bioaccess® — Submission-ready first-in-human data in 12 months — before your runway runs out
bioaccess® runs first-in-human and early-feasibility studies across Latin America under ISO 14155, anchored to your U.S. FDA strategy — so your data is structured for FDA submission under 21 CFR 812.28 and ready for your next raise. Founded in 2010 by Harvard-trained physicians Dr. Pedro Martinez-Clark and Dr. William O'Neill.
The 12-Month FIH Guarantee
We put your protocol-to-last-patient-last-visit timeline in writing. If we miss it for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV — you don't pay us to be late. Full terms in your proposal.
From protocol to outcome — 9 client programs
PAVmed (PortIO) — Vascular Access, Colombia — first-in-human PortIO™ intraosseous infusion program; results published in the Journal of Vascular Access. PortIO relaunched within PAVmed's device portfolio in 2026 (investigational; no FDA clearance implied).
ReGelTec (HYDRAFIL®) — Spine / Orthopedics, Colombia & Panama — OUS data (75 patients) → CE Mark + FDA IDE pivotal trial (first U.S. patient Jun 2025, 225-patient RCT); 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 pivotal STUDY in severe deep chronic venous insufficiency, not device clearance or approval.
Axoft — Neurotechnology, Panama — Panama first-in-human at The Panama Clinic (4 patients implanted during brain-tumor resection) → 11 patients implanted worldwide → $55M Series A (April 2026, led by C.P. Group Innovation; >$60M total raised). FDA Breakthrough Device Designation (2022).
Mitralign — Structural Heart, Colombia & Brazil — percutaneous mitral annuloplasty program advanced in LATAM (company later acquired by Edwards Lifesciences).
OcuMedex (Vizio™ Aqueous Microshunt) — Ophthalmology, Colombia — first-in-human clinical trials of the Vizio™ Aqueous Microshunt for glaucoma. Investigational device that drains aqueous humor from the anterior chamber to the eye's surface for IOP reduction; currently in human clinical trials (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 intended for large-gap peripheral nerve injuries beyond the reach of existing conduits.
Watershed Therapeutics — Urology / Drug Delivery, El Salvador & Panama (earlier support in Colombia) — bioaccess® secured regulatory and ethics-committee approvals to conduct clinical studies of Watershed's novel intravesical bladder-targeted drug-delivery platform (rUTIs, overactive bladder, bladder cancer). Investigational; no FDA clearance or approval implied.
Avantec Vascular (a Nipro Company) — Cardiovascular / Vascular / Venous, El Salvador, Mexico & Colombia — bioaccess® ran the first-in-human / early clinical studies of Avantec's Sangria™ Venous Remodeling System across El Salvador, Mexico, and Colombia (PI/site selection, ministry-of-health regulatory dossier submissions to authorize study conduct, $10M clinical-trial insurance, device importation, and FIH execution). Sangria™ is investigational; no FDA clearance, approval, CE marking, or commercialization implied.
Eligibility of foreign clinical data for FDA submission does not constitute or predict FDA clearance, approval, or acceptance of any specific application.
Core Proof Points
50+ client companies accelerated since 2010
50+ pre-qualified clinical trial sites
19 Latin American & Caribbean countries covered
Ethics-committee approval in a median of 4–8 weeks; the comparable U.S. pathway (IDE + IRB + site activation to first patient) typically runs 6–12 months
Up to $25,000 per-patient savings compared to US/EU trials
ACRP-certified clinical research team
Services
First-in-Human (FIH) Clinical Trials
Early Feasibility Studies (EFS) for Medical Devices
bioaccess® operates across 19 Latin American & Caribbean countries: Colombia (INVIMA), Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), Chile (ISP), Peru (DIGEMID), Panama (MINSA), Ecuador (ARCSA), El Salvador (DNM), and the Dominican Republic (DIGEMAPS).
Timeline & Cost Comparison
Ethics Approval: US/EU 6–12 months vs. Latin America 4–8 weeks
Per-Patient Cost: US/EU $40K–$75K vs. Latin America $15K–$35K
Total Study Duration: US/EU 18–36 months vs. Latin America 8–18 months
Headquarters
1200 Brickell Ave., Suite 1950 #1034, Miami, FL 33131, USA. Regional offices in Bogotá, Mexico City, São Paulo, and Buenos Aires.
