Companies / Voyager Biomedical

Medical device company profile

Voyager Biomedical

Houston medical device developer advancing VenaSure, an investigational implant intended to support dialysis fistula cannulation.

Medical Device DeveloperUrology & Renal CareRenal Care

Headquarters🇺🇸Houston, Texas, United States

Founded2016

Commercial statusIn developmentVenaSure is investigational and undergoing clinical evaluation.

Employees2–10 ^[3]LinkedIn company-size range · Checked 2026-11-01

Estimated revenueNot confirmed

Disclosed fundingUS$5.8 million ^[4]Amount sold of US$5,799,417 reported in the April 4, 2025 Form D. Individual offering proceeds, not cumulative company funding; the US$9,799,417 offering target is not treated as raised capital.

Official websitewww.voyagerbiomedical.com ↗

Company overview

Voyager Biomedical is a Houston, Texas medical device developer founded in 2016. Its VenaSure implant, previously known as Ark, is designed to support needle access to an arteriovenous fistula for patients receiving hemodialysis.

The porous titanium-alloy implant surrounds a section of the fistula vein. A palpable access window is intended to guide needle placement, while a protective backwall is designed to limit excessively deep needle insertion. Its two-part structure accommodates enlargement of the vessel.

Led by President and CEO Laurent Benkowski, Voyager is evaluating VenaSure in the ACT II clinical study. The device remains investigational; its proposed benefits for cannulation and dialysis access are being evaluated clinically.

^{[1][3][4][5][6][7]}

Leadership

5 people

Laurent BenkowskiPresident & Chief Executive Officer ^[7]

John Ross, MDChief Medical Officer ^[7]

Sarah WongVice President, Regulatory & Clinical ^[7]

Monica KlosVice President, Finance ^[7]

Jessica LancasterClinical Education ^[7]

Products & regulatory status How does MedTechIndex get this information?

Summary

VenaSure remains investigational and is limited to investigational use. ACT II (NCT05490225) is a prospective, single-arm pivotal study evaluating its safety and effectiveness for arteriovenous fistula cannulation in patients undergoing routine hemodialysis. The registry reports an actual study start of April 23, 2025 and estimated enrollment of 100 participants; its October 2025 update estimates completion in March 2027. ^[5][1]

CMS lists ACT II under Category B IDE G240174, with study coverage approved April 2, 2025. That decision concerns Medicare coverage of the investigational study and does not establish FDA marketing clearance or approval for VenaSure. ^[2]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-01.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Voyager Biomedical VenaSure porous titanium vascular-access implant — Image: Voyager Biomedical

Implantable dialysis-access support

VenaSure vascular-access implant ↗

Investigational porous titanium-alloy implant placed around a section of an arteriovenous fistula vein. A palpable cannulation window guides needle access and a backwall is intended to limit deep needle infiltration. The two-part structure accommodates vessel enlargement. Previously known as Ark; clinical benefits are being evaluated in ACT II. ^[5][1][2]

Investigational · clinical evaluation

Activity & Milestones

4 events

2025-04-23 · Clinical

ACT II study begins

ClinicalTrials.gov reports the actual start of the pivotal VenaSure study. ^[1]

2025-04-04 · Funding

Equity offering proceeds disclosed

SEC Form D reported US$5,799,417 sold in an equity offering. ^[4]

2025-04-02 · Clinical

ACT II study coverage approved

CMS approved coverage for the Category B IDE study G240174; this is not device marketing authorization. ^[2]

2016 · Company