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Figures cited from ClinicalTrials.gov NCT03193736, the British Journal of Ophthalmology STAR-I paper, published bioaccess® Panama pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the clinic and trial those sources support. We do not claim iSTAR Medical or MINIject as a bioaccess® client.

If you searched Panama Eye Centre clinical trial, Orillac-Calvo MINIject, STAR-I Panama, or go direct to the eye clinic in Panama, you are following a clinic name that is genuinely in the public file. Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a real ophthalmic research site in Panama City. It is not the operator of the MINSA / CNBI file.

bioaccess®’s position is simple and it is not adversarial: Panama Eye Centre is the site. The First-in-Human CRO still owns MINSA/CNBI, 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 Panama is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A STAR-I listing does not become a CRO.

This page is for the ophthalmic-clinic query. It does not repeat clinical trials in Panama, the March 2026 Panama essay, or The Panama Clinic first-in-human. Those pages stay the country system and the large-hospital page (Axoft, Newrotex). This page answers the Orillac-Calvo / Panama Eye Centre search.

Why the clinic name wins the search — and why that is not a CRO

Device registries and journals write the implant, the city, and the site. They rarely write the CRO. MINIject STAR-I is the clean public example for this Panama City eye clinic.

NCT03193736 (STAR-I), retrieved 23 August 2026: official title is a prospective, open, multicenter clinical trial with one cohort analysing the efficacy and safety of MINIject in patients with open-angle glaucoma uncontrolled by topical hypotensive medications. Lead sponsor: iSTAR Medical. Status: completed. Start 19 June 2017; primary completion 16 April 2018; completion 25 November 2019. Locations listed: Maxivision Eye Hospital, Hyderabad, India, and Clinica de ojos Orillac-Calvo, Panama City, Panama.

The British Journal of Ophthalmology two-year STAR-I paper (trial registration NCT03193736) identifies the Panama site as Panama Eye Centre (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama, and states IRB approval was obtained from that hospital (and from Maxivision). The paper reports a prospective, multicentre, first-in-human, single-arm study of stand-alone MINIject implantation in 25 patients; implants between June and October 2017 by three surgeons in Panama and India; two-year follow-up for 21 patients. We cite the published outcomes as journal facts, not as a bioaccess® result: mean IOP 23.2 to 13.8 mmHg at two years (-40.7 percent) on fewer medications, as the paper states. We will not add a PI name the registry listing we retrieved did not put in the site row.

That file is useful public information about a site-named Panama ophthalmic FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list iSTAR Medical as a client on our published pages, and this article will not invent that relationship.

Panama Eye Centre is a site. The CRO is the operator.

A Panama City eye clinic can provide the OR, imaging, and surgeons who have already taken a supraciliary micro-invasive glaucoma device through a published first-in-human cohort. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor goes direct:

• Discuss investigator interest and surgical feasibility — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote procedure and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• MINSA and CNBI. Panama’s Ministry of Health, through the Dirección Nacional de Farmacia y Drogas, is the national health authority. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). A hallway conversation with a surgeon is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a PI email.
• Clinical trial insurance. Required. Our Panama essay publishes a typical premium range of $5,000-$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

Going direct to Panama Eye Centre is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How MINSA and CNBI sit next to the clinic

Use the country pages for the full pathway. Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

• On Clinical Trials in Panama: ethics typically 3-5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6-8 weeks. Per-patient costs on that page: $12,000-$22,000. A 10-patient FIH is described as typically $200K-$300K. Currency is the U.S. dollar.
• On the March 2026 blog: early-feasibility is ethics-committee-driven; CNBI often 4-8 weeks; conservative submission-to-first-patient envelope 3-5 months including site prep and screening.

Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. All bioaccess® Panama 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.

What the STAR-I public file actually supports — and what it does not

• Device: MINIject (iSTAR Medical), STAR-I, NCT03193736.
• Panama site: Clinica de ojos Orillac-Calvo on ClinicalTrials.gov; Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo, in the BJO paper.
• Design: prospective, multicentre, first-in-human, single-arm; 25 implanted; Panama and India; completed 2019 on the registry.
• Not claimed here: that iSTAR retained bioaccess®; that this clinic is The Panama Clinic; that Axoft or Newrotex ran here; that we have a named PI on this page beyond the three-surgeon statement in the journal (PD, CH, IKA) — we will not guess local identities those initials do not prove.

What the CRO still does after you have a clinic name

1. Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates FIH device studies as a multi-country platform. That is the operator layer around a named Panama City eye clinic.

Not a critique of the clinic

Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a serious ophthalmic resource. This page is not a critique of the site. A published STAR-I cohort is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator. If the hospital you actually typed was The Panama Clinic, use that page instead of stretching this one.

Colombia is still on the map

A Panama clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	Panama Eye Centre / the site	bioaccess® / the CRO
Procedure	OR, imaging, glaucoma service	Protocol fit, training, device accountability
Ethics	Institutional committee calendar	Packet, ICF, IB, CNBI-registered process
National authority	Not the permit holder by appearing on STAR-I	MINSA / CNBI
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One building in Panama City	Colombia (INVIMA) still on the platform

Frequently asked questions

Can I contract Panama Eye Centre or Orillac-Calvo directly?

You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT03193736, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the clinic as the site if it is the right site for your protocol.

Is this the same as The Panama Clinic?

No. The Panama Clinic page covers Axoft and Newrotex, which publicly named bioaccess®, and Nanochon in independent press. This page is the sourced ophthalmic clinic for MINIject STAR-I. The buildings are separate.

What does the CRO still do if the clinic is already identified?

Regulatory-fit and country choice; the MINSA and CNBI packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia if Panama is not enough. The clinic still does the procedure.

Did bioaccess® run STAR-I?

We do not claim that. iSTAR Medical is the sponsor on the registry. This page exists because sponsors search the site name. It is not a STAR-I case study.

Next step

If the search that brought you here was Orillac-Calvo, Panama Eye Centre, or MINIject Panama, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Hospital: The Panama Clinic. Country: Panama, Colombia. Other clinics: CODET, Laser Center, Adrian Ebner.

Figures cited from named public press, the live Hospital Italiano Asuncion page, the bioaccess® Supira program page, and DINAVISA-related country copy, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the PI, hospital aliases, and trials those sources support. We do not claim Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients. Supira is cited from a live bioaccess® page; we do not invent a CRO sentence the 2022 sponsor release does not contain.

If you searched Adrian Ebner first-in-human, Adrián Ebner Paraguay clinical trial, Sanatorio Italiano Asuncion FIH, or go direct to the PI in Paraguay, you are following an investigator name that is genuinely in the public file. Dr. Adrián Ebner, Head of Cardiovascular at Sanatorio Italiano / Hospital Italiano / Italian Hospital, Asunción, is a real first-in-human cardiovascular investigator. He is not the operator of the DINAVISA file.

bioaccess®’s position is simple and it is not adversarial: Dr. Ebner and the Italian Hospital are the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or Panama if Asunción is not the only fit. Sponsors who skip the CRO and email the PI still have to rebuild that stack. A press release that names the surgeon does not make the surgeon a CRO.

This page is the PI-query page. The hospital-query page is already published at Hospital Italiano Asunción FIH. The program narrative stays at Supira Medical first-in-human trial, Paraguay. Do not treat this page as a second hospital essay. It answers the investigator-named search.

Why the PI name wins the search — and why that is not a CRO

Device press writes the implant, the city, and the surgeon. It rarely writes the CRO. Dr. Ebner is a repeated public example of that pattern. The hospital names in those releases vary — Sanatorio Italiano, Hospital Italiano, Italian Hospital Asunción — and we will use the alias each source used rather than collapsing them into a name we invented.

