_--Results Presented at CSI Focus D-HF Meeting Show Safe, Rapid Fluid and Sodium
Removal, Highlighting Potential New Approach to Manage Acute Decompensated Heart Failure--_

**MILFORD, Mass. and FRANKFURT, Germany, December 16, 2024** — Reprieve
Cardiovascular, Inc., a development-stage company focused on advancing acute
decompensated heart failure (ADHF) treatment, today announced the first-in-human
results of the Reprieve System at the CSI Focus D-HF (Device therapies in heart
failure) conference in Frankfurt, Germany. Results of the study demonstrated the
potential of the Reprieve System to safely accelerate and maximize decongestion while
reducing the likelihood of kidney injury for patients with ADHF.

"Heart failure patients with fluid volume overload are particularly challenging to manage due to the difficulty of achieving the right balance in decongestion—thoroughly enough to prevent readmission without damaging the kidney in the process” said Dr. Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University, Poland, who presented these results. “These initial findings demonstrate the potential of the Reprieve System to address the longstanding challenges of ADHF treatment by removing a significant amount of sodium, improving decongestion outcomes, reducing renal injury risks, and potentially shortening hospital stays. As heart failure management continues to evolve, this technology represents a significant step forward in developing precise, patient-centric approaches to decongestion management.”

ADHF is characterized by the sudden or gradual onset of symptoms such as difficulty breathing, leg or feet swelling, and fatigue, often requiring unplanned office visits, emergency room care, or hospitalizations, with an average stay of more than five days.¹  Nearly 1 in 4 patients are readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months.²  Managing fluid removal in ADHF patients has been a persistent challenge, as the primary treatment of diuretics is difficult to administer precisely without real-time information on patient response. This can lead to an increased risk of kidney injury, prolonged hospital stays, inadequate fluid removal at discharge, and frequent readmissions. 

Intended to personalize decongestion management and safely, quickly, and thoroughly remove excess fluid to improve patient outcomes and prevent hospital readmissions, the Reprieve System works to remove fluid and sodium through precise administration of diuretics, rapidly finding the optimal dose while delivering the necessary volume of fluid and sodium to support optimal kidney function. The Reprieve System uniquely combines real-time physiological monitoring with automated recommendations to escalate or end therapy, enabling physicians to tailor treatment to each patient’s specific needs during therapy. This innovative therapy is designed to integrate seamlessly into existing clinical workflows, improve patient care, and reduce the workload for clinicians treating heart failure patients.

A first-in-human, open-label, single-arm study to evaluate the ability of the Reprieve System to optimally decongest subjects with ADHF was conducted in Tbilisi, Georgia, and included 10 subjects. Participants received Reprieve System therapy until completion of therapy, or for a maximum of 72 hours, whichever came first. Follow-up clinical assessments were performed during treatment and post-treatment through 30 days post-discharge. Adverse events were assessed through 30 days. The primary efficacy endpoint was functional device success, defined as the device's ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician over the 72-hour maximum duration of therapy.  

The system successfully facilitated high-volume fluid and sodium removal with an average treatment duration of 18.3 hours and achieved:
- Net fluid loss of approximately 4.8L,
- Average weight reduction of 4.8 kg, and
- Net sodium loss of 653 mmol. 

Notably, kidney function remained stable, no patients developed acute kidney injury, and the average serum creatinine level decreased over the course of therapy, indicating effective decongestion without renal complications. No device or procedure related adverse events were reported through 30 days.

"We are encouraged by these initial results from the first-in-human study of the Reprieve System, which demonstrate its potential to enable clinicians to manage fluid overload safely and efficiently," said Mark Pacyna, Chief Executive Officer of Reprieve Cardiovascular. "We know greater sodium removal improves short and long-term outcomes for ADHF patients. We were also thrilled to complete enrollment in our U.S. FASTR pilot trial earlier this year and look forward to sharing those results in early 2025, with the goal of further validating the findings from this First-In-Human study of the Reprieve System. Looking ahead, we aim to prove the full potential of the Reprieve System in a global pivotal study next year, marking an important step toward our mission of transforming decongestion management for acute heart failure patients."

