Nuwellis Receives CE Mark for 24-Hour Blood Circuit Set
21 September 2021 - 10:00PM
Nuwellis, Inc. (NASDAQ: NUWE), a company focused on providing
solutions for patients suffering from fluid overload, today
announced that it has received CE Mark Certification for its
24-Hour Blood Circuit Set (UF 500-24 Hour). The UF 500-24 Hour
blood circuit set is only to be used with the company's Aquadex
SmartFlow® system. The CE marking allows Nuwellis to market the
24-hour Blood Circuit in the European Union (EU) and all other
countries that recognize this certification.
The new device will help Nuwellis expand access to
ultrafiltration among patients who need no more than 24 hours of
Aquadex therapy in the inpatient setting. Additionally, this
circuit can provide a more economical solution for hospitals to
treat patients in the outpatient/ambulatory setting, where therapy
can be delivered for up to 8 hours. Such use in the outpatient
setting provides Nuwellis the flexibility to better meet the
clinical and healthcare economic needs of European markets, while
at the same time improving lives by seeking to prevent
hospitalizations.
“For the past two years, we have watched hospitals around the
world experience tremendous capacity pressures, which has further
emphasized the important role that the ambulatory setting can play
in patient care,” said Nestor Jaramillo, Jr., president and CEO of
Nuwellis. “Receiving CE certification for the 24-hour Aquadex
circuit will make outpatient ultrafiltration treatment more
accessible for patients not responding to oral diuretics who may be
at risk of hospitalization.”
The Aquadex SmartFlow System simply, safely, and precisely
removes excess fluid (primarily salt and water) from patients
suffering from fluid overload who have not responded to medical
management, including diuretics. Providers can specify and adjust
the rate of fluid removed for each individual patient, resulting in
a gradual reduction of excess fluid. Up to 500 mL per hour of
excess fluid can be removed.
The 24-hour blood circuit is part of the Aquadex SmartFlow
system, which consists of three components:
- The console, which allows caregivers precise control of
ultrafiltration therapy.
- The peripheral catheter, which draws blood from and returns
blood to the patient.
- The blood circuit set, which filters the patient’s blood and
collects excess water and salt.
Ambulatory care is one of the fastest-growing and highest-margin
segments of the healthcare industry, according to a 2020 study by
McKinsey & Company. In the United States, there has also been
continuous development and expansion of healthcare treatments in
the outpatient market. These trends have been accelerated by the
COVID-19 pandemic and are expected to continue to grow as clinical
technology improves, providers and payers incentivize
out-of-hospital care, and consumers demand lower costs, improved
access and better experiences.
About Nuwellis
Nuwellis, 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 System
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.
Investor Contact:
George Montague
CFO, Nuwellis, Inc
IR@nuwellis.com
Media Contact:
Laurel Hood
Health+Commerce
laurel@healthandcommerce.com
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