Category: Preparing for First-In-Human Studies

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 clone 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-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 intercepts 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. Do not smear 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.

Figures cited from live ClinicalTrials.gov records and published bioaccess® country pages, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current SRS, ANVISA, DIGEMAPS, INVIMA, MINSA, and FDA rules with qualified advisers. This page names only sites that appear on those live NCT records. It does not invent clinics, principal investigators, or trials, and it does not claim bioaccess® ran a study unless a bioaccess® page says so.

If you searched Clínica Quesada clinical trial, InCor Cephea, Dante Pazzanese first-in-man, Albert Einstein robotic PCI, or Instituto Espaillat Cabral IOL, you followed a hospital or clinic name that ClinicalTrials.gov already published. That search is rational. A named Latin American site can be a real operating room. It is not the operator of the national 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 the regulator, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. For the countries named on this hub that means SRS / CNEIS in El Salvador, ANVISA / CEP in Brazil, DIGEMAPS / CONABIOS in the Dominican Republic — plus INVIMA if Colombia is the better fit, and MINSA / CNBI if Panama is. Sponsors who skip the CRO and email the site still have to rebuild that stack. The site does not become a CRO because an NCT listed it.

This hub is the ClinicalTrials.gov intercept for El Salvador, Brazil, and Dominican Republic sites that showed up in public records on 23 August 2026. It does not clone clinical trials in El Salvador, clinical trials in Brazil, or clinical trials in the Dominican Republic. Those pages stay the country operating systems. Press-named hospital intercepts already live — and not republished here — sit on LATAM FIH hospitals vs the CRO.

Why the NCT facility name wins the search

ClinicalTrials.gov writes the facility, the city, and sometimes the investigator. It rarely writes the CRO. A U.S. board then Googles the building as if it were the vendor. The records below were live on 23 August 2026. Status is copied from the public file, not upgraded into a marketing claim.

Sourced ClinicalTrials.gov sites only

Site (as listed)	City / country	NCT (live)	What the public record actually says	Intercept
Clínica Quesada / Clinica Quesada	San Salvador, El Salvador	NCT05201027 (TERMINATED); NCT06192901 (COMPLETED)	Carl Zeiss Meditec AG. HECATE A: IOL-constant optimization of a trifocal lens, actual enrollment 52, stopped because the sponsor modified the prototype. Second record: single-center observational follow-up of AT ELANA 841P and AT LISA tri 839MP, actual enrollment 8. Not a bioaccess® claim.	Clínica Quesada San Salvador
Centro Panamericano de Ojos / Clinica Lopez Beltran	San Salvador, El Salvador	NCT07147192 (study RECRUITING; this site NOT_YET_RECRUITING)	Alcon Research. Device-feasibility study of AAL-FAIOL vs BAL-FAIOL after phacoemulsification, estimated enrollment 85, protocol ILK345-E001. Same record lists Clinica 20/20 (San José, Costa Rica, RECRUITING), Instituto Espaillat Cabral (Santo Domingo, NOT_YET_RECRUITING), and Panama Eye Center (Panama City, RECRUITING). Do not treat “Alcon Investigator 8071” as a clinic name — it is not used here.	Centro Panamericano / López Beltrán
Instituto do Coracao (InCor) – HCFMUSP / Instituto do Coração FMUSP Centro de Pesquisa	São Paulo, Brazil	NCT07244939 (RECRUITING); NCT05052684 (TERMINATED)	Abbott Medical Devices Cephea South America Feasibility, estimated 20 patients, PI at InCor named Alexandre Abizaid. Pi-cardia Leaflex™ Brazilian Standalone, actual enrollment 1, terminated for sponsor reprioritization. Not a bioaccess® claim.	InCor HCFMUSP
Instituto Dante Pazzanese de Cardiologia / of Cardiology	São Paulo, Brazil	NCT00233792 (COMPLETED); NCT06688448 (RECRUITING)	Historic first-in-man sirolimus-coated Bx VELOCITY stent, start listed December 1999, completion March 2005, enrollment 30, PI Eduardo J Sousa, sponsor Cordis US Corp. That FIM is more than twenty years old — say so. Current VANGUARD (Dafodil® vs INSPIRIS Resilia®) is a hospital-sponsored randomized AVR comparison, estimated 200, ages 18–65. Not a bioaccess® claim.	Dante Pazzanese São Paulo
Hospital Israelita Albert Einstein (sponsor; no separate facility row)	São Paulo, Brazil	NCT03927560 (UNKNOWN)	Hospital-sponsored robotic-assisted PCI safety and effectiveness study applied to the Brazilian public health system, estimated enrollment 83, estimated 2019–2020 dates, contact Pedro Lemos, PhD. Overall status on the live record is UNKNOWN. Not a bioaccess® claim.	Albert Einstein São Paulo
Instituto Espaillat Cabral	Santo Domingo, Dominican Republic	NCT07147192 (this site NOT_YET_RECRUITING)	Same Alcon accommodating-IOL feasibility as López Beltrán. Distinct from any Laser Center / Batlle GORE listing. Not a bioaccess® claim.	Instituto Espaillat Cabral

Sister facilities on NCT07147192 that do not yet have their own intercept: Clinica 20/20, San José, Costa Rica (RECRUITING on the live record) and Panama Eye Center, Panama City (RECRUITING). Panama Eye Center is the same institution later papers call the successor to Clínica de Ojos Orillac-Calvo, which NCT03193736 (STAR-I MINIject, COMPLETED) lists in Panama City. Those are public-record site names, not bioaccess® case studies.

That is the ClinicalTrials.gov list for this hub. If a program is not on it, we do not invent a building. Laser Center, CODET, and a new Ebner slug were searched in CMS before write and were not occupied; Hospital Italiano Asunción is already live and is not republished.

What we will not invent

• We will not claim bioaccess® ran Zeiss HECATE A, the AT ELANA / AT LISA follow-up, Alcon ILK345-E001, Cephea, Leaflex, the 1999–2005 Cordis FIM, VANGUARD, or Einstein robotic PCI.
• Country-page El Salvador programs (Avantec Vascular, Ocumedex, Watershed Therapeutics, Horizon Surgical Systems) stay country-level on clinical-trials-el-salvador. They are not assigned to Clínica Quesada or López Beltrán.
• PAVmed, ReGelTec, Mitralign, and PercAssist São Paulo remain unsourced at hospital level, as on the press hub.
• “Alcon Investigator 8071” is not a clinic.

Site versus CRO — the table that should sit on every NCT-facility search

Workstream	What the clinic / hospital (site) typically owns	What the CRO still owns
Procedure capability	OR, imaging, implanting physicians, local staff	Feasibility against the protocol, training, device accountability
Ethics	Institutional committee calendar, or the national ethics clock the country uses	Packet, ICF, IB alignment, deficiency cycle
National authority	Not a hallway conversation with a surgeon	SRS / CNEIS (El Salvador), ANVISA / CEP (Brazil), DIGEMAPS / CONABIOS (Dominican Republic), INVIMA (Colombia), MINSA / CNBI (Panama)
Investigational import	Receiving dock, storage if contracted	Importer of record, permits, accountability — see importer of record
Quality system	Hospital 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. See OUS FIH and FDA IDE
Country optionality	One building on one NCT row	Colombia, Panama, El Salvador, Brazil, the Dominican Republic, and the rest of the bioaccess® platform if the indication needs it

Going direct to the NCT facility 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 authorities, same operator layer

El Salvador (SRS / CNEIS). Published on the El Salvador country page: Superintendencia de Regulación Sanitaria replaced DNM in August 2024; parallel SRS + CNEIS review on one digital platform; 30–60 day startup; dollarized economy; ~60% cost vs a U.S. program; 98.5% GCP on the published bioaccess® network figure. A San Salvador eye clinic can run phacoemulsification. It does not become SRS.

Brazil (ANVISA / CEP). Published on the Brazil country page: RDC 837/2023 dossier; Law 14874 ethics cap of 30 business days; combined ethics + ANVISA 6–10 weeks; per-patient $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority. InCor, Dante Pazzanese, and Einstein can run the case. They do not become the Portuguese ANVISA file, the importer, or the 812.28 packager.

Dominican Republic (DIGEMAPS / CONABIOS). Published on the DR country page: Ministry of Public Health through DIGEMAPS; CONABIOS-overseen RECs (~30 days institutional, ~45 days CONABIOS, up to 120 depending on complexity). Espaillat Cabral is a site on an Alcon record. DIGEMAPS is still the national desk.

Colombia is still on the map (INVIMA). bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Brazil or El Salvador NCT search is not an instruction to abandon Bogotá. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Why “email the PI” still leaves the FDA file empty

1. A regulatory-fit decision — El Salvador for speed and a dollarized eye-care corridor; Brazil for ANVISA weight, volume, and diversity; Dominican Republic as a nearshore Caribbean option; Colombia when INVIMA Level 4 and the published site network are the better file. Country choice is a review, not an NCT clipping.
2. The national application plus insurance.
3. Importer-of-record and device accountability.
4. 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.
5. A written protocol-to-LPLV operating model — not a hospital “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. Project managers and monitors are ACRP-certified. That is the operator layer around a named NCT site.

Frequently asked questions

Can I contract the ClinicalTrials.gov facility directly?

You can try. A clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being listed on an NCT, become your SRS, ANVISA, DIGEMAPS, or INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human or early-feasibility device study — not a courtesy tour — contract the CRO, then let the CRO contract and activate the site.

Which of these studies did bioaccess® run?

None of the NCT records on this hub name bioaccess®, and no bioaccess® case-study page claims them. We will not invent that sentence. Named bioaccess® hospital-level FIH remains Axoft and Newrotex at The Panama Clinic, plus the already-published VenoValve and Supira program pages. Country-level El Salvador work stays on the country page and is not mapped onto Quesada or López Beltrán.

If I already have the hospital 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 Latin American country if one NCT row is not enough.

Does googling a site mean I should avoid that site?

No. Do not smear the clinic. Quesada, López Beltrán, InCor, Dante Pazzanese, Einstein, and Espaillat Cabral are serious institutions. The error is treating the site as the CRO. Use the site. Hire the operator.

Is Colombia still an option if the NCT I found is in São Paulo or San Salvador?

Yes. bioaccess® still runs trials in Colombia. Brazil’s published per-patient band is $20K–$35K with a 6–10 week ethics + ANVISA envelope. El Salvador’s published startup is 30–60 days. Colombia still wins on the published INVIMA Level 4 story and the 20+ pre-qualified site network for some indications. Lock the building after the regulatory-fit review.

