Nuwellis Announces Data Supporting Lower Heart Failure Hospitalizations and Readmissions With Aquadex
14 December 2022 - 12:00AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, today
announced the peer-reviewed publication of the results from a
10-year, real-world retrospective analysis of 334 hospitalized
acute decompensated heart failure patients with fluid overload
treated with adjustable ultrafiltration (UF) using the Aquadex
FlexFlow System®. Published in the American Heart Journal Plus, the
analysis conducted by investigators at Abington Hospital-Jefferson
Health in Abington, Pennsylvania demonstrated significant
reductions in heart failure hospitalizations and 30-day hospital
readmission rates, as well as improvements in renal function
response, using Aquadex ultrafiltration.
The published study, titled “Ten-Year Real-World Experience with
Ultrafiltration for the Management of Acute Decompensated Heart
Failure,” findings included:
- Patients
experienced an overall 81% decrease in heart failure
hospitalizations per year;
-
Rehospitalizations for patients after receiving UF with Aquadex
were 48% less than the national average at 30 days (12.4% vs.
24%);
- 55% of patients
achieved sustained weight loss greater than 15 lbs.; and
- All patients
had stable renal function at follow-up.
“We found that ultrafiltration can be used safely and
effectively for significant volume removal among patients admitted
with decompensated heart failure. Compared to previous trials with
ultrafiltration, this real-world experience demonstrates that
ultrafiltration compares favorably for weight/volume loss and renal
function response, and this may be associated with a lower heart
failure rehospitalization rate. We found ultrafiltration to be safe
with regard to renal function, despite the cohort in this study
being sicker than those studied in other clinical trials,” said
Donald Haas, MD, Medical Director, Mechanical Circulatory Support
and Director, Comprehensive Heart Failure Program at
Abington-Jefferson Health, and Co-Investigator. “Importantly, the
rate and duration of ultrafiltration was slower and longer in our
study, and we believe that these considerations, combined with
adjustments to the UF rate as necessary, are crucial to safely
engendering large-volume decongestion.”
“These results are consistent with the AVOID-HF Win Ratio
analysis recently presented at the Heart Failure Society of America
(HFSA) 2022 Annual Scientific Meeting that demonstrated
statistically significant clinical superiority of ultrafiltration
therapy using the Aquadex System over diuretics in reducing heart
failure events within 30 and 90 days,” said Nestor Jaramillo, Jr.,
President and CEO of Nuwellis. “We are grateful to both Dr. Haas
and Dr. Robert Watson, Principal Investigator and Chief of
Cardiology and Co-Director, and to the study’s Sub-Investigators,
Maureen Hummel, CRNP, and Patricia Barrella, RN, MSN, for studying
their center’s experience with Aquadex FlexFlow. We look forward to
helping other healthcare providers learn from their findings.
Nuwellis is committed to making Aquadex therapy the standard of
care for fluid management in heart failure patients that are
unresponsive to diuretics.”
About NuwellisNuwellis, Inc. (Nasdaq: NUWE) is
a medical device company dedicated to transforming the lives of
patients suffering from fluid overload through science,
collaboration, and innovation. The Company is focused on
commercializing the Aquadex SmartFlow® system for ultrafiltration
therapy. Nuwellis is headquartered in Minneapolis, with a wholly
owned subsidiary in Ireland.
About the Aquadex SmartFlow®The Aquadex
SmartFlow system delivers clinically proven therapy using a simple,
flexible and predictable method of removing excess fluid from
patients suffering from hypervolemia (fluid overload). The Aquadex
SmartFlow system is indicated for temporary (up to 8 hours) or
extended (longer than 8 hours in patients who require
hospitalization) use in adult and pediatric patients weighing 20
kg. or more whose fluid overload is unresponsive to medical
management, including diuretics. All treatments must be
administered by a health care provider, within an outpatient or
inpatient clinical setting, under physician prescription, both
having received training in extracorporeal therapies. The Aquadex
FlexFlow, which was the specific Aquadex model used in the study
above, is an earlier version of the Aquadex SmartFlow. The
SmartFlow was commercially released by the Company on February 26,
2020.
Forward-Looking StatementsCertain statements in
this release may be considered forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including without limitation, statements regarding the new
market opportunities and anticipated growth in 2022 and beyond.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risks associated with
our ability to execute on our commercialization strategy, the
impact of the COVID-19 pandemic, the possibility that we may be
unable to raise sufficient funds necessary for our anticipated
operations, our post-market clinical data collection activities,
benefits of our products to patients, our expectations with respect
to product development and commercialization efforts, our ability
to increase market and physician acceptance of our products,
potentially competitive product offerings, intellectual property
protection, our ability to integrate acquired businesses, our
expectations regarding anticipated synergies with and benefits from
acquired businesses, and other risks and uncertainties described in
our filings with the SEC. Forward-looking statements speak only as
of the date when made. Nuwellis does not assume any obligation to
publicly update or revise any forward-looking statements, whether
due to new information, future events or otherwise.
CONTACTS
INVESTORS:Vivian CervantesGilmartin
Groupir@nuwellis.com
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