Named first-in-human press we will stand behind (verified 23 August 2026), with the CRO rule stated once so it is not missed:

• Protaryx transseptal puncture — December 2024. Cardiac Rhythm News reports completion of a first-in-human study on 3 December 2024 at Sanatorio Italiano de Asunción; five patients; ethics approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies; procedures by Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital, with guidance by Gagan Singh (UC Davis). The release discusses 510(k) intent. Not a bioaccess® client claim.
• Artio Amplifi vein dilation system — 2021. Interventional News reports Artio completed enrolment of a first-in-human study; five patients treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción. Not a bioaccess® client claim.
• NuVera NuVision ICE catheter — July 2020. PR Newswire (6 July 2020) and Cardiac Rhythm News: first-in-human use; first participant treated for an atrial septal defect by PI Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asunción, with remote live-feed support from the NuVera team in the U.S. Not a bioaccess® client claim.
• Thoratec HeartMate PHP — 2013. DAIC (28 March 2013): first human use of HeartMate PHP during high-risk PCI; procedures by Adrian Ebner, M.D., at Sanatorio Italiano in Asunción; chief of the Cardiovascular Department. Not a bioaccess® client claim.
• Vascudyne TRUE Vascular Graft. Company / OTS release: first-in-human use for hemodialysis access; first procedures by Adrian Ebner, MD, Director of Endovascular and Cardiovascular Surgery at Sanatorio Italiano in Asunción, as part of an early feasibility study; five patients in that announcement. Later literature lists Ebner among authors of a first-in-human evaluation of the TRUE AVC conduit. Not a bioaccess® client claim.
• Supira pVAD — September 2022. Sponsor release (16 September 2022) names PI Adrian Ebner at the Italian Hospital Asunción. The live bioaccess® program page places the same FIH at that hospital and reports later South American experience, Breakthrough designation, U.S. EFS (November 2024), and SUPPORT II (April 2026) as published there. We cite the bioaccess® page. We do not invent a CRO sentence the 2022 sponsor copy does not contain.

That list is how a sponsor finds Dr. Ebner without finding the operator. It is also how a founder concludes that emailing the PI is the whole first-in-human plan. It is not. DINAVISA still exists after you have the name.

The PI is a site. The CRO is the operator.

An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has taken several public first-in-human devices through first cases, sometimes with visiting or remote U.S. advisors. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

What a PI / hospital can typically do when a sponsor goes direct:

• Discuss investigator interest and procedural feasibility — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

What the PI is not built to own for an investigational device:

• DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs. A hallway conversation with a surgeon is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent an Asunción-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Eligibility is not clearance. Supira’s later U.S. EFS and SUPPORT II path, as published on the bioaccess® page, is exactly why the early Latin American dataset has to be built as a file, not as a souvenir implant.
• Multi-country optionality. If Paraguay enrollment or the indication later needs Colombia or Panama, a single-PI MSA will not stretch.

Going direct to Dr. Ebner is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How DINAVISA sits next to the PI (the short version)

The hospital page already states this. We repeat it here because the PI query is a different Google, not a different file.

DINAVISA is the national sanitary authority. Ethics sits with the institutional committee — Protaryx press, for example, names the Research Ethics Committee of the Paraguayan Institute of Social Studies for that study. Import sits on a permit. Monitoring sits on ISO 14155. Those layers are why a CRO exists after you already know Dr. Ebner’s name.

We will not invent a median DINAVISA day-count. The clocks we will repeat are already published elsewhere on bioaccessla.com and are country-specific, not PI-specific: Panama ethics 3-5 weeks and 6-8 weeks to first patient with bioaccess® coordination on Clinical Trials in Panama; Colombia ethics 4-6 weeks and per-patient $15,000-$25,000 on that same comparison. Ask for a Paraguay protocol-specific calendar.

All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

The Tangent tricuspid feasibility file (NCT07140562)

A sponsor searching Dr. Ebner’s name now also lands on a ClinicalTrials.gov record. Here the registry names him as the site contact, not as principal investigator (PI). A named contact is still a site. The operator layer is separate.

• Record: NCT07140562 — prospective, multi-center, single-arm study of the safety and technical feasibility of the Tangent Tricuspid Annular Therapy System for transcatheter valve repair in severe, symptomatic functional tricuspid regurgitation (TR).
• Sponsor: Tangent Cardiovascular Inc. (industry). No collaborator. No CRO named.
• Site: Sanatorio Italiano, Asunción, Paraguay — the only location row, listed as recruiting.
• Named person: Dr. Adrian Ebner, listed as the site contact. The record lists no overall official.
• Status and size: recruiting; estimated enrollment 25.
• Dates: actual start 15 July 2025; estimated primary completion August 2027; estimated completion September 2028; first posted 24 August 2025; last update posted 13 October 2026.
• Not claimed here: that bioaccess® ran or runs this study; that the record calls it first-in-human (its title says safety and feasibility); that the site is the CRO.

Registry checked 13 Oct 2026 (ClinicalTrials.gov record, live pull). Registry facts only. Not a claim that bioaccess® ran this study; the record names no contract research organization (CRO) and no collaborator. General information, not legal or regulatory advice.

What the CRO still does after you have a PI name

1. Regulatory-fit, not tourism. Paraguay has a dense public cardiovascular FIH press file at this investigator. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama.
2. Protocol, IB, ICF, insurance, and the DINAVISA packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Asunción PI.

Not a critique of the investigator

Dr. Ebner’s cardiovascular service and Sanatorio Italiano / Hospital Italiano Asunción are serious clinical resources. This page is not a critique of the PI. Visiting or remote U.S. advisors in the public releases are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the site. Hire the operator. For the hospital-named search, stay on Hospital Italiano Asunción FIH.

Colombia is still on the map

A Paraguay PI search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	Dr. Ebner / the site	bioaccess® / the CRO
Procedure	Cath lab, imaging, CV department, PI	Protocol fit, training, device accountability
Ethics	Institutional committee calendar	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by being named in press	DINAVISA
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One service in Asunción	Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

Frequently asked questions

Can I contract Dr. Ebner or Sanatorio Italiano directly?

You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Protaryx, Artio, NuVera, Thoratec, Vascudyne, or Supira press, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site.

Which of these programs is on a bioaccess® page?

Supira pVAD is on the live bioaccess® Paraguay program page and on the Hospital Italiano page. Protaryx, Artio Amplifi, NuVera NuVision ICE, Thoratec HeartMate PHP, and Vascudyne TRUE graft are named public press. We will not invent a CRO role on those five.

What does the CRO still do if the PI is already identified?

Regulatory-fit and country choice; the DINAVISA and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or Panama if Asunción is not enough. The hospital still does the procedure.

Is this the same page as Hospital Italiano Asunción FIH?

No. That page is the hospital-named page, centered on the Supira public file. This page is the PI-named page and lists the broader press file without converting those sponsors into clients.

Next step

If the search that brought you here was Adrian Ebner or Sanatorio Italiano, start as the operator: contact bioaccess®. Hospital page: Hospital Italiano Asunción FIH. Program: Supira Paraguay. Clinic hub: ophthalmic FIH clinics vs CRO. Hospital hub: LATAM hospitals vs CRO. Country: Colombia, Panama.

Figures cited from ClinicalTrials.gov NCT05557058, ICH GCP registry mirrors, published bioaccess® Dominican Republic pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the clinic, investigator, and trial those sources support. We do not claim W. L. Gore and Associates as a bioaccess® client.

If you searched Laser Center Santo Domingo clinical trial, Juan Batlle GORE glaucoma, Dominican Republic first-in-human ophthalmic, or go direct to the site in Santo Domingo, you are following a clinic name that is genuinely in the public file. Laser Center in Santo Domingo is a real ophthalmic research site. It is not the operator of the DIGEMAPS file.

bioaccess®’s position is simple and it is not adversarial: Laser Center is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package plus the option to add Colombia, Panama, Mexico, or El Salvador if the Dominican Republic is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A ClinicalTrials.gov row does not become a CRO.

This page is for that search. It does not repeat clinical trials in the Dominican Republic or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

Why the clinic name wins the search — and why that is not a CRO

Device registries write the implant, the city, the site, and sometimes the PI. They rarely write the CRO. The GORE Glaucoma Drainage Implant early feasibility study is the clean public example for Santo Domingo.

NCT05557058, retrieved 23 August 2026: official title is a prospective, single-center, early feasibility clinical study designed to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in subjects with primary open-angle glaucoma. Lead sponsor: W. L. Gore and Associates. Status: active, not recruiting. Start date 14 September 2022. Estimated enrollment 30. Design: interventional, randomized parallel arms for High and Low device configurations plus a non-randomized Modified configuration. Primary effectiveness listed on the registry: proportion of treated eyes with at least a 20 percent decrease in mean diurnal IOP at 6 months while maintaining the same or fewer hypotensive medications as at baseline. Single listed location: Laser Center, Santo Domingo, Dominican Republic.