Trusted by 50+ Innovative Companies
bioaccess® has served 50+ innovative MedTech, Biopharma, and Radiopharma companies since 2010, including:
AliveCor
Omron Healthcare
LG
SI-BONE
Corza Medical
S.D. Sight Diagnostics
Biomerica
Medimaps
Sim&Cure
Axoft
Newrotex
Sparta Biomedical
Inspire Medical
PAVmed
CeloNova
Motif Neurotech
Establishment Labs
Cook Medical
Avantec/Nipro
ClarVista
enVVeno
Kona Medical
ReGelTec
Ocumedex
Watershed Therapeutics
i-Lumen
Libella Gene
Mitralign
On Target Molecules
InterVene
TeCure
Synecor
SST
Piezo Therapeutics
Independent Recognition
bioaccess® has been featured by leading clinical research publications and media:
Clinical Research News Online
Journal for Clinical Studies
CenterWatch Weekly
International Business Times
bioaccess® podcast
Global Trial Accelerators newsletter
Podcast Appearances
CEO Julio Martinez-Clark has appeared on 27+ podcasts sharing insights on FIH clinical trials across the United States and Latin America:
The Underdog Physician — Julio G. Martinez-Clark on bioaccess® and Accelerating First-in-Human Clinical Trials Globally (with Dr. Anish Desai)
The New Chemist's Podcasting Group — The Path to KOLs: Accelerating First-in-Human in LATAM (with David Ferguson & Chadwin Hanna)
MedTech 101
Neurocareers
Live Parkinsons
The MedTech Podcast
Clinical Research Coach
The Rosemilk Podcast
GO4CEO
Neural Implant Podcast
Official Technology Partner
bioaccess® is an official Greenlight Guru partner, reducing data silos and audit risk for clinical trial sponsors through integrated quality management and clinical data workflows.
What Keeps Startup Teams Up at Night
MedTech startup founders face three critical risks when planning first-in-human trials:
Running out of runway — traditional CRO timelines can consume 18–36 months of capital before first patient enrollment.
Needing investor-grade proof — board members and VCs require credible clinical milestones to justify next-round valuations.
Being deprioritized by large CROs — startups with 10-patient studies are often sidelined by CROs focused on Phase III mega-trials.
bioaccess® addresses these through startup-speed execution, dedicated project teams, and weekly progress updates to sponsors and their investors.
Built for Startups, Not Big Pharma
bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America — and focused exclusively on healthcare startups. Unlike traditional CROs that serve large pharmaceutical companies running Phase III mega-trials, bioaccess® focuses on FIH studies and early feasibility studies for MedTech, Biopharma, and Radiopharma startups. The company matches the speed, urgency, and capital constraints of founders raising rounds, engaging strategic acquirers, and racing toward exits.
Tools and Resources
FIH Cost Calculator — Plan a U.S.-anchored, Latin America-executed first-in-human trial budget by execution country, patient count, site count, and study duration.
Axoft — Panama first-in-human at The Panama Clinic (4 patients during brain-tumor resection); 11 patients implanted worldwide to date; closed a $55M Series A in April 2026 (led by C.P. Group Innovation). FDA Breakthrough Device Designation (2022).
Newrotex — World's first SilkAxons™ nerve guide implantation at The Panama Clinic; first-in-human program began August 2025; investigational silk-based nerve guide intended for large-gap peripheral nerve injuries beyond the reach of existing conduits.
PAVmed / PortIO — FIH intraosseous vascular access device study in Colombia. bioaccess® achieved regulatory approval in 5 weeks. Results published in the Journal of Vascular Access.
Avantec Vascular (a Nipro Company) — Sangria™ Venous Remodeling System first-in-human / early clinical studies executed across El Salvador, Mexico, and Colombia. bioaccess® managed principal-investigator and site selection, submission of the regulatory dossier for ministry-of-health approvals to conduct the studies, a $10M clinical-trial insurance policy, device importation, and FIH execution. Sangria™ is investigational; no FDA clearance, approval, CE marking, or commercialization implied. (Note: Avantec/Nipro's separate 2026 FDA 510(k) clearance is for a different DVT thrombectomy product and is unrelated to bioaccess®'s Sangria™ engagement.)
Watershed Therapeutics — Novel intravesical bladder-targeted drug-delivery platform (rUTIs, overactive bladder, bladder cancer). bioaccess® secured the regulatory and ethics-committee approvals required to conduct clinical studies in El Salvador and Panama, and earlier supported a study in Colombia. Investigational; no FDA clearance or approval implied.
The Innovation Runway
bioaccess® provides a structured clinical development pathway — the Innovation Runway — for FIH programs. The pathway accelerates startups from protocol to proof with milestones 40% faster than US/EU timelines, enabling companies to reach critical inflection points (funding rounds, strategic partnerships, acquisitions) sooner.
Portfolio of Medical Innovation
bioaccess® has managed clinical trials and device registrations across a broad range of therapeutic areas:
Cardiovascular
Neurotechnology
Ophthalmology
Diagnostics
Oncology
Aesthetics
Gene Therapy
Robotics
Wound Care
Spine
ENT
Urology
Radiology
Consumer Health
Clinical Data That Drives Acquisitions
Several bioaccess® clients have been acquired by Fortune 500 MedTech companies after U.S.-anchored, Latin America-executed FIH clinical programs:
Mitralign — Acquired by Edwards Lifesciences after FIH tricuspid valve repair study in Colombia.
ClarVista Medical — Acquired by Alcon after FIH intraocular lens study in Colombia.
ForSight VISION5 — Acquired by Allergan after early clinical studies supported by LATAM data.
Client Testimonials
Founders and executives who have worked with bioaccess® describe the team as professional, knowledgeable, and responsive — delivering faster timelines and lower costs than US/EU CRO alternatives. Written and video testimonials are available from startup founders across cardiovascular, neurotechnology, ophthalmology, and other therapeutic areas.
