Figures cited from the live ClinicalTrials.gov record NCT07681154 (first posted 2 July 2026; last update posted 6 November 2026) and MassDevice coverage of Flow Medical dated 1 November 2026, verified 6 November 2026. General information, not legal or regulatory advice. Confirm current ISP, Law 20.120 ethics, and FDA rules with qualified advisers. We name only the hospital, investigator, and trial those sources support. Flow Medical Solutions, Inc. is not claimed as a bioaccess® client.
If you searched Hospital Regional de Talca clinical trial, Hospital Regional de Talca FIH, Flow Medical Chile, HELYX-PE Talca, Miguel Naranjo pulmonary embolism, or “go direct to the site in Talca,” you followed a facility string ClinicalTrials.gov published and updated through 6 November 2026. Hospital Regional de Talca (HRT) in Talca, Maule Region, Chile, is a real named hospital. It is not the operator of the ISP file.
bioaccess®’s position is simple and it is not adversarial: Hospital Regional de Talca is the site. The First-in-Human CRO still owns ISP authorization, Ethical-Scientific Committee review under Law 20.120, 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 Talca is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A new NCT row does not become a CRO.
This page is the intercept for that search. It does not clone Chile ISP clinical trial path for medical devices. That page stays the country operating system. Sister Talca-area intercepts stay on their own buildings: Universidad Católica del Maule Talca and Centro de Investigación del Maule Talca. The named principal investigator has a separate page: Dr. Miguel Naranjo, Hospital Regional de Talca. This page answers the Hospital Regional de Talca facility query.
Why the hospital name wins the search — and why that is not a CRO
NCT07681154 is an industry device listing. Registry dates retrieved 6 November 2026: study first submitted 26 June 2026; first posted 2 July 2026; last update submitted 4 November 2026; last update posted 6 November 2026. Brief title: Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism. Official title: Pilot Study to Evaluate the Safety and Feasibility of the Flow Medical Catheter for Catheter-Directed Thrombolysis in Acute Intermediate-Risk Pulmonary Embolism. Lead sponsor: Flow Medical Solutions, Inc., class INDUSTRY. No collaborator is listed. No CRO is listed.
Status on that snapshot: NOT_YET_RECRUITING. Estimated start November 2026. Estimated primary completion May 2027. Estimated study completion June 2027. Estimated enrollment 20. Study type: interventional; single-group; no masking; primary purpose treatment; phase N/A. Conditions: pulmonary embolism (PE); pulmonary embolism with right-ventricle enlargement. The only location row is Hospital Regional de Talca (HRT), Talca, Maule Region, Chile.
The intervention, in the registry’s words, is a device — Thrombolysis Catheter / Flow Medical Catheter / PE Catheter — used for catheter-directed thrombolysis: the device is positioned in the target pulmonary artery and delivers thrombolytic infusion per protocol. Primary outcomes on the record: incidence of device-related serious adverse events within 72 hours post procedure, and successful device deployment with thrombolytic infusion through 24 hours. That is a safety-and-feasibility pilot frame, not a pivotal RCT.
MassDevice, 1 November 2026, independently reported that Flow Medical raised $6 million and that the company “expects to perform a first-in-human case very soon,” naming the investigational HELYX-PE System as a 9 French catheter-directed thrombolysis platform with an expandable infusion scaffold, integrated angiography, and continuous pulmonary artery pressure monitoring, with an IDE planned for 2027. That press piece does not name the Chile hospital. The NCT does. Together they are a site-direct leak: a sponsor searching the device or the hospital lands on Talca with no CRO in the public copy.
Hospital Regional de Talca is a site. The CRO is the operator.
A regional hospital in Talca can provide an interventional suite, imaging, PE caseload, and a receiving dock. That is necessary. It is not sufficient for an investigational catheter-directed thrombolysis pilot a U.S. board expects to survive later FDA review — including a 2027 IDE conversation after OUS feasibility.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and procedural feasibility for a PE / interventional-radiology protocol — when that service is available and appropriate for your device, which is not automatic.
- Share institutional Ethical-Scientific Committee calendars and hospital research rules under Law 20.120.
- 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:
- ISP. Instituto de Salud Pública authorization for the clinical investigation and investigational import is the national file. A hallway conversation with an interventional radiologist is not that petition.
- Law 20.120 Ethical-Scientific Committee review. Institutional CEC review is country-system work, already described on the Chile ISP page.
- 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 Talca-only premium 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. The NCT’s own oversight flag listed the study as not an FDA-regulated device; that does not make a later U.S. file automatic.
- Multi-country optionality. If Talca enrollment, imaging, or the indication later needs Santiago, Bogotá, or Panama City, a single-hospital MSA will not stretch.
