Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device

Rhea-AI Summary

Nuwellis, Inc. announces that its strategic partner, SeaStar Medical Holding Corporation, has received an Approvable Letter from the FDA for its pediatric Selective Cytopheretic Device (SCD-PED). The SCD-PED will provide a new therapy option for children with acute kidney injury and sepsis. The Approvable Letter indicates that SeaStar Medical's HDE application meets the requirements for an Approval Order, with minor administrative steps remaining. Clinical data showed a 77% reduction in mortality rate and no dialysis dependency at Day 601,2.

MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED). The SCD-PED will provide a new therapy option for children weighing 10 kilograms or more who have acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in a hospital intensive care unit.

The Approvable Letter indicates that SeaStar Medical’s Humanitarian Device Exemption (HDE) application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization. For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan.

Nuwellis and SeaStar Medical previously announced an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED. “We’re excited to collaborate with SeaStar Medical to bring this innovative product to market, which, upon FDA approval, will represent a new revenue stream for Nuwellis,” said Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis. “Most importantly, the clinical data used for the approval in support of the HDE application showed a 77% reduction in mortality rate and no dialysis dependency at Day 60^1,2.”

“Receipt of this Approvable Letter is a major accomplishment indicating that the FDA supports SeaStar Medical’s application and acknowledges the potential of our device to save lives and eliminate dialysis dependency in critically ill children with AKI and sepsis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “SeaStar intends to work closely with the FDA to complete the final steps outlined in the Letter and anticipate the much-needed availability of the product in pediatric intensive care units by early next year.”

SeaStar Medical’s SCD-PED therapy is a patented, cell-directed extracorporeal tool for managing cytokine storm-induced hyperinflammation. The therapy precisely targets and neutralizes activated toxic immune cells that drive cytokine storms (an overreaction of the immune system) that can ultimately cause organ damage and failure for critically ill patients. Clinical studies have demonstrated the SCD-PED’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.^1,2,3

About Nuwellis
Nuwellis, 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, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or Twitter.

About SeaStar Medical, Inc.
Denver-based SeaStar Medical is a medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit http://www.seastarmedical.com/ or visit us on LinkedIn or Twitter.

Forward-Looking Statements
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 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 due to new information, future events or otherwise.

¹ Goldstein, Stuart L., et al. “Use of the Selective Cytopheretic Device in Critically Ill Children.” Kidney International Reports, vol. 6, no. 3, 18 Dec. 2020, pp. 775–784., https://doi.org/10.1016/j.ekir.2020.12.010.
² Tumlin, James A., et al. “A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.” PLOS ONE, vol. 10, no. 8, 2015, https://doi.org/10.1371/journal.pone.0132482.
³ Yessayan, Lenar T., et al. “Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.” Critical Care Explorations, vol. 4, no. 5, 19 May 2022, https://doi.org/10.1097/cce.0000000000000694.

CONTACTS

INVESTORS:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com

FAQ

What is the company that received the Approvable Letter from the FDA?

The company that received the Approvable Letter from the FDA is SeaStar Medical Holding Corporation.

What is the name of the medical device that received the Approvable Letter?

The medical device that received the Approvable Letter is the Selective Cytopheretic Device (SCD-PED).

What condition does the SCD-PED treat?

The SCD-PED treats acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in a hospital intensive care unit.

What are the remaining steps for the HDE to be active for commercialization?

The remaining steps for the HDE to be active for commercialization include revisions to product labeling and minor modifications to the post-approval study plan.

What were the results of the clinical data used for the approval of the HDE application?

The clinical data showed a 77% reduction in mortality rate and no dialysis dependency at Day 601,2.

What is the therapy provided by SeaStar Medical's SCD-PED?

SeaStar Medical's SCD-PED therapy is a patented, cell-directed extracorporeal tool for managing cytokine storm-induced hyperinflammation.

What potential benefits does the SCD-PED offer?

Clinical studies have demonstrated the SCD-PED's potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.