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

Potential New Treatment for Acute Heart Failure Presented at the
Heart Failure 2019 Congress

• TARGET-1 and TARGET-2 trials: safe decongestion using first fully
  automated fluid management system
• Significant increase in diuresis, net negative fluid balance,
  improvement of kidney function and improvement in clinical symptoms
• Significant drop in CVP while systolic BP remained stable

MILFORD, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/ADHF?src=hash" target="_blank"gt;#ADHFlt;/agt;–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.

Please visit us at HF2019 Booth I1 Level 1

Contacts

Edna Kaplan
KOGS Communication
+1-781-639-1910
[email protected]