Sparta Biomedical — FDA Breakthrough Device Designation for Bionic Cartilage

Sparta Biomedical's Ormi™ implant and Galene® bionic cartilage—a synthetic matrix replicating natural cartilage for osteoarthritis—earned FDA Breakthrough Device Designation through clinical data generated via bioaccess®.

Study facts

• Sponsor / company: Sparta Biomedical
• Indication / area: Orthopedics
• Country: Colombia, Dominican Republic
• Study type: Early Feasibility Study (EFS)

Key metrics

• FDA Designation: Breakthrough
• Cost Savings: ~30%
• Follow-up: 12 months
• Patients Affected: 500M+

The challenge

Over 500 million people worldwide suffer from osteoarthritis with no regenerative solution. Sparta Biomedical needed early human feasibility data to support their FDA Breakthrough Device Designation application, but US early feasibility studies are prohibitively expensive and slow for a startup.

bioaccess® solution

bioaccess® designed and executed an early feasibility study in Colombia and the Dominican Republic, managing site selection with top orthopedic surgeons, patient recruitment of knee osteoarthritis patients, implant logistics, and structured follow-up assessments. The clinical data package was specifically designed to meet FDA Breakthrough Device submission requirements.

Results

• FDA Breakthrough Device Designation granted
• Early feasibility data in human knees validated the bionic cartilage concept
• Study completed at approximately 30% lower per-patient cost than equivalent US study
• Patient outcomes at 12 months exceeded preclinical predictions
• Data accepted by FDA as supporting evidence for Breakthrough pathway

Frequently asked

What did bioaccess® do for Sparta Biomedical?

bioaccess® designed and executed an early feasibility study in Colombia and the Dominican Republic, managing site selection with top orthopedic surgeons, patient recruitment of knee osteoarthritis patients, implant logistics, and structured follow-up assessments.

Where was the Sparta Biomedical Early Feasibility Study (EFS) study run?

The Sparta Biomedical Early Feasibility Study (EFS) study was executed in Colombia, Dominican Republic by bioaccess® in the orthopedics area.

What was the outcome of the Sparta Biomedical study?

Reported outcomes for Sparta Biomedical's device: FDA Breakthrough Device Designation granted; Early feasibility data in human knees validated the bionic cartilage concept; Study completed at approximately 30% lower per-patient cost than equivalent US study.

Run a similar trial: Clinical trials in Colombia · Clinical trials in Dominican Republic

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