Nuwellis Inc. Announces Pilot Agreement With DaVita Inc.
June 20 2023 - 8:30AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, today
announced it has entered into a Supply and Collaboration Agreement
with DaVita Inc. (NYSE: DVA) to pilot Aquadex ultrafiltration
therapy to treat adult patients with congestive heart failure and
related conditions within select U.S. markets. Today, DaVita
provides extracorporeal therapies such as continuous renal
replacement therapy and apheresis to patients across a network of
hospitals and outpatient clinics.
Pairing the Aquadex system with DaVita’s care team could expand
access to ultrafiltration therapy to millions of heart failure
patients in the U.S. suffering from fluid overload and reduce
related healthcare costs for providers and payers.
“We are honored that DaVita is collaborating with Nuwellis to
pilot a services model alongside Aquadex,” said Nestor Jaramillo,
Jr., President and CEO of Nuwellis. “We believe DaVita’s clinical
infrastructure could potentially help accelerate the clinical
adoption of ultrafiltration when first-line medical treatments are
ineffective. Our clinical and commercial teams are excited and
ready to begin working together on the pilot program to introduce
ultrafiltration to a broader patient population.”
“Ultrafiltration therapy using Aquadex is a novel solution for
patients suffering from fluid overload – a key driver of negative
outcomes in heart failure patients. It offers clinicians the
opportunity to restore fluid balance and alleviate heart failure
symptoms precisely and gently,” said John Jefferies, MD, Chief
Medical Officer of Nuwellis. “We believe the pilot with DaVita can
support the role ultrafiltration can play in heart failure patient
management and could enable accelerated commercial expansion of
this therapy. Near-term, there’s value in providing these services
in acute settings for hospital patients. Nuwellis also sees a
future path to treating heart failure patients earlier, in
outpatient settings.”
The pilot program is expected to launch by the end of the third
quarter 2023 and extend through May 31, 2024. Via the pilot,
ultrafiltration therapy using Aquadex would be available at a
combination of DaVita’s hospital customers and outpatient center
locations, with both companies collaborating on the roll-out of the
therapy, clinician training, and patient support. At the conclusion
of the pilot, DaVita has the option to extend the supply agreement
with Nuwellis for continued provision of both inpatient and
outpatient ultrafiltration services for up to 10 years.
In conjunction with the agreement, Nuwellis issued DaVita a
warrant for approximately 1.3 million shares of Nuwellis Inc.
common stock. The warrant is subject to certain vesting milestones
and a blocker that prevents the warrant from being exercised for a
number of shares that would represent greater than 19.9% ownership
in Nuwellis. Nuwellis has also granted DaVita registration rights
and rights to participate in future equity financings of Nuwellis,
in each case conditioned on DaVita electing to extend the Supply
and Collaboration Agreement after completion of the pilot. Details
of the Supply and Collaboration Agreement may be found in Nuwellis’
Current Report on Form 8-K, to be filed with the Securities and
Exchange Commission later today.
About NuwellisNuwellis, Inc.
(Nasdaq: NUWE) is a medical technology 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,
Minnesota, with a wholly owned subsidiary in Ireland. For more
information visit www.nuwellis.com or visit us on LinkedIn and
Twitter.
About the
Aquadex SmartFlow
SystemThe Aquadex SmartFlow system delivers
clinically proven therapy using a simple, flexible, and smart
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 2023 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.
CONTACTS
Nuwellis, Inc.
Investors:Vivian CervantesGilmartin
Groupir@nuwellis.com
Media:Annika
ParrishHealth+Commercenuwellis@healthandcommerce.com
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