Latest news with #HumanitarianDeviceExemption
Associated Press
2 days ago
- Health
- Associated Press
EXECUTIVE INTERVIEW: SeaStar CMO And Pediatric Specialist Talk About Promising Therapy To Treat Pediatric AKI
By Meg Flippin, Benzinga DETROIT, MICHIGAN - June 27, 2025 ( NEWMEDIAWIRE ) - Dr. Kevin Chung, Chief Medical Officer at SeaStar Medical Holding Corporation (NASDAQ: ICU) and Dr. Stuart L. Goldstein, MD, from Cincinnati Children's Hospital Medical Center, were recently guests on Benzinga's All-Access. The two were on hand to discuss QUELIMMUNE, SeaStar Medical's humanitarian medical device that was granted U.S. FDA approval to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. Dr. Goldstein was the chief investigator for the two studies that led to the FDA approval. Pediatric AKI is a sudden episode of kidney failure that happens within a few hours or days. It can be brought on by several conditions including sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver and potentially lead to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, patients may face complications including chronic kidney disease or end-stage renal disease requiring dialysis. Treating The Untreatable There are about 4,000 cases of pediatric AKI each year in the U.S., Dr. Chung shared, and the mortality rate among those patients is high at 50%. QUELIMMUNE, which was granted approval under a Humanitarian Device Exemption (HDE) by the FDA in February 2024, was developed to treat AKI among children. 'QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,' said Dr. Chung in the interview. 'The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm, and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.' That reduction in mortality is quite promising given that while there have been medical advances in treating AKI over the years, including targeted medications, nothing has been able to help patients with AKI so severe that it requires dialysis or inflammation so bad that it has increased the chance of death, Dr. Goldstein noted. But QUELIMMUNE proved very effective in trials, surprising even Dr. Goldstein, and that is why it received FDA approval and is being used in hospitals around the country. 'What we saw as we started the initial trial is kids that had a 50% chance of mortality, not only did that go in half, but we saw a dramatic improvement almost in 24 to 48 hours, which was quite shocking to us frankly,' said Dr. Goldstein. What's more, of the patients who survived, they were off dialysis sixty to ninety days later, something unheard of. Typically, 10-30% of pediatric patients who survive an AKI episode require chronic dialysis, Dr. Goldstein shared. 'It's a dramatic improvement that you see almost within the first one to two days. It is nothing I've seen before in clinical medicine in the last quarter century,' he stated further. Looking Beyond Pediatric AKI In addition to treating pediatric AKI, SeaStar is currently engaged in a trial evaluating the safety and efficacy of QUELIMMUNE for treating adult AKI. The study has over 100 patients enrolled, and the company is shooting for a total of 200. Beyond that, Dr. Chung said the idea is to use QUELIMMUNE for any condition in which the innate immune system is disturbed. 'The therapy itself is organ- and disease-agnostic,' said Dr. Chung, noting the company has six Breakthrough Device Designations from the FDA. BDD is designed to encourage speedier development of certain medical devices when there is a reasonable chance of providing a better treatment or diagnosis than the current standard of care. The BDD status is reserved for those diseases that are life-threatening or can cause irreversibly debilitating effects on patients. 'Other disease states are definitely going to be next,' Dr. Chung told Benzinga. Featured image from Shutterstock . This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originally published on Benzinga. Read further disclosures here.
Business Wire
4 days ago
- Health
- Business Wire
New Hope for Chronic Nausea: Enterra Medical Begins NAVIGATE Study After Gaining FDA IDE Approval and Breakthrough Device Designation
ST. LOUIS PARK, Minn.--(BUSINESS WIRE)--Enterra Medical, Inc., a leader in innovative treatments for gastrointestinal disorders, has initiated the NAVIGATE study to evaluate the safety and effectiveness of Gastric Electrical Stimulation (GES) as a treatment for patients with chronic nausea that have normal gastric emptying. This study was approved as an IDE study by the U.S. Food and Drug Administration (FDA) and was subsequently granted Breakthrough Device designation. NAVIGATE and its potential therapy indication represent a promising advancement for a patient population with extremely limited treatment options. Unlike previous GES studies that focused on patients with refractory gastroparesis, this study is evaluating patients who experience chronic nausea with severe symptoms, despite normal gastric emptying. The NAVIGATE study will assess whether the Enterra ® Therapy System provides safe and effective improvement for nausea severity, vomiting frequency, and quality of life measures for individuals who have not found relief through available diet and drug therapies. Unlike previous GES studies that focused on patients with refractory gastroparesis, this study is evaluating patients who experience chronic nausea with severe symptoms, despite normal gastric emptying. Importantly, NAVIGATE also allows enrollment of patients who have previously undergone pyloric interventions. 'Patients with normal gastric emptying can experience symptoms equally severe as those with delayed emptying, making us question if gastric emptying status is as central to patients' symptoms as previously believed,' said Prof. Jan Tack, Global Principal Investigator for the NAVIGATE study. While patients with refractory gastroparesis have been treated with GES for over two decades, the NAVIGATE study aims to expand the patient population that may benefit from GES therapy. NAVIGATE is a multi-center, randomized, double-blind, placebo-controlled study that will enroll at least 148 subjects across leading medical institutions throughout the U.S., Europe, and the United Kingdom. The first patient was enrolled at the University of Louisville by the team of Gastroenterologist Dr. Abigail Stocker and Surgeon Dr. John Olsofka. Find all currently enrolling centers for the NAVIGATE study on About Enterra Therapy Enterra Therapy was approved by FDA in 2000 under a Humanitarian Device Exemption (HDE). A unique therapy called Gastric Electrical Stimulation (GES), Enterra Therapy delivers mild electrical pulses to the nerves and smooth muscles of the stomach to control the chronic nausea and vomiting symptoms associated with gastroparesis. To learn more about Enterra Therapy visit the company's website and follow us on LinkedIn. About Enterra Medical Enterra Medical was founded in 2022 to help people living with chronic nausea and vomiting find the relief to take back their seat at the table. Learn more and view important safety information at Enterra ® is a registered trademark of Enterra Medical, Inc. in the US, EU, and other regions. This press release contains 'forward-looking statements' concerning the development of Enterra Medical's products, the benefits and attributes of such products, and the company's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Enterra Medical undertakes no obligation to update any forward-looking statements for any reason.