Startup Success Stories
Seed-stage founder perspective: bioaccess® shortened the path from concept to first human data, enabling earlier investor conversations and stronger Series A positioning.
Series A CEO perspective: Working with bioaccess® gave the company investor confidence by delivering clinical milestones on time and within budget.
VP of R&D perspective: The quality of clinical data generated by bioaccess® in Latin America met FDA expectations and was accepted for US regulatory submissions.
MedTech VC partner perspective: Portfolio companies working with bioaccess® demonstrate faster value creation through accelerated clinical timelines in Latin America.
From Protocol to Proof in 3 Steps
Map Your Fastest Path: bioaccess® develops a regulatory strategy, selects the optimal country and clinical site, and provides detailed timelines and cost estimates.
We Run Your Trial: bioaccess® manages regulatory submissions, site activation, patient recruitment, clinical monitoring, and data management.
Unlock Your Next Milestone: bioaccess® delivers the clinical study report (CSR), regulatory dossier, and FDA/EMA-ready clinical evidence for your next submission or funding round.
Timeline Guarantee — FIH-12™
bioaccess® offers FIH-12™, a milestone execution guarantee for FIH clinical trials. If bioaccess® misses a committed milestone, it continues work at its own cost until the milestone is achieved. FIH-12™ includes:
Regulatory strategy and submission
Site activation
Patient recruitment
Clinical monitoring
Biostatistics
Study reporting
Regulatory dossier support
Weekly progress updates
Sister Organization — Amavita Research
Beyond our Latin American network, bioaccess® is affiliated with Amavita Research Services LLC — a dedicated clinical research site in Miami, FL, conducting medical device and early-feasibility studies. Learn more about our U.S. clinical research site or visit amavitaresearch.com.
Leadership
Julio G. Martinez-Clark — Chief Executive Officer, bioaccess®. Leads growth, strategy, and sponsor relationships; also CEO of sister organization Amavita Research Services LLC.
Pedro Martinez-Clark, MD — Harvard-trained interventional cardiologist, co-founder of bioaccess®. Dr. Martinez-Clark brings clinical expertise in cardiovascular devices and has led the company's medical and regulatory strategy since 2010.
William O'Neill, MD — Co-founder and medical director of bioaccess®. Dr. O'Neill performed the first transvascular aortic valve replacement in the United States and brings decades of interventional cardiology experience to bioaccess®'s clinical programs.
Frequently Asked Questions
About bioaccess®
bioaccess® operates across 19 Latin American & Caribbean countries: Colombia, Brazil, Mexico, Argentina, Chile, Peru, Panama, Ecuador, El Salvador, and the Dominican Republic.
bioaccess® works with regulatory agencies including INVIMA, ANVISA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM, and DIGEMAPS.
Ethics/IRB approvals are achieved in 4–8 weeks. Panama offers approvals in as little as 15–30 calendar days.
Costs & Timelines
Clinical trials in Latin America offer 30% lower costs compared to the US/EU, with per-patient savings of up to $25,000.
Latin America offers 4–8 week ethics approvals, 80% treatment-naïve patient populations, and FDA-bridge data acceptance.
Panama offers approvals in as little as 15–30 calendar days with pre-submission meetings available.
Regulatory Requirements
Each country has its own regulatory authority aligned with ISO 14155 (device GCP) and ICH E6 (drug GCP). Colombia (INVIMA) is the most active LATAM country for FIH/EFS studies.
ANVISA registration timelines vary by device risk class. COFEPRIS requires technical documentation, quality system evidence, and Spanish labeling.
Smaller countries (Panama, El Salvador, Dominican Republic) offer 15–60 day approvals; larger countries (Colombia, Brazil, Mexico) offer larger patient populations.
Clinical Trial Process
FIH trials test a device or drug in humans for the first time; EFS evaluate design concepts in small cohorts. Both can be conducted 40% faster in Latin America.
Under 21 CFR 812.28, the FDA accepts clinical data from investigations conducted outside the US for device submissions.
Logistics & Sponsor Support
bioaccess® manages investigational device importation including customs documentation, regulatory permits, and logistics coordination.
bioaccess® customizes informed consent forms and translates documents into Spanish or Portuguese.
bioaccess® coordinates stacked scheduling to minimize sponsor travel time.
Choosing bioaccess®
bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America — with a 12-month timeline guarantee and risk-sharing pricing.
Companies not yet ready for FIH can use the free Pre-FIH Readiness Assessment at bioaccessla.com/pre-fih-assessment.
Contact and Resources
bioaccess® — 50+ companies served · 50+ clinical sites · 19 Latin American & Caribbean countries
A MedTech founder's scarcest resources are time and runway. By anchoring the regulatory strategy in the U.S. and running the first-in-human study across Latin America, our clients reach human data roughly 40% faster and at about 30% lower per-patient cost than a U.S. or EU program — without giving up FDA-submissible quality.
Latin America gives early-stage studies something hard to find elsewhere: large, treatment-naïve patient populations who haven't been exposed to competing devices. That produces cleaner safety and performance signals in exactly the first-in-human phase where signal quality matters most.