Nuwellis to Advance Treatment of Critically-Ill Children and Babies Under $1.7 Million NIH Grant
The new device will build on the existing technology of the company’s Aquadex SmartFlow® system, and will be funded in part by a
“Historically, providers who treat children face tremendous challenges as we try to adapt therapies designed for adults to small children,” said
CRRT machines are fluid management devices designed to aid or replace kidney function by removing excess fluid and toxins when the patient’s kidneys are unable to support the demands of the body. The new device will be designed to lower the potential complications, enhance the functionality of traditional CRRT machines, and incorporate technologies that are needed to address issues relevant to small children.
Newborns who are born without sufficient kidney function need life-sustaining therapies until they are big enough for chronic dialysis machines. In addition, those who develop sudden temporary kidney failure will ultimately benefit from the innovation by enabling the clinician to support them while their kidneys are not working.
“The gentle, predictable and effective fluid management design of Aquadex SmartFlow makes it uniquely beneficial for pediatric patients,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “But when it comes to patient care, especially the care of children and babies, we can’t settle for good enough. Physicians have expressed a real need for neonatal fluid management therapies designed specifically to support the small body size of children and we’re committed to getting safe innovation to market as fast as possible. We’re immensely grateful to the
Aquadex SmartFlow® ultrafiltration is currently approved for adults and pediatric patients weighing 20 kg (44 lbs) or more, and works to remove excess fluid to alleviate kidney burden.
About the Aquadex SmartFlow System
The 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.
Certain 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 2021 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.
George MontagueChief Financial Officer, Nuwellis, Inc.firstname.lastname@example.org Matt Bacso, CFA Gilmartin Group LLCMatt.email@example.com MEDIA: Jessica StebingHealth+Commerce firstname.lastname@example.org
Source: Nuwellis, Inc.