Nexsphere‑F FDA Pivotal Trial Starts

NEXTBIOMEDICAL has enrolled the first patient in the RESORB U.S. FDA pivotal trial for Nexsphere‑F, marking the operational start of a U.S. regulatory pathway. That regulatory milestone could change referral and treatment options for patients with refractory knee osteoarthritis pain by initiating the dataset intended to support eventual U.S. availability.

Company materials report CE‑MDD certification and ongoing clinical use across multiple European centers, and the firm has announced first‑patient enrollment in the U.S. program via RESORB pivotal trial enrollment. Notably, these facts are company‑reported program statements that provide real‑world exposure while the pivotal dataset accrues, and they frame the operational context in which clinical experience is accumulating.

Peer‑reviewed reports cited by the company describe a 155‑patient cohort with a reported mean 67% pain reduction at six months and no device‑related serious adverse events. Those cohort results are promising but require confirmation in a randomized pivotal readout before changing standard referral pathways. Because the device deploys resorbable microspheres that transiently occlude targeted peri‑articular vessels and dissolve within hours to produce local nociceptive interruption, procedural technique will emphasize angiographic targeting, short‑duration occlusion, and immediate post‑procedure monitoring for vascular or embolic complications. Consequently, candidate selection will likely favor patients with focal vascular targets on pre‑procedure imaging and clinicians should plan a peri‑procedural workflow that includes angiographic mapping and short‑term surveillance rather than prolonged inpatient observation.