**About Heart Failure**\
Heart failure is a significant and growing public health issue, affecting over 6.7 million Americans today. Acute decompensated heart failure, characterized by a rapid onset of fluid volume overload, leads to over one million hospital admissions annually in the U.S. alone. Despite current treatment options, nearly 25% of patients are readmitted within 30 days, highlighting the need for more effective management strategies.

**About Reprieve Cardiovascular, Inc.**\
Reprieve Cardiovascular is committed to advancing the treatment of heart failure by developing groundbreaking technologies that bring intelligence to decongestion management. The company's innovative therapies aim to improve the lives of over 25 million heart failure patients worldwide. Headquartered in Milford, Massachusetts, Reprieve Cardiovascular is dedicated to pioneering solutions that address the complex challenges of heart failure management.

**Contact**:\
Julia Fuller\
(858) 692-2001\
julia@fordhutmanmedia.com 

-----------------
¹ Truveta Real-World Analysis: 262,673K Patient Cohort\
² American Heart Association. "Heart Failure Statistics." Circulation Research, 2021. Accessed December 3, 2024. https://www.ahajournals.org/doi/pdf/10.1161/CIRCRESAHA.121.318186






First-In-Human Study Demonstrates the Potential of the Reprieve System in  Patients with Acute Decompensated Heart Failure

_FASTR Trial Assessing the Safety and Efficacy of the Reprieve System Compared to Optimal Diuretic Therapy_

**Milford, MA — October 7, 2024 —** [Reprieve Cardiovascular](https://reprievecardio.com/), Inc., a development-stage company pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced the completion of enrollment in the "**F**luid Management of **A**cute Decompensated Heart Failure **S**ubjects **T**reated With **R**eprieve System (“FASTR”) trial.

The FASTR trial aims to compare the effectiveness of decongestive therapy administered by the Reprieve System with Optimal Diuretic Therapy (ODT) in patients diagnosed with ADHF. The primary objective of the study is to determine whether the Reprieve System can more efficiently decongest ADHF patients compared to standard-of-care therapy.

"For decades, managing fluid removal in patients with ADHF has presented a significant challenge, with many failed trials of new drugs or devices," said James Udelson, M.D., Chief of Cardiology at Tufts Medical Center in Boston and principal investigator of the FASTR trial. "Diuretics, which have been the only widely used therapeutic option, are difficult to administer precisely without real-time information on patient response, making it challenging to balance rapid fluid removal with the risk of kidney injury, and thus are rarely used optimally. In addition, these patients are often faced with [lengthy hospital stays, incomplete decongestion at discharge and frequent readmissions](https://www.jacc.org/doi/10.1016/j.jchf.2024.04.002?utm_medium=email_newsletter&utm_source=jaccjournals&utm_campaign=spub&utm_content=20240408&utm_medium=email_newsletter&utm_source=spub&utm_campaign=toc&utm_content=20240405) due to fluid volume overload. The Reprieve System is a promising heart failure management solution that can be easily implemented into existing clinical workflows, while also elevating the current level of care. As a result, this may help ease the workload burden for clinicians treating heart failure patients."

Intended to personalize decongestion management and safely, quickly, and completely remove excess fluid to improve patient outcomes and prevent hospital readmissions, the Reprieve System works with the kidneys to remove fluid through precise administration of diuretics, rapidly finding the optimal dose while ensuring they receive an adequate amount of sodium to support optimal kidney function. The Reprieve System uniquely combines real-time physiological monitoring with automated recommendations to escalate or end therapy, enabling physicians to tailor treatment to each patient’s specific needs during therapy. This approach aims to safely accelerate fluid removal and improve patient outcomes while reducing the likelihood of kidney injury and hospital readmissions for patients with ADHF.