ICH GCP registry mirrors of the same NCT list the principal investigator as Juan F. Batlle Pichardo, M.D., Laser Center. That is useful public information about a site-named Dominican ophthalmic EFS. It is not a bioaccess® case study. As of this writing, bioaccess® does not list W. L. Gore as a client on our published pages, and this article will not invent that relationship.

That listing is how a sponsor finds Laser Center without finding the operator. Winning the query means answering it as the CRO that already publishes Dominican Republic first-in-human device operations and still runs the rest of the Latin American platform.

Laser Center is a site. The CRO is the operator.

A Santo Domingo ophthalmic center can provide the OR, imaging, and an investigator who is already named on a public early-feasibility glaucoma implant listing. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor goes direct:

• Discuss investigator interest and surgical feasibility with a service such as Dr. Batlle Pichardo when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote procedure and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• DIGEMAPS. The Ministry of Public Health, through the Directorate General of Medicines, Food and Health Products, is the national authority. A hallway conversation with a surgeon is not that file.
• CONABIOS-overseen ethics. Institutional REC review and CONABIOS-level review are country-system work, already described on the Dominican Republic page.
• Investigational import. Ethics letter, investigator brochure, and an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santo Domingo-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance.
• Multi-country optionality. If Dominican enrollment or the indication later needs Colombia or Panama, a single-clinic MSA will not stretch.

Going direct to Laser Center is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How DIGEMAPS and CONABIOS sit next to the clinic

Use the country page for the full pathway. Facts a sponsor searching this clinic needs on one screen, already published on Clinical Trials in the Dominican Republic:

The Ministry of Public Health through DIGEMAPS is the national regulatory authority. Ethics oversight is coordinated by CONABIOS, which supervises Research Ethics Committees. Institutional REC review averages about 30 days. CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Protocols follow the Declaration of Helsinki and CIOMS guidelines. bioaccess® prepares dossiers and coordinates with DIGEMAPS through start-up. Foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not a promise of clearance, when the study is run under ISO 14155 with proper authorization and ethics approval.

We will not invent a Laser Center-only day-count. Ask for a protocol-specific calendar. A surgeon email is not a DIGEMAPS approval.

What the GORE public file actually supports — and what it does not

• Device: GORE Glaucoma Drainage Implant, several configurations (registry).
• Site: Laser Center, Santo Domingo, Dominican Republic (NCT05557058 locations).
• PI on registry mirrors: Juan F. Batlle Pichardo, M.D., Laser Center.
• Design: prospective, single-center, early feasibility; estimated n=30; start 14 September 2022; active, not recruiting on the 23 August 2026 snapshot.
• Not claimed here: that the NCT named bioaccess®; that Laser Center is the only ophthalmic site in the Dominican Republic; that we have GORE outcomes; that Centro Laser marketing copy is the same as a first-in-human quality system.

What the CRO still does after you have a clinic name

1. Regulatory-fit, not tourism. The Dominican Republic is a sourced ophthalmic EFS geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Santo Domingo site.

Not a critique of the clinic

Laser Center and Dr. Batlle Pichardo are serious ophthalmic resources. This page is not a critique of the site. A public EFS listing is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

Colombia is still on the map

A Santo Domingo search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	Laser Center / the site	bioaccess® / the CRO
Procedure	OR, imaging, glaucoma service, PI	Protocol fit, training, device accountability
Ethics	Institutional REC calendar	Packet, ICF, IB, CONABIOS coordination
National authority	Not the permit holder by being listed on an NCT	DIGEMAPS
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One building in Santo Domingo	Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

Frequently asked questions

Can I contract Laser Center Santo Domingo directly?

You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT05557058, become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Laser Center as the site if it is the right site for your protocol.

Who is the PI on the GORE GDI listing?

Juan F. Batlle Pichardo, M.D., Laser Center, as stated on ICH GCP mirrors of NCT05557058. That fact does not make the PI your CRO.

What does the CRO still do if the clinic is already identified?

Regulatory-fit and country choice; the DIGEMAPS and CONABIOS packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or Panama if Santo Domingo is not enough. The clinic still does the procedure.

Is an early feasibility study the same as a commercial first implant in LATAM?

No. NCT05557058 is an investigational early feasibility program. A commercial first implant is launch activity. Do not mix the two when you brief a board.

Next step

If the search that brought you here was Laser Center or Juan Batlle, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: CODET Vision Tijuana, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country: Dominican Republic, Colombia, Panama.

Figures cited from CODET Vision Institute public pages, ClinicalTrials.gov NCT04756908, published bioaccess® Mexico pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS and FDA rules with qualified advisers. We name only the clinic, investigator, and trials those sources support. We do not claim CODET, Opira, Crystalens, or RxSight as bioaccess® clients.

If you searched CODET Vision Institute clinical trials, Arturo Chayet first-in-human, Tijuana ophthalmic FIH, or fly to Tijuana and skip the CRO, you are following a clinic name that is genuinely in the public file. CODET Vision Institute in Tijuana is a real ophthalmic research site. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: CODET is the site. The First-in-Human CRO still owns COFEPRIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, the Dominican Republic, or El Salvador if Tijuana is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A 20-mile drive from San Diego International Airport does not become a CRO.

This page is for that search. It does not repeat clinical trials in Mexico or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

Why the clinic name wins the search — and why that is not a CRO

Clinic marketing writes the implant, the city, the founder, and the airport. It rarely writes the CRO. CODET’s own clinical-research page (retrieved 23 August 2026) is the clean public example for Tijuana:

• Ophthalmologists work with industry from start to finish: from first-in-human through commercialization and beyond.
• The institute is located less than 20 miles south of San Diego International Airport and not more than 100 miles from Orange County.
• Dr. Arturo Chayet has been a clinical-trial investigator and consultant to ophthalmic industry since 1994, with work in refractive surgery, cataract, and intraocular lenses. CODET states he is typically the first surgeon to test new technologies for early-stage vision-care companies.

That copy is useful. It is how a U.S. sponsor finds CODET without finding an operator. The same page is also how a founder concludes that flying SAN to Tijuana is the whole first-in-human plan. It is not. COFEPRIS still exists on the Mexican side of that 20-mile drive.

This article will not invent a bioaccess® relationship CODET’s pages do not contain. It will say what is true now: if you are googling this clinic for a new ophthalmic first-in-human device study, the CRO you want is the one that already publishes Mexico device operations and still runs the rest of the Latin American platform — including Colombia.

What the public CODET file actually supports — and what it does not

• Site: CODET Vision Institute, Tijuana, Mexico (codetvision.com/clinical-research).
• Investigator: Dr. Arturo Chayet, founder, named on CODET doctor and research pages (doctor page).
• Opira AIOL: ClinicalTrials.gov NCT04756908 — Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, a commercial multifocal IOL, and a commercial monofocal IOL. Sponsor FSV6, Ltd. Locations listed include Codet Vision Institute, Tijuana, Mexico (and Clinica 2020, San Jose, Costa Rica). Status on the registry snapshot we retrieved: unknown / recruiting on mirrors. We report the listing, not a result.
• Crystalens: CODET cataract pages state that in 1999 Dr. Chayet conducted the first clinical trial on accommodating IOLs for Ionics (now Bausch + Lomb) and that he was instrumental in developing Crystalens, described there as the first FDA-approved accommodating IOL.
• RxSight Light Adjustable Lens: CODET LAL and research pages state a 2002-2024 Calhoun Vision / RxSight collaboration, first LAL surgery in the world at CODET in 2002, 600+ clinical-trial LAL procedures before public availability, and FDA Phase III completion as claimed on CODET’s research page. ClinicalTrials.gov NCT04529616 lists CODET Vision Institute, Tijuana as the Mexico site for an RxSight LAL / LDD exploratory study.
• Not claimed here: that Opira, Crystalens, RxSight, Calhoun, Ionics, or CODET retained bioaccess®; that Tijuana is outside COFEPRIS; that every CODET commercial procedure is an investigational FIH; that Ocumetics Mexico City work ran at CODET (the Ocumetics bioaccess® page is Mexico City / country-level, not a CODET claim).

