Meet the Entrepreneur

Fitting the Cordella Heart Failure System is a simple outpatient procedure that takes less than an hour where a sensor is implanted into the pulmonary artery, one of the body’s main blood vessels. From here, it can sense and wirelessly transfer information, including heart pressure. Once implanted, all the patient needs to do is hold a small hand-held device up to their chest for about 20 seconds, daily. The data obtained from the internal sensors is then passed onto the patient’s cardiologist who uses it to make appropriate decisions regarding the patient’s ongoing care, such as changes to medications, and the likes.

The intention is that this system will reduce hospital visits and ultimately improve and extend the lives of the many patients that are suffering with chronic heart failure.

Q: What was the inspiration for the Company?

I am a PhD in mechanical engineering and I met co-founder, Anthony Nunez, a cardiothoracic surgeon, back in February 2007. We soon discovered that we both had experience with family members suffering from heart failure and we had seen the detrimental effect this had, both on those with the condition, and on their loved ones. We also recognised the burden that heart failure has on the current health system. All of this inspired us to combine our expertise and start Endotronix.

We founded the Company in June 2007. We were only a small company at first, working on our early prototypes and designs. In 2016 we raised a $32m investment round, attracting International VCs with deep healthcare experience and medtech expertise who recognised the potential of Endotronix. The new investor base absolutely transformed the Company, catalysing our growth and accelerating our milestones.

Four years on, we are proud that our Cordella product has the opportunity to become standard of care for many patients.

Q: How did you meet the Seroba team and why do you think they came on board?

I lived in Dublin doing my PhD and knew of the medtech development ecosystem. We met the team two years before they invested and the decision to partner with them made a lot of sense. They monitored our development and how we responded to internal and market conditions for a while. When we hit a point of critical mass, with strong preclinical data, we began to talk seriously about working together. The relationship was about more than just funding, our platform ticked a lot of boxes for Seroba. They could see the patient need was great and also that the growing costs for hospitals treating heart failure patients could be greatly reduced. Early detection of worsening heart failure leads to a reduced need for readmissions, better quality of life for patients and lower healthcare costs.

As well as Seroba, we have a mix of investors from both the US and EU including SV Health, Lumira, BioVentures, Aperture Venture Partners, LSP and two medtech strategic investors.

Q: How has the partnership with Seroba worked? What do you value most about the team’s involvement?

At the early stages, Jennifer and the team asked a lot of searching questions; it was clear that they had done their homework. This made us even more confident that Seroba were going to be a good partner.

Four years on, we are pleased to say they have helped us by making some phenomenal introductions on the clinical side. Seroba provide exceptional leadership and have introduced us to a number of other investors with specific expertise. They are fully prepared to roll up their sleeves and get involved, which makes for an excellent partnership between us.

Q: What have been the highlights for the Company in the past year?

While 2020 has brought many challenges to our world, at Endotronix we remain focused on advancing the treatment of heart failure for patients and clinicians. In the last year we have refined and honed our product-offering to create a best-in-class remote heart failure management platform and pulmonary artery (PA) pressure sensor. We are actively enrolling patients in our SIRONA II CE Mark trial, which will provide E.U. market access, and our pivotal PROACTIVE-HF IDE trial, which will provide U.S. market access.

We anticipate full enrolment in SIRONA II by early 2021 and PROACTIVE-HF enrolment is well underway across all regions of the U.S. In addition, we were proud to see the results from our SIRONA First-in-Human trial presented at the American Heart Association (AHA) Annual Conference 2019 as well as published in the European Journal of Heart Failure.

More recently, our team is focused on the upcoming PMA regulatory submissions and working together to deliver an excellent customer experience at each touch point: sensor implantation in the cath lab, remote management by the clinician, and at-home patient use. We are excited about the pending commercial launch in 2022.

Q: So the challenging times have not slowed your progress.

In fact, several trends are aligning with our strategy. First, Covid-19 has accelerated the shift towards remote management for the vulnerable heart failure patients. Secondly, in July this year the U.S. market had effective nationwide reimbursement approved for PA sensor implantation. And lastly, we are on the cusp of clinical data in 2021 that will validate PA pressure data and may well expand indications for PA sensors, increasing the market size by 2-3 times. So yes, we are making great progress and it’s been an exciting time for us, despite the challenges.

Q: How is the Company doing at the moment? What are your immediate priorities?

As I mentioned earlier, our current focus is enrolment in the SIRONA II and PROACTIVE-HF trials. We have excellent clinician partners in both the E.U. and U.S. who are engaged and enrolling patients. Our 7 SIRONA II sites in Ireland, Germany and Belgium are all actively enrolling patients, and we continue to add new PROACTIVE-HF sites each month and anticipate being at a total of 40 enrolling sites by year-end.

Our immediate business priority for Cordella is to help clinicians treat their patients. However, an offshoot of all the data we will be collecting is the potential to use artificial intelligence in the future to enable earlier diagnosis and preventative treatment of the condition. Not only will this provide clinicians with further insights, but it will help us to understand the underlying mechanism of action behind heart failure.

Q: What is your plan for the next 2-3 years?

It will be an important time for Endotronix. All the hard work of the team will come to fruition. In the next 2-3 years, we anticipate full commercialization of the best-in-class Cordella HF System and Sensor in both the U.S. and Europe. Compelling data for PA pressure-guided therapy will be in, reimbursement will be in place and we will have the premier product in a duopoly market.

Q: What keeps you up at night?

y daughter coming in and waking me up! Jokes aside, at night I always find myself thinking about the potential of the Company – we have great technology and a fantastic team. We believe we can really impact the cardiology market and improve the lives of so many patients. However, it takes time and time is expensive. We are up against the clock and therefore it is really important that we move quickly and overcome challenges as they arise.

Q: If you had one piece of advice for new entrepreneurs, what would it be?

Firstly, I would emphasize the importance of believing in yourself and persisting with the concept you started out with. When I look back, I think my naïveté was actually a huge asset. It meant that I always believed I could do it and kept my focus on finding a way to make it happen. Above all else, for new entrepreneurs, I would stress the importance of surrounding yourself with smart, passionate and experienced people.