A searchable, filterable record of the first-in-human, early-feasibility, clinical, and market-access programs bioaccess® is associated with. Filter by device type, country, regulatory route, and development stage; every row links to its source and full case study.
| Sponsor | Program / device | Indication | bioaccess® role | Countries | Status | Source |
|---|---|---|---|---|---|---|
| Axoft | — | Neurotechnology | First-in-Human (FIH) | Panama | — | Case study |
| Newrotex | — | Peripheral Nerve Repair | First-in-Human (FIH) | Panama | Investigational | Case study |
| Avantec Vascular (a Nipro Company) | — | Cardiovascular / Vascular / Venous | First-in-Human (FIH) | El Salvador, Mexico, Colombia | Investigational | Case study |
| Sparta Biomedical | — | Orthopedics | Early Feasibility Study (EFS) | Colombia, Dominican Republic | — | Case study |
| Inspire Medical | — | Sleep Medicine / ENT | Post-Market Clinical Follow-Up | Brazil, Colombia | — | Case study |
| PAVmed (PortIO) | — | Vascular Access | First-in-Human (FIH) | Colombia | — | Case study |
| CeloNova BioSciences | — | Interventional Cardiology | Pivotal Clinical Trial | Brazil, Colombia | — | Case study |
| Motif Neurotech | — | Neurotechnology / Psychiatry | First-in-Human (FIH) | Colombia | — | Case study |
| Establishment Labs | — | Plastic & Reconstructive Surgery | Pivotal Clinical Trial | Costa Rica & Colombia | — | Case study |
| Cook Advanced Technologies (Cook Medical) / MED Institute | — | Cardiovascular / Vascular / Venous Disease | First-in-Human (FIH) Early Feasibility Study | Colombia | — | Case study |
| ClarVista Medical | — | Ophthalmology | First-in-Human (FIH) | Colombia | — | Case study |
| enVVeno Medical | — | Vascular Surgery | First-in-Human (FIH) | Colombia | — | Case study |
| Kona Medical | — | Cardiovascular / Hypertension | Early Feasibility Study (EFS) | Colombia | — | Case study |
| ReGelTec | — | Spine / Orthopedics | First-in-Human (FIH) | Colombia, Panama | — | Case study |
| OcuMedex | — | Ophthalmology | First-in-Human (FIH) | Colombia | In human clinical trials | Case study |
| Watershed Therapeutics | — | Urology / Drug Delivery | First-in-Human (FIH) | El Salvador, Panama, Colombia | Investigational | Case study |
| i-Lumen Scientific | — | Ophthalmology | Early Feasibility Study (EFS) | Colombia | — | Case study |
| Libella Gene Therapeutics | — | Gene Therapy / Longevity | First-in-Human (FIH) | Colombia | — | Case study |
| Mitralign | — | Structural Heart | Clinical Study | Colombia, Brazil | — | Case study |
| On.Target Molecules Biotech | — | Oncology | Pre-Submission Regulatory Engagement | El Salvador, Costa Rica | In progress | Case study |
| InterVene | — | Vascular Surgery | First-in-Human (FIH) | Colombia | — | Case study |
| TeCure, Inc. | — | Gastroenterology / Metabolic Disorders | First-in-Human (FIH) | Chile, Argentina | Breakthrough Device | Case study |
| Synecor | — | Cardiac Rhythm Management | Early Feasibility Study (EFS) | Colombia, Brazil | — | Case study |
| Spinal Stabilization Technologies | — | Orthopedics / Spine | Feasibility Study, PMCF | Paraguay, Colombia | — | Case study |
| Mitralign | — | Structural Heart | First-in-Human (FIH) | Colombia | — | Case study |
| Resurge Therapeutics | — | Urology / Men's Health | First-in-Human (FIH) | Dominican Republic | — | Case study |
| Perceptive Technologies | — | Dental Robotics / AI | First-in-Human (FIH) | Colombia | — | Case study |
| A U.S.-based medical-robotics company (name withheld) | — | Surgical Robotics | First-in-Human (FIH) | Latin America | — | Case study |
| TriAgenics, Inc. | — | Pediatric Dentistry / Oral Surgery | Phase 0 / First-in-Human | Panama, El Salvador | FIH In Progress | Case study |
| CryoConcepts, LP | — | Dermatology / Cryosurgery | Market Access — COFEPRIS Registration | Mexico | — | Case study |
| Hasten | Ampcare TENS Device | Pain Management / Rehabilitation | Market Access — COFEPRIS-04-050 Registration | Mexico | — | Case study |
Each entry is drawn from bioaccess®'s published case-study record and reflects programs on which bioaccess® served as clinical research partner, importer/registration holder, or regulatory lead, as stated in each case study. Most early-feasibility device programs are not registered on ClinicalTrials.gov, so a registry (NCT) record is not available for every row; blank fields mean the item is not stated on the underlying record. Investigational products referenced are not FDA cleared or approved unless expressly stated. Under 21 CFR 812.28, the FDA may accept data from a clinical investigation conducted outside the United States to support an IDE or a device marketing application when the applicable criteria are satisfied; acceptance is determined on a submission-by-submission basis.
Related: Client portfolio · Independent LATAM early-phase trials tracker · First-in-Human CRO