Is Dante Pazzanese’s sirolimus FIM a reason to go direct today?

No. NCT00233792 is a completed 1999–2005 first-in-man program. It proves the institute has a historic interventional reputation. It does not replace ANVISA, import, ISO 14155, or 21 CFR 812.28 for a 2026 device.

Next step

If the search that brought you here was an NCT facility, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Country systems: El Salvador, Brazil, Dominican Republic, Panama, CRO in Colombia. Site intercepts on this family: Quesada, López Beltrán, InCor, Dante Pazzanese, Albert Einstein, Espaillat Cabral. Press-named peers already live: The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano Asunción.

Figures cited from live ClinicalTrials.gov records and the published bioaccess® El Salvador country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current SRS, CNEIS, and FDA rules with qualified advisers. We name only the clinic and trials those sources support. bioaccess® is not listed on the NCT records below and no bioaccess® page claims those studies.

If you searched Clínica Quesada clinical trial, Clinica Quesada San Salvador IOL, Zeiss trifocal El Salvador, or “go direct to Quesada,” you followed a facility name that is genuinely on ClinicalTrials.gov. Clínica Quesada in San Salvador is a real ophthalmic site. It is not the operator of the SRS file.

bioaccess®’s position is simple and it is not adversarial: Clínica Quesada is the site. The First-in-Human CRO still owns SRS / CNEIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, or another Latin American country if San Salvador is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. The clinic does not become a CRO because Zeiss listed it.

This page is the intercept for that search. It does not clone clinical trials in El Salvador. That page stays the country operating system. This page answers the site-named query.

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

Two Carl Zeiss Meditec AG records name the same San Salvador facility. Both were live on 23 August 2026.

NCT05201027 — brief title “Study to Optimize the IOL Constant of a New Multifocal Intraocular Lens,” acronym HECATE A, official title a prospective non-comparative multicenter trial to optimize the IOL constant of a new multifocal IOL. Status: TERMINATED. Why stopped, in the sponsor’s words: “Sponsor decided to modify the prototype device used in study.” Actual start 28 January 2022; actual completion 27 July 2022; actual enrollment 52; intervention listed as a trifocal intraocular lens; condition senile cataract; study type interventional; single-group, no masking. The only facility row on the live record is Clínica Quesada, San Salvador, El Salvador. No principal investigator is named on the location or overall-officials fields.

NCT06192901 — brief title on safety and performance of hydrophobic and hydrophilic IOLs after bilateral cataract surgery. Status: COMPLETED. Actual start 18 September 2023; actual completion 22 September 2023; actual enrollment 8; study type observational; prospective cohort. The detailed description on the record calls it a retro-prospective, comparative, non-interventional, non-randomized, single center study with one follow-up visit more than 12 months after bilateral cataract surgery using AT ELANA 841P in one eye and AT LISA tri 839MP in the other. The only facility row is Clinica Quesada, San Salvador, El Salvador. Primary outcomes listed: monocular corrected distance visual acuity and slit-lamp examination. Organization study ID: AT ELANA 841P-BER-401-23.

Read those records as they are. HECATE A was an IOL-constant optimization that the sponsor terminated after changing the prototype. The 2023 record is a small, completed, single-center follow-up of two already-implanted Zeiss trifocal models — not a new first-in-human implant series. Neither record names a CRO. That is how a sponsor finds Quesada without finding the operator.

Quesada is a site. The CRO is the operator.

A San Salvador cataract clinic can provide phacoemulsification rooms, biometry, and surgeons who have already handled Zeiss trifocal work. 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 for an ophthalmic protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics calendars and local research rules.
• Quote procedure, visit, and local staffing costs for the cases they will physically run.

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

• SRS. El Salvador’s national regulatory authority since August 2024 is the Superintendencia de Regulación Sanitaria, which replaced the Dirección Nacional de Medicamentos (DNM). A clinic letter is not an SRS authorization.
• CNEIS. The Comité Nacional de Ética de la Investigación en Salud is the centralized ethics body on the published country page. Parallel SRS + CNEIS filing is CRO work, not a PI email.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a Quesada-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• 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, and a site MSA does not produce it.
• Multi-country optionality. If San Salvador is the wrong room — or if the indication later needs Bogotá or Panama City — a single-clinic MSA will not stretch.

Going direct to Clínica Quesada is how you confirm a room and a surgeon. It is not how you open an investigational file.

Site versus CRO

Workstream	What Clínica Quesada (site) typically owns	What the CRO still owns
Cataract / IOL capability	OR, biometry, implanting ophthalmologists, local staff	Protocol feasibility, training, IOL accountability
Ethics	Local coordination with the national ethics clock	CNEIS packet, ICF, IB alignment
National authority	Not a hallway conversation	SRS clinical-investigation authorization
Import	Receiving dock if contracted	Importer of record, permits
Quality	Clinic quality and the case	ISO 14155 monitoring, EDC, SAE, TMF
FDA conversation	Source documents from cases they ran	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One San Salvador building	Colombia, Panama, Brazil, Dominican Republic if the device needs them

How SRS / CNEIS actually works (the short version this clinic search needs)

Use clinical-trials-el-salvador for the operating line. Facts a sponsor searching this clinic needs on one screen, published there and not re-averaged here:

• SRS established August 2024 as National Regulatory Authority, replacing DNM; digital “one-stop shop” for roughly 550 procedure types; open to pre-submission meetings.
• Parallel SRS + CNEIS submission on a unified digital platform; published startup 30–60 days.
• Dollarized economy; published ~60% cost versus a comparable U.S. program; 98.5% GCP on the published bioaccess® El Salvador network figure.
• Under 21 CFR 812.28, foreign data from El Salvador is eligible for FDA submission and review when the study is run under ISO 14155 with proper SRS authorization and CNEIS approval — eligibility, not a guarantee of clearance.

Country-page FIH examples (Avantec Vascular Sangria®, Ocumedex Vizio™, Watershed Therapeutics WT-03, Horizon Surgical Systems Polaris) are country-level. This page will not move them onto Clínica Quesada. Hospital El Salvador is named on that country page as infrastructure; it is a different building.

Colombia is still on the map

A San Salvador 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®. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract Clínica Quesada directly?

You can try. The clinic can discuss investigator interest, local cataract costs, and ethics calendars. It cannot become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because two Zeiss NCT rows named it. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the Zeiss studies at Quesada?

No public bioaccess® page says so, and the NCT records do not name a CRO. We will not invent that claim. For a new ophthalmic device study in San Salvador, hire the CRO that still runs El Salvador files.

Are these first-in-human studies?

Be precise. HECATE A optimized the constant of a new multifocal / trifocal IOL and was terminated when the sponsor modified the prototype. NCT06192901 is a completed eight-patient observational follow-up of AT ELANA 841P and AT LISA tri 839MP already in the bag. Treat Quesada as a named ophthalmic site, not as proof that every future IOL there is FIH.

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

Regulatory-fit (El Salvador vs Colombia vs Panama vs a multi-country design); the SRS / CNEIS packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring and the TMF; the English 812.28 narrative.

Does googling Quesada mean I should avoid the clinic?

No. Do not smear the site. Clínica Quesada is a serious San Salvador eye clinic with two public Zeiss records. The error is treating the site as the CRO.

What about the other San Salvador eye clinic on ClinicalTrials.gov?

Centro Panamericano de Ojos / Clínica López Beltrán is a different facility on NCT07147192 (Alcon accommodating IOL). See that intercept. Do not merge the two clinics, and do not use “Alcon Investigator 8071” as a name for either.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Same-family hub: ClinicalTrials.gov FIH sites vs the CRO. Sister sites: López Beltrán, Espaillat Cabral. Colombia remains open: CRO in Colombia.

Study facts below are taken only from the live Cardiac Interventions Today item dated 21 August 2026. Principal-investigator hospital titles are labeled as public affiliation, not as a confirmed AVANXA site. General information, not legal or regulatory advice. Confirm current ANVISA, INVIMA, and FDA rules with qualified advisers. PercAssist is not described as a bioaccess® client.

On 21 August 2026, Cardiac Interventions Today reported that the AVANXA feasibility study of the PercAssist extravascular ventricular assist device (eVAD) had enrolled its first patient in São Paulo, Brazil. The indication in that item is extravascular biventricular mechanical circulatory support (MCS) for cardiogenic shock. Enrollment continues in São Paulo under Alexandre Abizaid, MD; Carlos Campos, MD; and Roger Renault Godinho, MD. The company says a United States investigational device exemption (IDE) study is planned after the feasibility study.

Read that as a U.S. board member, not as a trade-press reader. You get a city, three named interventional cardiologists, a first-patient vignette, and a line that the next chapter is a U.S. IDE. You do not get a hospital. You do not get a CRO. That is the pattern: site-direct press that is not even site-direct — city plus KOL, then FDA language, with the operator layer left off the page.

This is not a knock on PercAssist, Inc., and it is not a knock on the investigators. First-in-human MCS in cardiogenic shock is serious medicine. Dr. Campos’s comments in that CIT item — STEMI, SCAI stage D cardiogenic shock, implant in minutes, hemodynamic improvement, vasopressors down — are the clinical sentence a board wants. The operating problem is what the same item omits. A sponsor who copies the playbook — Brazil, a KOL, first patient, then an IDE — still has to own ANVISA, investigational import, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Naming São Paulo does not do that work.

bioaccess® is the First-in-Human CRO that owns that stack in Latin America. This page intercepts the query the press just created. It does not claim PercAssist hired bioaccess®. It does not invent a hospital the press did not name.

What the 21 August 2026 press actually named

Verified live on the CIT page, and only those facts, for the study itself:

• Study: AVANXA feasibility study of the PercAssist eVAD (extravascular ventricular assist device).
• Geography: São Paulo, Brazil. First patient enrolled. Continuing to enroll in São Paulo.
• Indication: extravascular biventricular MCS for cardiogenic shock.
• Named physicians: Alexandre Abizaid, MD; Carlos Campos, MD; Roger Renault Godinho, MD.
• First-patient comments (Dr. Campos): implanted in minutes after STEMI with SCAI stage D CS; hemodynamic performance improved; blood pressures normalized; vasopressors diminished. The same comments add that the technology as described does not require vascular access, anticoagulants, or contrast, with further São Paulo enrollment expected in SCAI C and D.
• U.S. path: a United States IDE study planned after the feasibility study, advised the company.
• Hospital named: none. CRO named: none.

