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NEXT BIOMEDICAL's Nexpowder Receives FDA Approval for Lower GI Bleeding

• NEXT BIOMEDICAL's Nexpowder has gained FDA approval for use in lower gastrointestinal (GI) bleeding, expanding its indication from the upper GI tract. • Nexpowder-S, a next-generation version incorporating sucralfate, has also been approved by the MFDS in Korea, enhancing its performance and efficacy. • The company is actively pursuing licensing opportunities in South America, the Middle East, and Japan, aiming for global market expansion. • Nexpowder is currently distributed in 29 European countries and 45 U.S. states through Medtronic, with exports showing a 108.69% year-on-year increase.

NEXT BIOMEDICAL, a South Korean medical solutions company, has announced that its Nexpowder product has received FDA approval for use in managing lower gastrointestinal (GI) bleeding. This approval broadens the application of Nexpowder, which was previously indicated for upper GI tract bleeding, offering a new option for patients experiencing lower GI bleeds.
Nexpowder is designed for endoscopic hemostasis and the prevention of bleeding in the gastrointestinal tract. It provides rapid and efficient hemostasis in emergency situations. According to NEXT BIOMEDICAL, they are actively pursuing licensing opportunities for Nexpowder in South America, the Middle East, and Japan, signaling a strategic move towards global market penetration.

Nexpowder-S Approval

In related news, NEXT BIOMEDICAL has also secured final product approval from the Ministry of Food and Drug Safety (MFDS) in Korea for Nexpowder-S, a next-generation version of its endoscopic hemostatic agent. Nexpowder-S incorporates sucralfate, a treatment commonly used for peptic ulcers, to enhance both the performance and efficacy of the original Nexpowder formulation.

Global Expansion and Market Position

NEXT BIOMEDICAL is actively expanding its global presence. Nexpowder is currently distributed in 29 European countries and 45 U.S. states through a partnership with Medtronic. The company has also entered into a licensing agreement with a Japanese medical device manufacturer. The company reported a 108.69 percent year-on-year increase in export volume in its third-quarter earnings report, reflecting strong sales growth.
"With this indication expansion, Nexpowder can now be effectively utilized in various areas of gastrointestinal bleeding prevention," said Lee Don-haeng, CEO of NEXT BIOMEDICAL. "We aim to further accelerate sales growth by establishing Nexpowder as a trusted solution in the global market."
A NEXT BIOMEDICAL official stated, "Nexpowder-S offers improved performance and the potential for expanded indications, setting it apart from competitors. As demand for powder-type hemostatic agents grows in clinical settings, we are positioning this advanced product to maintain our technological edge."
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Reference News

[1]
NEXT BIOMEDICAL wins approval for GI bleeding prevention powder < Device/ICT < Article
koreabiomed.com · Nov 27, 2024

NEXT BIOMEDICAL secures MFDS approval for Nexpowder-S, an enhanced endoscopic hemostatic agent with sucralfate, aiming f...

[2]
NEXT BIOMEDICAL secures FDA approval for Nexpowder in lower GI bleeding - KBR
koreabiomed.com · Nov 29, 2024

NEXT BIOMEDICAL received U.S. FDA approval for Nexpowder's use in lower GI bleeding, expanding its indication from upper...

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