The trial enrolled a total of 100 patients who were randomized into two groups. The experimental group received personalized treatment using the Reprieve System. The active comparator group received Optimal Diuretic Therapy.

The primary efficacy endpoint of the study is the total urine sodium output at 24 hours post-treatment initiation. The primary safety endpoint includes clinically significant acute kidney injury, symptomatic hypotension or hypertensive emergency. Secondary outcomes will assess the net fluid removal during treatment, heart failure rehospitalization and the total time on loop diuretics.

"Completing enrollment in the FASTR trial marks a significant milestone for Reprieve as we advance our mission to improve the lives of patients living with heart failure," said Mark Pacyna, Chief Executive Officer of Reprieve Cardiovascular. "We designed this study as a large, randomized pilot, which is uncommon in this space, to rigorously assess the safety and effectiveness of the Reprieve System in US patients before embarking on a global pivotal trial. We would like to thank and recognize all the clinical research teams for their partnership in the FASTR trial. We look forward to advancing our clinical program, with the initiation of a pivotal study before the end of the year and a data readout from the FASTR trial in the first half of 2025.”

**About Heart Failure**

Heart failure is a significant and growing public health issue, affecting over 6.7 million Americans today. Acute decompensated heart failure, characterized by a rapid onset of fluid volume overload, leads to over one million hospital admissions annually in the U.S. alone. Despite current treatment options, nearly 25% of patients are readmitted within 30 days, highlighting the need for more effective management strategies.

**About Reprieve Cardiovascular, Inc.**

Reprieve Cardiovascular is committed to advancing the treatment of heart failure by developing groundbreaking technologies that bring intelligence to decongestion management. The company's innovative therapies aim to improve the lives of over 25 million heart failure patients worldwide. Headquartered in Milford, Massachusetts, Reprieve Cardiovascular is dedicated to pioneering solutions that address the complex challenges of heart failure management.

###

**Contact:**

Julia Fuller\
Ford Hutman Media\
858-692-2001\
[julia@fordhutmanmedia.com](mailto:julia@fordhutmanmedia.com)



Reprieve Cardiovascular Completes Enrollment in Randomized Pilot Trial Evaluating First-of-its-Kind Personalized Fluid Management System for Acute Decompensated Heart  Failure

_-- Reprieve Cardiovascular Partners with Leading Heart Failure Researchers and Truveta to Analyze Real-World Heart Failure Patient Data to Highlight Opportunities to Improve the Current Patient Management Paradigm --_

**MILFORD, Mass., May 02, 2024**-- Reprieve Cardiovascular, Inc. ('Reprieve'), a development stage company focused on pioneering an intelligent approach to acute decompensated heart failure (ADHF) treatment, today highlighted the publication of [TREAT-AHF study results in ](https://www.jacc.org/doi/10.1016/j.jchf.2024.04.002?utm_medium=email_newsletter&utm_source=jaccjournals&utm_campaign=spub&utm_content=20240408&utm_medium=email_newsletter&utm_source=spub&utm_campaign=toc&utm_content=20240405)[_JACC: Heart Failure_](https://www.jacc.org/doi/10.1016/j.jchf.2024.04.002?utm_medium=email_newsletter&utm_source=jaccjournals&utm_campaign=spub&utm_content=20240408&utm_medium=email_newsletter&utm_source=spub&utm_campaign=toc&utm_content=20240405).

Heart failure (HF) is a leading cause of hospitalization in the United States. Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss are not well described. Nearly 20 years ago, the Acute Decompensated Heart Failure National Registry (ADHERE) was published¹ and described inpatient HF treatment patterns and decongestion outcomes in a prospective national database of HF hospitalizations across 275 community and academic medical centers.

