Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage company focused
on improving the quality of life for people with fluid overload,
today announced key takeaways from its recent physician-led webinar
discussing the benefits of treating fluid overloaded heart failure
(HF) patients with Aquadex® ultrafiltration (UF) in the outpatient
setting – the first step toward commercializing this opportunity.
The webinar featured perspectives from leading heart failure
clinicians from across the U.S.:
- Ramesh Emani, MD, Interventional Heart Failure Cardiologist and
Associate Professor of Clinical Medicine, Division of Cardiology,
The Ohio State University – Columbus, OH
- Detlef Wencker, MD, Advanced Heart Failure Specialists –
Dallas, TX
- Pat Correlli, PA-C, Chief Outpatient Physician’s Associate and
Lead Clinician of Outpatient Congestive Heart Failure at MedStar
Good Samaritan Hospital – Baltimore, MD
Panelists discussed the clinical and economic challenges
associated with the current standards of care for managing fluid
overload among heart failure patients, explored strategies for
treating these patients in the outpatient setting, and shared their
experiences with outpatient Aquadex UF therapy. Under the current
standard of care, patients often have long hospital stays and
hospitals are typically only partially reimbursed for the cost of
care. Furthermore, hospitals receive no reimbursement for patients
that are readmitted within 30 days of initial discharge. According
to Premier Applied Sciences data, the average total unreimbursed
cost per inpatient encounter is $24,027, which highlights the
importance of reducing unscheduled 30-day readmissions. While
reimbursement for ultrafiltration varies from state to state,
panelists said, in their experience, reimbursement for the
administration of Aquadex in the outpatient setting has been
favorable for their hospitals.
“Outpatient ultrafiltration treatment with Aquadex presents a
unique opportunity to break the cycle of heart failure
readmissions, reducing the associated financial burden to
healthcare systems, and improving patient quality of life,” said
Nestor Jaramillo, Jr., President and CEO of Nuwellis. “In addition,
it represents a new patient segment with the same call point as our
regular heart failure segment. Treating heart failure patients with
the Aquadex System in the outpatient setting is similar to how
other patients receive dialysis in outpatient clinics. We
appreciate the panelists sharing their extensive experience and
thank them for their continued dedication to expanding medical
knowledge on the benefits of effective fluid management.”According
to the panelists, heart failure patients with fluid overload are
often caught in a cycle where they are hospitalized, inadequately
decongested, sent home, and then rehospitalized when congestion
issues resurface. In fact, national data suggests that 24% of these
patients will be rehospitalized within 30 days of discharge, and
50% within 90 days. In a study conducted by Lin et al.,
investigators evaluated the impact of repeat HF hospitalizations on
all-cause mortality and determined the risk variables related to
patient mortality. They found that mean survival time was 2.6, 1.8,
1.5, and 1.3 years after the first, second, third, and fourth
hospitalization, respectively, and concluded that repeat
hospitalizations were a strong predictor of mortality for existing
patients with HF1.
The webinar panelists also shared how ultrafiltration with
Aquadex therapy is being used in the outpatient setting to
effectively address this challenge. According to Dr. Emani,
ultrafiltration adequately decongests patients without significant
injury to the kidneys, as evidenced by a reduction in unscheduled
30-day readmissions (up to 79%), significant weight loss, and
stable serum creatinine levels in patients studied at The Ohio
State University.
Panelist Patrick Correlli described the impact of
ultrafiltration on heart failure patients in his hospital as a
paradigm shift. “Now we’re finding we can really have a lot of
success in doing this for outpatients, and this doesn’t have to be
captive to the inpatient world,” said Correlli.
Patient satisfaction is another key benefit of ultrafiltration.
“The feedback we’ve received has been almost universally positive.
Patients really like having this as an option. And when we can tell
them, you are going to get this treatment and then go home, it is
all that much better,” said Dr. Emani.
The full webinar is available on the Nuwellis website and
YouTube channel.
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, 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.
1Andrew H Lin et al. Mil Med. 2017 Sep.
CONTACTS
INVESTORS:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Matt Bacso, CFA
Gilmartin Group LLC
Matt.Bacso@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
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