CODET is a site. The CRO is the operator.

A Tijuana ophthalmic institute can provide the OR, imaging, a bilingual staff, and an investigator who has taken accommodating IOLs and a light-adjustable lens through long public histories. 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 a site can typically do when a sponsor goes direct:

• Discuss investigator interest and surgical feasibility with a service such as Dr. Chayet’s — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote procedure and local staffing costs for the cases they will physically run.
• Host a same-day visit after a SAN landing. That is logistics, not a national file.

What the site is not built to own for an investigational device:

• COFEPRIS. Mexico’s Comision Federal para la Proteccion contra Riesgos Sanitarios is the national health authority for a device investigation. A hallway conversation in Tijuana is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Tijuana-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance.
• Multi-country optionality. If Tijuana enrollment or the indication later needs Colombia, Panama, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

Going direct to CODET is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How COFEPRIS sits next to a 20-mile drive (the short version)

Use the country page for the full pathway. The facts a sponsor searching this clinic needs on one screen:

COFEPRIS governs clinical investigations in Mexico under the General Health Law. For medical-device trials, sponsors submit a clinical investigation application including protocol, investigator brochure, informed consent, ethics-committee approval, and proof of insurance. Published on Clinical Trials in Mexico: ethics typically 4-6 weeks; COFEPRIS review typically 4-8 weeks after ethics clearance; combined start-up cited as 2.8 months. bioaccess® manages the process in Spanish. The Ocumetics Mexico results page separately publishes an 8-12 week COFEPRIS band versus a 6-12 month FDA IDE comparison; that is a Mexico-country figure, not a CODET hallway estimate, and it is not an Ocumetics-at-CODET claim.

We will not invent a Tijuana-only day-count. Ask for a protocol-specific calendar. A surgeon’s email is not a COFEPRIS approval. All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

What the CRO still does after you have a clinic name

1. Regulatory-fit, not tourism. Tijuana is convenient. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform; country choice is a review, not a boarding pass.
2. Protocol, IB, ICF, insurance, and the COFEPRIS packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE. See Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages — not a clinic hallway number.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Tijuana site.

Not a critique of the clinic

CODET Vision Institute and Dr. Chayet’s research service are serious ophthalmic resources. This page is not a critique of the site. A 20-year LAL history is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

Colombia is still on the map

A Tijuana search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	CODET / the site	bioaccess® / the CRO
Procedure	OR, imaging, refractive and cataract service, PI	Protocol fit, training, device accountability
Ethics	Institutional committee calendar	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by sitting 20 miles from SAN	COFEPRIS
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One building in Tijuana	Colombia (INVIMA), Panama (MINSA/CNBI), Dominican Republic (DIGEMAPS), El Salvador (SRS) still on the platform

Frequently asked questions

Can I contract CODET Vision Institute directly?

You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars, and it can host a visit after a SAN landing. It cannot, by publishing first-in-human-through-commercialization copy, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate CODET as the site if CODET is the right site for your protocol.

Who is the named investigator on CODET’s research pages?

Dr. Arturo Chayet, founder, as stated on CODET’s doctor and clinical-research pages. That fact does not make the PI your CRO.

Does NCT04756908 prove CODET is already running my IOL?

No. NCT04756908 lists Codet Vision Institute, Tijuana, for the Opira AIOL comparison study sponsored by FSV6, Ltd. It is a public site listing. It is not your protocol, not your COFEPRIS approval, and not a bioaccess® case study.

What does the CRO still do if the clinic is already identified?

Regulatory-fit and country choice; the COFEPRIS and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or another bioaccess® market if Tijuana is not enough. The clinic still does the procedure.

Is this the same as a commercial LAL or Crystalens case at CODET?

No. CODET’s Crystalens and RxSight LAL histories mix development-era trials and later commercial experience. A commercial implant is not a first-in-human investigational device study. Do not brief a board as if a medical-tourism LAL schedule were an ISO 14155 investigation.

Next step

If the search that brought you here was CODET or Arturo Chayet, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: Laser Center Santo Domingo, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country systems: Mexico, Colombia, Panama. Related: The Panama Clinic, LATAM hospitals vs CRO.

Figures cited from published bioaccess® pages, CODET Vision Institute site copy, ClinicalTrials.gov, and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, DIGEMAPS/CONABIOS, DINAVISA, MINSA/CNBI, SRS/CNEIS, and FDA rules with qualified advisers. This page names only clinics, investigators, and trials those sources support. It does not invent Salvadoran clinic names.

If you searched ophthalmic first-in-human clinic Latin America, CODET Vision Tijuana clinical trials, Laser Center Santo Domingo GORE glaucoma, Adrian Ebner FIH, Panama Eye Centre MINIject, or go direct to the eye clinic and skip the CRO, you are following a site name that showed up on a clinic page or a registry listing. That search is rational. A named Latin American eye clinic or a named Asuncion PI can be a real first-in-human site. It is not the operator of the investigational file.

bioaccess®’s position is simple and it is not adversarial: the clinic or hospital is the site. The First-in-Human CRO still owns COFEPRIS / DIGEMAPS / DINAVISA / MINSA / SRS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email the surgeon still have to rebuild that stack. The clinic does not become a CRO because it is less than 20 miles from San Diego International Airport, or because ClinicalTrials.gov listed it.

This hub is the page for direct-to-site ophthalmic and small-clinic first-in-human queries. It sits next to the May 2026 essay Ophthalmic first-in-human studies in Latin America: why smaller markets often move fastest and the hospital hub LATAM FIH hospitals vs the CRO. Those pages stay the country math and the large-hospital list. This page answers the clinic-named query.

Why the clinic name wins the search — and why that is not a CRO

Device press and clinic marketing write the implant, the city, the operating room, and the surgeon. They rarely write the CRO. A U.S. board then Googles the clinic as if it were the vendor. Four public, sourced examples, each verified live on 23 August 2026:

• CODET Vision Institute, Tijuana, Mexico. CODET’s own clinical-research page says its ophthalmologists work with industry from first-in-human through commercialization and beyond, and that the institute sits less than 20 miles south of San Diego International Airport. Dr. Arturo Chayet is the named founder and long-running investigator. Classic direct-to-site pattern: a sponsor flies San Diego to Tijuana and treats the clinic as the whole stack.
• Laser Center, Santo Domingo, Dominican Republic. ClinicalTrials.gov NCT05557058 — GORE Glaucoma Drainage Implant early feasibility, sponsor W. L. Gore and Associates — lists the single site as Laser Center, Santo Domingo. Independent registry mirrors name Juan F. Batlle Pichardo, M.D., as principal investigator.
• Dr. Adrian Ebner, Sanatorio Italiano / Hospital Italiano, Asuncion, Paraguay. Named first-in-human press often lists the PI and the hospital and omits a CRO. The hospital page is already published. This family adds the PI-query page.
• Clinica de Ojos Orillac-Calvo / Panama Eye Centre, Panama City. ClinicalTrials.gov NCT03193736 (iSTAR Medical MINIject, STAR-I) lists Clinica de ojos Orillac-Calvo, Panama City. The British Journal of Ophthalmology STAR-I paper identifies the same site as Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo.

That is how a sponsor finds a room without finding the operator. Winning the query means answering it as the CRO that already runs first-in-human device files in those countries — not treating the clinic as a rival.

Sourced clinics and investigators only

Site or investigator (sourced)	City / country	Named public file	What we will not invent	Page
CODET Vision Institute / Dr. Arturo Chayet	Tijuana, Mexico	CODET clinical-research copy (FIH through commercialization; less than 20 miles from SAN). Opira AIOL NCT04756908 lists Codet Vision Institute, Tijuana. Crystalens and RxSight LAL history on CODET pages.	That CODET, Opira, Crystalens, or RxSight is a bioaccess® client. That flying SAN to TIJ replaces COFEPRIS.	CODET Vision Tijuana FIH
Laser Center / Juan F. Batlle Pichardo, M.D.	Santo Domingo, Dominican Republic	GORE GDI EFS NCT05557058, site Laser Center, Santo Domingo; PI named on ICH GCP registry mirrors.	That W. L. Gore is a bioaccess® client. That the site is DIGEMAPS.	Laser Center Santo Domingo FIH
Dr. Adrian Ebner (PI query)	Asuncion, Paraguay	Protaryx Dec 2024; Artio Amplifi 2021; NuVera NuVision ICE 2020; Thoratec HeartMate PHP 2013; Vascudyne TRUE graft; Supira pVAD on the bioaccess® program page.	A CRO role on Protaryx, Artio, NuVera, Thoratec, or Vascudyne. The hospital page already covers Supira as the site story.	Adrian Ebner Paraguay FIH · Hospital Italiano Asuncion FIH
Clinica de Ojos Orillac-Calvo / Panama Eye Centre	Panama City, Panama	MINIject STAR-I NCT03193736 (iSTAR Medical).	That iSTAR / MINIject is a bioaccess® client. That the clinic is MINSA/CNBI.	Panama Eye Centre MINIject

That is the clinic-and-PI list. If a program is not on it, we do not invent a building.