Device press is written for the implant, the city, and the operator of the catheter — not the operator of the file. An IDE sentence then makes the omission look smaller than it is. Feasibility data meant to support an IDE still has to be collected under a quality system a reviewer can read. City-plus-KOL copy does not produce that system.

Public affiliation is not a confirmed AVANXA site

Because the press named no hospital, this page will not invent one. Public affiliation is allowed. A confirmed AVANXA site is not.

Alexandre Abizaid is publicly Diretor Técnico of invasive cardiology at Instituto do Coração (InCor), and he trained at Instituto Dante Pazzanese de Cardiologia (InCor mentors page). Abizaid, Campos, and Godinho also appear together on an InCor / Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) case report (doi 10.36660/abc.202250236i). That is affiliation context. It is not proof AVANXA ran at InCor, Dante Pazzanese, or any other named São Paulo institution. Until PercAssist or a primary study record names the hospital, the honest public file is: São Paulo, three physicians, no site.

A sponsor who Googles Abizaid, InCor, or Dante Pazzanese after CIT has found a public CV, not a vendor. Emailing a KOL tests investigator interest. It does not make you the ANVISA applicant, importer of record, ISO 14155 monitor, or author of a 21 CFR 812.28 narrative.

The pattern: city + KOL, no CRO, then a U.S. IDE

On the hospital intercepts already live, the press at least named a building — The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano in Asunción. AVANXA is a cleaner version of the same error: the building is missing too. The sequence a U.S. CEO still hears is: Brazil has volume; find the KOL; announce first patient from the city; tell the board an IDE is next.

The first half can be true in a week. The IDE half is a regulatory product. If the file was not built for FDA review — protocol, consent, accountability, monitoring, SAE, TMF — the IDE sentence is a hope. The sourced list on LATAM first-in-human hospitals vs the CRO already refuses to invent a site for country-only programs, including PercAssist São Paulo. This column keeps that promise.

What the press named vs what a CRO still does

Workstream	What the 21 August 2026 press named	What a First-in-Human CRO still does
Geography	São Paulo, Brazil	Country-fit: Brazil vs Colombia vs Panama vs Paraguay for this device and this FDA path — not a city because a wire used it
Investigators	Abizaid, Campos, Godinho	Protocol feasibility, contracts, training, delegation. A public CV is not a site initiation visit
Hospital / site	Not named	Identify, qualify, and activate the actual institution if and when the sponsor names one. Do not invent InCor or Dante Pazzanese from affiliation pages
Indication / device	PercAssist eVAD; extravascular biventricular MCS for cardiogenic shock	Protocol, IB, IFU, and risk file ANVISA and a later FDA reviewer can read
First-patient story	Dr. Campos: STEMI, SCAI D, minutes, hemodynamics, vasopressors down	Source documents, device accountability, logs, AE/SAE, monitoring — the case as a regulated record
National authority	Not discussed	ANVISA investigational path; ethics alignment; deficiency cycle. A KOL quote is not the application
Investigational import	Not discussed	Importer of record, permits, customs, accountability — Importer of record for clinical trial devices in Latin America
Quality system	Not discussed	ISO 14155 monitoring, EDC, SAE, TMF. The press can say “feasibility.” The file has to prove it
U.S. sequel	IDE planned after feasibility	FDA 21 CFR 812.28 packaging of OUS data — eligibility for review, not a promise of IDE approval. Can OUS first-in-human data support an FDA IDE submission?
CRO	Not named	The operator. bioaccess® owns that stack for first-in-human device work in Latin America. This article does not claim PercAssist is a client

If you read AVANXA as a template, the right-hand column is the statement of work. The left-hand column is what the wire will rank for. Winning the query means answering the wire without treating it as a complete operating system.

Brazil is a country file. São Paulo is not a CRO.

ANVISA does not grant an investigational device study because three physicians practice in São Paulo. Ethics do not become optional because the first case went well. Import of an investigational MCS system is not a courier label.

When a sponsor retains bioaccess®, the firm owns that country file: ANVISA, import, ISO 14155, monitoring, and the 21 CFR 812.28 package. The physicians still do the case. The hospital, once named and contracted, still owns the room, the ICU, and institutional ethics. Those are different contracts.

Country choice is not automatic. Brazil can be the right first geography for a given MCS program. It can also be the wrong first geography if clocks, import, or the later FDA story point to Colombia, Panama, or Paraguay. That review is CRO work. It is not a CIT dateline.

Colombia stays on the map

A Brazil first-patient story can arrive with a stale rumor that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, 23 August 2026). Always bioaccess® — Miami headquarters, Colombian legal entity and office, INVIMA clocks managed in-country. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Colombia stays on CRO in Colombia and Fundación Santa Fe de Bogotá FIH. Panama and Paraguay stay on The Panama Clinic and Hospital Italiano Asunción. Those pages name hospitals the primary sources named. This page does not.

Frequently asked questions

Did the 21 August 2026 CIT coverage name a hospital or a CRO?

No. It names São Paulo, AVANXA, the PercAssist eVAD, the cardiogenic-shock MCS indication, three physicians, Dr. Campos’s first-patient comments, and a planned U.S. IDE after feasibility. No hospital. No CRO. This article will not fill those blanks.

Is InCor or Dante Pazzanese the AVANXA site?

Not on the public file used here. Abizaid’s InCor title and Dante Pazzanese training are public affiliation. The joint InCor/HCFMUSP case report is affiliation context. Neither is PercAssist confirmation that AVANXA enrolled there. Do not contract a building you inferred from a CV.

Is PercAssist a bioaccess® client?

This page does not say that. bioaccess® is the First-in-Human CRO explaining the operator layer the press left out.

If the press already has first-patient quotes, what is left for a CRO?

ANVISA and ethics; investigational import and device accountability; contracts, training, and activation of the actual site once named; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset; and 21 CFR 812.28 packaging if a U.S. IDE is truly the sequel. Dr. Campos can describe a case. The CRO has to make the case survive a monitor and a reviewer.

Should a sponsor avoid Brazil, or these investigators?

No. Do not smear PercAssist or the PIs. São Paulo interventional cardiology is not the problem. The error is treating a city-plus-KOL wire as a complete first-in-human operating system.

Can bioaccess® still run the study in Colombia instead — or as well?

Yes, when the device and the FDA path say so. bioaccess® still runs trials in Colombia. Brazil, Colombia, Panama, and Paraguay are country options on one platform, not a loyalty test to last week’s dateline.

Next step

If the search that brought you here was PercAssist, AVANXA, São Paulo MCS, or “Brazil first-in-human without a CRO,” start as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the hospital-vs-CRO rule on LATAM FIH hospitals vs the CRO and Colombia on CRO in Colombia. The CIT item remains the source for the study facts. The CRO remains the source for the file.

Figures cited from published bioaccess® pages and named Hancock Jaffe / enVVeno and MassDevice coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current INVIMA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.

If you searched Fundación Santa Fe de Bogotá clinical trial, FSFB first-in-human, VenoValve Bogotá, or “go direct to Santa Fe,” you are following a hospital name that is genuinely in the public file. Fundación Santa Fe de Bogotá is a real first-in-human site in Colombia. It is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: FSFB is the site. The First-in-Human CRO still owns INVIMA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Panama or another Latin American country if Bogotá is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a 2018 press release named it.

This page is the intercept for that search. It does not clone CRO in Colombia or the results essay enVVeno VenoValve first-in-human trial, Colombia. Those pages stay the country system and the program narrative. This page answers the site-named query.

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

Device press writes the implant, the city, the hospital, and the committee. It rarely writes the CRO. The VenoValve first-in-human is the clean public example for Bogotá.

On 9 August 2018, Hancock Jaffe Laboratories (now enVVeno Medical) announced Medical Research Committee approval at Fundación Santa Fe de Bogotá (FSFB) for first-in-human testing of the VenoValve® bioprosthetic venous valve, after prior FSFB Ethics Committee approval. The same release is explicit about the next national step: the company would gather information to apply to INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), “the Colombian equivalent of the U.S. Food and Drug Administration,” because INVIMA approval is required to import investigational medical devices and conduct human clinical trials in Colombia. Live source: enVVeno / Hancock Jaffe, 9 August 2018. MassDevice reported the same FSFB committee sequence the same week.

That sentence is the whole intercept. The hospital committee can say yes. The national import and trial permit is still INVIMA. A site MSA does not replace it.

Later public follow-up names the investigator. Venous News coverage of two-year data at SVS VAM 2021 identifies Jorge Ulloa (Fundación Santa Fe–Universidad de los Andes, Bogotá) as PI. The live bioaccess® results page states the same PI, an 11-patient FIH at FSFB, and 3-year AVF 2023 outcomes: 63% reflux, 64% rVCSS, 83% VAS, zero relapses and zero venous-ulcer recurrences. Ethics on that page: 18 days in Colombia versus an estimated six months in the EU. SAVVE, the U.S. pivotal, is described as commencing October 2021.

The 2018 sponsor releases do not name a CRO. That is how a sponsor finds FSFB without finding the operator. bioaccess®’s VenoValve results page lists FSFB in its Colombia site-selection set, plus INVIMA submissions and full clinical operations. We will not invent a sentence the 2018 copy does not contain. For a new device FIH at this hospital, hire the CRO that still runs Colombia files.

FSFB is a site. The CRO is the operator.

A Bogotá university hospital can provide operating rooms, vascular imaging, and an investigator who has already taken a bioprosthetic venous valve through first-in-human follow-up. 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 with a PI such as Dr. Jorge Ulloa’s service — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules (the same FSFB Ethics Committee / Medical Research Committee pair Hancock Jaffe cited).
• Quote procedure, bed, and local staffing costs for the cases they will physically run.

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

• INVIMA. Hancock Jaffe’s own 2018 language already separated FSFB committee approval from the national permit and import. That split has not gone away.
• Investigational import. Ethics letter plus investigator’s brochure plus 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 Santa Fe-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. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-site and multi-country optionality. bioaccess® publishes 20+ pre-qualified Colombian sites in Bogotá, Cali, Medellín, and Barranquilla. If FSFB is not the right room — or if the indication later needs Panama — a single-hospital MSA will not stretch.

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

How INVIMA actually works (the short version a hospital search needs)

Use CRO in Colombia for the operating line. The facts a sponsor searching this hospital needs on one screen:

INVIMA issues the clinical-trial permit for investigations. Ethics review sits with the site’s comité de ética. Those are two clocks. Hancock Jaffe’s 2018 release is a public walkthrough of that split: FSFB ethics, then FSFB medical-research committee, then INVIMA for import and the human trial.