As a national community-based cohort, **T**rajectory and **R**esponse to **E**mergently **A**dministered **T**herapy for **A**cute **H**eart **F**ailure (TREAT-AHF) is a contemporary registry that characterizes a diverse population of 262,673 patients with HF from 2015 to 2022. In the TREAT-AHF study, the distribution of inpatient body weight change was similar to those reported from ADHERE nearly two decades ago. Discharge weight was higher than admission weight in 20% of HF hospitalizations, highlighting the challenges facing physicians and patients to effectively remove excess fluid. Furthermore, there was considerable variation in weight loss from diuretic use related to differences in patient characteristics and clinical practices. The TREAT-AHF study also demonstrated the median length of stay was 5.8 days (ranging from 3.7 to 9.7 days), which underscores the extended, variable duration of inpatient decongestion treatment. This unpredictability manifests in resource and scheduling challenges for patients, physicians and administrators.

"Decongestion therapy is a critical part of acute heart failure management. The TREAT-AHF analysis provides a contemporary understanding of the state of decongestion therapy across a broad set of health systems across the United States. We found there has been little change in diuretic management compared with prior cohort studies. There needs to be a call to action for developing and testing novel strategies for improving decongestion for patients hospitalized with heart failure," stated Dr. Alexander Sandhu, Division of Cardiovascular Medicine and Stanford Prevention Research Center, Department of Medicine at Stanford University.

**Additional Heart Failure Research Presented**

Acute HF hospitalization represents a critical opportunity for the rapid initiation of evidence-based medications. However, data on GDMT use at discharge are mostly derived from national quality improvement registries. At the American College of Cardiology 2024 scientific sessions, [a TREAT-AHF subset was presented](https://www.abstractsonline.com/pp8/?_gl=1*q287co*_ga*OTk2NDA4OTU4LjE3MTEzNzk1MTU.*_ga_2V8VW4Y237*MTcxMTM3OTUxNS4xLjEuMTcxMTM3OTY3My40My4wLjA.#!/10973/presentation/11586) that looked at guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF).

The study findings: Inpatient utilization of GDMT among diverse community-based health systems was lower than rates observed in national quality improvement registries where participation is voluntary. Discontinuation of GDMT before discharge, contrary to the guidelines, occurred in a substantial proportion of hospitalizations despite previous inpatient administration. Hypotension, hyperkalemia, and worsening renal function were strong factors associated with discontinuation, but discontinuation was unexplained by clinical factors in many hospitalizations. Implementation of novel strategies to achieve comprehensive use of GDMT is urgently needed among acute HF hospitalizations.

"Guideline-directed medical therapy underuse and discontinuation during hospitalization for heart failure results in poor quality of care and worse outcomes for patients. We need to develop in-hospital management strategies including for clinical decongestion that allow restoration of euvolemia while also facilitating continuing and new initiation and/or up-titration of GDMT for heart failure," stated Dr. Andrew Ambrosy, Assistant Medical Director for the Clinical Trials Program at the Division of Research and a cardiologist with The Permanente Medical Group.

**Advancing Acute Heart Failure Patient Management Through the Analysis of Real-World Data**

Reprieve is partnering with industry-leading heart failure researchers and Truveta to understand and advance acute heart failure patient outcomes. Truveta delivers the most complete, timely, and clean electronic health record data, including images, clinician notes, and labs from more than 30 health systems linked with social drivers of health (SDOH), claims, and mortality data, empowering researchers with scientifically rigorous analytics. Truveta Data provides daily updated, regulatory-grade data from more than 100 million de-identified patients in all 50 states from more than 800 hospitals and 20,000 clinics to provide a timely and representative view of patient care in the US.

Through this partnership, Reprieve is providing heart failure researchers access to Truveta Data to facilitate the understanding of contemporary care of patients with ADHF. The partnership with Truveta contributed to the TREAT-AHF analysis and the publication of the manuscripts.

