SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Nextbiomedical announced today that its novel hemostatic powder, Nexpowder™, has been published in GUT (Impact Factor: 23), one of the world's most influential journals in gastroenterology. The large-scale randomized controlled trial (RCT) demonstrates that Nexpowder™ significantly reduces the risk of rebleeding following successful endoscopic hemostasis in patients with non-variceal upper gastrointestinal bleeding (NVUGIB).
The study, titled "Prevention of rebleeding after primary haemostasis using haemostatic powder in non-variceal upper gastrointestinal bleeding: a multicentre randomized controlled trial," was conducted across three leading university hospitals in South Korea. A total of 341 patients who achieved primary hemostasis were randomized to receive either standard therapy alone or standard therapy with the addition of Nexpowder™.
Key findings include:
- 72-hour rebleeding rate: 2.9% in the Nexpowder™ group vs. 11.3% in the control group (p = 0.005)
- 30-day cumulative rebleeding rate: 7.0% vs. 18.8% (p = 0.004)
- Ulcer subgroup (3-day rebleeding): 3.0% vs. 12.0% (p = 0.004)
Nexpowder™ is a proprietary powder-based hemostatic agent that adheres to bleeding lesions and forms a protective gel upon contact with moisture, creating an effective physical barrier. This design helps to prevent early and delayed rebleeding, particularly in high-risk lesions such as peptic ulcers.
In endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB), the administration of proton pump inhibitors (PPIs) is a pharmacological approach to suppress gastric acid secretion and is included as a standard treatment in clinical guidelines. This is the first study to demonstrate a reduction in gastrointestinal rebleeding since PPIs were included in clinical guidelines, providing clinical evidence that Nexpowder™ may contribute to rebleeding prevention following endoscopic hemostasis.
Nexpowder™ as a first-in-class solution for rebleeding prevention," said the Chief Technology Officer of Nextbiomedical. "With statistically significant outcomes from a well-powered, multicenter randomized controlled trial, Nexpowder™ demonstrates clinically meaningful benefit beyond current standard therapies. These results not only reinforce the scientific validity of our platform, but also suggest a potential paradigm shift in the management of upper GI bleeding. We believe this data will support broader global adoption and inform future guideline development.
"Nexpowder™ is currently distributed in the United States and Europe through a global partnership with Medtronic. Nextbiomedical continues to expand its post-market clinical program in key regions to support broader use across indications and geographies.
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SOURCE NEXTBIOMEDICAL CO., LTD.