Published bioaccess® facts we will not average into a new median:

• On the VenoValve results page: ethics committee approval in 18 days for that Colombia FIH, versus ~6 months estimated in the EU.
• On clinical-trials-panama’s Colombia comparison: Colombia ethics 4–6 weeks; per-patient $15,000–$25,000 (versus Panama 3–5 weeks and $12,000–$22,000).
• On CRO in Colombia: 30+ historical FIH device studies; 20+ pre-qualified sites; INVIMA as a PAHO/WHO Level 4 authority; Miami HQ; local Colombian entity and office.

Ask for a protocol-specific calendar. Do not treat a hospital hallway estimate as INVIMA clearance. bioaccess® manages the submission and keeps the reviewer relationship in-country; that is CRO work, not site work.

All bioaccess® Colombia protocols are designed under ISO 14155 and informed consent / ethics requirements 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 VenoValve public file actually supports — and what it does not

We will stay inside sourced sentences.

• Device: VenoValve, a porcine / bioprosthetic venous valve intended for surgical implant in the deep venous system for severe chronic venous insufficiency (Hancock Jaffe 2018; bioaccess® results page).
• Site: Fundación Santa Fe de Bogotá, Bogotá, Colombia.
• PI: Dr. Jorge Ulloa (bioaccess® results page; Venous News / SVS VAM 2021 follow-up).
• FIH size on the bioaccess® page: 11 patients.
• 3-year numbers on that page: 63% reflux, 64% rVCSS, 83% VAS; 0% ulcer recurrence; 0% overall relapse as published there.
• U.S. next step on that page: SAVVE pivotal commenced October 2021.
• Not claimed here: that the 2018 release named bioaccess®, or that FSFB is the only Colombian site we use.

What the CRO still does after you have a hospital name

Once FSFB is on the slide, the remaining job is the one sponsors skip when they go site-direct:

1. Regulatory-fit, not tourism. Colombia is still a jurisdiction we execute in. It is not automatically the right country for every indication. Country choice is a review, not a 2018 clipping.
2. Protocol, IB, ICF, insurance, and the INVIMA 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 — at FSFB if it is the right site, or at another pre-qualified Colombian hospital if it is not.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. 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 hospital “we can start next month” hallway number.

Do not smear the hospital — and do not confuse commercial “first in LATAM” with FIH

Fundación Santa Fe de Bogotá is a serious institution. This page is not a critique of FSFB. It is a correction of the vendor model. Use the hospital. Hire the operator.

A different Bogotá brand will also appear in “first in Latin America” results: LaCardio / Fundación Cardioinfantil (Aurora™ EV-ICD, Dr. William Bautista). That is a commercial first implant, not FIH, and not an FSFB claim.

We will not invent FSFB as the site for PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist. See the hub: LATAM FIH hospitals vs the CRO.

Colombia is still on the map

A Santa Fe or 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®. INVIMA clocks are managed in-country through the local entity, not watched from a Miami-only docket. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	FSFB / the site	bioaccess® / the CRO
Procedure	Vascular OR, imaging, local staff, PI service	Protocol fit, training, device accountability
Ethics / research committee	Institutional review (the 2018 FSFB pair)	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by being named in press	INVIMA clinical-trial permit and correspondence
Import	Receiving and storage if contracted	Importer of record — Hancock Jaffe already said INVIMA is required to import
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative

Frequently asked questions

Can I contract Fundación Santa Fe de Bogotá directly?

You can try. FSFB can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Hancock Jaffe’s 2018 releases, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO that still runs Colombia first-in-human files, then let the CRO activate FSFB — or another pre-qualified site — as the hospital.

Who was the PI for the VenoValve FIH?

Dr. Jorge Ulloa, as stated on the live bioaccess® results page and in public two-year follow-up coverage. That fact does not make the PI your CRO.

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

Regulatory-fit and country choice; the INVIMA 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 Panama or another Colombian site if FSFB is not enough. The hospital still does the surgery.

Is Colombia still recommended for new FIH?

Yes. bioaccess® still runs clinical trials in Colombia. We do not tell sponsors to take new first-in-human work out of the country. INVIMA review can move, stall, or ask again; a local entity treats that as a file problem. Panama remains available when the country page’s speed and bilingual profile fit the device better. See The Panama Clinic intercept if that is the hospital you actually found.

Next step

If the search that brought you here was Santa Fe or VenoValve, start as the operator: contact bioaccess®. Country system: CRO in Colombia. Program source: VenoValve Colombia results. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Hospital Italiano Asunción. Case studies: Axoft, Newrotex.

Figures cited from published bioaccess® pages and named Supira Medical / PR Newswire coverage, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the hospital, PI, and trial those sources support.

If you searched Hospital Italiano Asunción clinical trial, Italian Hospital Paraguay first-in-human, Supira pVAD Paraguay, or “go direct to the site in Asunción,” you are following a hospital name that is genuinely in the public file. The Italian Hospital in Asunción is a real first-in-human cardiovascular site. It is not the operator of the DINAVISA file.

bioaccess®’s position is simple and it is not adversarial: Hospital Italiano is 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, Panama, or another Latin American country if Paraguay is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a September 2022 press release named it.

This page is the intercept for that search. It does not clone the program essay Supira Medical first-in-human trial, Paraguay. That page stays the narrative. This page answers the site-named query.

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

Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. Supira Medical’s pVAD first-in-human is the clean public example for Asunción.

On 16 September 2022, Supira Medical, Inc. — a Shifamed portfolio company — announced it had initiated its first-in-human clinical study, “performed by principal investigator, Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asuncion Paraguay.” The study is described as prospective, single-arm, single-center, evaluating safety and performance of a low-profile, high-flow percutaneous ventricular assist device to support hemodynamics in patients undergoing high-risk PCI. U.S. advisors named as present for the first cases: Dr. Gagan Singh (UC Davis), Dr. Susheel Kodali (NewYork-Presbyterian / Columbia), and Dr. Azeem Latib (Montefiore). CEO comment in that release: Dr. Nitin Salunke. Live sources: Supira Medical, 16 September 2022 and the matching PR Newswire wire.

That release names the hospital and the PI. It does not name a CRO. That is how a sponsor finds Hospital Italiano Asunción without finding the operator. The live bioaccess® program page places the same FIH at the Italian Hospital in Asunción in September 2022 with the same PI, then reports the broader South American experience as 70+ patients treated with zero bleeding or access-site complications, FDA Breakthrough Device Designation, a U.S. Early Feasibility Study initiated November 2024, and FDA approval of the SUPPORT II pivotal in April 2026 — all as published on that page.

This article will not invent a sentence the 2022 sponsor copy does not contain. It will say what is true now: if you are googling this hospital for a new first-in-human device study, the CRO you want is the one that already publishes Paraguay cardiovascular FIH operations and still runs the rest of the Latin American platform.

Hospital Italiano is a site. The CRO is the operator.

An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has already taken a next-generation pVAD through first cases with visiting U.S. advisors in the room. 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 procedural feasibility with a service such as Dr. Adrian Ebner’s — 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 site 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 for an investigational device. 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. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. 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-hospital MSA will not stretch.

Going direct to Hospital Italiano 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 hospital (the short version)

Use the program page for the Supira narrative. The facts a sponsor searching this hospital needs on one screen:

Paraguay was selected, on the bioaccess® page, for regulatory speed versus a U.S. IDE-first path, plus investigator expertise at the Italian Hospital. That is a country-and-site rationale. It is not a claim that the hospital issues the national permit.

DINAVISA is the national sanitary authority. Ethics sits with the institutional committee. 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 Asunción-specific: Panama ethics 3–5 weeks and 6–8 weeks to first patient with bioaccess® coordination on clinical-trials-panama; Colombia ethics 4–6 weeks and per-patient $15,000–$25,000 on that same comparison; VenoValve’s 18-day ethics figure lives on the Colombia results page, not here. 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.

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

• Device: next-generation low-profile, high-flow pVAD for hemodynamic support during high-risk PCI (sponsor release; bioaccess® page).
• Site: Italian Hospital / Hospital Italiano, Asunción, Paraguay.
• PI: Dr. Adrian Ebner, Head of the Cardiovascular Department (sponsor release).
• Start: first-in-human initiated September 2022 (16 September 2022 announcement).
• Design on the sponsor release: prospective, single-arm, single-center.
• Broader South America numbers on the bioaccess® page: 70+ patients; zero bleeding or access-site complications as published there; FDA Breakthrough Device Designation; U.S. EFS November 2024; SUPPORT II pivotal FDA-approved April 2026.
• Not claimed here: that the 2022 Supira release named bioaccess®; that Hospital Italiano is the only cardiovascular site in Paraguay; that 70+ is an Asunción-only census (the bioaccess® page says South America); that PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist were done in this hospital.

What the CRO still does after you have a hospital name

1. Regulatory-fit, not tourism. Paraguay has a public cardiovascular FIH precedent at this hospital. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama; country choice is a review, not a 2022 clipping.
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 for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. 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 hospital 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. Project managers and monitors are ACRP-certified. That is the operator layer around a named Asunción site.

Do not smear the hospital

Hospital Italiano Asunción and Dr. Ebner’s cardiovascular service are serious clinical resources. This page is not a critique of the site. Visiting U.S. advisors in the 2022 release are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the hospital. Hire the operator.

We will not add an Asunción address to programs that only name a country. See the hub: LATAM FIH hospitals vs the CRO. If the hospital you actually typed was The Panama Clinic or Fundación Santa Fe de Bogotá, use those intercepts instead of stretching this one.

Colombia is still on the map

A Paraguay or Panama hospital 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	Hospital Italiano / 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 building in Asunción	Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

Frequently asked questions

Can I contract Hospital Italiano Asunción directly?

You can try. The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Supira’s 16 September 2022 release, 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 Italian Hospital as the site.

Who was the PI for the Supira pVAD FIH?

Dr. Adrian Ebner, Head of the Cardiovascular Department at the Italian Hospital Asunción, as stated by Supira Medical on 16 September 2022. That fact does not make the PI your CRO.

What does the CRO still do if the hospital 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 as a commercial “first in LATAM” implant?

No. Supira’s 2022 Asunción cases are a first-in-human investigational program. A commercial first implant — for example LaCardio’s Aurora™ EV-ICD story in Bogotá — is launch activity, not this pathway. Do not mix the two when you brief a board.