"Reprieve is committed to understanding the ADHF patient journey. The clinical evidence from the TREAT-HF study demonstrates that heart failure decongestion management has not substantially changed in 20 years," said Mark Pacyna, chief executive officer of Reprieve Cardiovascular. "The data highlights the opportunities to improve care, but it will take a sustained partnership among hospital systems, physicians, nurses, and industry partners to solve this. Reprieve is committed to building these partnerships."

**About Acute Decompensated Heart Failure**

ADHF is the sudden or gradual onset of the signs or symptoms of heart failure (difficulty breathing, leg or feet swelling, and fatigue) requiring unplanned office visits, emergency room visits, or hospitalization. Specifically, ADHF is caused by a rapid onset of fluid volume overload. Five million patients a year are admitted with heart failure diagnoses in the U.S., with 40 percent of these patients being admitted with worsening heart failure. ADHF is one of the leading admission diagnoses around the world. Often, patients are re-admitted to the hospital repeatedly to treat fluid volume overload, and each hospitalization substantially increases a patient's morbidity and mortality.

**About Reprieve Cardiovascular, Inc.**

Reprieve Cardiovascular, Inc. is developing innovative and groundbreaking therapies that aim to improve the lives of more than 25 million heart failure patients around the world. Reprieve is bringing intelligence to decongestion management to safely accelerate fluid removal for every heart failure patient. In 2022, Reprieve initiated the FASTR Trial (pilot study) to compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy in the treatment of patients diagnosed with acute decompensated heart failure.

Reprieve is a privately held medical device company, headquartered in Milford, Massachusetts, USA.

**Contact:**\
John Jordan\
(508) 505-5597\
john@fordhutmanmedia.com

¹Adams KF., Fonarow GC., Emerman CL., et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J 2005;149(2):209–16. Doi: 10.1016/j.ahj.2004.08.005.

New Study Published in JACC: Heart Failure Reveals that Despite Significant Efforts to Improve Acute Heart Failure Treatment Over the Past 20 Years, Management Remains Unchanged

_\-- Financing Enables Company to Advance Current and Future Clinical Programs --_

_\-- Heart Failure is Common and Costly: Over One Million Patients a Year Are Admitted with primary Heart Failure Diagnoses in the U.S. –_

**MILFORD, Mass., February 20, 2024** -- [Reprieve Cardiovascular](https://reprievecardio.com/), Inc., a development stage company focused on pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced it has raised a total of $42 million in series A financing. The total round was co-led by Lightstone Ventures and Sante Ventures and joined by Deerfield Management, Genesis Capital, and Arboretum Ventures. The funding will advance the Company’s clinical and development programs, including the ongoing FASTR trial and its upcoming pivotal trial.

Over 6.7M Americans are living with heart failure today¹. ADHF is the sudden or gradual onset of the signs or symptoms of heart failure (difficulty breathing, leg or feet swelling, and fatigue) requiring unplanned office visits, emergency room visits, or hospitalizations. Specifically, ADHF is caused by a rapid onset of fluid volume overload. Over one million patients a year are admitted with a primary heart failure diagnosis² in the U.S., and millions more around the world, with an average hospital stay of more than 5 days³. Unfortunately, nearly 1 in 4 patients are readmitted to the hospital within 30 days to re-treat fluid volume overload, and approximately half are back within 6 months⁴.

“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 Mark Pacyna, chief executive officer of Reprieve Cardiovascular.

Intended to personalize decongestion management and safely, quickly, and completely 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 ADHF. Pacyna continued, “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.”

**Company Expands Management Team**

During the past three years, Reprieve Cardiovascular has grown significantly. Today, the leadership team is composed of domain experts in product development, regulatory, clinical, and commercial strategy who bring decades of medical device and cardiovascular experience and a track record of success in developing life-changing healthcare solutions.

Leading Reprieve is Chief Executive Officer Mark Pacyna, who joined Reprieve in May 2021. Before Reprieve, Mark spent 16 years with Medtronic in various leadership positions. Most recently, Mark served as the Vice President & General Manager of Medtronic’s Peripheral Vascular Business.

