Figures cited from named public press (Capstan Medical IR and matching trade items retrieved 1 September 2026) and the published bioaccess® Chile country page. Press mention_n is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ISP, Law 20.120, and FDA rules with qualified advisers. We name only the facility, PI, and sponsor those sources support. We do not invent a CRO the wires did not name. We do not claim Hospital Clínico Universidad Católica or Capstan Medical as a bioaccess® client.
If you searched Hospital Clínico Universidad Católica first-in-human, PUC Santiago CRO, Gonzalo Martinez TMVR Chile, or “go direct Capstan Chile,” you followed a hospital name that is genuinely in the public file. Hospital Clínico Universidad Católica in Santiago is a real structural-heart site. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: the hospital is the site. 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 — plus the option to add Colombia or another Latin American country if Santiago is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A press release that names the building does not become a CRO.
This page is the intercept for the Capstan robotic TMVR press cluster. It does not clone Bradford Hill (a Chile oncology site already distinguished on the Chile hub — not a device FIH CRO we operate). It is not a Brazil InCor page. Linking other country intercepts is correct. Cloning them is not.
Why the hospital name wins the search — and why that is not a CRO
Device press writes the implant, the city, the hospital, and the surgeon. It rarely writes the CRO. On the 1 September 2026 LATAM device FIH/EFS press sweep, Hospital Clínico Universidad Católica (PUC), Santiago, Chile, is rank 5, mention_n=5. Example URLs the ranking actually used:
- Capstan Medical IR, 6 March 2025 — world’s first robotic-catheter mitral valve replacements. The matching Cardiac Interventions Today rewrite (6 March 2025) states the procedures were performed on two patients at Hospital Clínico Universidad Católica in Santiago, Chile, by Gonzalo Martinez, MD, along with Santiago Garcia, MD, who supported the cases. Martinez is identified as Director, Endovascular Therapy Center at the Pontifical Catholic University of Chile. Garcia is identified as Director, Structural Heart Program at The Christ Hospital in Cincinnati — a visiting U.S. operator, not a Santiago site CRO.
- Matching trade: Cardiac Interventions Today; Cardiovascular News (CRT 2025); Cardiovascular Business; MedTech Dive (11 March 2025). Those items name the same hospital and Martinez. None of them name a CRO.
That is useful public information about a press-named Santiago FIH site. It is how a founder googles “Capstan Chile” or “Gonzalo Martinez TMVR” and lands on a university hospital without landing on ISP, Law 20.120, importer of record, ISO 14155, or 21 CFR 812.28. We cite those URLs as facility evidence. We will not invent a CRO. We will not claim bioaccess® ran the Capstan FIH. No live bioaccess® case-study page names this hospital as a client site. Capstan’s December 2024 Series C (cited in the CIT rewrite as $110 million, with continued work toward pivotal trials) is company news, not a bioaccess® claim.
The site is the site. The CRO is the operator.
A Santiago university hospital can provide rooms, imaging, coordinators, and an investigator the sponsor already put in the wire. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.
What the hospital can typically do when a sponsor “goes direct”:
- Discuss investigator interest and whether a protocol can sit in an existing structural-heart service.
- Share Ethical-Scientific Committee calendars and hospital research rules.
- Quote visit, staffing, and local procedure costs for the cases they will physically run.
What the hospital is not built to own for an investigational device:
- ISP. Instituto de Salud Pública authorizes medical studies and issues investigational-device import authorizations. Live Chile blogs already put a typical ISP review in a band of about 30 business days. We will not invent a new median.
- Law 20.120. An accredited Comité Ético Científico must issue a written favorable review and the host institution must authorize the study before it begins.
- Investigational import — issued by ISP, separate from later commercial registration. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a PUC-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
- The 21 CFR 812.28 package. Eligibility is not clearance. A site MSA does not produce it.
- Multi-country optionality. If Santiago enrollment or the indication later needs Colombia, Brazil, or Panama, a single-hospital MSA will not stretch.
Going direct to Hospital Clínico Universidad Católica is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Hospital Clínico Universidad Católica (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Rooms, imaging, structural-heart service, local staff | Protocol fit, training, device accountability |
| Ethics | Comité Ético Científico calendar and host-institution authorization | Packet, ICF, IB, Law 20.120 alignment |
| National authority | Not the permit holder by appearing in a Capstan IR | ISP study authorization (~30 business days already published on Chile blogs) |
| Import | Receiving and storage if contracted | Importer of record (ISP import authorization) |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One Santiago campus | Colombia (INVIMA) and the rest of the bioaccess® platform |
How ISP and Law 20.120 actually work (the short version)
Use clinical-trials-chile for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- ISP is Chile’s national authority for authorizing medical studies and investigational-device import.
- Typical ISP application review already published on live Chile blogs: about 30 business days. Commercial ISP registration is a 30–90 day band on the market-access page — a different file.
- Law 20.120 governs research on humans. Written Ethical-Scientific Committee review plus host-institution authorization before start.
- This site does not publish ISP as PAHO/WHO Level 4. We will not invent that badge.
- Headline ~30% lower per-patient cost versus typical US/EU programs is experience since 2010, not a formal study.
- Under 21 CFR 812.28, foreign clinical data from Chile is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ISP authorization and Ethical-Scientific Committee approval. Eligibility is not a guarantee of clearance or approval. See OUS FIH and FDA IDE.
Ask for a protocol-specific calendar. A hospital email is not an ISP approval. bioaccess® manages the file. That is CRO work, not site work.
All bioaccess® Chile 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 — not a guarantee of clearance or approval.
Do not smear the hospital — and do not treat a visiting U.S. operator as the CRO
Hospital Clínico Universidad Católica is a serious academic resource. Five independent press URLs naming the building is a signal of public visibility, not a punchline. Use the site when the protocol fits. Hire the operator.
Santiago Garcia’s role in the CIT rewrite is support from Cincinnati. Visiting U.S. operators are not ranked as LATAM site PIs and are not a substitute for ISP, import, or ISO 14155. Bradford Hill remains a Chile oncology site, not this hospital and not this CRO.
What the CRO still does after you have a PUC slide
- Regulatory-fit, not tourism. Chile is a sourced device geography. One Santiago campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the ISP / Law 20.120 packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this hospital only if it fits the protocol.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — eligibility, not a promise of FDA action.
The firm was founded in 2010. That is the operator layer around a press-named hospital.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract Hospital Clínico Universidad Católica directly for a device FIH?
You can try. The hospital can discuss investigator interest, local visit costs, and Ethical-Scientific Committee calendars. It cannot, by appearing in five Capstan URLs, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.
Did bioaccess® run the Capstan robotic TMVR FIH?
No public bioaccess® case-study page names this hospital. We will not invent that claim. mention_n=5 is a press-URL count, not bioaccess® enrollment.
Is Gonzalo Martinez the CRO?
No. Press names him as the Santiago operator of the Capstan first cases. A named PI is the site. He is not ISP, import, insurance, ISO 14155, or 21 CFR 812.28.
If I already have PUC, what does the CRO still do?
Regulatory-fit (Chile vs Colombia vs a multi-country design); the ISP / Law 20.120 packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Santiago room is not enough.
Next step
If the search that brought you here was Hospital Clínico Universidad Católica, PUC Santiago, Capstan TMVR, or Gonzalo Martinez, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country: clinical trials in Chile.
Julio G. Martinez-Clark, CEO · bioaccess®