General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.
What was announced
On 22 October 2025, Atlanta-based Nyra Medical announced its first-in-human study of the Cardiac Leaflet Enhancer (CARLEN) System for functional mitral regurgitation. It said the study had enrolled more than 10 patients and was being conducted at centers in the Republic of Georgia, Paraguay and Uzbekistan, and that the data will inform its FDA strategy, including a potential U.S. early feasibility study (PR Newswire, 22 October 2025).
Why it matters for planning
- A Latin American country already sits beside Central Asia and the Caucasus in a U.S. structural heart FIH.
- The same FDA rule, 21 CFR 812.28, governs the foreign data from every one of those sites.
- A multi-region FIH lets a sponsor keep enrolling if one country slows down.
Standards and U.S. data acceptance
The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.
How Latin America compares
- Same FDA rule: 21 CFR 812.28.
- Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
- Time zone: 0–2 hours from U.S. Eastern.
- U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
- Trade-offs: Spanish or Portuguese documents and investigational import permits.
More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Georgia · Armenia · Clinical Accelerator comparison · Vantage Clinical comparison
Frequently asked questions
Where is the Nyra CARLEN FIH running?
At centers in the Republic of Georgia, Paraguay and Uzbekistan, per Nyra's 22 October 2025 press release.
Can Latin American FIH data support a U.S. EFS?
Foreign data can support FDA submissions under 21 CFR 812.28 if GCP is followed and FDA can validate it; FDA decides case by case.
Next step
Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.
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