El Salvador — country level only

Julio Martinez-Clark’s position, 23 August 2026: ophthalmic clinics exist in El Salvador, and smaller LATAM markets often move fastest for a 5 to 15 patient ophthalmic first-in-human. That sentence is already the thesis of the May 2026 ophthalmic essay. The bioaccess® column does not name a Salvadoran eye clinic. This hub will not invent one.

What we will repeat is already published on clinical trials in El Salvador: Superintendencia de Regulacion Sanitaria (SRS, established August 2024) and Comite Nacional de Etica de la Investigacion en Salud (CNEIS) can run in parallel, with a published 30-60 day startup window; the economy is dollarized; foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not clearance. If a later primary source names a Salvadoran ophthalmic FIH site, we can add a page. Until then, the country system is the honest answer.

Colombia remains on the map. bioaccess® still runs clinical trials in Colombia. Those other markets are options when the device needs them.

Site versus CRO — the table that should sit on every clinic search

Workstream	What the clinic / hospital (site) typically owns	What the CRO still owns
Surgical / procedure capability	OR, imaging, implanting physicians, local staff, bilingual front desk	Feasibility against the protocol, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not a hallway conversation with a surgeon, and not a 20-mile drive from SAN	COFEPRIS (Mexico), DIGEMAPS + CONABIOS (Dominican Republic), DINAVISA (Paraguay), MINSA/CNBI (Panama), SRS/CNEIS (El Salvador)
Investigational import	Receiving dock, storage if contracted	Importer of record, permits, accountability
Quality system	Clinic quality and the case itself	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from the cases they ran	21 CFR 812.28 eligibility package — not a promise of clearance
Country optionality	One building	Colombia and the rest of the bioaccess® platform if the indication needs it

Going direct to the clinic is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation that a U.S. board expects to survive FDA review.

Four countries, four authorities — same operator layer

Mexico (COFEPRIS). Published on Clinical Trials in Mexico: COFEPRIS governs device investigations; ethics typically 4-6 weeks; COFEPRIS review typically 4-8 weeks after ethics clearance; combined start-up cited there as 2.8 months, the fastest median in Latin America on that page. Tijuana proximity to SAN is logistics. It is not a COFEPRIS waiver. Page: CODET Vision Tijuana FIH.

Dominican Republic (DIGEMAPS / CONABIOS). Published on Clinical Trials in the Dominican Republic: Ministry of Public Health through DIGEMAPS is the national authority; CONABIOS oversees research ethics committees; institutional REC review averages about 30 days; CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Laser Center can run the case. It does not become DIGEMAPS. Page: Laser Center Santo Domingo FIH.

Paraguay (DINAVISA). The national sanitary authority for an investigational device is not Dr. Ebner’s inbox. The hospital page and the PI page split the query: Hospital Italiano Asuncion FIH and Adrian Ebner Paraguay FIH. Supira sits on a live bioaccess® program page. Protaryx, Artio, NuVera, Thoratec, and Vascudyne are named public press. We will not invent a CRO sentence those releases do not contain.

Panama (MINSA / CNBI). Published on Clinical Trials in Panama: ethics typically 3-5 weeks; with bioaccess® coordination, protocol to first patient averages 6-8 weeks; per-patient $12,000-$22,000. The Panama Clinic page remains the large-hospital page. Panama Eye Centre / Orillac-Calvo is the sourced ophthalmic clinic for MINIject STAR-I. Page: Panama Eye Centre MINIject.

Why email the PI still leaves the FDA file empty

A principal investigator can tell you whether the anatomy is feasible. That is necessary. It does not produce:

• A regulatory-fit decision — Tijuana is convenient; Santo Domingo is a sourced glaucoma EFS site; Asuncion has a dense cardiovascular FIH press file; Panama is fast and bilingual; El Salvador is a published small-market clock; Colombia still wins on site network and INVIMA Level 4 credibility for some indications. Country choice is a review, not a boarding pass.
• The national application plus insurance.
• Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE. See Can OUS first-in-human data support an FDA IDE submission?.
• A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages — not a clinic we-can-start-next-month hallway number.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named clinic.

Not a critique of the clinic

CODET Vision Institute, Laser Center Santo Domingo, Dr. Ebner’s cardiovascular service, and Panama Eye Centre / Orillac-Calvo are serious clinical resources. This hub is not a critique of those sites. Use the clinic. Hire the operator.

Colombia is still on the map

A Tijuana, Santo Domingo, or skip-the-CRO search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®.The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract the eye clinic directly?

You can try. A clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by sitting near SAN or by appearing on ClinicalTrials.gov, become your COFEPRIS, DIGEMAPS, DINAVISA, MINSA, or SRS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the clinic as the site.

Which ophthalmic or small-clinic FIH sites can bioaccess® actually name?

On this hub: CODET Vision Institute (Tijuana); Laser Center (Santo Domingo); Dr. Adrian Ebner / Sanatorio Italiano-Hospital Italiano (Asuncion); Clinica de Ojos Orillac-Calvo / Panama Eye Centre (Panama City). El Salvador is country-level only. We will not add an invented Salvadoran clinic, and we will not claim CODET, GORE, iSTAR, Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients.

If I already have the clinic name, what does the CRO still do?

Regulatory-fit and country choice; the national authority packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or another bioaccess® market if one site is not enough. The clinic still does the procedure. Those are different contracts.

Does googling a clinic mean I should avoid that clinic?

No. This is not a critique of the site. The error is treating the site as the CRO.

Next step

If the search that brought you here was a clinic, start as the operator: contact bioaccess® or book from First-in-Human CRO. Clinic pages: CODET Vision Tijuana, Laser Center Santo Domingo, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Hospital pages already published: The Panama Clinic, Hospital Italiano Asuncion, LATAM hospitals vs CRO. Country systems: Mexico, Dominican Republic, Panama, El Salvador, Colombia. Essay: smaller ophthalmic markets.

Figures cited from the live ClinicalTrials.gov record NCT07147192 and the published bioaccess® Dominican Republic and El Salvador country pages, verified 23 August 2026; registry status re-checked 27 September 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. Instituto Espaillat Cabral is distinct from Laser Center / Batlle GORE listings. bioaccess® is not listed on the NCT and no bioaccess® page claims this Alcon study. “Alcon Investigator 8071” is not used as a clinic name.

If you searched Instituto Espaillat Cabral clinical trial, Espaillat Cabral IOL, Alcon accommodating IOL Santo Domingo, or “go direct to Espaillat,” you followed a facility name ClinicalTrials.gov published. Instituto Espaillat Cabral in Santo Domingo is a real ophthalmic site. It is not the operator of the DIGEMAPS file.

bioaccess®’s position is simple and it is not adversarial: Espaillat Cabral is the site. The First-in-Human CRO still owns DIGEMAPS / CONABIOS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus El Salvador, Panama, Costa Rica, or Colombia if one Santo Domingo room is not the design. Sponsors who skip the CRO and email the institute still have to rebuild that stack.

This page does not repeat clinical trials in the Dominican Republic. That page stays the country system. This page answers the site-named query. It is not a Laser Center page.

