Mitralign — From EU Delays to 14-Month Acceleration via Colombia

Mitralign was developing a percutaneous annuloplasty system for mitral valve repair but faced 9 months of delays at EU sites in Poland and Germany. By shifting FIH work to Colombia with bioaccess® support, Mitralign achieved 18-day ethics approval vs ~6 months in the EU, enrolled 11 patients in 8 weeks vs a 24-week EU average, and submitted to the EU roughly 14 months ahead of schedule.

Study facts

• Sponsor / company: Mitralign
• Indication / area: Structural Heart
• Country: Colombia
• Study type: First-in-Human (FIH)

Key metrics

• Ethics Approval: 18 days
• Enrolled in 8 Weeks: 11 patients
• Faster EU Submission: 14 months
• Cost Savings vs EU: ~60%

The challenge

Mitralign's percutaneous annuloplasty system for mitral valve repair was stalled by 9 months of regulatory and site-readiness delays at EU clinical sites in Poland and Germany, jeopardizing their development timeline and investor commitments.

bioaccess® solution

bioaccess® redirected the FIH program to Colombia, securing ethics approval in just 18 days. The clinical team enrolled 11 patients in 8 weeks — compared to a 24-week EU average — and generated the safety and feasibility data needed for EU submission approximately 14 months ahead of the original schedule.

Results

• Ethics approval in 18 days vs ~6 months in the EU
• 11 patients enrolled in 8 weeks vs 24-week EU average
• EU submission accelerated by approximately 14 months
• Estimated ~60% cost savings compared to EU execution
• FIH data package accepted for EU regulatory review

Frequently asked

What did bioaccess® do for Mitralign?

bioaccess® redirected the FIH program to Colombia, securing ethics approval in just 18 days. The clinical team enrolled 11 patients in 8 weeks — compared to a 24-week EU average — and generated the safety and feasibility data needed for EU submission approximately 14 months ahead of the original schedule.

Where was the Mitralign First-in-Human (FIH) study run?

The Mitralign First-in-Human (FIH) study was executed in Colombia by bioaccess® in the structural heart area.

What was the outcome of the Mitralign study?

Reported outcomes for Mitralign's device: Ethics approval in 18 days vs ~6 months in the EU; 11 patients enrolled in 8 weeks vs 24-week EU average; EU submission accelerated by approximately 14 months.

Run a similar trial: Clinical trials in Colombia

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