# Novel 3-D Printed Implant for Improved Hemodialysis Access

> **NIH NIH R44** · BIOTEX, INC. · 2021 · $1,358,290

## Abstract

Project Summary/Abstract
 The overall goal of this Direct to Phase II SBIR proposal is to develop the Ark, a novel device for
providing improved access, protection, and functionality during placement of hemodialysis needles. In
the US alone, over 700,000 patients receive hemodialysis treatment, and creation of an arteriovenous
fistula (AVF) and access vein is the preferred access point for dialysis needles. Most access veins suffer
from the following shortcomings: long waiting periods to mature; challenging to access; prone to damage
by needle penetration through the vessel; and limited useful life, failing largely because of both excessive
and poor punctures. As a result, many dialysis patients do not receive the treatment required for
continued quality of life.
 The Ark is designed to remediate the limitations of the current practice and aid long-term use of
access veins. The Ark is intended for surgical implantation around the access vein, ideally at the time of
AVF creation. The infrastructure promotes ingrowth of surrounding soft tissues reinforcing the strength
of the vein, while providing an opening for easy needle access and a back wall for vessel protection
from inadvertent penetration. The implant provides a palpable structure beneath the skin, promoting
more accurate needle puncture, improving both caregiver efficacy and patient comfort. Initial prototypes
of the Ark have gone through preliminary benchtop and animal studies demonstrating feasibility and
significant promise. Continued efforts will build on these results to optimize the design, perform
cannulation studies in a relevant AVF animal model, complete required design controls and validation
activities, and perform a chronic GLP study, supporting a planned submission for FDA Clearance. We
expect the end result of this effort will greatly facilitate the move toward home-based dialysis, resulting
in significant impact on patient health and health care cost savings.

## Key facts

- **NIH application ID:** 10222783
- **Project number:** 5R44HL154933-02
- **Recipient organization:** BIOTEX, INC.
- **Principal Investigator:** Ashok Gowda
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,358,290
- **Award type:** 5
- **Project period:** 2020-07-24 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10222783

## Citation

> US National Institutes of Health, RePORTER application 10222783, Novel 3-D Printed Implant for Improved Hemodialysis Access (5R44HL154933-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10222783. Licensed CC0.

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