What NCT07147192 actually says for Santo Domingo

NCT07147192 — Feasibility Study of an Accommodating IOL Design. Sponsor: Alcon Research. Organization study ID: ILK345-E001. Overall status: ACTIVE_NOT_RECRUITING (last update posted 2 September 2026). The record no longer shows a per-site status for the Espaillat row or any other location. Actual start 3 December 2025; estimated primary completion October 2026 and estimated study completion October 2026; estimated enrollment 85; device-feasibility, contralateral AAL-FAIOL vs BAL-FAIOL after phacoemulsification, 14–35 days between eyes, ~1 year follow-up, optional laser adjustment of the AAL lens. Conducted in Central America per the brief summary (the location table also includes the Dominican Republic). Primary outcome: cumulative ocular adverse events including secondary surgical interventions. Ages 22+. Central contact: Alcon Call Center. Study director: Clinical Trial Lead, Surgical, Alcon Research, LLC. No local PI is named on the Espaillat row.

Sister rows on the same live record, with no per-site status shown: Clinica 20/20, San José, Costa Rica; Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador; Panama Eye Center, Panama City. See the López Beltrán page for the San Salvador twin. Panama Eye Center is publicly identified in MINIject literature as formerly Clínica de Ojos Orillac-Calvo; NCT03193736 lists that Panama City name for STAR-I (COMPLETED). Those are public-record facts, not bioaccess® case studies.

Distinct from Laser Center

Santo Domingo has more than one ophthalmic brand in device-trial search results. This page is only Instituto Espaillat Cabral as written on NCT07147192. Laser Center does not have its own page. We will not merge Espaillat Cabral with Laser Center, CODET, or a Batlle GORE study. If a later wave publishes those buildings, they will get their own pages.

The institute is a site. The CRO is the operator.

Espaillat Cabral can provide cataract rooms and surgeons who can, when activated, implant an investigational accommodating IOL. That is necessary. It is not sufficient for a four-country feasibility file a U.S. board expects to survive FDA review.

• DIGEMAPS. The Ministry of Public Health’s Directorate General of Medicines, Food and Health Products is the national authority on the published DR country page. A clinic letter is not that dossier.
• CONABIOS / REC. Published clocks: institutional REC ~30 days; CONABIOS-level ~45 days, up to 120 depending on complexity. Someone still has to write the packet.
• Investigational import into the Dominican Republic — importer of record.
• ISO 14155 monitoring that also covers sister rows in El Salvador, Panama, and Costa Rica.
• 21 CFR 812.28 — eligibility, not clearance. OUS FIH and FDA IDE.

Site versus CRO

Workstream	What Espaillat Cabral typically owns	What the CRO still owns
Cataract / accommodating IOL capability	OR, biometry, implanting ophthalmologists	Protocol feasibility, training, AAL-FAIOL / BAL-FAIOL accountability
Ethics	Institutional REC coordination	CONABIOS-overseen packet, ICF, IB alignment
National authority	Not a hallway conversation	DIGEMAPS
Import	Receiving dock if contracted	Importer of record
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative
Country optionality	One Santo Domingo row on a study now listed as active, not recruiting	Panama, El Salvador, Costa Rica, Colombia if the design needs them

DIGEMAPS in one screen

Published on Clinical Trials in the Dominican Republic: DIGEMAPS as national authority; CONABIOS-overseen RECs; Helsinki / CIOMS; 21 CFR 812.28 eligibility with ISO 14155; nearshore U.S. flights; experience-based ~30% lower program cost versus a U.S./EU baseline on that page. Those are country figures, not an Espaillat quote.

El Salvador’s published 30–60 day parallel SRS / CNEIS clock and Panama’s published MINSA / CNBI pathway sit on their country pages if the same Alcon design is the reason you are also looking at San Salvador or Panama City.

Four NCT rows, one operator problem

ILK345-E001 is already a multi-country design. The live record now lists the whole study as active, not recruiting, and shows no per-site status. Emailing Espaillat Cabral does not activate Panama Eye Center, Clinica 20/20, or López Beltrán, and it does not file DIGEMAPS, SRS, or MINSA. Which country takes a sponsor’s next case is a CRO sequencing decision, not a verdict on any site. The file is still the CRO’s.

What a registry status is not

A registry status is not a quality judgment and not a reason to attack the institute. ACTIVE_NOT_RECRUITING means Alcon’s public record no longer lists this study as enrolling. For a sponsor’s own device, a CRO still has to file DIGEMAPS, clear CONABIOS-overseen ethics, import the device, train the team, and monitor to ISO 14155 before any site is operationally ready. Treating the NCT status as the entire startup plan is how boards lose a quarter.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Santo Domingo NCT row is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Instituto Espaillat Cabral directly?

You can try. The institute can discuss interest and local cataract costs. It cannot become your DIGEMAPS applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Alcon listed it. The Alcon study is listed as active, not recruiting. Contract the CRO; let the CRO activate the site for your own protocol, or a sister country if that is the honest design.

Did bioaccess® run ILK345-E001 at Espaillat?

No public bioaccess® page says so. We will not invent that claim.

Is this the Laser Center / Batlle study?

No. This page is only Instituto Espaillat Cabral on NCT07147192. The buildings are separate.

Is this first-in-human?

The record’s primary purpose is DEVICE_FEASIBILITY. That is the honest label.

If I already have the institute name, what does the CRO still do?

Regulatory-fit across the NCT countries plus Colombia; DIGEMAPS / CONABIOS; insurance; import; activation; ISO 14155; 812.28.

Does googling Espaillat mean I should avoid the institute?

No. This is not a critique of the site. The error is treating the site as the CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Dominican Republic · CT.gov hub · López Beltrán · Quesada · CRO in Colombia.

Figures cited from the live ClinicalTrials.gov record NCT03927560 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the hospital and trial that record supports. The overall status on the live file is UNKNOWN. bioaccess® is not listed on the NCT and no bioaccess® page claims this robotic-PCI study.

If you searched Hospital Israelita Albert Einstein clinical trial, Einstein São Paulo robotic PCI, Pedro Lemos robotic PCI Brazil, or “go direct to Einstein,” you followed a hospital that is the sponsor of a public device-procedure record. Hospital Israelita Albert Einstein in São Paulo is a real tertiary site. It is not the CRO for your investigational device.

bioaccess®’s position is simple and it is not adversarial: Einstein is the site (and, on this NCT, the academic sponsor). The First-in-Human CRO still owns ANVISA / CEP when the investigation is yours, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if that is the better file. A hospital-sponsored robotic-PCI protocol does not make Einstein the vendor for a U.S. startup’s next implant.

This page does not repeat clinical trials in Brazil. That page stays the country system. This page answers the hospital-named query.

What NCT03927560 actually says (live 23 August 2026)

NCT03927560 — brief title: Robotic-Assisted Percutaneous Coronary Intervention. Official title: a safety and effectiveness study applied to the Brazilian public health system. Organization study ID: Robotic First. Lead sponsor: Hospital Israelita Albert Einstein (class OTHER). Status: UNKNOWN. Estimated start 10 June 2019; estimated completion 10 March 2020; estimated enrollment 83; interventional, single-group, no masking; intervention: robotic-assisted percutaneous coronary intervention; condition: coronary artery disease. Brief summary: PCI is safe but fully operator-dependent and associated with radiation exposure; this study will evaluate robotic-assisted PCI as an alternative to manual operation. Primary outcomes listed: procedure complications and procedure success.

Key inclusion on the record: age ≥ 18; symptomatic ischemic heart disease and/or objective ischemia; elective (non-urgent) PCI; obstructive target lesion(s) > 50% by visual analysis; interventional plan includes robotic manipulation in at least one treatment as judged by the operator; acceptable surgical-revascularization candidate. Key exclusions include STEMI in the prior 48 hours, LVEF < 30%, and creatinine > 2.0 mg/dL or CrCl < 30 ml/min.

The live record lists no facility rows. The hospital appears as sponsor. Central contact: Pedro Lemos, PhD, phone +55 (11) 2151-4306, email pedro.lemos@einstein.br on the public file. No overall official is listed. We will not invent a cath-lab address the NCT omitted, and we will not upgrade UNKNOWN to completed or recruiting.

Read the record as it is: an Einstein-sponsored robotic-PCI safety and effectiveness study aimed at the Brazilian public health system, with 2019–2020 estimated dates and an unknown current status. It is not a first-in-human of a new coronary implant, and it is not a bioaccess® case study.

