Reprieve Cardiovascular recently raised $42 million in Series A funding, coming out of stealth mode.

The Milford, Massachusetts-based company is developing systems aimed at customizing decongestion management and removing excess body fluids to improve patient outcomes and prevent readmissions. The Reprieve system monitors physiological parameters such as urine output to provide personalized diuretic dosing and hydration for patients with acute decompensated heart failure (ADHF).

“Today, the standard of care for fluid removal in patients with heart failure is diuretics. Diuretics were first approved 60 years ago and remain a major treatment option, but optimal dosing can be difficult without real-time patient information. Yes,” said CEO Mark Pacyna. “Reprieve Cardiovascular brings intelligent decongestion management to heart failure patients. The Reprieve System gives physicians and care teams visibility and control throughout treatment.”

Repriv expects to use the funding to advance its clinical development programs, including the ongoing FASTR trial and future pivotal trials. Lightstone Ventures and Sante Ventures co-led the round, with participation from Deerfield Management, Genesis Capital, and Arboretum Ventures.

While in stealth mode, Reprieve has been growing its leadership team. Mr. Pasina joined the company in May 2021. Prior to joining Ripley, she spent 16 years at Medtronic in various leadership positions, most recently as vice president and general manager of Medtronic’s peripheral vascular business.

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

MD+DI: Do you ultimately aim to address unmet needs within heart failure more broadly? Will the Reprieve System be the first of many products?

Pashina: There is a good chance that it will improve the overall condition of heart failure. There are many different angles to chronic care, but there is also a huge need for acute heart failure patients who are overcrowded and short of breath in the hospital, and they need to meet that. Turn off excess liquid. So we thought addressing that urgent need was a starting point. We are not changing the underlying conditions of heart failure, but we are reducing their acute symptoms.

MD+DI: What is the origin of the grace system?

Pashina: The origin of this idea is that these acute patients are the number one reason for hospitalization for Medicare patients in the United States, and therefore spend a large amount of their health care dollars. Therefore, these patients present in large numbers and are hospitalized on average. As you can see, this is a huge burden on the system. And that was an opportunity for us to realize that there was a way to more aggressively remove all the fluid while being careful about potential damage to the kidneys.

The company spun out from Reprieve is kidney guard In Boston. And RenalGuard had a product in a clinical program designed to address acute kidney injury by providing saline to soften the effects on the kidneys.

That’s what actually happens in acute heart failure. The kidneys are basically the organs that regulate all the fluids in the body. So when you take a diuretic today, it forces your kidneys to produce urine. As you can see, the kidneys don’t like it very much, so they adapt to the dose. . This is why it is so difficult to get rid of fluid, because the kidneys don’t always get rid of it. So adding a little water back can help soften some of the signals to the kidneys and counteract the potentially harmful effects that diuretics have on the kidneys. It also allows the kidneys to be manipulated for longer to remove more fluid from the patient.

MD+DI: How do you incorporate intelligent aspects into your technology?

Pashina: We say that personalized and intelligent systems make this possible. Diuretics have been the cornerstone of his treatment for 60 years, but the interesting thing about diuretics is that they are threshold drugs. So the level you need, the level I need, the level Julia needs are all different. Each one of us. Therefore, a certain threshold must be exceeded in order to have a robust response and produce more urine. At this time, doctors do not know what that threshold is for each patient. So if a patient is taking X number of her doses at home, we start treatment based on the rule of thumb of taking X number of her 1.5 doses and go from there. …but they don’t have perfect information, so they start dosing in the morning and check again that afternoon or the next day to see if it’s working or not working well enough. Yes, they increase the dose. This makes it very time consuming to find the right dose that the patient needs.

What we do is we have a dose detection algorithm. Because we monitor real-time urine production as a signal to know when the dose that affects that individual has been reached. Whereas with the current medical system it often takes days to find a dose, we individually customize the dose and can do it within the first hour. .

MD+DI: Besides urine output, are there any other outputs or biometrics you’re looking at for signals?

Pashina: The two main things we look at are the total urine volume and the sodium content of the urine. Why does sodium content matter? In fact, a central mechanism the body uses to regulate fluid balance is how much sodium is in the body. So when you remove sodium and your kidneys excrete sodium, they also excrete fluid with it. So we actually use the sodium content of the urine and the total urine volume as inputs into the system to tell us how much fluid we’re drinking and how the patient is going to cope in the long term. I’m looking into it.

MD+DI: So, just to be clear, this seems to be aimed at optimizing diuretics, not replacing them?

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

MD+DI: Looking at funding and the current funding environment, what kind of feedback are you receiving from investors? What companies and technologies do they find most exciting about this investment opportunity?

Pashina: It’s a challenging environment, but if you’re in the right space with a large unmet clinical need, I think that’s what investors are always looking for. Acute heart failure remains one of the greatest unmet needs. From an individual funding perspective, it’s the fact that we’re so close to a pivotal trial and have real clinical data that they’ve been able to see and understand and get a measure of the risk that’s left in the program. . It was very helpful to us. … generated both within the U.S. through his FASTR pilot trial, which is currently enrolled, and the work we’ve done outside of the U.S. … So with a combination of great data and a big market opportunity, and Right timing.

MD+DI: What kind of schedule do you have in mind for those trials?

Pashina: We expect to receive approval to begin pivotal trials in the second half of 2024.

MD+DI: Are you thinking about your future exit strategy? Are you thinking about going public at some point, or are you hoping to be noticed by a strategic company and acquired?

Pashina: Prior to joining Ripley, I worked for Medtronic for 16 years, part of which was in Medtronic’s M&A group. So I have a pretty good understanding of how a lot of big organizations think about things. …It’s still too early to understand what direction this is going to go. More importantly, I think if we’re going to build this organization, if we’re going to build this technology, if we’re going to build this market, we’re going to do it for this long term…We need to make the right decisions today. Let’s say, and we’re going to make the right decisions if the strategists have an interest in inheriting something that’s been built the right way.