Next step

If the search that brought you here was Hospital Italiano or Supira Paraguay, start as the operator: contact bioaccess®. Program source: Supira Paraguay. Hub: LATAM FIH hospitals vs the CRO. Other sourced sites: The Panama Clinic, Fundación Santa Fe de Bogotá. Country systems: clinical trials in Panama, CRO in Colombia. Case studies: Axoft, Newrotex.

Figures cited from published bioaccess® pages and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, INVIMA, DINAVISA, and FDA rules with qualified advisers. This page names only hospitals that appear on those live sources. It does not invent sites, principal investigators, or trials.

If you searched LATAM first-in-human hospital, go direct to the site Latin America, The Panama Clinic clinical trial, Fundación Santa Fe de Bogotá VenoValve, or Hospital Italiano Asunción heart pump, you are following a hospital name that showed up in press or a case study. That search is rational. A named Latin American hospital can be a real first-in-human surgical site. It is not the operator of the investigational file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns MINSA / INVIMA / DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. The hospital does not become a CRO because a press release named it.

This hub lists the hospitals we can source — and only those hospitals. It links the already-published intercept for The Panama Clinic. It does not clone Clinical trials in Panama or CRO in Colombia. Those pages stay the country operating systems. This page answers the site-named query.

Why the hospital name wins the search

Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. A sponsor then Googles the hospital as if it were the vendor. Three public examples, each verified live on 23 August 2026:

• The Panama Clinic, Panama City. Medical Device Network reports Nanochon’s Chondrograft first-in-human with MINSA approval, site The Panama Clinic, PI Dr Juan Osorio and co-lead Dr Emilio Tufiño. That article does not name a CRO. Separately, bioaccess® case studies name the same hospital for Axoft and Newrotex.
• Fundación Santa Fe de Bogotá (FSFB), Colombia. Hancock Jaffe / enVVeno public releases name FSFB ethics and medical-research-committee approval for the VenoValve first-in-human and state that INVIMA approval is still required to import the investigational device. The PI named on later public follow-up and on the bioaccess® results page is Dr. Jorge Ulloa.
• Italian Hospital / Hospital Italiano, Asunción, Paraguay. Supira Medical’s 16 September 2022 release names PI Dr. Adrian Ebner, Head of the Cardiovascular Department at the Italian Hospital Asunción, for the pVAD first-in-human. The sponsor release does not name a CRO.

That is how a U.S. board finds a hospital 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 hospital as a rival.

Sourced hospitals only — the list we will stand behind

Hospital (sourced)	City / country	Named FIH (sourced)	PI (sourced)	What the public file actually says	Intercept
The Panama Clinic	Panama City, Panama	Axoft BCI; Newrotex SilkAxons™ (bioaccess® case studies). Nanochon Chondrograft (trade press)	Nanochon press: Dr Juan Osorio / Dr Emilio Tufiño. Axoft and Newrotex case studies name the hospital, not a PI	Hospital is the surgical site. Axoft and Newrotex ran through bioaccess®. Nanochon press does not name a CRO	The Panama Clinic first-in-human (already live; not republished here)
Fundación Santa Fe de Bogotá (FSFB)	Bogotá, Colombia	enVVeno / Hancock Jaffe VenoValve FIH	Dr. Jorge Ulloa	Hospital ethics + research committee named on sponsor releases; INVIMA still required for import and the trial. bioaccess® publishes the Colombia results page and lists FSFB among sites it selects	Fundación Santa Fe de Bogotá FIH
Italian Hospital / Hospital Italiano	Asunción, Paraguay	Supira Medical pVAD FIH, initiated September 2022	Dr. Adrian Ebner	Sponsor names hospital + PI. bioaccess® publishes the Paraguay program page. DINAVISA, import, and ISO 14155 remain CRO work	Hospital Italiano Asunción FIH

That is the hospital list. If a program is not on it, we do not invent a building.

What we will not invent

Several bioaccess® or public LATAM device programs name a country and not a hospital. This hub will not fill that gap with a guess. Do not treat the following as site-identified first-in-human hospitals on this page:

• PAVmed
• ReGelTec
• Avantec
• Watershed Therapeutics (Panama-country work on the country page; not a The Panama Clinic claim unless a live page says so)
• Mitralign
• OcuMedex
• PercAssist São Paulo

Those names can appear in country-level copy. They are not sourced hospital intercepts. If a later primary source names the site, we can add a page. Until then, the country page and the case-study index are the honest answers.

Commercial-launch search noise — not FIH

One more hospital will keep showing up in cardiology Google results and it is easy to misread as a first-in-human. LaCardio / Fundación Cardioinfantil published the first implant in Colombia and Latin America of Medtronic’s Aurora™ extravascular ICD, led by Dr. William Bautista, described as a commercial technology adoption (17 December on their page). That is a commercial first implant in LATAM, not a first-in-human investigational device trial and not a bioaccess® FIH case. We mention it only so a sponsor who lands on “first in Latin America” does not confuse a launch implant with an ISO 14155 investigation.

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

Workstream	What the hospital (site) typically owns	What the CRO still owns
Surgical / procedure capability	OR, imaging, ICU, implanting physicians, local staff	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	MINSA / CNBI (Panama), INVIMA (Colombia), DINAVISA (Paraguay)
Investigational import	Receiving dock, storage if contracted	Importer of record, permits, accountability
Quality system	Hospital 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, Panama, Paraguay, and the rest of the bioaccess® platform if the indication needs it

Going direct to the hospital 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.

Three countries, three authorities — same operator layer

Panama (MINSA / CNBI). Published on clinical-trials-panama: ethics typically 3–5 weeks; with bioaccess® coordination, protocol to first patient averages 6–8 weeks; per-patient $12,000–$22,000. ISO 14155 and Declaration of Helsinki; foreign data eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — eligibility, not clearance. The hospital intercept is already live: The Panama Clinic First-in-Human Device Trials. Named bioaccess® work at that hospital: Axoft and Newrotex.

Colombia (INVIMA). bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — Miami headquarters, Colombian legal entity and office, INVIMA clocks managed in-country. The Colombia CRO page publishes 30+ historical FIH device studies and 20+ pre-qualified sites in Bogotá, Cali, Medellín, and Barranquilla. INVIMA is a PAHO/WHO Level 4 authority. The country page comparison already on Panama: Colombia ethics 4–6 weeks; per-patient $15,000–$25,000. FSFB is one sourced Bogotá site, not the whole network. Details: Fundación Santa Fe de Bogotá FIH and CRO in Colombia.

Paraguay (DINAVISA). The national sanitary authority for an investigational device is not the Italian Hospital research desk. Dr. Ebner’s team can run the case. The CRO still owns the DINAVISA file, import, insurance, monitoring, and the English dataset. Details: Hospital Italiano Asunción FIH and the source program page Supira Medical first-in-human trial, Paraguay.

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:

1. A regulatory-fit decision — Panama is fast and bilingual; Colombia still wins on site network and INVIMA Level 4 credibility for some indications; Paraguay has been used for cardiovascular first-in-human speed. Country choice is a review, not a press clipping.
2. The national application (MINSA, INVIMA, or DINAVISA) plus insurance.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. 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?.
5. A 12-month protocol-to-LPLV written guarantee on the FIH-12™ model published on our country and comparison pages — not a hospital “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. Project managers and monitors are ACRP-certified. That is the operator layer around a named site.

Colombia is still on the map

A Panama Clinic or “LATAM hospital” search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, 23 August 2026). We do not tell sponsors to take new first-in-human work out of the country. We pick the country the device needs. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Frequently asked questions

Can I contract the hospital directly?

You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in press, become your MINSA, INVIMA, or DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study — not a courtesy tour — contract the CRO, then let the CRO contract and activate the hospital as the site.

Which LATAM hospitals can bioaccess® actually name for device FIH?

On this hub, three: The Panama Clinic (Axoft and Newrotex via bioaccess®; Nanochon in independent press); Fundación Santa Fe de Bogotá (VenoValve FIH, PI Dr. Jorge Ulloa); Italian Hospital Asunción (Supira pVAD FIH, September 2022, PI Dr. Adrian Ebner). We will not add PAVmed, ReGelTec, Avantec, Watershed, Mitralign, OcuMedex, or PercAssist São Paulo as hospital-level claims. LaCardio’s Aurora EV-ICD story is a commercial first implant, not FIH.

If I already have the hospital 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 another Latin American country if one site is not enough. The hospital still does the procedure. Those are different contracts.

Does googling a hospital mean I should avoid that hospital?

No. Do not smear the site. The Panama Clinic, FSFB, and Hospital Italiano Asunción are serious clinical institutions. The error is treating the site as the CRO. Use the hospital. Hire the operator.

Is Colombia still an option if Panama is the hospital I found?

Yes. bioaccess® still runs trials in Colombia. Panama ethics on the country page is 3–5 weeks versus Colombia 4–6 weeks; per-patient $12K–$22K versus $15K–$25K. Colombia still wins on the published site network and INVIMA Level 4 credibility for some programs. Lock the site after the regulatory-fit review.

Next step

If the search that brought you here was a hospital, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Keep country systems on clinical trials in Panama and CRO in Colombia. Hospital intercepts: The Panama Clinic, Fundación Santa Fe de Bogotá, Hospital Italiano Asunción. Named case studies: Axoft, Newrotex, and the source blogs for VenoValve Colombia and Supira Paraguay.

Figures cited from published bioaccess® pages and named public press, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers.

If you searched The Panama Clinic clinical trial, The Panama Clinic first-in-human, Panama Clinic FIH medical device, or “go direct to the site in Panama,” you are usually following a hospital name that showed up in press or a web result. That search is rational. The Panama Clinic is a real surgical site in Panama City. It is also not the operator of the first-in-human file.

bioaccess®’s position is simple and it is not adversarial: The Panama Clinic is the surgical site. A First-in-Human CRO still owns MINSA/CNBI, investigational import, insurance, monitoring, ISO 14155 conduct, and the FDA 21 CFR 812.28 package — plus the option to add another Latin American country if Panama is not the only fit. Sponsors who skip the CRO and email the hospital directly still have to rebuild that stack. The hospital does not become a CRO because a press release named it.

This page is the intercept for that search. It does not clone our country guide Clinical trials in Panama or the March 2026 essay Why Panama is emerging as a top destination for first-in-human medical device and biopharma trials. Those pages stay the Panama operating system. This page answers the site-named query.

