[Special Stock] NextBio Targets 15 Trillion Arthritis Market with World's First Technology... "Unprecedented Innovation"

Nextbiomedical is showing strong performance. On the 9th, Donhaeng Lee, CEO of Nextbiomedical, stated at the 'Korea Investment Week (KIW) 2024' held at the Conrad Hotel in Yeouido-dong, Seoul, "We must present original products such as First-in-class (world's first products)" and added, "Only by gaining clinical efficacy recognition can we survive in overseas markets."

Nextbiomedical introduced 'NexPowder,' the world's first endoscopic hemostatic agent capable of preventing bleeding. The product has signed overseas distribution rights contracts with Medtronic and is sold in 29 countries, including the United States and Europe.

Expectations for NexSphere F, a musculoskeletal pain embolization treatment agent, are also influencing the company's valuation. With the acceleration of an aging society, the number of patients with degenerative arthritis caused by cartilage wear due to aging is increasing. In the 'arthritis treatment' market, which is expected to grow up to 15 trillion KRW, Nextbiomedical is pursuing approval from the U.S. Food and Drug Administration (FDA) for an innovative medical device never seen before.

As of 2:09 AM on the 10th, Nextbiomedical is trading at 33,850 KRW, up 12.09% from the previous day.

Recently, Nextbiomedical received FDA approval for the clinical trial plan (IDE) of NexSphere F, a musculoskeletal pain embolization treatment agent. NexSphere F is the only product worldwide certified for arthritis embolization with European CE certification and Korean MFDS certification.

NexSphere F, a biodegradable musculoskeletal pain embolization treatment agent, embolizes abnormal blood vessels causing arthritis pain with fast-acting microparticles that decompose within a short time (2-6 hours), necrotizing the nerve cells that cause pain and thereby reducing it. Unlike non-biodegradable products, which can cause side effects such as skin discoloration, necrosis, and post-procedure pain, NexSphere F has distinct advantages and is attracting significant market interest. In fact, the company has secured excellent pain treatment efficacy and safety in over 800 patients in Japan.

NexSphere F is classified as an FDA medical device 'De Novo,' an innovative medical device never seen before. De Novo approval means it is the first approval for this technology. The product confirmed excellent pain treatment efficacy and safety in over 800 patients in Japan. NexSphere F is the only product worldwide with European CE-MDD approval for use in musculoskeletal pain embolization treatment, and from the third quarter, it has signed distribution rights contracts with multiple European distributors to target the European market.

Until now, most treatments involved taking painkillers or steroid injections to temporarily reduce inflammation or pain. Although hyaluronic acid injections temporarily act as lubricants between joints, they require periodic administration.

The global market size related to NexSphere F, including musculoskeletal pain relief, amounts to about 3.6 trillion KRW. With U.S. approval, the company expects to make a full-scale entry into the U.S. market and anticipates additional business cooperation with global companies.

According to MarketsandMarkets, the osteoarthritis treatment market was about 7.3 billion USD (approximately 10 trillion KRW) in 2020 but is expected to grow to about 11 billion USD (approximately 15 trillion KRW) next year.

Seonyeong Park, a researcher at Mirae Asset Securities, explained, "Nextbiomedical submitted a clinical trial plan (IDE) for FDA approval of NexSphere F," adding, "The approval clinical trial will be conducted in an open-label, randomized manner with 108 patients at 20 major university hospitals in the United States." She continued, "In the U.S., separate approvals are required for each indication even for the same product," and added, "So far, no embolic material has been approved for arthritis embolization." Furthermore, she emphasized, "We expect market penetration to expand as clinical evidence accumulates."