PAVmed (PortIO) — Accelerating PortIO Intraosseous Vascular Access to Market
PAVmed partnered with bioaccess® to conduct first-in-human studies for their PortIO™ intraosseous infusion system, a novel long-term vascular access device designed to eliminate complications of traditional central venous catheters. PortIO was relaunched within PAVmed's device portfolio in 2026. PortIO remains investigational; nothing here implies FDA clearance or approval.
Study facts
- Sponsor / company: PAVmed (PortIO)
- Indication / area: Vascular Access
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- Trial Type: FIH
- Approval Time: 5 weeks
- Infections Addressed: 250K/yr
- Timeline: Ahead of schedule
The challenge
PAVmed needed rapid clinical validation of a novel approach to long-term vascular access. Central venous catheters cause over 250,000 bloodstream infections annually in the US alone. The company needed human data fast to differentiate from competitors and satisfy investors.
bioaccess® solution
bioaccess® executed the first-in-human study in Colombia, managing regulatory approval, clinical site preparation with interventional radiology teams, patient enrollment, device implantation logistics, and structured safety and performance data collection per FDA guidance.
Results
- First-in-human implantations completed successfully
- Safety profile validated in human subjects
- Clinical data generated for FDA submission planning
- Regulatory approval in Colombia secured in 5 weeks
- Study completed within budget and ahead of projected timeline
Frequently asked
- What did bioaccess® do for PAVmed (PortIO)?
- bioaccess® executed the first-in-human study in Colombia, managing regulatory approval, clinical site preparation with interventional radiology teams, patient enrollment, device implantation logistics, and structured safety and performance data collection per FDA guidance.
- Where was the PAVmed (PortIO) First-in-Human (FIH) study run?
- The PAVmed (PortIO) First-in-Human (FIH) study was executed in Colombia by bioaccess® in the vascular access area.
- What was the outcome of the PAVmed (PortIO) study?
- Reported outcomes for PAVmed (PortIO)'s device: First-in-human implantations completed successfully; Safety profile validated in human subjects; Clinical data generated for FDA submission planning.
Run a similar trial: Clinical trials in Colombia
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