Latin America First-in-Human Benchmarks 2026 — bioaccess®

Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.

How fast, how much, and will the FDA accept it — benchmarks from bioaccess®'s first-in-human platform across the U.S. and 10 Latin American markets. Figures are planning benchmarks, not guarantees.

Headline Benchmarks — LATAM vs US/EU

Metric	Latin America (bioaccess® platform)	US / EU
Ethics-committee approval	4–8 weeks	6–12 months
Protocol → first patient	6–8 weeks	6–12 months
Per-patient site cost	$15K–$35K	$40K–$75K
Device regulatory standard	ISO 14155 + Declaration of Helsinki	ISO 14155 + Declaration of Helsinki
FDA pathway	Data eligible for submission/review under 21 CFR 812.28 (case-by-case; not a guarantee of clearance)	Domestic IDE

Per-Patient Cost by Therapeutic Area

Site clinical cost including site overhead. Excludes CRO/PM fees and the sponsor's investigational device. Figures de-identified across programs.

Therapeutic area	Per-patient site cost
Ophthalmology — outpatient implant	≈ $13K / patient
Orthopedics — surgical implant (inpatient)	≈ $25K–$28K / patient
Peripheral vascular / endovascular — cath-lab, device-heavy	≈ $23K–$38K / patient

Per-patient site cost scales with procedure intensity: outpatient at the low end, surgical-implant and cath-lab at the high end.

Cost & Timeline to Regulatory Approval, by Country

• Mexico: regulatory startup → approval package from ≈ $188K (excludes sponsor device, trial insurance, and the study beyond approval).
• Colombia: from ≈ $305K — roughly 1.6× Mexico due to the additional INVIMA technical-dossier step (GICASE / Sala Especializada).
• Panama: among the fastest — ethics approval ≈ 3–5 weeks via MINSA plus CNBI-registered committees.

Will the FDA Accept Latin American Data?

21 CFR 812.28 in plain English: the FDA can accept clinical data from a study conducted outside the United States to support an IDE or a marketing submission, provided the study was run under Good Clinical Practice with adequate human-subject protection and the data are validatable by FDA. It is a case-by-case pathway — not automatic — and design should be aligned with the FDA (typically via a Pre-Submission) before enrollment.

• ReGelTec (HYDRAFIL). Colombia first-in-human study (Barranquilla, 2019; 20 patients; back-pain scores 7.1 → 2.0 at 6 months) supported a subsequent FDA-approved IDE for the US pivotal (HYDRAFIL-D). bioaccess® was the CRO. Sources: regeltec.com, nasdaq.com.
• Newrotex (SilkAxons). Panama first-in-human program; regulatory approval landed roughly two weeks after ethics submission; bioaccess® ran regulatory and clinical operations. Sources: newrotex.com, medtechinnovator.org.
• Industry pattern (not attributed to bioaccess®). A publicly reported venous-device sponsor ran a Colombia first-in-human study at the FDA's suggestion before its US pivotal, with three-year data appearing in the peer-reviewed literature — evidence that FDA treats a LATAM FIH as a valid stepping stone. Pathway signal, not a claim of approval.

Methodology

Benchmarks are derived from bioaccess®'s operating data and standardized work-order rate card across its U.S. + 10-country Latin American platform: 44 sponsor programs engaged to date across 16 medical specialties, with 11 currently active. Figures are estimates and planning benchmarks — not guarantees of price, timing, or regulatory outcome. Ranges are de-identified; no client, device, hospital, or investigator details are included. Last reviewed: July 2026.

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