[Click eStock] "NextBio, The Time for Upcoming Innovative Medical Devices"

On the 11th, Samsung Securities analyzed Nextbiomedical as an innovative medical device company that entered the U.S. market early based on its technological capabilities.

Jeong Donghee, a researcher at Samsung Securities, explained, "Nexpeer F is the world's first biodegradable musculoskeletal pain embolization treatment," adding, "On the 2nd, the FDA approved the clinical trial plan."

He continued, "The clinical trials will be conducted with funds secured through the initial public offering (IPO)," and added, "The goal is to obtain approval in the first quarter of 2027." Furthermore, he noted, "It has already obtained CEMDD approval in Europe," and predicted, "Through post-marketing clinical trials, additional data on the clinical superiority of the biodegradable product, which differs from the non-biodegradable products already on the market, will be secured, and full-scale commercialization will begin from 2026."

Researcher Jeong analyzed, "Currently, in Korea, both primary treatment and rescue therapy for bleeding caused by endoscopic procedures are covered by insurance," and said, "In the U.S., in addition to existing approval for upper gastrointestinal hemostasis, expansion of indications for lower gastrointestinal hemostasis is underway." He emphasized, "Ultimately, the goal is to secure market share for all endoscopic bleeding through registration as a standard treatment by the American Society for Gastrointestinal Endoscopy (ASGE)."

He explained, "Two post-marketing clinical trials to expand use in the prevention market, which is estimated to be more than four times the size of the simple hemostasis market, are being conducted in Europe by the global partner Medtronic (MDT US)." He added, "Results will be announced next year," and estimated, "Sales of about 20 billion KRW for treatment and 15 billion KRW for prevention are expected."

Researcher Jeong said, "The one-month lock-up release date is on the 20th, and thereafter, short-term overhang issues are limited," and predicted, "With the global interest rate cut period arriving in September, there is a favorable situation for medical device companies centered on innovative technologies." He stated, "It is time to pay attention to the possibility of a turnaround to profitability next year, along with the expansion of Nexpowder indications and alleviation of overhang within this year."