Creating Pediatric-Specific CRRT for an Underserved Patient Population

Children are among the most vulnerable in our population, yet innovation for pediatric patients is stagnant. Caregivers adapt therapies designed for adults to treat small children, which presents many challenges. Creating more suitable therapeutic options for this underserved patient population is extremely important.
 
Adult patients with fluid overload sometimes have fluid removed via a Continuous Renal Replacement Therapy (CRRT) device. However, due to the large volume of blood required by CRRT devices, this therapy is not always well tolerated in pediatric patients. Pediatric patients deserve gentler treatments, especially when related to critical conditions such as heart failure, kidney disease, sepsis and severe burns, among others.
 
I serve as the president and chief executive officer of Nuwellis Inc., a medical device company dedicated to transforming care for patients suffering from fluid imbalance. In August, our company announced plans to fill this under-met need for pediatric patients with the development of a pediatric-specific CRRT device, funded in part by a $1.7 million grant from the National Institutes of Health. Nuwellis will collaborate with Koronis Biomedical Technologies Corporation (the grant recipient) to design and develop a custom pediatric product that addresses the limitations of currently available therapies. 
 
This new device will leverage our existing technology: the Aquadex SmartFlow system. Aquadex filters the patient’s blood, removing excess plasma water precisely, predictably and gently to help improve hemodynamic function. Providers can specify and adjust the amount and rate of fluid removed from each patient to help protect against dangerous changes in the patient’s blood pressure, heart rate or electrolyte balance that can occur when fluids are removed too aggressively. Our existing platform gives providers a simple, gentle, flexible and smart fluid management tool to treat fluid overload.
 
Our technology received FDA 510(k) clearance in 2020 for use in pediatric patients who weigh 20kg or more, which made the treatment option available to smaller patients. While this is significant in the fact that it can help some pediatric patients, we want to offer a safe, reliable treatment option treat a greater range of pediatric patients, including those with kidney disfunction. The new product will also feature enhanced diagnostic capabilities to assist providers in making more informed decisions for their patients. 
 
This device will benefit not only pediatric patients, but also have a tremendous impact on their families as well. As a parent, all you can wish for is your child to be safe and healthy. This device could provide parents with babies suffering from fluid overload and kidney dysfunction a great deal of hope and peace of mind. At Nuwellis, our purpose-driven team will continue to prioritize the care of this population who cannot speak up for themselves. We look forward to continuing our work with Koronis Biomedical Technologies Corporation to address this under-met need and transform the lives of pediatric patients suffering from fluid overload.