Faraday, a novel automated peritoneal dialysis device with dialysate customization

Ended Project Grant Awarded Last action

Award ID
R44DK116436
Recipient
Awarding agency
Obligated
$5,012,121

Award facts

Completion date
Originally
Funding
  • $3,341,414.00 Federal
  • $1,670,707.00 Non-federal
Place of performance
Oklahoma City, OK, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $839,649 $0
Amendment $839,649 $839,649
Amendment $831,058 $0
Original award $831,058 $831,058

Quick answers

Who received award R44DK116436?

R44DK116436 was awarded to Simergent LLC by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on September 20, 2017.

How much is award R44DK116436 worth?

$5,012,121 has been obligated on R44DK116436: $3,341,414 in federal funding and $1,670,707 in non-federal funding.

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