SBIR-STTR Award

There are currently over 326,000 patients on peritoneal dialysis (PD) around the globe. Clinical outcomes are dictated largely by the dextrose and sodium concentrations used in each session. However, the state of the art in APD systems is woefully deficient: clinicians must choose from only 3 dialysate dextrose concentrations available and have no choice for sodium concentration. While researchers have widely published the benefits of limiting glucose exposure to prolong the life of the peritoneal membrane, no APD device allows users to deliver an intermediate dextrose concentration. In addition, recent evidence suggests that hypertensive PD patients (up to 80% of the PD population) could benefit from a reduced dialysate sodium concentration to remove excess sodium from the bloodstream and improve blood pressure. To dramatically improve the clinical options for optimal PD therapy, Simergent proposes the Faraday™: an automated peritoneal dialysis (APD) device which can enable individualized glucose sparing and sodium adjustment therapies by creating on-demand custom solution concentrations needed to improve cardiac outcomes and prolong membrane function. In this Phase I SBIR project, we will develop an APD pumping engine prototype that will take the patient’s own home tap water, sterilize it, then accurately admix it with one to four additional sources. An enormous side benefit of our technology is that its use can reduce the shipping, storage, and lifting burden of dialysate bags by 92% by mixing concentrated dialysate solutions with sterile water generated at the patient’s home. Specific Aim 1: Create a prototype admixing disposable tubing set: Design and manufacture a disposable cassette and associated tubing set capable of admixing fluids from 5 sources and delivering to a mixing bag. Specific Aim 2: Manufacture and test working APD pumping engine prototype: Design and manufacture a functioning prototype hardware & software system to interface with the cassette and validate the volumetric accuracy is ?1.5%. Specific Aim 3: Create customizable sodium concentrations: Design and demonstrate a mechanism which will accurately admix low-sodium dialysate and hypertonic saline (2 sources) to create sodium concentrations ranging from 100 to 170 mmol/l in increments of 10 mmol/l to support personalized sodium adjustment therapies. Specific Aim 4: Create customizable dextrose concentrations: Design and demonstrate a mechanism which will accurately admix 5 sources: concentrated dialysate solution (2 dextrose concentrations), buffer solution, saline, and sterile water to create solutions ranging from 1.0% to 4.5% dextrose in increments of 0.25%. Our Phase I feasibility results will culminate in a revolutionary prototype demonstration subsystem critical for admixing fluids from disparate sources. In Phase II, we will integrate this into a fully functioning APD device.

Public Health Relevance Statement:
PROJECT NARRATIVE Peritoneal dialysis devices and solutions have changed very little in the past 25 years. In this Phase I SBIR project, Simergent proposes the development of an automated peritoneal dialysis device capable of admixing its own dialysate solution and allowing the nephrologist to customize the sodium and dextrose concentration to meet the patient’s clinical needs. If widely distributed, ultimately the product would dramatically improve the cardiovascular outcomes of peritoneal dialysis patients.

Project Terms:
Abdomen; base; Blood Circulation; Blood Pressure; Buffers; Cardiac; Cardiovascular system; Catheters; Clinical; Clinical Trials; Custom; design; Development; Devices; Dialysis patients; Dialysis procedure; Diffuse; Electrolytes; Engineering; Exposure to; Filtration; Glucose; Healthcare; Home environment; Hyponatremia; Implant; improved; Income; individual patient; innovation; Kinetics; Legal patent; Life; Lifting; Liquid substance; Measures; Medical; Membrane; Modeling; novel; Operative Surgical Procedures; Organ; Outcome; Patients; Peritoneal; Peritoneal Dialysis; Peritoneum; Pharmaceutical Preparations; Phase; Population; prototype; Publishing; Pump; Research Personnel; Saline; Shipping; Side; Small Business Innovation Research Grant; Sodium; software systems; Source; Sterility; System; targeted treatment; Technology; Testing; Toxin; wasting; Water; Water Supply

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 sodiumconcentrations used in each treatment. However, the flexibility of APD systems is woefully deficient. While thebenefits of limiting glucose exposure to extend the life of the peritoneum are known, no APD device allowsusers to deliver a gradually decreasing dextrose concentration. Recent evidence shows that hypertensive PDpatients could benefit from a currently unavailable reduced dialysate sodium admixture to remove excesssodium from the blood and improve blood pressure. The recently announced Advanced American KidneyHealth 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 therapiesthat remove excess sodium in the bloodstream while minimizing dextrose exposure. We have developed abenchtop APD pumping engine prototype that accurately admixes custom solutions from five input fluids via aproprietary 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 todrastically reduce cardiovascular deaths and early PD technique failure.Specific Aim 1: Develop regulatory pathway with FDA: Our goal is to develop design history file documentsand meet with the FDA in a pre-sub meeting to ensure they agree with our predicate device, water sterilizationrequirements, product architecture, high-level risk mitigations, and safety systems.Specific Aim 2: Optimize current pumping engine:. The cassette and pneumatics manifold will beminiaturized, and a cassette-to-hardware door interface mechanism will be developed. Flow rate testing willconfirm 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 beoptimized in a table-top sized portable enclosure to create a device that admixes at 1.5% accuracy. We willdevelop 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 sterilizationsystem 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 sodiumand dextrose tailoring APD therapies designed to reduce cardiovascular deaths and early PD technique failure.

Public Health Relevance Statement:
PROJECT NARRATIVE Peritoneal dialysis devices and solutions have changed very little in the past 25 years. In this Phase II SBIR project, Simergent proposes the continued development of Faraday, an automated peritoneal dialysis device based on our Phase I prototype, which is capable of admixing its own dialysate solution from purified tap water and allowing the nephrologist to customize the sodium and dextrose concentrations to meet the patient's clinical needs. If widely distributed, ultimately the product could dramatically improve the cardiovascular outcomes of peritoneal dialysis patients by removing excess sodium from hypertensive patients and reducing excess dextrose exposure, which is harmful to the peritoneal membrane.

Project Terms: