FOR IMMEDIATE RELEASE

Truway Health Releases TVA-2026 Clinical Study Evaluating Ultrasound-Guided Peripheral Vascular Access

Prospective randomized study will compare ultrasound-guided vascular access with standard peripheral cannulation techniques, with first-attempt cannulation success as the primary outcome

NEW YORK — August 24, 2026 — Truway Health, Inc. today announced that its new clinical research protocol, TruVascular Access – Ultrasound-Guided Vascular Access Study (TVA-2026), Protocol ID TWH-TVA-2026-001, has been released through the ClinicalTrials.gov Protocol Registration and Results System (PRS) for review.

TVA-2026 is designed as a prospective, randomized, parallel-assignment clinical study comparing real-time ultrasound-guided peripheral vascular access with conventional peripheral vascular-access techniques based on visualization, palpation, and anatomical landmarks.

The study's primary objective is to determine whether ultrasound guidance improves first-attempt peripheral vascular cannulation success in participants requiring clinically indicated peripheral venous access.

Secondary and exploratory outcomes are expected to evaluate factors including the number of cannulation attempts, time to successful vascular access, requirement for rescue or escalation, patient-reported procedural pain, access-related complications, functional catheter survival, difficult intravenous access characteristics, vessel anatomy, and operator-related procedural variables.

Advancing Evidence-Based Vascular Access

Peripheral intravenous catheter placement is among the most frequently performed procedures in health care, yet vascular access can become challenging when vessels are difficult to visualize or palpate.

TVA-2026 is intended to generate prospective comparative evidence concerning whether a standardized ultrasound-guided approach can improve procedural performance and help identify the clinical, anatomical, and operational factors associated with successful vascular access.

The study includes two planned groups:

Experimental Group — Ultrasound-Guided Peripheral Vascular Access
Participants will undergo clinically indicated peripheral vascular access using real-time ultrasound visualization for vessel identification and catheter placement.

Active Comparator — Standard Peripheral Vascular Access
Participants will undergo conventional peripheral vascular access using standard visualization, palpation, landmark, and vein-selection methods without initial real-time ultrasound guidance.

Protocol-defined rescue procedures may be used whenever clinically necessary, and participant safety will take priority over study assignment.

Broader Clinical Research Infrastructure

TVA-2026 forms part of Truway Health's expanding clinical research infrastructure focused on medical technology, diagnostics, procedural optimization, digital health, and real-world clinical data.

The protocol is structured to support standardized collection of procedural and outcome information that may include:

• First-attempt cannulation success

• Successful vascular access within two attempts

• Total cannulation attempts

• Procedure duration

• Difficult intravenous access characteristics

• Vessel depth and diameter

• Catheter characteristics

• Patient-reported pain and satisfaction

• Operator-reported procedural difficulty

• Rescue or escalation procedures

• Vascular-access-related complications

• Functional catheter survival

Truway Health also plans controlled sharing of de-identified individual participant data and supporting study materials with qualified researchers following study completion and publication of primary results, subject to applicable consent, privacy, regulatory, and data-use requirements.

Research Governance and Participant Protection

TVA-2026 is being developed within a protocol-governance framework incorporating human-subject protections, informed-consent requirements, privacy safeguards, clinical safety controls, device oversight, data-integrity procedures, and auditable study documentation.

The protocol carries the Truway Health identifier:

Protocol ID: TWH-TVA-2026-001

Any Truway Health internal IRB or governance identifiers associated with the protocol are internal tracking references and should not be interpreted as approval issued by an independent institutional review board.

Participant enrollment will not begin until all applicable human-subject protection, site-readiness, regulatory, and study-activation requirements have been satisfied.

ClinicalTrials.gov Status

As of August 24, 2026, the TVA-2026 record has been released through the ClinicalTrials.gov PRS.

A PRS status of Released indicates that the sponsor has transmitted the record for ClinicalTrials.gov processing/review. It does not by itself mean that an NCT number has already been assigned or that the study record has been publicly posted.

Truway Health will update its public study information when an official ClinicalTrials.gov identifier becomes available.

About Truway Health, Inc.

Truway Health, Inc. is a health care and medical technology organization engaged in medical-device commercialization, health care procurement, diagnostic technologies, clinical research, digital health infrastructure, and the development of data-driven approaches to improving health care delivery.

Through its research programs, Truway Health seeks to evaluate emerging technologies and clinical workflows using structured protocols, measurable outcomes, transparent research governance, and responsible data stewardship.

Study Information

Study: TruVascular Access – Ultrasound-Guided Vascular Access Study (TVA-2026)
Protocol ID: TWH-TVA-2026-001
Sponsor: Truway Health, Inc.
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Outcome: First-attempt peripheral vascular cannulation success
ClinicalTrials.gov NCT ID: Not yet assigned as of August 24, 2026
PRS Status: Released

Media & Research Inquiries

Truway Health, Inc.
Clinical Research & Corporate Communications
Website: truwayhealth.com

Forward-Looking Statement: This release describes a planned clinical research protocol and anticipated study activities. Study design, enrollment, dates, locations, endpoints, regulatory status, and other elements may change during scientific, regulatory, IRB, or ClinicalTrials.gov review. Nothing in this announcement should be interpreted as establishing the safety, effectiveness, superiority, or regulatory approval of any medical device, procedure, or clinical intervention.