Over an average lifetime, your heart will beat some 2.5 billion times, with millions of litres of blood moving through its valves. It is an extremely complex and essential organ, so preserving its health, with minimal interference, is a healthcare priority. The latest technologies – like that produced by JenaValve – have opened the door for more issues to be treated without the need for costly and potentially risky open-heart surgery.
Its focus is on aortic regurgitation – when the aortic valve in the heart fails to close properly, allowing already oxygenated blood to flow back from the aorta into the heart, rather than continuing to the rest of the body. Around 10% of adults are affected,https://www.edwards.com/healthcare-professionals/conditions-procedures/aortic-regurgitationwith consequences ranging from shortness of breath and fatigue to – in severe cases – heart failure, strokes and ultimately death.
“JenaValve helps people who have heart failure from a leaky valve. Up until this point, valves have been repaired by opening people’s chests,” says Duane Pinto, chief medical officer of JenaValve and an interventional cardiologist. “Not every patient can survive such a procedure, and that’s where the JenaValve comes in – it’s for patients who are high risk for surgery.”
The company has developed the first transcatheter technology, a minimally invasive procedure that is specifically designed to treat aortic regurgitation. Their replacement valve is made of porcine pericardial tissue, which is derived from the membrane that surrounds a pig’s heart. This tissue is in turn encased in a self-expanding metal frame made of nitinol, a super-elastic alloy of nickel and titanium.
“We can repair their valve by inserting a catheter in the leg and threading it up into the heart and putting the JenaValve in,” Pinto says.
“As physicians, we have two things that we want to accomplish. We want people to feel better. We want them to live longer. And this device accomplishes both of those things.”
The minimal invasion is particularly important as aortic regurgitation is more prevalent among older people, who are in turn less able to cope with surgery.
“It’s unique because what we’re doing here is really providing a life-saving therapy,” says John Kilcoyne, JenaValve’s CEO.
However, developing new healthcare procedures, trialling them and securing regulatory approval (from the likes of US Food and Drug Administration) is long and complicated, requiring investment.
“It takes time to run clinical trials. It takes time to work with our colleagues in the FDA. It takes a special group of private equity investors to recognise that and to not necessarily focus on the immediate returns,” says Pinto.
Clinical data indicates that the technology could also potentially be used for other related conditions, such as aortic stenosis – when the aortic valve opening is narrowed, restricting the flow of oxygenating blood into the aorta and then the rest of the body.
“We are just on the precipice of the patients that we can help. That’s very exciting to me,” Pinto says. “That’s going to multiply the group of patients that we can treat and have less suffering at the time of their procedures in order to have a better life.”
Investment insights
By David Braga Malta, Principal Health, Private Equity, Pictet Alternative Advisors
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We are in the business of helping great technologies become viable commercial products. In our world, success has a few elements. One of them is patient impact; a second one is impact for investors; and the third one is the time frame in which you can generate those returns.
JenaValve is one such example of succeeding on all three dimensions. Pictet’s thematic private equity Health strategy invested in JenaValve in November 2022, taking part in the Series C financing round.
The company had a proven technology, which was wanted by doctors. When we first invested, demand was greater than what the company could manufacture. And they were at a point in their strategy that they needed to tap into the largest market – the US. To get FDA approval, they needed to do a large clinical trial, which in turn required additional funds. It was the opportunity for us to partake in this journey.
The proceeds are being used to finance the completion of clinical development and to accelerate the commercialisation of the underlying technology.
But beyond this, there are multiple things that private equity groups can bring. In the case of JenaValve, at one point they suffered from an issue in the supply chain, and we could help identify alternatives.
As JenaValve developed, it caught the attention of larger peers. In July 2024 it entered an acquisition agreement with Edward Lifesciences, a US-listed group focused on structural heart disease and critical care monitoring. As a result, Pictet was able to generate attractive returns for our private equity clients.
