Endoscopy, a procedure that uses specialized instruments to examine the inside of the body, has significantly altered the approach to managing health complications. Unlike traditional surgery, endoscopy relies on tools rather than hands for tasks such as biopsies and polyp removal.

In the U.S., patients arriving at the emergency room with symptoms like vomiting blood or a bleeding vessel previously required immediate surgical intervention. Now, these issues are often addressed endoscopically, offering a less invasive option that can expedite recovery and lower overall risk.

“The primary missions for all gastroenterologists and surgeons are hemostasis and preventing rebleeding,” said said Lee Don-haeng, CEO of NEXT BIOMEDICAL and a gastroenterologist specializing in therapeutic endoscopy, at a press conference in Seoul, Thursday.  “Traditionally, polyps were removed with a device akin to a hook, but this often led to bleeding that required surgical correction."

The endoscopy clip, a metal device used to clamp bleeding vessels or approximate lesion edges, has become the standard tool for managing gastrointestinal (GI) bleeding. Despite its effectiveness, the potential for rebleeding remains, especially due to irritation from food or stomach acid. 

"Rebleeding continues to be a challenge, which prompted NEXT BIOMEDICAL to develop a new product designed to cover the site and prevent further bleeding," said Lee.

Marking the company's 10th anniversary and the upcoming initial public offering (IPO), Lee unveiled Nexpowder—a novel hemostatic adhesive powder designed for managing persistent and active upper GI bleeding. 

NEXT BIOMEDICAL, a Korean medical device company specializing in therapeutic materials utilizing drug delivery systems, is set to be listed on Kosdaq this August. The company, which collaborates with the American-Irish medical device giant Medtronic, has introduced Nexpowder as the “world’s first" endoscopic hemostatic agent aimed at preventing GI bleeding. 

Nexpowder, composed of biocompatible polymers, is applied via endoscope and forms a gel upon contact with moisture. This gel compresses and protects the wound, effectively stopping or preventing bleeding. 

“Unlike other products that react with blood, Nexpowder dissolves quickly, forming a highly adhesive gel that remains in place even with stomach movement,” Lee said. “Over 50,000 patients worldwide have used our product without any reported cases of perforation.”

The product has been approved by Korea’s Ministry of Food and Drug Safety (MFDS), the U.S. Food and Drug Administration (FDA), and has received CE marking under the European Union (EU)'s Medical Device Regulation (MDR), confirming its compliance with EU health, safety, and environmental standards.

Since signing a global licensing agreement with Medtronic in 2020, NEXT BIOMEDICAL has expanded its reach. The company began generating revenue in Europe in 2022 and in the U.S. in 2023, with Nexpowder now available in 29 countries. Despite challenges from Covid-19, the company’s revenue has surged, with exports accounting for 88 percent of total revenue, particularly strong in the U.S. and Europe.

The company’s revenue has doubled from 2.8 billion won ($2.05 million) in 2020 to 4.9 billion won in 2022, and it has already surpassed last year's figure of 5 billion won in the first half of 2023. Lee forecasts annual revenue to reach around 13 billion won, doubling each year.

“Unlike other biotech companies that generate revenue through technology exports or royalties, we earn income by exporting finished products,” Lee said. 

NEXT BIOMEDICAL plans to expand Nexpowder's use to include lower GI bleeding by the end of the year. The company has already submitted an application to the FDA for use in colonoscopy procedures, with expectations for approval by year-end. “Given that lower GI procedures in the U.S. are about twice as common as upper GI procedures, this expansion will significantly grow our market,” Lee said.

“As the market expands, we expect competitors to introduce similar products,” said Lee Eun-hye, chief technology officer (CTO) of the Business Development Division at NEXT BIOMEDICAL. “To stay ahead, we have developed an advanced endoscopic treatment that incorporates a novel anti-cancer drug. We are currently seeking approval from the MFDS and plan to launch this drug-embedded product in Korea next year, followed by a global rollout.”

With 36 percent of its workforce dedicated to R&D and 70 percent of the clinical team with research backgrounds, Lee described NEXT BIOMEDICAL’s mission as focusing on “developing new products that don’t yet exist in the market.”

Another one of the company's innovations is Nexsphere-F, a fast-resorbable, gelatin-based embolic microsphere designed for treating musculoskeletal embolization. 

Nexsphere-F stands out as the "world’s first fast-dissolving treatment for arthritis pain," Lee said. "The microspheres target abnormal blood vessels and break down within two to six hours, offering pain relief without any side effects."

The product has earned CE-Medical Device Directive (MDD) certification in Europe and is currently undergoing post-market clinical trials in Korea for approval under the New Health Technology Assessment System. Additionally, Nexsphere-F is slated to begin post-market clinical trials in Europe.

NEXT BIOMEDICAL has also filed an investigational device exemption (IDE) application with the FDA. Plans are in place to assess Nexsphere-F’s efficacy and safety in a clinical trial involving 108 patients across 20 major U.S. university hospitals.

Following its public listing, NEXT BIOMEDICAL aims to establish Nexphere-F as a “standard-of-care” treatment based on clinical evidence, paving the way for new market opportunities and solidifying its position as a leader in the global healthcare sector.

NEXT BIOMEDICAL will offer one million shares on the Korea Exchange, with the price set between 24,000 won and 29,000 won per share. This initial offering is expected to raise between 24 billion won and 29 billion won.

Demand forecasting will run until Aug. 2, after which the final offer price will be determined. The general subscription period is slated for Aug. 7-8, with the Kosdaq listing scheduled for Aug. 20.