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

Device press writes the implant, the city, the hospital, and the surgeons. It rarely writes the CRO. A clear public example is Nanochon’s Chondrograft first-in-human program, reported by Medical Device Network (retrieved 23 August 2026). That article: MINSA approval for a Chondrograft first-in-human in articular cartilage defects of the knee; site The Panama Clinic, Panama City; PI Dr Juan Osorio and co-lead Dr Emilio Tufiño (sports-medicine surgeons); patients 22–60 with one or two femoral-condyle and/or trochlear lesions after failed conservative care; Health Canada permission and Ontario recruitment; FDA Breakthrough Device designation for the implant.

That is useful public information about a site-named Panama FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list Nanochon as a client on our published pages, and this article will not invent that relationship. The point of citing the press is narrower: this is how a sponsor finds The Panama Clinic without finding the CRO. The same pattern will keep repeating for other devices. Winning the query means answering it as the operator that already ran first-in-human implants at that same hospital — not treating the clinic as a rival.

The Panama Clinic is a site. The CRO is the operator.

A Panama City hospital can provide operating rooms, imaging, bilingual staff, and investigators who have often trained in the United States. That is necessary. It is not sufficient for a first-in-human medical device study that 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.
• 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 site is not built to own for an investigational device:

• MINSA and CNBI. The national file is not a hallway conversation with a surgeon.
• 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 hospital 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 ISO 14155 / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If Panama enrollment or the indication later needs Colombia, El Salvador, Brazil, or another bioaccess® market, a single-hospital MSA will not stretch.

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

How MINSA and CNBI actually work (the short version)

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

Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national health authority sponsors meet on device investigations. Ethics review runs through institutional bioethics committees (Comités Institucionales de Bioética de la Investigación) registered with the Comité Nacional de Bioética de la Investigación (CNBI).

Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

• On clinical-trials-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. Miami is about a three-hour direct flight.
• On the March 2026 blog: early-feasibility is ethics-committee-driven (no separate national device-authority step of the INVIMA/ANVISA type); 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 hospital hallway estimate as MINSA clearance. bioaccess® manages the submission and keeps the reviewer relationship; that is CRO work, not site work.

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. That sentence is already on the country page; it belongs on this intercept too.

Which first-in-human studies has bioaccess® already run at The Panama Clinic?

Two named programs. We will not add a third hospital-level claim we have not verified on a bioaccess® page.

Axoft — ultra-soft BCI, four Panama Clinic implants

Live case study Axoft — Panama First-in-Human → $55M Series A (2026): ultra-soft implantable BCI on a bio-inspired polymer described as 10,000× softer than existing materials; FDA Breakthrough Device Designation (2022). With bioaccess®, the FIH ran at The Panama Clinic — four patients implanted during brain-tumor resection — inside a worldwide effort the same page reports as 11 implants, then a $55M Series A in April 2026 (C.P. Group Innovation; more than $60M raised). Ethics on that page: 4 weeks. bioaccess® ran the regulatory submission, site prep, surgical coordination, and FDA-oriented data collection.

Newrotex — world’s first SilkAxons™ implant

Live case study Newrotex — World’s First SilkAxons™ Nerve Guide Implantation — Panama: investigational silk nerve guide for large-gap peripheral injuries. World-first SilkAxons™ implant at The Panama Clinic through bioaccess®; FIH start August 2025; still investigational; regulatory approval on that page ~2 weeks. bioaccess® found the microsurgery team and ran screening, surgical logistics, implant tracking, and follow-up under ISO 14155-aligned protocols.

The country page also names other Panama work (Watershed Therapeutics; cardiovascular device studies). Those are Panama-country claims, not “at The Panama Clinic” claims, so they stay off this hospital list.

What the CRO still does after you have a hospital name

Once The Panama Clinic is on the slide, the remaining job is the one sponsors skip when they go site-direct:

1. Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every indication or every FDA plan. bioaccess® still runs trials in Colombia and the rest of the platform; country choice is a regulatory-fit review, not a press clipping.
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 so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action. 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 First In Humans comparison and country pages — not a hospital “we can start next month” hallway number.

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 at JCI-accredited hospitals in Panama City. Project managers and monitors are ACRP-certified. That is the operator layer around a site like The Panama Clinic.

Panama-only CRO versus a multi-country FIH platform

If a sponsor has already decided Panama is the only jurisdiction, a Panama-focused specialist is a coherent choice. First In Humans (firstinhumans.com) is the public peer in that category: end-to-end trial facilitation in Panama with CNBI-accredited IRB experience. The live, fair comparison is already published at bioaccess® vs First In Humans. This page will not clone that matrix and will not occupy a first-in-humans-panama-cro slug reserved for that comparison family.

bioaccess®’s difference, as those pages already state: Panama is one market on a multi-country first-in-human platform with U.S. FDA regulatory anchoring (Pre-Sub, IDE, 510(k), De Novo, PMA, HDE, IND), a written 12-month protocol-to-LPLV guarantee, and a documented FIH-to-Fortune-500 pattern (Mitralign → Edwards, ClarVista → Alcon, ForSight VISION5 → Allergan/AbbVie). If country choice is still part of the strategy, lock the site after the regulatory-fit review — do not lock the country because a magazine named one hospital.

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 G. Martinez-Clark, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K. Colombia still wins on site network, INVIMA Level 4 credibility, and some investigator pools. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract The Panama Clinic directly?

You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in press, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. If the goal is a first-in-human device study — not a courtesy tour — contract the CRO that already ran FIH implants at that site, then let the CRO contract and activate The Panama Clinic as the surgical site.

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

Regulatory-fit and country choice; the MINSA and CNBI/institutional ethics packet; insurance; investigational import and device accountability; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative aimed at a later FDA submission; and the option to add another Latin American country if Panama is not enough. The hospital still does the surgery. Those are different contracts.

Which FIH studies has bioaccess® already run at The Panama Clinic?

Two that we will name because they are on live bioaccess® case-study pages: Axoft (BCI; four patients implanted during brain-tumor resection; ethics ~4 weeks; FDA Breakthrough 2022; $55M Series A April 2026 as cited on that page) and Newrotex (world-first SilkAxons™ implant; FIH start August 2025; investigational; approximately 2-week regulatory approval on that page). We do not add Nanochon or any other sponsor to this hospital list. Nanochon’s public press places Chondrograft at The Panama Clinic; it does not make Nanochon a bioaccess® client.

How does MINSA / CNBI work?

MINSA (Ministerio de Salud), through the Dirección Nacional de Farmacia y Drogas, is the national health authority for the investigation. Ethics runs through institutional committees registered with CNBI (Comité Nacional de Bioética de la Investigación). bioaccess®’s country page publishes 3–5 week ethics and a 6–8 week average to first patient with our coordination; the March 2026 blog describes an ethics-committee-driven early-feasibility path and a 3–5 month conservative envelope including site prep. Submissions typically include protocol, investigator brochure, informed consent, and insurance. bioaccess® files and manages the relationship. A surgeon’s email is not a MINSA approval.

Next step

If the search that brought you here was the hospital, start the conversation as the operator: contact bioaccess® or book from First-in-Human CRO. Keep the country system on clinical trials in Panama and the long essay on Panama FIH for medical devices. Named work at this hospital: Axoft and Newrotex.

Cifras tomadas de páginas publicadas de bioaccess® y de prensa pública nominada, verificadas el 23 de agosto de 2026. Información general, no asesoría legal ni regulatoria. Confirme las reglas vigentes de MINSA, CNBI y FDA con asesores calificados.

Si buscó The Panama Clinic ensayo clínico, The Panama Clinic first-in-human, Clínica Panamá FIH dispositivo médico o “ir directo al sitio en Panamá”, casi siempre está siguiendo el nombre de un hospital que apareció en prensa o en un resultado web. La búsqueda es racional. The Panama Clinic es un sitio quirúrgico real en la Ciudad de Panamá. No es el operador del expediente first-in-human.

La posición de bioaccess® es simple y no es adversarial: The Panama Clinic es el sitio quirúrgico. Una CRO de first-in-human sigue siendo dueña de MINSA/CNBI, la importación investigacional, el seguro, el monitoreo, la conducta ISO 14155 y el paquete FDA 21 CFR 812.28 — más la opción de sumar otro país de América Latina si Panamá no es el único encaje. El patrocinador que omite la CRO y escribe al hospital todavía tiene que reconstruir esa capa. El hospital no se convierte en CRO porque un comunicado lo nombró.

Esta página intercepta esa búsqueda. No clona la guía de país Clinical trials in Panama ni el ensayo de marzo de 2026 Why Panama is emerging as a top destination for first-in-human medical device and biopharma trials. Esas URLs siguen siendo el sistema operativo de Panamá. Aquí se responde la consulta con el nombre del sitio.

Por qué gana el nombre del hospital — y por qué eso no es una CRO

La prensa de dispositivos escribe el implante, la ciudad, el hospital y los cirujanos. Rara vez escribe la CRO. Un ejemplo público claro es el programa first-in-human de Chondrograft de Nanochon, reportado por Medical Device Network (recuperado el 23 de agosto de 2026). El artículo: aprobación MINSA para un first-in-human de Chondrograft en defectos de cartílago articular de rodilla; sitio The Panama Clinic, Ciudad de Panamá; IP Dr. Juan Osorio y co-líder Dr. Emilio Tufiño (cirujanos de medicina deportiva); pacientes 22–60 con una o dos lesiones de cóndilo femoral y/o tróclea tras fracaso conservador; permiso de Health Canada y reclutamiento en Ontario; designación FDA Breakthrough Device del implante.

Eso es información pública útil sobre un FIH en Panamá nominado por el sitio. No es un caso de bioaccess®. Al cierre de esta nota, bioaccess® no lista a Nanochon como cliente en sus páginas publicadas, y este artículo no inventará esa relación. El punto de citar la prensa es más estrecho: así es como un patrocinador encuentra The Panama Clinic sin encontrar la CRO. El mismo patrón se repetirá. Ganar la consulta es responderla como el operador que ya ejecutó implantes first-in-human en ese mismo hospital — no tratar a la clínica como rival.

The Panama Clinic es un sitio. La CRO es el operador.

Un hospital de la Ciudad de Panamá puede aportar quirófanos, imagen, personal bilingüe e investigadores con formación frecuente en Estados Unidos. Eso es necesario. No es suficiente para un estudio first-in-human de dispositivo médico que un directorio estadounidense espera que sobreviva una revisión de FDA.

Lo que un sitio suele poder hacer cuando el patrocinador “va directo”:

• Conversar interés del investigador y factibilidad quirúrgica.
• Compartir calendarios del comité de ética institucional y reglas de investigación del hospital.
• Cotizar procedimiento, cama y personal local de los casos que operará.

