# Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization

> **NIH NIH R44** · SIMERGENT, LLC · 2021 · $831,058

## Abstract

PROJECT SUMMARY
Up to 80% of the over 326,000 patients on peritoneal dialysis (PD) around the globe have hypertension and 56%
will die due to cardiovascular issues. Clinical outcomes are dictated largely by the dextrose and sodium
concentrations used in each treatment. However, the flexibility of APD systems is woefully deficient. While the
benefits of limiting glucose exposure to extend the life of the peritoneum are known, no APD device allows
users to deliver a gradually decreasing dextrose concentration. Recent evidence shows that hypertensive PD
patients could benefit from a currently unavailable reduced dialysate sodium admixture to remove excess
sodium from the blood and improve blood pressure. The recently announced Advanced American Kidney
Health Initiative (AAKHI) calls for 80% of new ESRD patients in 2025 to receive home dialysis or a transplant,
which will result in an increase from 10% to ~50% of dialysis patients using PD.
Our innovative Faraday™ APD technology created in a Phase I SBIR project enables admixing PD therapies
that remove excess sodium in the bloodstream while minimizing dextrose exposure. We have developed a
benchtop APD pumping engine prototype that accurately admixes custom solutions from five input fluids via a
proprietary cassette and pneumatics. Our Phase II development will culminate in a fully functioning,
commercializable, user-friendly APD device and tap water filtration system with custom therapies designed to
drastically reduce cardiovascular deaths and early PD technique failure.
Specific Aim 1: Develop regulatory pathway with FDA: Our goal is to develop design history file documents
and meet with the FDA in a pre-sub meeting to ensure they agree with our predicate device, water sterilization
requirements, product architecture, high-level risk mitigations, and safety systems.
Specific Aim 2: Optimize current pumping engine:. The cassette and pneumatics manifold will be
miniaturized, and a cassette-to-hardware door interface mechanism will be developed. Flow rate testing will
confirm flow rates >190 ml/min Fill and >125 ml/min Drain with the optimized pumping engine.
Specific Aim 3: Integrate pumping engine into fully functioning APD cycler: All hardware elements will be
optimized in a table-top sized portable enclosure to create a device that admixes at 1.5% accuracy. We will
develop a best-in-class UI with setup animations and intuitive therapy programming and operation.
Specific Aim 4: Develop water purification system: We will design and build a water filtration and sterilization
system to create injection-quality water to meet FDA requirements for sterility of TVC <0.1 CFU/ml, endotoxins
<0.1 EU/ml (95% confidence), and chemical contaminants per ISO 23500 and USP <1231>.
Our Phase II development will culminate in a commercializable, user-friendly tabletop APD device with sodium
and dextrose tailoring APD therapies designed to reduce cardiovascular deaths and early PD technique failure.

## Key facts

- **NIH application ID:** 10325976
- **Project number:** 2R44DK116436-02A1
- **Recipient organization:** SIMERGENT, LLC
- **Principal Investigator:** Steve J Lindo
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $831,058
- **Award type:** 2
- **Project period:** 2017-09-20 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325976

## Citation

> US National Institutes of Health, RePORTER application 10325976, Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization (2R44DK116436-02A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10325976. Licensed CC0.

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