Newrotex — World's First SilkAxons™ Nerve Guide Implantation — Panama

Newrotex developed SilkAxons™, an investigational silk-based bioengineered nerve guide intended for large-gap peripheral nerve injuries that fall beyond the reach of existing commercial nerve conduits. The world's first SilkAxons™ implantation was completed at The Panama Clinic through bioaccess®, with the first-in-human program beginning in August 2025. SilkAxons™ remains investigational.

Study facts

• Sponsor / company: Newrotex
• Indication / area: Peripheral Nerve Repair
• Country: Panama
• Study type: First-in-Human (FIH)

Key metrics

• World First: Yes
• FIH Site: The Panama Clinic
• FIH Start: Aug 2025
• Status: Investigational

The challenge

Peripheral nerve injuries with gaps beyond a few centimeters cannot be repaired with existing commercial nerve conduits, leaving many patients without treatment options. Newrotex had a novel silk-based approach but needed to prove human feasibility quickly to attract Series A funding and engage strategic partners.

bioaccess® solution

bioaccess® identified an appropriate clinical site at The Panama Clinic with an experienced microsurgery team and secured rapid regulatory and ethics approval. Our clinical operations team managed the full trial execution — patient screening, surgical logistics, implant tracking, and follow-up data collection — under ISO 14155-aligned protocols.

Results

• World's first human implantation of a silk-based nerve guide (SilkAxons™)
• First-in-human program at The Panama Clinic began August 2025
• SilkAxons™ is an investigational device intended for large-gap peripheral nerve injuries beyond the reach of existing conduits
• Regulatory approval obtained in Panama in approximately 2 weeks
• Clinical data package positioned for FDA Pre-Submission engagement

Frequently asked

What did bioaccess® do for Newrotex?

bioaccess® identified an appropriate clinical site at The Panama Clinic with an experienced microsurgery team and secured rapid regulatory and ethics approval.

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

The Newrotex First-in-Human (FIH) study was executed in Panama by bioaccess® in the peripheral nerve repair area.

What was the outcome of the Newrotex study?

Reported outcomes for Newrotex's device: World's first human implantation of a silk-based nerve guide (SilkAxons™); First-in-human program at The Panama Clinic began August 2025; SilkAxons™ is an investigational device intended for large-gap peripheral nerve injuries beyond the reach of existing conduits.

Run a similar trial: Clinical trials in Panama

First-in-Human Clinical Trials pillar · LATAM FIH Benchmarks 2026 · ← All case studies · Contact bioaccess®