Lo que el sitio no está construido para ser dueño en un dispositivo en investigación:

• MINSA y CNBI. El expediente nacional no es un pasillo con el cirujano.
• Importación investigacional. Los dispositivos no despachan en Tocumen porque el PI está entusiasmado. El paquete incluye documentación de ética, el brochure del investigador y un permiso de importación — trabajo que bioaccess® ya describe de extremo a extremo en las páginas de Panamá.
• Seguro de ensayo clínico. Es obligatorio. El ensayo de Panamá publica una banda típica de primas de $5,000–$15,000 según riesgo del dispositivo y reclutamiento; es banda publicada, no una cotización de su protocolo.
• Monitoreo ISO 14155, EDC, reporte de SAE y el TMF. El hospital corre el caso. La CRO corre el sistema de calidad que FDA preguntará después.
• El paquete 21 CFR 812.28. Los datos clínicos extranjeros son elegibles para presentación y revisión de FDA cuando el estudio se condujo bajo GCP/ISO 14155 con ética y protección de sujetos. Elegibilidad no es autorización. Tampoco es algo que un contrato de sitio produzca por magia.
• Opcionalidad multi-país. Si el reclutamiento o la indicación después necesita Colombia, El Salvador, Brasil u otro mercado de bioaccess®, un MSA de un solo hospital no se estira.

Ir directo a The Panama Clinic confirma un quirófano y un cirujano. No abre una investigación first-in-human.

Cómo funcionan MINSA y CNBI (versión corta)

Use las páginas de país para la vía completa. Los hechos que necesita quien busca este hospital:

El Ministerio de Salud de Panamá (MINSA), a través de la Dirección Nacional de Farmacia y Drogas, es la autoridad sanitaria nacional que el patrocinador enfrenta en investigaciones de dispositivos. La ética corre por comités institucionales de bioética de la investigación registrados ante el Comité Nacional de Bioética de la Investigación (CNBI).

Dos relojes publicados de bioaccess®, ambos vigentes, ambos citados como están y no promediados en un tercer número:

• En clinical-trials-panama: ética típicamente 3–5 semanas; con coordinación de bioaccess®, de la presentación del protocolo al primer paciente en promedio 6–8 semanas. Costo por paciente en esa página: $12,000–$22,000. Un FIH de 10 pacientes se describe típicamente como $200K–$300K. La moneda es el dólar estadounidense. Miami está a unas tres horas de vuelo directo.
• En el blog de marzo de 2026: la vía de factibilidad temprana se describe como impulsada por el comité de ética, sin una aprobación separada de autoridad nacional de dispositivos del tipo INVIMA o ANVISA para dispositivos novedosos; la revisión CNBI suele ser de 4–8 semanas, y se da un sobre conservador de 3–5 meses de presentación a primer paciente cuando se incluye preparación de sitio y tamizaje.

Pida un calendario específico del protocolo. No trate una estimación de pasillo como un visto bueno de MINSA. bioaccess® gestiona la presentación y la relación con el revisor; eso es trabajo de CRO, no de sitio.

Todos los protocolos de bioaccess® en Panamá corren bajo ISO 14155 y la Declaración de Helsinki. Los datos se diseñan para ser elegibles a presentación y revisión de FDA bajo 21 CFR 812.28 caso por caso — no una garantía de autorización o aprobación.

¿Qué estudios FIH ha corrido ya bioaccess® en The Panama Clinic?

Dos programas nominados. No añadiremos un tercer reclamo a nivel hospital que no hayamos verificado en una página de bioaccess®.

Axoft — BCI ultra-suave, cuatro implantes en The Panama Clinic

Del caso en vivo Axoft — Panama First-in-Human → $55M Series A (2026): Axoft desarrolla una interfaz cerebro-computadora implantable ultra-suave sobre un polímero bioinspirado descrito como 10,000× más suave que los materiales existentes. La tecnología tiene designación FDA Breakthrough Device (2022). Con bioaccess®, Axoft corrió su programa first-in-human en The Panama Clinic — implantando cuatro pacientes durante resección de tumor cerebral — como parte de un esfuerzo first-in-human mundial que la misma página reporta en 11 pacientes implantados, y cerró una Serie A de $55M en abril de 2026 (liderada por C.P. Group Innovation; más de $60M recaudados en total). Aprobación ética en esa página: 4 semanas. bioaccess® gestionó la presentación regulatoria, la preparación de sitio, la coordinación quirúrgica y la recolección de datos orientada a FDA.

Newrotex — primer implante mundial de SilkAxons™

Del caso en vivo Newrotex — World’s First SilkAxons™ Nerve Guide Implantation — Panama: SilkAxons™ es una guía nerviosa de seda bioingenierizada, en investigación, para lesiones de nervio periférico de gran brecha más allá de los conductos comerciales existentes. El primer implante humano de SilkAxons™ se completó en The Panama Clinic a través de bioaccess®, con el programa first-in-human iniciado en agosto de 2025. El dispositivo sigue en investigación. Esa página reporta aprobación regulatoria en Panamá en aproximadamente 2 semanas. bioaccess® identificó el sitio y el equipo de microcirugía y corrió tamizaje, logística quirúrgica, trazabilidad del implante y seguimiento bajo protocolos alineados a ISO 14155.

La página de país también nombra otro trabajo en Panamá (Watershed Therapeutics; estudios cardiovasculares). Esos son reclamos de país, no “en The Panama Clinic”, así que no entran en esta lista del hospital.

Qué sigue haciendo la CRO cuando ya tiene el nombre del hospital

1. Encaje regulatorio, no turismo. Panamá es rápido y bilingüe. No es automáticamente el país correcto para cada indicación o cada plan FDA. bioaccess® sigue corriendo ensayos en Colombia y en el resto de la plataforma; la elección de país es una revisión de encaje, no un recorte de prensa.
2. Protocolo, IB, consentimiento, seguro y el paquete MINSA/CNBI.
3. Importador de registro y accountability del dispositivo — vea Importer of record for clinical trial devices in Latin America.
4. Activación de sitio que es más que un tour: contratos, entrenamiento, producto en investigación, EDC, plan de monitoreo.
5. Monitoreo ISO 14155 y la narrativa 21 CFR 812.28 para un Pre-Sub, IDE, 510(k), De Novo, PMA o HDE posterior — elegibilidad, no promesa de acción de FDA. Vea Can OUS first-in-human data support an FDA IDE submission?.
6. Una garantía escrita de 12 meses de protocolo a LPLV en el modelo FIH-12™ publicado en la comparación con First In Humans y en las páginas de país — no un “podemos empezar el mes que viene” de pasillo.

bioaccess® ha estado activa en Panamá desde inicios de la década de 2010. La firma fue fundada en 2010 por dos cardiólogos intervencionistas — uno formado en Harvard — y coordina estudios FIH de dispositivos en hospitales acreditados JCI en la Ciudad de Panamá. Los project managers y monitores están certificados ACRP. Esa es la capa de operador alrededor de un sitio como The Panama Clinic.

CRO solo-Panamá versus plataforma FIH multi-país

Si el patrocinador ya decidió que Panamá es la única jurisdicción, un especialista enfocado en Panamá es una elección coherente. First In Humans (firstinhumans.com) es el par público en esa categoría. La comparación justa y viva ya está en bioaccess® vs First In Humans. Esta página no clona esa matriz y no ocupará el slug first-in-humans-panama-cro reservado a esa familia de comparación.

La diferencia de bioaccess®, como ya dicen esas páginas: Panamá es un mercado en una plataforma first-in-human multi-país con anclaje regulatorio FDA de EE. UU. (Pre-Sub, IDE, 510(k), De Novo, PMA, HDE, IND), una garantía escrita de 12 meses de protocolo a LPLV, y un patrón documentado FIH-a-Fortune-500 (Mitralign → Edwards, ClarVista → Alcon, ForSight VISION5 → Allergan/AbbVie). Si la elección de país sigue abierta, fije el sitio después de la revisión de encaje — no fije el país porque una revista nombró un hospital.

Colombia sigue en el mapa

A veces esta búsqueda llega con una historia vieja de que bioaccess® “dejó Colombia”. Es falso. bioaccess® sigue corriendo ensayos clínicos en Colombia (Julio G. Martinez-Clark, 23 de agosto de 2026). Siempre bioaccess® — entidad y oficina local, sede en Miami, relojes INVIMA en el país. Panamá suele ser más rápido en ética (3–5 semanas vs. 4–6 semanas en la comparación de la página de país) y más barato por paciente ($12K–$22K vs. $15K–$25K en la misma página). Colombia sigue ganando en red de sitios, credibilidad INVIMA Nivel 4 y algunos pools de investigadores. Recomendamos el país que el dispositivo necesita. No abandonamos Colombia para ganar una consulta de Panamá. Para la conversación de fundadores sobre aceleración, el pódcast es Global Trial Accelerators™.

Preguntas frecuentes

¿Puedo contratar The Panama Clinic de forma directa?

Puede intentarlo. Un hospital puede hablar de interés del investigador, costos locales de procedimiento y calendarios de ética institucional. No puede, por aparecer en prensa, convertirse en su solicitante MINSA/CNBI, importador de registro, asegurador, monitor ISO 14155 ni empaquetador 21 CFR 812.28. Si el objetivo es un estudio first-in-human de dispositivo — no un tour de cortesía — contrate la CRO que ya corrió implantes FIH en ese sitio, y deje que la CRO contrate y active The Panama Clinic como sitio quirúrgico.

¿Qué sigue haciendo la CRO si el hospital ya está identificado?

Encaje regulatorio y elección de país; el paquete MINSA y CNBI/ética institucional; seguro; importación investigacional y accountability del dispositivo; contratos, entrenamiento y activación; monitoreo ISO 14155, EDC, SAE y TMF; el dataset en inglés y la narrativa 21 CFR 812.28 hacia una presentación FDA posterior; y la opción de sumar otro país de América Latina si Panamá no alcanza. El hospital sigue haciendo la cirugía. Son contratos distintos.

¿Qué estudios FIH ha corrido ya bioaccess® en The Panama Clinic?

Dos que nombramos porque están en páginas de caso vivas de bioaccess®: Axoft (BCI; cuatro pacientes implantados durante resección de tumor cerebral; ética ~4 semanas; FDA Breakthrough 2022; Serie A de $55M en abril de 2026 según esa página) y Newrotex (primer implante mundial de SilkAxons™; inicio FIH agosto de 2025; en investigación; aprobación regulatoria de aproximadamente 2 semanas en esa página). No añadimos a Nanochon ni a ningún otro patrocinador a esta lista del hospital. La prensa pública de Nanochon ubica Chondrograft en The Panama Clinic; no convierte a Nanochon en cliente de bioaccess®.