“We’re excited to share the Reprieve story as the company emerges from stealth mode ahead of their pivotal trial,” said Jan Garfinkle, founding and managing partner of Arboretum Ventures. “The Series A funding reinforces our belief in the Reprieve team, and in the need for a new technology that can improve the lives of patients suffering from acute decompensated heart failure around the world.”

**About Reprieve Cardiovascular, Inc.**

[Reprieve Cardiovascular, Inc.](https://reprievecardio.com/) is developing innovative and groundbreaking therapies that aim to improve the lives of more than 25 million heart failure patients around the world. Reprieve is bringing intelligence to decongestion management to safely accelerate fluid removal for heart failure patients. In 2022, Reprieve initiated the FASTR Trial (pilot study) to compare decongestive therapy administered by the Reprieve Decongestion Management System to Optimal Diuretic Therapy in the treatment of patients diagnosed with acute decompensated heart failure.

Reprieve is a privately held medical device company, headquartered in Milford, Massachusetts, USA.

**About the** **FASTR Trial**

The Company is currently conducting the FASTR Trial (**F**luid management of **A**cute decompensated heart failure **S**ubjects **T**reated with **R**eprieve system). The objective of this pilot study is to determine if decongestive therapy administered by the Reprieve System can more efficiently decongest ADHF patients as compared to standard-of-care diuretic therapy. This trial is enrolling patients in the United States and Europe.

**References**

1. Tsao, C. W., Aday, A. W., Almarzooq, Z. I., Anderson, C. A. M., Arora, P., Avery, C. L., Baker-Smith, C. M., Beaton, A. Z., Boehme, A. K., Buxton, A. E., Commodore-Mensah, Y., Elkind, M. S. V., Evenson, K. R., Eze-Nliam, C., Fugar, S., Generoso, G., Heard, D. G., Hiremath, S., Ho, J. E., & Kalani, R. (2023). Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. _Circulation_, _147_(8). <https://doi.org/10.1161/cir.0000000000001123>
2. Kuno T, Briasoulis A, Tsugawa Y. National Trends in Heart Failure Hospitalization and Readmissions Associated With Policy Changes. _JAMA Cardiol._ 2022;7(1):114. doi:10.1001/jamacardio.2021.4416
3. Akintoye, E., Briasoulis, A., Egbe, A., Dunlay, S. M., Kushwaha, S., Levine, D., Afonso, L., Mozaffarian, D., & Weinberger, J. (2017). National Trends in Admission and In‐Hospital Mortality of Patients With Heart Failure in the United States (2001–2014). _Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease_, _6_(12). <https://doi.org/10.1161/JAHA.117.006955>
4. Khan, M. S., Sreenivasan, J., Lateef, N., Abougergi, M. S., Greene, S. J., Ahmad, T., Anker, S. D., Fonarow, G. C., & Butler, J. (2021). Trends in 30- and 90-Day Readmission Rates for Heart Failure. _Circulation: Heart Failure_, _14_(4). <https://doi.org/10.1161/circheartfailure.121.008335>

Reprieve Cardiovascular Emerges from Stealth Mode after $42 Million Series A Financing to Bring Intelligent Fluid Management to Heart Failure Patients

**MILFORD, Mass., Dec. 13, 2019 /PRNewswire/** -- Reprieve Cardiovascular®, a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF), today announced the results of the first-in-human clinical trial with the company's second generation device, the Personalized Volume Management System (PVM). The study demonstrated that the fully automated fluid management system resulted in safe, effective, efficient and long-lasting decongestion for patients with Acute Heart Failure. The results were presented today at the Device Therapies in Heart Failure (D-HF 2019) meeting in Paris, France.

The 15-patient clinical trial was designed to determine whether the Reprieve Personalized Volume Management System could more efficiently and safely achieve reductions in net volume and AHF symptoms.