A hospital sponsor is still not your CRO

Academic hospitals sponsor their own procedure-innovation protocols. That is normal. It does not transfer ANVISA, import, or 812.28 ownership to a U.S. company that later emails the same contact because Google surfaced “Einstein robotic PCI.”

What Einstein can typically do when a sponsor “goes direct”:

• Discuss whether a service line — here, a public contact associated with robotic PCI — has interest and capacity for your protocol, which is not automatic.
• Share institutional CEP calendars and hospital research rules.
• Quote procedure, bed, and local staffing costs for cases they will physically run.

What the hospital is not built to own for your investigational device:

• ANVISA under RDC 837/2023 when your device — not their robotic-PCI technique protocol — is the investigational article.
• CEP packet writing, deficiency cycles, and the Law 14874 clock as a managed workstream.
• Investigational import and accountability — importer of record.
• ISO 14155 monitoring, EDC, SAE, TMF designed for a later FDA file.
• 21 CFR 812.28 eligibility package. See OUS FIH and FDA IDE.
• Country optionality. If Einstein is the wrong room, InCor, Dante Pazzanese, or a Colombian site will not appear on an Einstein MSA.

Site versus CRO

Workstream	What Einstein typically owns	What the CRO still owns
PCI / robotic capability	Cath lab, imaging, operators, hospital quality	Feasibility of your device protocol, training, accountability
Ethics	Institutional CEP calendar	Packet, ICF, IB alignment
National authority	Hospital-sponsored filings for hospital-sponsored work	ANVISA dossier when you are the commercial sponsor of an investigational device
Import	Receiving dock if contracted	Importer of record
Quality	The case and hospital quality system	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative
Country optionality	One São Paulo hospital	The bioaccess® platform, including Colombia

ANVISA in one screen

Published on the Brazil country page: 6–10 weeks ethics + ANVISA; $20,000–$35,000 per patient; 15+ pre-qualified sites; WHO-listed authority; trial authorization is not market registration. Do not treat those figures as an Einstein-only quote, and do not treat an UNKNOWN 2019 protocol as a current clock.

Do not confuse Einstein with InCor or Dante Pazzanese

Googling “São Paulo device trial” will surface all three. InCor is the recruiting Cephea South America site (PI Alexandre Abizaid) and the terminated Leaflex facility. Dante Pazzanese holds the 1999–2005 sirolimus FIM and the recruiting VANGUARD AVR comparison. Einstein holds a hospital-sponsored robotic-PCI record whose status is UNKNOWN and which lists no facility row. Use the page that matches the NCT you actually opened. If you do not have an NCT yet, start with country fit on Clinical Trials in Brazil and CRO in Colombia, then let the CRO name the building.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A São Paulo private-hospital search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital Israelita Albert Einstein directly?

You can try. The hospital can discuss interest and CEP calendars. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because it sponsored a robotic-PCI record. Contract the CRO; let the CRO activate Einstein — or another São Paulo or Colombian site — as the site.

Did bioaccess® run NCT03927560?

No public bioaccess® page says so. We will not invent that claim.

Is this first-in-human?

The record is a safety and effectiveness study of robotic-assisted PCI in the Brazilian public-health framing. We will not relabel it FIH. Use this page because sponsors Google the hospital for device trials, not because we are inflating the design.

The status is UNKNOWN. Why write a page?

Because the hospital name still ranks. Honesty about UNKNOWN is the page. We will not pretend the study is recruiting or completed.

If I already have Einstein, what does the CRO still do?

Regulatory-fit; ANVISA / CEP for your device; insurance; import; activation; ISO 14155; 812.28; optionality versus InCor, Dante Pazzanese, or Colombia.

Does googling Einstein mean I should avoid the hospital?

No. This is not a critique of Albert Einstein. The error is treating a hospital sponsor as your CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Dante Pazzanese · CRO in Colombia.

Figures cited from live ClinicalTrials.gov records NCT00233792 and NCT06688448 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the institute and trials those records support. The 1999–2005 sirolimus FIM is historic — we say so. bioaccess® is not listed on either NCT and no bioaccess® page claims these studies.

If you searched Dante Pazzanese first-in-man, Instituto Dante Pazzanese clinical trial, sirolimus stent Brazil FIM, or “go direct to Pazzanese,” you followed a facility name ClinicalTrials.gov published. Instituto Dante Pazzanese de Cardiologia in São Paulo is a real tertiary cardiology site. It is not the operator of today’s ANVISA file.

bioaccess®’s position is simple and it is not adversarial: Dante Pazzanese is the site. The First-in-Human CRO still owns ANVISA / CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus Colombia if INVIMA is the better next file. Sponsors who skip the CRO and email the institute still have to rebuild that stack. A historic first-in-man plaque does not make the hospital a CRO.

This page does not repeat clinical trials in Brazil. That page stays the country system. This page answers the institute-named query.

What the public NCT file actually says

NCT00233792 — brief title: FIM-BR – First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent. Official title: evaluation of the sirolimus-coated modified BX VELOCITY balloon-expandable stent in de novo or restenotic native coronary lesions. Lead sponsor: Cordis US Corp. Status: COMPLETED. Start listed December 1999; actual completion March 2005; actual enrollment 30; phases 1 and 2; single-center, non-randomized; interventions: sirolimus-coated Bx VELOCITY, fast-release and slow-release, on the Raptor OTW delivery system; repeat angiography at four months; twelve-month follow-up. Facility: Instituto Dante Pazzanese of Cardiology, São Paulo, Brazil. Principal investigator on the record: Eduardo J Sousa, MD. This is a genuine historic first-in-man program. It is also more than twenty years old. Treat it as history, not as a 2026 startup clock.

NCT06688448 — VANGUARD, “Valvular Assessment of New Generation Aortic Replacement Devices.” Official title: comparative efficacy and durability of next-generation biological aortic prostheses. Lead sponsor: Instituto Dante Pazzanese de Cardiologia (other/academic). Status: RECRUITING. Actual start 1 December 2024; estimated completion 1 December 2036; estimated enrollment 200; ages 18–65; randomized, open-label, parallel, single-center AVR. Interventions: Dafodil® prosthesis and INSPIRIS Resilia® (the record also writes “Inspires Resilia”). Primary outcome: rate of bioprosthetic valve deterioration. The detailed description states the trial is conducted at a tertiary cardiology hospital of the Brazilian Unified Health System (SUS); Fundação Adib Jatene is named as a resource; device supply is supported by Meril Life Sciences and Edwards Lifesciences. Location: Instituto Dante Pazzanese de Cardiologia, São Paulo, RECRUITING, with named contacts Tacianne Rolemberg Delamain and Patrícia Paiva / Patricia Paiva. This is a hospital-sponsored comparison of two commercial-generation bioprostheses. It is not a first-in-human of an unapproved startup valve, and we will not market it as one.

Neither record names bioaccess®. That is how a sponsor finds Dante Pazzanese without finding the operator for a new investigational device.

Historic FIM is not today’s operator layer

Eduardo Sousa’s sirolimus FIM is part of interventional cardiology’s public memory. It is fair to say the institute has run first-in-man coronary work. It is not fair to tell a 2026 board that “Pazzanese already knows how to file ANVISA, import an investigational TMVR, monitor to ISO 14155, and package 21 CFR 812.28 because they did a Cordis stent in 1999.” Those workstreams have been rewritten — RDC 837/2023, Law 14874, importer-of-record practice, and FDA’s foreign-data rule among them.

VANGUARD shows the other trap: a recruiting, hospital-sponsored surgical-valve RCT can look like “the hospital is already running devices.” It is running its comparison of Dafodil and INSPIRIS inside SUS. Your unapproved device is a different contract, a different dossier, and usually a different import.

Site versus CRO

Workstream	What Dante Pazzanese typically owns	What the CRO still owns
Cardiac capability	Cath lab, OR, imaging, implanting physicians, SUS tertiary infrastructure	Protocol feasibility, training, investigational-device accountability
Ethics	Institutional CEP calendar	Packet, ICF, IB alignment
National authority	Not a hallway conversation, even after a famous FIM	ANVISA RDC 837/2023 dossier when the study is a clinical investigation of your device
Import	Receiving dock if contracted	Importer of record — LATAM import page
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. OUS FIH and FDA IDE
Country optionality	One São Paulo institute	InCor, Einstein, Colombia, Panama if the indication needs them

ANVISA in one screen

Published on the Brazil country page: ethics + ANVISA typically 6–10 weeks; CEP review capped at 30 business days under Law 14874; per-patient $20,000–$35,000; 15+ pre-qualified sites; trial authorization ≠ RDC 751/2022 market registration. Those are country figures, not a Pazzanese quote.

