# Product and Regulatory Development of a Needle-Free Hemodialysis Access Port

> **NIH NIH R44** · HEALIONICS CORPORATION · 2021 · $984,472

## Abstract

Product and Regulatory Development of a Needle-Free Hemodialysis Access Port
PROJECT SUMMARY
Objective: The overall objective of this SBIR Phase IIB Bridge Award project is to advance a new Needle-Free
 Hemodialysis Access Port to the stage of IDE approval for a subsequent first in Human study.
Significance: For the nearly 500,000 End Stage Renal Disease (ESRD) kidney failure patients in the US on hemodialysis
 (HD), the need for thrice-weekly in-clinic treatments requiring cannulation by large dialysis needles (up to 2 mm
 diameter) is time consuming, painful and unpleasant and makes maintenance of a reliable vascular access site
 extremely challenging. As a result of high failure rates with the established permanent vascular access methods –
 arteriovenous (AV) fistulas and AV grafts – more than half of all first-year hemodialysis patients, and more than 20%
 longer term, are treated via infection-prone catheters. There are frequent hospitalizations with unsustainable costs
 to the healthcare system and a miserable quality of life for most patients.
Home HD treatment saves $20,000 per patient year, can be done at the patient’s convenience, significantly
improves patient health, and has the major quality-of-life benefit of enabling many patients to continue productive
employment. Patient surveys cite needle aversion as the biggest obstacle to increased home self-treatment. A new
access option that overcomes this barrier would encourage increased home HD.
Innovation: Previous percutaneous port devices providing blunt cannula access to the lumen of an AV graft were
 functional and patient-appreciated but eventually failed clinically and commercially from infection issues at the exit
 site and poor patency of the grafts. Healionics has developed technologies that overcome these issues by use of its
 STAR porous biomaterial at tissue interfaces, enabling a reintroduction of the needle-free HD access port concept.
 STAR’s optimized pore geometry induces a permanently vascularized tissue interface that leverages the body’s
 natural defenses against bacterial infection. Application of STAR to the outside of an AV graft eliminates capsular
 contraction forces, preserving graft wall flexibility and preventing the usual failure mode of progressive venous-end
 neointimal hyperplasia. Improvements to the hemostasis valve design and other components are expected to
 further improve reliability and safety versus earlier port devices.
Approach: Specific aims for the project are 1) extend the prototype development and initial preclinical testing done
 under R44HL26256 into a more complete device design, 2) conduct formal technical verification, fabrication process
 development, reliability testing and preclinical studies, and 3) prepare and submit a successful IDE application to
 the FDA. IDE approval will allow a first-in-human Early Feasibility Study to begin soon after conclusion of the SBIR
 Phase IIB project period, supported by investment funding secured ...

## Key facts

- **NIH application ID:** 10202696
- **Project number:** 5R44HL126256-06
- **Recipient organization:** HEALIONICS CORPORATION
- **Principal Investigator:** Andrew Marshall
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $984,472
- **Award type:** 5
- **Project period:** 2015-04-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10202696

## Citation

> US National Institutes of Health, RePORTER application 10202696, Product and Regulatory Development of a Needle-Free Hemodialysis Access Port (5R44HL126256-06). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10202696. Licensed CC0.

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