TeCure, Inc. — First-in-Human Study of the EndoCure™ System for Type 2 Diabetes

TeCure, Inc. developed the EndoCure™ System, an FDA Breakthrough Device Designation recipient for duodenal mucosal resurfacing (DMR) to treat Type 2 Diabetes. bioaccess® is managing the site search and selection for the first-in-human clinical trial across Chile and Argentina, after an initial strategy pivot from Ecuador due to local investigator GCP training concerns. The program includes PI identification, site qualification, pre-study visits, and regulatory strategy development across multiple Latin American countries.

Study facts

• Sponsor / company: TeCure, Inc.
• Indication / area: Gastroenterology / Metabolic Disorders
• Country: Chile, Argentina
• Study type: First-in-Human (FIH)

Key metrics

• Trial Type: FIH
• Device: EndoCure™
• Indication: Type 2 Diabetes
• FDA Status: Breakthrough Device

The challenge

TeCure needed to conduct a first-in-human study of their FDA Breakthrough Device-designated EndoCure™ System for duodenal mucosal resurfacing. Initial plans focused on Ecuador, but the team identified concerns regarding local physicians' GCP training qualifications, requiring a strategic pivot to identify properly qualified investigators and sites in alternative Latin American markets.

bioaccess® solution

bioaccess® executed a strategic pivot, redirecting the site search to Chile and Argentina. The team launched a targeted outreach campaign identifying 16 qualified gastroenterologists and interventional endoscopists across both countries, initiated NDA execution with top candidates, and began evaluating sites with therapeutic endoscopy capabilities. bioaccess® also coordinated with a local CRO partner (ACTIVA-CRO) for regulatory support and clinical monitoring in Chile.

Results

• Site search redirected from Ecuador to Chile and Argentina within weeks
• 16 qualified PI candidates identified across both countries
• Top PI recommendations delivered including investigators at leading institutions
• NDA execution underway with multiple investigators
• CRO partnership established for local regulatory and monitoring support
• FDA Breakthrough Device Designation program supported through LATAM FIH pathway

Frequently asked

What did bioaccess® do for TeCure, Inc.?

bioaccess® executed a strategic pivot, redirecting the site search to Chile and Argentina. The team launched a targeted outreach campaign identifying 16 qualified gastroenterologists and interventional endoscopists across both countries, initiated NDA execution with top candidates, and began evaluating sites with thera

Where was the TeCure, Inc. First-in-Human (FIH) study run?

The TeCure, Inc. First-in-Human (FIH) study was executed in Chile, Argentina by bioaccess® in the gastroenterology / metabolic disorders area.

What was the outcome of the TeCure, Inc. study?

Reported outcomes for TeCure, Inc.'s device: Site search redirected from Ecuador to Chile and Argentina within weeks; 16 qualified PI candidates identified across both countries; Top PI recommendations delivered including investigators at leading institutions.

Run a similar trial: Clinical trials in Chile · Clinical trials in Argentina

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