Do not confuse three São Paulo cardiology brands

InCor (HCFMUSP) is the Cephea / Leaflex facility. Hospital Israelita Albert Einstein is the sponsor of an UNKNOWN robotic-PCI record. Dante Pazzanese is the historic Cordis FIM institute and the VANGUARD AVR site. They are all in São Paulo and they are not interchangeable. A sponsor who emails “the São Paulo heart hospital” has not selected a site. bioaccess®’s job is to pick the room after the regulatory-fit review — and to keep Colombia on the table when INVIMA is the cleaner file — not to flatten three NCT brands into one hallway.

We will also not assign PercAssist, PAVmed, ReGelTec, or Mitralign to Dante Pazzanese. Those names remain country-level or unsourced at hospital level on the press hub.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A 1999 São Paulo FIM is not a reason to leave INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Dante Pazzanese directly?

You can try. The institute can discuss investigator interest, CEP calendars, and procedure costs. It cannot become your ANVISA applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Cordis ran a FIM there a generation ago. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the sirolimus FIM or VANGUARD?

No. We will not invent that claim. Named bioaccess® hospital-level FIH remains on the Panama Clinic, Santa Fe, and Asunción pages and their source case-study pages.

Is VANGUARD first-in-human?

Not as labeled. It is a recruiting randomized comparison of two named bioprostheses, hospital-sponsored, with industry device supply. Use it as evidence the institute is active in surgical valves — not as your startup’s FIH template.

If I already have the institute name, what does the CRO still do?

Regulatory-fit; ANVISA / CEP; insurance; import; activation; ISO 14155; 812.28; the option to use InCor or a Colombian site instead of or besides Pazzanese.

Does googling the historic FIM mean I should avoid the institute?

No. This is not a critique of Dante Pazzanese. The error is treating a 1999–2005 first-in-man as the 2026 CRO.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · InCor · Albert Einstein · CRO in Colombia.

Figures cited from live ClinicalTrials.gov records NCT07244939 and NCT05052684 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the institute and trials those records support. bioaccess® is not listed on either NCT and no bioaccess® page claims Cephea or Leaflex at InCor.

If you searched InCor Cephea, Instituto do Coração HCFMUSP clinical trial, InCor first-in-human mitral, or “go direct to InCor,” you followed a facility name ClinicalTrials.gov published. Instituto do Coração (InCor) — Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — is a real cardiovascular site. It is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: InCor is the site. The First-in-Human CRO still owns ANVISA / CEP, 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 São Paulo is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. The hospital does not become a CRO because Abbott or Pi-cardia listed it.

This page does not repeat clinical trials in Brazil. That page stays the country system — including the published note that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America. This page answers the InCor-named query.

What the public NCT file actually says

NCT07244939 — Cephea South America Feasibility Study. Lead sponsor: Abbott Medical Devices. Organization study ID: ABT-CIP-10554. Status: RECRUITING. Actual start 17 June 2025; estimated completion September 2028; estimated enrollment 20; interventional, single-group, no masking; intervention: Cephea Mitral Valve System; conditions: mitral regurgitation and mitral stenosis. Objective on the brief summary: preliminary safety and effectiveness of the Cephea Mitral Valve System for symptomatic mitral valve disease (regurgitation, stenosis, or mixed) when the site heart team judges transcatheter therapy more appropriate than open surgery. Primary outcomes listed: freedom from all-cause mortality; reduction of MR to ≤ Grade I. Key inclusion: MR ≥ Grade III and/or severe mitral stenosis (area ≤ 1.5 cm²), LVEF ≥ 30%. The São Paulo row is Instituto do Coracao (InCor) – HCFMUSP, status RECRUITING, principal investigator Alexandre Abizaid, contact João Mourão. Sister South America rows on the same record: Instituto Nacional del Torax and Hospital Clinico San Borja Arriarán, both Santiago, Chile, both recruiting. Study director: Barathi Sethuraman, Abbott Structural Heart.

NCT05052684 — The Leaflex™ Brazilian Standalone Study. Lead sponsor: Pi-cardia. Status: TERMINATED. Why stopped: “Reprioritization of attention and resources by Sponsor.” Actual start 3 October 2022; actual completion 14 November 2024; actual enrollment 1; intervention: Leaflex™ Performer; condition: aortic valve stenosis; single-group safety and performance design. Facility listed: Instituto do Coração FMUSP Centro de Pesquisa, São Paulo, Brazil. Study director: Hadas Givon, Pi-cardia. No site PI is named on the live location row.

Neither record names a CRO. That is how a sponsor finds InCor without finding the operator. We will not claim bioaccess® ran either study.

InCor is a site. The CRO is the operator.

InCor can provide structural-heart rooms, imaging, and an investigator of Abizaid’s public stature. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation with a São Paulo operator is not that dossier.
• CEP. Institutional ethics under Law 14874; published country-page cap of 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have InCor” still leaves the packet to write.
• Investigational import into Brazil is a separate permit from the trial authorization and from later ANVISA market registration (RDC 751/2022 / BRH). See importer of record.
• ISO 14155 monitoring, EDC, SAE, TMF — including if you later add the Chilean rows on the Cephea record or a Colombian alternative.
• 21 CFR 812.28 — eligibility of foreign data for FDA submission and review, not clearance. See OUS FIH and FDA IDE.

Site versus CRO

Workstream	What InCor / HCFMUSP typically owns	What the CRO still owns
Structural-heart capability	OR / hybrid room, imaging, implanting physicians, ICU	Protocol feasibility, training, device accountability
Ethics	Institutional CEP calendar and local rules	Packet, ICF, IB alignment, deficiency cycle
National authority	Not a hallway conversation	ANVISA clinical-investigation dossier (RDC 837/2023)
Import	Receiving dock, storage if contracted	Importer of record, permits
Quality	Hospital quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they ran	21 CFR 812.28 narrative
Country optionality	One São Paulo complex (plus Chile on Cephea)	Colombia and the rest of the bioaccess® platform

ANVISA in one screen (from the country page, not a new median)

Published on Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837; per-patient $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority; trial authorization and market registration are separate workstreams. Those figures are country-page figures. They are not InCor-only quotes.

Chile on the same Cephea record is not InCor

NCT07244939 is a South America feasibility, not a São Paulo-only story. Instituto Nacional del Torax (PI Jorge Sandoval) and Hospital Clinico San Borja Arriarán (PI Gabriel Maluenda) are recruiting in Santiago. That is another reason “email InCor” is not a study. A multi-country structural-heart file still needs one operator for import, monitoring, and the English dataset — whether the next case is in São Paulo or Santiago. We are not publishing Chilean pages in this wave; we are refusing to pretend those rows do not exist.

Colombia is still on the map

bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Cephea São Paulo search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract InCor directly?

You can try. The institute can discuss investigator interest, local procedure costs, and CEP calendars. It cannot become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Abbott listed Alexandre Abizaid. Contract the CRO; let the CRO activate InCor as the site.

Did bioaccess® run Cephea or Leaflex at InCor?

No public bioaccess® page says so. We will not invent that claim. PercAssist São Paulo remains an unsourced hospital-level name on our press hub and is not assigned to InCor here.

Leaflex enrolled one patient and stopped. Does that smear InCor?

No. The live record says the sponsor reprioritized. That is a sponsor decision, not a reason to attack the institute. This is not a critique of the site.

If I already have InCor, what does the CRO still do?

Regulatory-fit (Brazil vs Colombia vs a Chile-plus-Brazil design); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one São Paulo room is not enough.

Is Colombia still an option?

Yes. Brazil’s published per-patient band is higher than Colombia’s published $15,000–$25,000 band on the Panama/Colombia comparison. Colombia still wins for some indications on INVIMA Level 4 and the published site network. Lock the building after the review.

Next step

Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · Dante Pazzanese · Albert Einstein · CRO in Colombia.