**Data highlights:**

- Average net fluid removal: -5.9 L/therapy, normalized to -4.5 L/24 hr.
- Average weight loss after mean treatment duration of 31 hrs: -6.8 kg.
- Average weight loss of -5.7 kg (from baseline) was maintained at 30-day follow-up in 12 patients who completed the 30-day follow-up.
- Average sodium removal was -798 mmol per therapy, normalized to -611 mmol/24 hr.
- No re-hospitalization of patients who have completed the 30-day follow-up.
- No significant adverse events were reported.

**Device benefits for AHF treatment:**

- The Reprieve Personalized Volume Management System, designed to speed fluid removal and symptom relief with the lowest effective diuretic dose for each patient, automatically tailors diuretic dosing.
- **"Set and forget"** convenience.
- Provides personalized fluid management to prevent hypotension and the activation of salt- and water-retaining renal mechanisms.

"We're very encouraged by these first in man results with our new Personalized Volume Management System," said Reprieve Cardiovascular Chief Medical Officer Howard Levin, M.D. "The trends in all of the core metrics that matter to heart failure physicians and patients, including length of stay, weight reduction, and re-hospitalization point in a positive direction. We look forward to continuing this clinical work to support the adoption of PVM as a standard of care for improved treatment of patients with ADHF."

**About ADHF**

ADHF is a sudden onset of heart failure symptoms, which typically include difficulty breathing (dyspnea), swelling in the extremities, and fatigue. The signs and symptoms of fluid overload are responsible for 90% of heart failure hospital admissions. Current treatment for ADHF includes diuretic therapy that aims to restore healthy fluid levels in the kidneys and throughout the body. Standard diuretic therapy, however, can be unpredictable and lose effectiveness as a patient's condition deteriorates. In some patients, diuretics can trigger a condition called "diuretic resistance," which blunts the function of diuretics and can exacerbate the severity of fluid overload, potentially resulting in acute kidney injury.

**About Reprieve Cardiovascular's Personalized Volume Management System**

Reprieve Cardiovascular's Personalized Volume Management System, a second-generation automated fluid management system, is designed to better manage diuretic therapy for patients with Acute Decompensated Heart Failure (ADHF) and may relieve a number of symptoms related to this condition. The therapy is designed to enable more precise, predictable and efficient management of a patient's fluid levels, guarding against dangerous fluid imbalances and enabling better control over diuretic therapy. Potential benefits include speeding decongestion while protecting core organ function, reducing symptoms of congestive heart failure such as shortness of breath, ascites, and swelling, reduced time in hospital, reduced readmission rates, and a better quality of life for patients.
**
About Reprieve Cardiovascular**
Reprieve Cardiovascular is a pioneering medical device company focused on automated fluid management technologies for acute heart failure treatment. The company's Reprieve technology is being investigated as an innovative fluid management treatment that provides clinicians with the ability to precisely control a patient's fluid volume and may enable improved cardiac care with safe, effective decongestion of acutely decompensated heart failure patients (ADHF). Reprieve Cardiovascular, Inc. and RenalGuard Solutions, Inc. are subsidiaries of parent company CardioRenal Systems, Inc. For more information, visit www.reprievecardio.com and follow us on Twitter at @ReprieveCardio.

Clinical Data from Reprieve Cardiovascular's Successful First-in-Human Therapy for Acute Heart Failure Presented

**MILFORD, MA – May 25, 2019** – Reprieve Cardiovascular™, a pioneering medical device company focused on improving outcomes for patients suffering from Acute Decompensated Heart Failure (ADHF), today announced the results of two non-randomized, prospective clinical trials in patients hospitalized with Acute Heart Failure (AHF). The two studies demonstrate that using Reprieve-Guided Diuretic Therapy, the first fully automated fluid management system, allows for safe decongestion for patients with AHF. The results were presented today at the Heart Failure 2019 Congress, 25-28 May, in Athens, Greece.

