bioaccess® managed the LATAM clinical operations for SST's PerQdisc™ nucleus replacement device, executing feasibility and PMCF studies across Paraguay and Colombia that helped SST achieve CE Mark approval, FDA Breakthrough Device Designation, and enrollment of their first US IDE trial patient.
SST needed to generate clinical evidence across multiple study types — feasibility, post-market clinical follow-up (PMCF), and eventually support for an FDA IDE trial — while operating with startup-level resources. Conducting these studies in the US or Europe would have been prohibitively expensive and slow, with traditional CRO timelines of 18–24 months for site activation and regulatory approval alone. SST required a partner who could activate sites rapidly, manage complex spine surgery protocols, and deliver ICH-GCP compliant data that would satisfy both EU notified bodies and the FDA.
bioaccess® managed SST's LATAM clinical operations across multiple study phases. For the LOPAIN1 feasibility study, bioaccess® activated clinical sites in Paraguay, managing ethics committee submissions, regulatory filings, investigator coordination, and surgical case management for the PerQdisc implant procedure. For the PMCF program, bioaccess® conducted site selection and activation in Colombia, engaging institutions including Fundación Hospital Universidad del Norte and Clínica Uros. bioaccess® handled the full spectrum of trial management — from protocol adaptation for local regulatory requirements, to patient screening and enrollment, surgical coordination with spine surgeons, and post-operative data collection using validated outcome measures (ODI, VAS). The clinical data generated through bioaccess®'s LATAM network was instrumental in SST's regulatory submissions.