U-M research-based technology receives FDA Humanitarian Device Exemption for pediatric kidney injury treatment

4/12/2024

By Kate Barnes, Office of the Vice President for Research & Alana Ritt, Innovation Partnerships

SeaStar Medical Holding Corporation, a public company (NASDAQ: ICU) based on research conducted at the University of Michigan and licensed by U-M’s Innovation Partnerships, recently received a Humanitarian Device Exemption (HDE) Approval Order from the U.S. Food and Drug Administration (FDA) for their Selective Cytopheretic Device-Pediatric (SCD-PED). An HDE Approval Order states that a given Humanitarian Use Device (HUDs) has been determined to provide a probable benefit to patient health. This approval is the first for the medical device company’s newly branded Quelimmune product family, and the product can now be commercially marketed as a HUD.

“The SCD-PED provides an extraordinary new type of treatment for pediatric patients experiencing acute kidney failure,” said Dr. H. David Humes, professor of Nephrology and Internal Medicine at the University of Michigan, whose lab developed the technology on which the SCD-PED is based.

“This device helps to temper dysregulated inflammatory responses, one of the leading causes of death from acute kidney injury due to sepsis, by ‘calming’ the patient’s white blood cells at the source of injury and infection. This kind of injury can cause high risk of pain and suffering, particularly in children, so having a treatment that is so effective is vital and life saving.”

Innovation Partnerships, a unit within the U-M Office of the Vice President for Research, provided licensing support to SeaStar Medical during the company’s early stages. Innovation Partnerships serves as the primary gateway for researchers seeking to increase the impact of their work by connecting with the private sector through corporate-sponsored research collaborations, licensing discussions, or connections with entrepreneurs and investors to support startup company formation. 

“The day when an innovative new therapy for patients receives regulatory approval is always cause for celebration, and this announcement is particularly wonderful because of its potential to improve outcomes for pediatric patients with acute kidney injury,” said Kelly Sexton, associate vice president for research – Innovation Partnerships and Economic Impact.

“I extend my sincere congratulations to U-M inventor David Humes and his research laboratory, as well as the entire SeaStar Medical team on this significant achievement.”

SeaStar Medical, which develops proprietary solutions to reduce the consequences of hyperinflammation on vital organs, created the SCD-PED for use in children weighing 10 kilograms (22 pounds) or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy. The SCD-PED is being marketed under the Quelimmune brand.

“This first regulatory approval is a major accomplishment for our company and, most importantly, it provides critically ill children with AKI access to a much-needed new therapy,” said Eric Schlorff, SeaStar Medical CEO.

“Only about one-half of the children in the ICU with AKI requiring CKRT survive, and those who do are at increased risk of long-term conditions such as chronic kidney disease. In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.”

Learn more about SeaStar Medical at https://seastarmedical.com/ 

Learn more about the technology behind the Selective Cytopheretic Device-Pediatric (SCD-PED) at https://www.michiganmedicine.org/health-lab/new-device-can-treat-injury-sepsis

Editor’s Note: this article’s title has been edited for clarity.