The 19-patient TARGET-1 and TARGET-2 clinical trials were designed to determine whether the Reprieve-Guided Diuretic Therapy system could achieve safe net volume reduction while significantly alleviating related symptoms in ADHF patients.

The data reported a significant increase in diuresis, net negative fluid balance, improved kidney function and improvement in clinical symptoms. 

Patients served as their own controls with each patient undergoing 24 hours of standard diuretic therapy with intravenous furosemide followed by 24 hours of diuresis with the automated Reprieve-Guided System. The average urine output increased from 1986 ml in the standard therapy to 6284 ml during a 24-hour therapy period. In addition, there were improvements in net fluid loss, and renal function accompanied by favorable hemodynamic changes.

“The therapy appears to be safe and quite effective,” said Professor Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University, Poland. “Reprieve’s automated fluid management technology provided faster, more controlled fluid removal while protecting acute heart failure patients from dangerous drops in blood pressure. It maintained optimal intravascular fluid volume and with it, cardiac output and renal perfusion.”

ADHF is a sudden onset of heart failure symptoms, which typically include difficulty breathing (dyspnea), swelling in the extremities, and fatigue. The signs and symptoms of fluid overload are responsible for 90% of heart failure hospital admissions. Current treatment for ADHF includes diuretic therapy that aims to restore healthy fluid levels in the kidneys and throughout the body. Standard diuretic therapy, however, can be unpredictable and lose effectiveness as a patient’s condition deteriorates. In some patients, diuretics can trigger a condition called “diuretic resistance,” which blunts the function of diuretics and can exacerbate the severity of fluid overload, potentially
resulting in acute kidney injury. 

“Reprieve-Guided Diuretic Therapy is among the first non-pharmacologic advance in treating fluid overload in Acute Heart Failure patients since diuretics were introduced in the 1960s,” said Jim Dillon, Reprieve Cardiovascular’s President and CEO. “These results support our continued efforts to evaluate the impact of our therapy on alleviating the pain points clinicians continuously tell us about that complicate care of patients with acute heart failure. These include long hospital stays, high readmission rates, and ultimately poor long-term patient prognosis.”

**Problems and Optimization of Volume Management in AHF: Symposium 25 May,
12:15 pm (Session 2120, Agora 1)**

Leading heart failure experts Howard Levin, M.D., Prof. Piotr Ponikowski and Jeffrey Testani, M.D. will discuss the latest advances in AHF treatment, including a novel physiological approach to volume management.

**About Reprieve Cardiovascular’s Guided Diuretic Therapy**

Reprieve Cardiovascular’s Guided Diuretic Therapy is designed to manage fluids during diuretic therapy for patients with Acute Decompensated Heart Failure (ADHF) and may relieve a number of symptoms related to this condition. The therapy has the potential to enable precise and predictable management of a patient’s fluid levels, guarding against dangerous fluid imbalances and enabling better control over diuretic therapy, thus increasing diuretic efficiency. Potential benefits include speeding decongestion while protecting core organ function, reducing symptoms of congestive heart failure such as shortness of breath, ascites, and swelling, reduced time in hospital, reduced
readmission rates, and a better quality of life for patients. 

**About Reprieve Cardiovascular**

Reprieve Cardiovascular is a pioneering medical device company focused on automated fluid management technologies for acute heart failure. The company’s Reprieve technology is being investigated as an innovative fluid management treatment. Providing clinicians with the ability to precisely control a patient’s fluid volume may enable improved cardiac care with safe, effective decongestion of acute decompensated heart failure patients (ADHF). Reprieve Cardiovascular, Inc. and RenalGuard Solutions, Inc. are subsidiaries of parent company CardioRenal Systems, Inc. For more information, visit www.reprievecardio.com and follow Reprieve Cardiovascular on Twitter at @ReprieveCardio.

Reprieve Cardiovascular Announces Late-Breaking Acute Heart  Failure Clinical Trial Data

News

The Reprieve System is currently only available for Investigational Use in the US.