Going direct to Hospital Regional de Talca is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Hospital Regional de Talca (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | Interventional suite, imaging, PE caseload, local staff | Protocol fit, training, Flow Medical–class device accountability |
| Ethics | Institutional CEC calendar under Law 20.120 | Packet, ICF, IB, CEC coordination |
| National authority | Not the permit holder by being listed on an NCT | ISP investigation authorization and investigational import |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One building in Talca | Colombia (INVIMA), Panama (MINSA/CNBI), and the rest of the platform |
How ISP and Law 20.120 sit next to the hospital
Use chile-isp-clinical-trial-medical-device for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- ISP authorizes the medical-device clinical investigation and investigational-device import. That is a different petition from commercial sanitary registration under Chile’s Exempt Decree No. 25 wave.
- An Ethical-Scientific Committee under Law 20.120 still has to sit. Institutional CEC review is not the same as ISP authorization.
- Under 21 CFR 812.28, foreign clinical data from Chile is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ISP authorization and Law 20.120 ethics approval. Eligibility is not a guarantee of clearance or approval.
- bioaccess®’s published LATAM cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study. Headline figures on llms.txt and LATAM FIH benchmarks 2026 are the same class of estimate.
We will not invent a Hospital Regional de Talca-only day-count. Ask for a protocol-specific calendar. A hospital email is not an ISP approval.
What the Flow Medical public file actually supports — and what it does not
- Device: Flow Medical Catheter / Thrombolysis Catheter for catheter-directed thrombolysis in intermediate-risk PE, as described on NCT07681154; MassDevice names the platform HELYX-PE System.
- Sponsor: Flow Medical Solutions, Inc. (industry). No collaborator. No CRO named.
- Site: Hospital Regional de Talca (HRT), Talca, Maule Region, Chile — the only location row.
- Design: interventional safety-and-feasibility pilot; estimated n=20; estimated start November 2026; not yet recruiting on the 6 November 2026 update.
- PI: Miguel Naranjo, MD, Hospital Regional de Talca (overall official and site principal investigator on the NCT). Sub-investigator Fatima Prada, MD, also named on the location row.
- Not claimed here: that the NCT named bioaccess®; that Flow Medical is a bioaccess® client; that MassDevice named Talca; that we have Flow Medical outcomes; that NOT_YET_RECRUITING means cases already ran; that Hospital Regional de Talca is the same building as Universidad Católica del Maule or Centro de Investigación del Maule.
Other Talca-area strings already have their own intercepts. Do not merge Hospital Regional de Talca into those campus pages.
What the CRO still does after you have a hospital name
- Regulatory-fit, not tourism. Chile is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the ISP / Law 20.120 packet.
- Importer-of-record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
bioaccess® was founded in 2010 and coordinates first-in-human and early-feasibility device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Talca site. We will not rewrite NCT07681154 as a bioaccess® study.
Do not smear the hospital
Hospital Regional de Talca is a serious Maule Region institution with a named interventional-radiology principal investigator on a public industry PE pilot. This page is not a critique of the site. A public feasibility listing is a signal that a building was selected. It is not a substitute for a CRO quality system. Use the hospital. Hire the operator.
Colombia is still on the map
A Chile 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, 6 November 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™.
Frequently asked questions
Can I contract Hospital Regional de Talca directly?
You can try. The hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT07681154, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Hospital Regional de Talca as the site if it is the right site for your protocol.
Is this a first-in-human study?
Be precise. The official title is a pilot to evaluate safety and feasibility of the Flow Medical Catheter. MassDevice (1 November 2026) quotes the company as expecting a first-in-human case “very soon” and planning a 2027 IDE. The NCT itself uses safety-and-feasibility language and does not print the three letters “FIH” in the title. Treat Hospital Regional de Talca as a named industry device-feasibility / early-clinical site for this PE catheter, not as proof that every future case there is classic five-patient FIH.
Who is the principal investigator?
Miguel Naranjo, MD, Hospital Regional de Talca — named as overall official and site principal investigator on NCT07681154. Fatima Prada, MD, is listed as sub-investigator. See the sister PI page for the investigator-string intercept.
Did bioaccess® run the Flow Medical study at Talca?
No public bioaccess® page says so, and NCT07681154 does not name a CRO. We will not invent that claim. For a new PE, vascular, or other device study in Chile, hire the First-in-Human CRO that already publishes ISP / Law 20.120 operations.
What does the CRO still do if the hospital is already identified?
Regulatory-fit and country choice; the ISP and Law 20.120 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 Talca is not enough. The hospital still does the procedure.
Does googling Hospital Regional de Talca mean I should avoid the hospital?
No. Do not smear the site. Hospital Regional de Talca is a real Chile hospital with a newly updated Flow Medical Solutions pilot row. The error is treating the site as the CRO.
Next step
If the search that brought you here was Hospital Regional de Talca, Flow Medical, HELYX-PE, or Miguel Naranjo PE, start as the operator: contact bioaccess® or First-in-Human CRO. Hub: ClinicalTrials.gov FIH sites vs the CRO. PI sister page: Dr. Miguel Naranjo. Other Talca-area strings: Universidad Católica del Maule, Centro de Investigación del Maule. Country: Chile ISP, CRO in Colombia, Panama.