Axoft — Panama First-in-Human → $55M Series A (2026)

Axoft is developing an ultra-soft implantable brain-computer interface built on a bio-inspired polymer 10,000× softer than existing materials. The technology holds FDA Breakthrough Device Designation (2022). Working with bioaccess®, Axoft ran its first-in-human program at The Panama Clinic — implanting four patients during brain-tumor resection — as part of a broader worldwide first-in-human effort that has now reached 11 patients implanted, and closed a $55M Series A in April 2026 (led by C.P. Group Innovation; >$60M total raised to date).

Study facts

• Sponsor / company: Axoft
• Indication / area: Neurotechnology
• Country: Panama
• Study type: First-in-Human (FIH)

Key metrics

• Panama FIH Patients: 4
• Worldwide Implants: 11
• Series A (Apr 2026): $55M
• Ethics Approval: 4 weeks

The challenge

Axoft needed to demonstrate human safety and feasibility of a radically new brain-computer interface material before their next funding round. Traditional US/EU pathways would have consumed 18–24 months for ethics and regulatory approval alone—time the startup simply didn't have given its financial runway.

bioaccess® solution

bioaccess® leveraged its clinical site network in Panama — anchored at The Panama Clinic — to secure ethics approval in 4 weeks. Our team managed the full regulatory submission, site preparation, surgical coordination with neurosurgeons performing intra-operative implantations during brain-tumor resection, and data collection structured for FDA submission. The Innovation Runway model let Axoft preserve capital while generating the clinical evidence investors and regulators demanded.

Results

• FDA Breakthrough Device Designation granted (2022) for the brain-computer interface technology
• First-in-human program at The Panama Clinic — 4 patients implanted during brain-tumor resection
• 11 patients implanted worldwide to date across the broader first-in-human effort
• Ethics approval secured in 4 weeks
• FDA-submissible clinical dataset generated to support U.S. regulatory strategy
• Closed a $55M Series A in April 2026 (led by C.P. Group Innovation; >$60M total raised)

Frequently asked

What did bioaccess® do for Axoft?

bioaccess® leveraged its clinical site network in Panama — anchored at The Panama Clinic — to secure ethics approval in 4 weeks.

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

The Axoft First-in-Human (FIH) study was executed in Panama by bioaccess® in the neurotechnology area.

What was the outcome of the Axoft study?

Reported outcomes for Axoft's device: FDA Breakthrough Device Designation granted (2022) for the brain-computer interface technology; First-in-human program at The Panama Clinic — 4 patients implanted during brain-tumor resection; 11 patients implanted worldwide to date across the broader first-in-human effort.

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