New Cardiovascular Company Emerges from Stealth Mode

Reprieve Cardiovascular recently emerged from stealth mode after raising $42 million in series A financing.

The Milford, MA-based company is developing a system intended to personalize decongestion management and remove excess fluid to improve patient outcomes and prevent hospital readmissions. The Reprieve System monitors physiological parameters such as urine output to deliver personalized diuretic dosing and fluid replacement for patients with acute decompensated heart failure (ADHF).

“Today, the standard of care for heart failure patient fluid removal is diuretics. Originally approved 60 years ago, diuretics remain the primary treatment option but can be difficult to administer optimally without real-time patient information,” said CEO Mark Pacyna. “Reprieve Cardiovascular is bringing intelligent decongestion management to heart failure patients. The Reprieve System provides physicians and care teams added visibility and control throughout treatment.”

Reprieve expects to use the funding to advance its clinical and development programs, including an ongoing FASTR trial and an upcoming pivotal trial. Lightstone Ventures and Sante Ventures co-led the round, which also included Deerfield Management, Genesis Capital, and Arboretum Ventures.

While in stealth mode, Reprieve has been growing its leadership team. Pacyna joined the company in May 2021. Before Reprieve, he spent 16 years at Medtronic in various leadership positions, most recently as VP and general manager of Medtronic’s peripheral vascular business.

MD+DI recently spoke with Pacyna to learn more about Reprieve Cardiovascular. The Q&A below has been edited for length and clarity.

MD+DI: Are you looking to eventually tackle unmet needs within heart failure more broadly? Will the Reprieve System be the first of many products?

Pacyna: There is ample opportunity to improve heart failure overall, right? You’ve got the chronic care and there’s a lot of different angles to that, but you also have this substantial need for the acute heart failure patients that show up to the hospital volume overloaded, shortness of breath, and they need to get that excess fluid off. So, we felt like the best place for us to start was to address that acute need. We aren't changing the underlying disease of heart failure, but we are alleviating those acute symptoms.

MD+DI: What was the genesis of the Reprieve System?

Pacyna: The genesis of the idea is that these acute patients take up a substantial amount of healthcare dollars because they’re the single largest admission reason for Medicare patients in the U.S. So, there’s a lot of these patients showing up and on average, they’re in the hospital over 5 days, so as you can appreciate, that's a significant burden on the system. And that was the opportunity that we saw is that there was a way to more aggressively get all that fluid off, while at the same time making sure that you're mindful of the potential injuries to the kidney.

The company that Reprieve spun out of was a company called RenalGuard in Boston. And RenalGuard had a product in clinical program designed to address acute kidney injury by providing saline to moderate the effects on the kidney.

That’s really what’s happening in acute heart failure. The kidney is the organ that basically moderates all the fluid within the body and so you take a diuretic today and that forces the kidney to produce urine and the kidney doesn't really love that, as you can appreciate, and it adapts to the doses. And this is why it's so hard to get the fluid off is because the kidney doesn't necessarily give that fluid up. So, by giving a little bit of fluid back, you can moderate some of those signals to the kidney and moderate the potentially harmful effects of diuretics on the kidney. And it allows you to work with the kidney longer to get more fluid off these patients.

MD+DI: Where does your technology come in with the intelligent aspect?

Pacyna: We say it's a personalized and intelligent system to do this. Diuretics have been the foundation of treatment for 60 years, and what's interesting about diuretics is they’re a threshold drug. So, the level that you need, the level that I need, the level that Julia needs is all different. Every one of us. So, you have to get over a certain threshold for you to have a robust response and to produce a lot of urine. Right now, physicians don't know what that threshold is for each patient and so they go based on rules of thumb that if the patient is on X dose at home maybe they go X times 1.5 and they start there. ... But they don't have perfect information, so they'll start them on a dose in the morning, they'll check back either that afternoon or the next day to see if it worked and it didn't work well enough, they'll up the dose. That's why it takes so long to find the appropriate dose that those patients need.

What we do is we have a dose finding algorithm because we're watching real time urine production as a signal for us to know when we've gotten to a dose that is going to be impactful for that individual. We’re really personalizing the dose and we can do that within the first hour versus what oftentimes today in the healthcare system can take a couple days to find.

MD+DI: Are there any other outputs or biometrics that you’re looking at for signals in addition to urine output?

Pacyna: The two main things that we look at is total urine output as well as the sodium content of the urine. Why is the sodium content important? Actually the core mechanism that the body uses to regulate fluid balance is how much sodium you have in your system. So, if you get rid of the sodium and if the kidney excretes sodium, the fluid will go with that. So, we really look at urine sodium content as well as total urine output as inputs into our system of how much fluid we're taking off and how those patients are going to do long term.

MD+DI: So, just to be clear, it sounds like this is not meant to replace diuretics but optimize them?

Pacyna: I think that’s very well said, that’s exactly what we’re doing.

MD+DI: Turning to the financing and the current environment for fundraising, what kind of feedback have you received from your investors? What about the company and the technology seem to get them the most excited what do they find most attractive about this investment opportunity?

Pacyna: It is a challenging environment, but I think if you're in the right space with a big unmet clinical need, that's what investors are always looking for. Acute heart failure remains one of those big unmet needs. From an individual funding standpoint, the fact that we're very close to going into a pivotal trial and there's real clinical data that they've been able to take a look at and understand and get a gauge of the risk that's left in the program was very helpful for us. ... We generated both in the U.S. through the FASTR pilot trial that we're currently enrolling in as well as work we've done outside the U.S. ... So, the combination of having good data, having a big market opportunity, and the right timing.

MD+DI: What timelines are you looking at for those trials?

Pacyna: We would anticipate receiving approval to start a pivotal trial in the back half of 2024.

MD+DI: Are you thinking about potential exit strategies down the road? Are you thinking about going public eventually, or maybe hoping to catch the eye of one of the strategics and get acquired?

Pacyna: I spent 16 years at Medtronic before Reprieve, and part of that time was in Medtronic’s mergers and acquisitions group. So, I have a pretty good sense for how a lot of the bigger organizations think through things. ... It's still way too early for us to understand where this is going to go. More importantly, I think if we build this organization and build the technology and try to build the marketplace that we will be doing that long term ... we're going to make the right decisions today and we're going to make the right decisions if a strategic were to become interested that they will be inheriting something that has been built the right way.