Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.
If you searched Dr. Juan Gabriel Sordo, Juan Gabriel Sordo first-in-human, or Syntra principal investigator Chile, you found a real investigator in the public record. Arissa Medical names Dr. Juan Gabriel Sordo, interventional neuroradiology, as principal investigator of its Syntra™ intrasaccular-device first-in-human pilot at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile. A principal investigator is not the CRO.
bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.
What the public record says
- NeuroNews International, 22 January 2024: first patients enrolled in the first-in-human, early feasibility Syntra study; initial cases done at the Asenjo institute by principal investigator Dr. Sordo (listed with Clínica Santa María, Santiago). Source.
- Arissa Medical, 8 October 2026: 12-month angiographic follow-up complete in all 16 pilot patients, with 15 of 16 achieving adequate occlusion and no device-related serious adverse events. Dr. Sordo is quoted as principal investigator on the device’s intrasaccular approach for wide-neck aneurysms. Source; NeuroNews coverage.
- Oversight named: a UCLA-affiliated independent medical monitor and a blinded core lab. No CRO is named. Syntra is limited to investigational use, and the study is not listed on ClinicalTrials.gov as of 15 October 2026.
The facility-level page is here: Instituto de Neurocirugía Asenjo, Santiago: the site is not the CRO.
PI versus CRO
| Workstream | Principal investigator | First-in-Human CRO |
|---|---|---|
| Clinical judgment and cases | Yes | Supports with protocol training and monitoring |
| ISP file and amendments | Signs what the site must sign | Prepares, submits, and answers deficiencies |
| Ethics committee packet | Presents as investigator | Builds the dossier and tracks the calendar |
| Device import | No | Importer of record for the investigational device |
| ISO 14155 monitoring and TMF | Keeps source documents | Monitors, reconciles, and closes out |
| FDA 21 CFR 812.28 | Provides site data | Builds the foreign-data narrative for the U.S. submission |
How ISP actually works (the short version)
Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”
All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.
FAQ
Did bioaccess® work on Dr. Sordo’s Syntra study?
No. This page reports public sources only and claims no role in that study.
Does bioaccess® only work in Chile?
No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.
What should a neurovascular sponsor do next?
Keep the investigator conversation going and put an operator behind it: contact bioaccess® or see First-in-Human CRO.
Julio G. Martinez-Clark, CEO · bioaccess®
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