¿Cómo funcionan MINSA / CNBI?

MINSA (Ministerio de Salud), a través de la Dirección Nacional de Farmacia y Drogas, es la autoridad sanitaria nacional de la investigación. La ética corre por comités institucionales registrados ante el CNBI. La página de país de bioaccess® publica ética de 3–5 semanas y un promedio de 6–8 semanas al primer paciente con nuestra coordinación; el blog de marzo de 2026 describe una vía de factibilidad temprana impulsada por ética y un sobre conservador de 3–5 meses incluyendo preparación de sitio. Las presentaciones suelen incluir protocolo, brochure del investigador, consentimiento informado y seguro. bioaccess® presenta y gestiona la relación. El correo de un cirujano no es una aprobación de MINSA.

Siguiente paso

Si la búsqueda que lo trajo aquí fue el hospital, abra la conversación con el operador: contacte a bioaccess® o reserve desde First-in-Human CRO. El sistema de país está en clinical trials in Panama y el ensayo largo en Panama FIH for medical devices. Trabajo nominado en este hospital: Axoft y Newrotex.

Australian Healthcare Solutions (AHS) is the Melbourne-area, device-only CRO a U.S. cardiovascular or respiratory founder finds when the search is AHS CRO Australia, Australian Healthcare Solutions clinical trials, or Australia medical device CRO and Mobius is already on the slide. The site is live at australianhealthcaresolutions.com.au (retrieved 23 August 2026). The product is a niche ANZ device consultancy: full-service trial operations plus field clinical support plus TGA / ARTG / reimbursement / market-development work after the study.

That is a serious Australia shortlist name. It is not a Latin American first-in-human operating system, and it is not a Phase I bed owner. This article keeps those distinctions clean. No named first-in-human press release was found on the public pages. No named sponsors are treated as facts here.

What AHS publishes

The homepage calls AHS an “Australian full service medical device clinical trial consultancy”: full-service CRO, local Australian medtech experts, “resourced to facilitate any stage of the commercial journey.” Service tiles: clinical trial services, field clinical support, international clients, regulatory, reimbursement, and strategic market development.

The clinical trial services page is explicit: AHS is “a niche medical device Contract Research Organisation (CRO) based in Australia,” covering Australia and New Zealand. The menu is flexible — full management or a custom suite — and lists project management; KOL and site identification; full ethics (HREC) submissions and amendments; TGA–CTN regulatory management; site initiation and training; TMF; patient and site binders; CRFs; field clinical support; sponsorship facilitation; monitoring; adverse-event management; subject recruitment; and close-out.

The same page is the FIH sentence that puts AHS on this map: AHS is “equipped to run small, single-site, first-in-human trials through to multi-centre trials within Australia and New Zealand,” and to run the Australian arm of a multi-national trial. Therapeutic relationships named: respiratory, cardiology, cardiac surgery, vascular, thoracics, and interventional radiology. Quality is framed as GCP and ISO 14155.

The about page adds that AHS works with domestic and international clients and has “particular experience in partnering with medical device clients based out of the USA.” Founding is on the people page, not as a corporate-history essay: Matt Godden “founded Australian Healthcare Solutions after leaving the corporate sector in 2008.” His last corporate role is published as Director of Medtronic Australasia’s Cardiovascular business, after more than 25 years in healthcare in Australia and Asia-Pacific, including a regional strategic market-development role at Medtronic. MBA (Mt. Eliza), Bachelor of Education (La Trobe), Diploma of Applied Science (RMIT).

Also named on our-people: Cath Martland, Marketing Director (healthcare and nutrition marketing; postgraduate marketing, Masters in Nutrition and Dietetics, science degree). Consultants: Arianne Jolly, Clinical Trial Consultant (device and pharma research since 2001; independent consulting from November 2013 — protocol, ethics, monitoring, CRF, QA, GCP training); Kea Imgraben, Regulatory Consultant (device/IVD RA across 44 countries since 1996; prior Telstra Business Woman of the Year, South Australia, private-sector category, 2002).

Competitive research places the firm in Melbourne (Camberwell / Abbotsford, Victoria). The about page says “based in Australia” without reprinting a street address in the fetch used here.

No named sponsor FIH press release was found on the public pages reviewed. The FIH claim is a capability sentence. Treat it as such until a de-identified TMF shows up in the RFP.

Where an ex-Medtronic ANZ device CRO is the right tool

Hire AHS when the protocol is a respiratory, structural, vascular, cardiac-surgery, thoracic, or IR device that needs ANZ hospital sites, field clinical people in the lab, and a partner who will still be in the room for ARTG listing and reimbursement after the last follow-up. That commercialisation overlay is closer to a market-access shop than a Phase I unit. U.S. sponsors are an explicit customer type on the about page.

Do not hire AHS as a substitute for the Australia-versus-Latin-America cash conversation. CTN, HREC, and ISO 14155 are country and quality features. The 43.5% offset is an entity feature. AHS can run the trial. AHS cannot make a Delaware C-corp into an eligible Australian R&D company by signing a CRO contract.

On the Australia device slide, put AHS next to Mobius (the public EFS-to-pivotal story), Ascend (2024 device-only), and CROW Clinical (field clinical engineers). They are not interchangeable. Mobius publishes named device history. AHS publishes a Medtronic-cardiovascular operator and a first-in-human-through-multicentre sentence. CROW publishes engineers in the lab.

Australia cash is not a 43.5% price cut

Reuse only, no new table. Sources: bioaccess® vs Australia, rebate math, and the live Mobius pillar.

• On a gross, cash-contracting basis, Latin America runs, in bioaccess®’s program experience, about 35–45% below Australia (varies with design and FX).
• A fully captured 43.5% refundable offset for groups under A$20 million aggregated turnover narrows the effective gap to roughly 5–15%. In some programs it can close or reverse the gap.
• You generally need an eligible Australian company. You fund the gross now. Cash returns after year-end lodgement.
• End-to-end start-up is broadly comparable once Australian site governance is counted. CTN is not the whole clock.

bioaccess® contracts and starts in Latin America with no foreign subsidiary. If the rebate is how the round was sold and counsel will form the entity, Australia can win — with AHS or Mobius as the ANZ prime. If the entity is unscoped, the rebate is not in the cash forecast.

What bioaccess® is selling instead

bioaccess® is The First-in-Human CRO. Co-founded 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). IMH ASSETS CORP. Miami HQ, 1200 Brickell Ave, Suite 1950 #1034. Offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. FIH-only since 2010. 50+ pre-qualified sites, 19 countries; 50+ FIH/EFS supported; 50+ clients (about page). ISO 14155. English 21 CFR 812.28 data room. U.S. Eastern-time sponsor desk.

Colombia is not retired. As of 23 August 2026 we still run clinical trials in Colombia, keep a local entity and office, manage INVIMA in-country, and carry 30+ historical FIH device studies and 20+ sites in Bogotá, Cali, Medellín, and Barranquilla. See CRO in Colombia. Commercial registro sanitario is a separate live service.

AHS sells ANZ device operations plus Australian market access. bioaccess® sells first-in-human execution in Latin America plus LATAM sanitary registration through its own holders. Those can be sequential: generate human data where the cash and volume work, register later where you will sell. Mixing them into one Australia CRO contract is how founders discover that ARTG listing did not produce an INVIMA number.

AHS vs bioaccess® — device FIH comparison

Dimension	Australian Healthcare Solutions (AHS)	bioaccess®
Public age	Founded 2008 (Godden, after Medtronic Australasia CV)	Founded 2010
Home geography	Australia / ANZ; competitive map: Melbourne	Miami HQ; local LATAM entities including Colombia
Mix	Device only; FIH through multi-centre ANZ; TGA/ARTG + reimbursement	FIH/EFS devices (also biopharma / radiopharma FIH)
Named FIH sponsors	None on public site	Published case studies on bioaccessla.com
Leadership (site)	Matt Godden, Strategic Director; Cath Martland; Arianne Jolly; Kea Imgraben	Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill
Quality language	GCP + ISO 14155	ISO 14155 → 21 CFR 812.28 (FDA decides)
Gross cash	Australia cost base; rebate only with an eligible AU entity	~35–45% below Australia on gross, program experience
After the trial	ARTG, reimbursement, strategic market development in Australia	Live multi-country LATAM sanitary registration / holder
Colombia	Not a Colombia CRO	Still executing; local entity; INVIMA in-country

How to keep AHS on the list without confusing the job

If ANZ is locked, the indication sits in AHS’s published therapeutic list, and you want field support plus a reimbursement conversation, AHS belongs on the RFP next to Mobius. Ask for a named or de-identified device FIH: class, implant versus non-implant, n, ISO 14155 monitoring plan, English TMF, and FDA-file use. If that package exists, they can be the ANZ prime.

If the number that matters is gross cash this quarter, you will not form an Australian company, or you need Latin American surgical volume and a Miami desk — including Colombia when that is the right file — put bioaccess® in the prime column. Request a proposal at contact.

FAQ — AHS Australia device CRO

Does AHS run first-in-human device trials?

The clinical-trial-services page says yes: single-site FIH through multi-centre ANZ, plus Australian arms of multi-national trials. Named FIH press is not on the public site.

Who leads AHS?

Matt Godden, Strategic Director and founder (ex-Medtronic Australasia Cardiovascular). Cath Martland is Marketing Director. Arianne Jolly and Kea Imgraben are named consultants.

Is AHS cheaper than Latin America after the R&D tax incentive?

The incentive is a country rule, not an AHS discount. On cash out the door, Latin America is typically 35–45% lower in bioaccess®’s program experience. The rebate narrows that only if you fully capture 43.5% through an eligible Australian company. See the rebate math.

AHS or Mobius?

Both are Australian device specialists founded in 2008. Mobius publishes Tendyne and a named CT.gov sponsorship. AHS publishes Medtronic-cardiovascular leadership and a FIH-through-multicentre sentence plus ARTG/reimbursement. Diligence the TMF, not the founding year.

Does bioaccess® still run first-in-human trials in Colombia?

Yes. As of 23 August 2026 we still run clinical trials in Colombia. INVIMA clocks are managed in-country.

Competitor facts from australianhealthcaresolutions.com.au pages listed above, 23 August 2026. Melbourne placement from competitive map. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians.