where I think we’re about to see a lot of activity in the space.
Up until recently, 2018 in fact, the Abbott device has still been the only one on the market, and they’ve been moving to solidify their position as market leaders. Their product, the MitraClip offers repairs for a specific type of mitral regurgitation and is limited by the fact that it can’t replace either a worn out or heavily stenosed (narrowed) valve.
Back in 2015 they put $250M into acquiring Tendyne, a business who developed their own mitral valve replacement technology. In breaking news last month, the Tendyne product has reported favourable outcomes from the first 100 patients treated with their TMVR system.
Unfortunately for them, it’s not all about Abbott. Edwards Lifesciences have been making their own inroads into the market, and are arguably the biggest player in the structural heart space, with a suite of products across pulmonary and aortic valve replacement and implementation.
Their forays into the mitral space have also seen the $100M acquisition of Harpoon Medical in December last year, another specialist business in minimally invasive mitral valve repair. They claim their tech shortens both the duration of the procedure and recovery times, over prior devices like the MitraClip. They’re still in the early stages of securing regulatory approval, but will no doubt be appearing on the US and European markets in the near future.
Harpoon’s CEO Bill Niland was quoted as saying “It would have been really hard for us to compete with big companies” were it not for the Edwards acquisition, but that hasn’t stopped some other smaller players from looking to enter the space, whether waiting to be acquired or not.
Cardiac Dimensions are one such mitral specialist, and their Carillon system has been CE marked, and has also been given a significant vote of confidence in the form of an additional $39M worth of funding. Another smaller business are Mitralign, who raised $10M of their own funding in February, and have some really exciting tech, even venturing into the uncharted waters of the tricuspid valve treatment too.
Lastly, Highlife Medical are also an exciting prospect albeit one at the earliest stage of all the businesses I’ve mentioned. Their aim is to produce a minimally invasive prosthetic mitral valve – watch this (or their) space for more innovation from Georg Börtlein – an innovator who previously sold CoreValue, a TAVI business acquired by Medtronic, for over $800M in 2009.
After a period of stagnation, where Abbott were the only business in town, the mitral market looks to be maturing at a faster rate than ever, and I think that 2018/19 will be the most significant time yet for the industry as a whole host of companies are on the verge of commercialising their products.
As always, hearing the thoughts of the experts in my network is the most important part of writing content like this. So please, let me know your thoughts on mitral below: do you think 2018/19 will see a mitral boom?