Refer Report
Next Biomedical announced on the 2nd that its musculoskeletal pain embolization treatment ‘Nexsphere-F’ received approval for an investigational new drug (IDE) from the U.S. Food and Drug Administration (FDA).
The recently approved US pivotal clinical trial will be a multicenter, randomized, open-label study that will enroll 120 patients at 20 major US academic hospitals to determine the efficacy and safety of Nexphere F.
Nexsphere F is an innovative medical device that has been introduced to the world for the first time. Therefore, in order to obtain approval, it must go through the ‘de novo’ process, which involves going through the stages from clinical trials.
Nexphere F, a fast-dissolving musculoskeletal pain embolization treatment, reduces pain by embolizing abnormal blood vessels that cause arthritis pain with fast-acting microspheres that break down within a short period of time (2 to 6 hours) and killing the nerve cells that cause pain.
In the case of non-degradable products, they are receiving a lot of attention in the market because they have the advantage of being differentiated from other side effects such as skin discoloration, necrosis, and post-procedure pain. In fact, the company has secured excellent pain treatment effects and safety in over 800 patients in Japan.
In addition, Nexphere F is the only product in the world to have received European certification (CE-MDD) for use in the treatment of musculoskeletal pain embolism, and has been advancing into the European market by signing licensing agreements with a number of European distributors since the third quarter.
According to a Next Biomedical official, “This US IDE approval will serve as a foundation for our full-scale entry into the US market in the future, and we expect additional business discussions to take place with global companies.” They added, “We will also further accelerate our entry into the global market and pursue strategic commercialization to preempt the musculoskeletal pain embolization treatment market in the future.”
Reporter Oh Hyun-ah 5hyun@hankyung.com
Source: korean