Case Studies — First-in-Human Clinical Trial Results — bioaccess®

bioaccess® has run first-in-human and early-feasibility studies across Latin America for MedTech, Biopharma, and Radiopharma startups since 2010, generated under good clinical practice (ISO 14155) so the resulting data is eligible for FDA acceptance under 21 CFR 812.28 — acceptance is determined by FDA on a submission-by-submission basis. These case studies describe the scope of bioaccess®'s work — regulatory strategy, site selection, ethics submissions, and study execution — for named client programs. Investigational status and regulatory disclaimers apply to each; no FDA clearance or approval is implied by inclusion.

Client programs

• PAVmed (PortIO) — Vascular Access, Colombia — first-in-human PortIO™ intraosseous infusion program; results published in the Journal of Vascular Access.
• ReGelTec (HYDRAFIL®) — Spine / Orthopedics, Colombia & Panama — OUS data (75 patients) → CE Mark + FDA IDE pivotal trial; peer-reviewed results in Pain Physician, Jan 2026.
• enVVeno Medical (enVVe®) — Vascular Surgery, Colombia — LATAM first-in-human foundation → first-ever FDA IDE approval for a non-surgical replacement venous valve; U.S. pivotal TAVVE® study authorized April 29, 2026. The IDE authorizes the study, not device clearance or approval.
• Axoft — Neurotechnology, Panama — Panama first-in-human at The Panama Clinic → 11 patients implanted worldwide → $55M Series A (April 2026). FDA Breakthrough Device Designation (2022).
• Mitralign — Structural Heart, Colombia & Brazil — percutaneous mitral annuloplasty program (company later acquired by Edwards Lifesciences).
• OcuMedex (Vizio™ Aqueous Microshunt) — Ophthalmology, Colombia — first-in-human trials of an investigational aqueous microshunt for glaucoma (no FDA clearance implied).
• Newrotex (SilkAxons™) — Peripheral Nerve Repair, Panama — world's first SilkAxons™ implantation at The Panama Clinic (FIH began August 2025); investigational silk-based nerve guide.
• Watershed Therapeutics — Urology / Drug Delivery, El Salvador & Panama (earlier support in Colombia) — regulatory and ethics-committee approvals for an investigational intravesical bladder-targeted drug-delivery platform.
• Avantec Vascular (a Nipro Company) — Cardiovascular / Venous, El Salvador, Mexico & Colombia — first-in-human / early clinical studies of the investigational Sangria™ Venous Remodeling System.

Clinical data that drives acquisitions

• Mitralign — acquired by Edwards Lifesciences after a FIH tricuspid valve repair study in Colombia.
• ClarVista Medical — acquired by Alcon after a FIH intraocular lens study in Colombia.
• ForSight VISION5 — acquired by Allergan after early clinical studies supported by LATAM data.

Eligibility of foreign clinical data for FDA submission does not constitute or predict FDA clearance, approval, or acceptance of any specific application.

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