Nuwellis Announces New Clinical Data Demonstrating 100% Survival at 30 Days Following Use of Ultrafiltration in High-Risk Postoperative Coronary Artery Bypass Grafting (CABG) Patients
31 August 2022 - 9:00PM
Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage company focused
on transforming the lives of people with fluid overload, today
announced the publication of key clinical data supporting the use
of ultrafiltration with the Aquadex FlexFlow® System in high-risk
postoperative coronary artery bypass grafting (CABG) patients in
the Journal of Cardiac Surgery.
The study, “The Use of Simple Ultrafiltration Technology as a
Fluid Management Strategy for High-Risk Coronary Artery Bypass
Grafting Surgery,” is a real-world retrospective review of
postoperative isolated CABG patients who were treated in the
Division of Cardiothoracic Surgery at Baylor Scott & White
Health in Temple, Texas between January 1, 2020 and July 31, 2021.
A total of 254 CABG procedures were performed during this period,
and ultrafiltration was used in 17 (6.7%) patients. Despite an
elevated mean Society of Thoracic Surgeons mortality score of 5.7%
(range 0.6-50.0), the 30-day survival rate of patients treated with
ultrafiltration was 100%.
“Ultrafiltration technology has been used for decades to
successfully treat advanced heart failure patients and data hav
been published to demonstrate its outcomes, but its application in
cardiac surgery to treat fluid overload is innovative,” said Daniel
Beckles, M.D., Surgical Director of Heart Transplantation and
Mechanical Circulatory Support at Baylor Scott & White Health
and the study’s lead author. “These favorable results are
consistent with the clinical findings in other large academic
centers using ultrafiltration technology in cardiac surgery, and we
are eager to gather additional multi-institutional data about the
use of Aquadex for this challenging patient population.”
According to the Society of Thoracic Surgery Adult Cardiac
Surgery Database, isolated CABG for coronary artery disease (CAD)
is the most commonly performed cardiac surgery procedure, with over
162,000 per year.1 The increased age of patients, in addition to
risk factors for CAD (hypertension, diabetes, obesity and chronic
kidney disease), increases the perioperative risk for acute
kidney injury and subsequent fluid overload. Excess fluid overload
in the perioperative phase of care has been associated with
increased morbidity and mortality for CABG patients.2
“We are pleased with the results of this first-of-its-kind study
highlighting the benefits of Aquadex therapy for high-risk CABG
patients,” said Nestor Jaramillo, Jr., President and CEO of
Nuwellis. “The Aquadex System offers a significant opportunity to
the medical community to improve clinical outcomes. In 2019, we
made the decision to expand our strategic focus to include the use
of Aquadex in critical care (cardiac surgery) and pediatric
settings. Today, critical care represents approximately 40% of our
total revenue, confirming the execution of the strategy and the
clinical value of the Aquadex System in this patient segment.”
In addition to cardiovascular surgery, Nuwellis continues to
make significant progress in other key areas of patient need,
including heart failure and pediatrics. The company recently
announced the first patient enrolled in its REVERSE-HF clinical
study, which is evaluating the clinical outcomes and economic value
of its Aquadex® ultrafiltration therapy in comparison to
intravenous (IV) diuretics for the treatment of fluid overload in
patients with worsening heart failure. Nuwellis is also developing
a new, fully integrated pediatric continuous renal replacement
therapy (CRRT) device designed to provide care for small babies and
children. This device is being funded in part by a $1.7 million
grant from the National Institutes of Health (NIH). Nuwellis has
partnered with Minneapolis-based research and development firm
Koronis Biomedical Technologies Corporation (KBT), the grant
recipient, to design and develop a custom pediatric product that
will enable clinicians to better care for babies with limited
kidney function.
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
developing, manufacturing and commercializing the Aquadex
SmartFlow® system for ultrafiltration therapy. Nuwellis is
headquartered in Minneapolis, Minn., with a wholly-owned subsidiary
in Ireland.
About the Aquadex SmartFlow SystemThe 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.
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
as a result of new information, future events or otherwise.
1 Bowdish ME, D’Agostino RS, Thourani VH, Schwann TA, Krohn C,
Desai N, Shahian DM, Fernandez FG, Badhwar V. STS Adult Cardiac
Surgery Database: 2021 Update on Outcomes, Quality, and Research.
Ann Thorac Surg 2021;111:1770-80.2 Pal S. Primary Causes of
End-Stage Renal Disease. US Pharm. 2016;41(8):6.
CONTACTS
INVESTORS:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Leigh Salvo
Gilmartin Group LLC
leigh@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Newellis (NASDAQ:NUWE)
Historical Stock Chart
From Jul 2023 to Jul 2024