Q&A with Winners of the KidneyX Redesign Dialysis Phase 1

By ASN Staff

Kidney News Online reached out to all 15 winners of the KidneyX Redesign Dialysis Phase 1 competition to get more information on their projects.

All winners answered the following questions:

  1. Briefly summarize your project.
  2. What future goals do you have for your project after winning the KidneyX prize competition?
     

The winners were presented in three different categories based on their project’s basis. These include:

Diagnostics
Improving Dialysis
Engineering

Please keep up-to-date with KidneyX information and the rollout of future prize competitions on kidneyx.org.

Diagnostics

University of Alabama at Birmingham

  1. Our wearable telehealth device is worn over the patient’s arteriovenous fistula or graft. It detects dialysis vascular access clotting in real time by using sound wave data and machine learning algorithms. This proactive approach allows for early clot detection and early referral for intervention, thus avoiding missed dialysis related distress symptoms for the patient and related medical complications.
  2. We will now be working on miniaturizing the device and validating the algorithms before commercializing the device.  We are also working on devising machine learning algorithms to help detect vascular access stenosis.
     

Outset Medical, Inc.

  1. The Outset project focuses on personalizing dialysis treatments by using machine integrated sensors to automatically obtain physiologic measurements. These embedded sensors will monitor a patient’s vascular access health, volume status, and cardiac parameters without the need for manual steps or workflow interruption. This seamlessly collected data, and will allow physicians to customize a patient's treatment based on personal data history and provide an avenue for the clinical predictiveness needed to decrease intradialytic complications and dialysis related hospitalizations.
  2. This project will be incorporated as a key component of our data and analytics ecosystem. Incorporating the sensors into the device will not only reduce overall cost but also eliminate many of the barriers to collecting this data – additional equipment, manual measurement steps, and cross-platform communication. The application of machine learning and advanced analytical techniques to these large sets of high quality data will be used to focus on improving patient outcomes.
     

Stanford University, Fluo Medical

  1. The vision for the Fluo device is a wearable, real-time monitor of arteriovenous fistula attributes that identifies failing or properly maturing arteriovenous fistulas; patients would benefit from a reduction in fistula failures. To operate, the device would not require significant time, skills, or concurrent connection to a hemodialysis machine. When these failures are identified, providers may be notified in order to evaluate if early interventions are necessary for the patient.
  2. The future goals of Fluo Medical involve collaborating with field experts to develop a cost-effective works-like prototype, collecting patient and care team input to increase device adoption, enhancing clinical research and further developing intellectual property.
     

Binnovate Digital Health BV

  1. RenalTracker is a digitally-delivered lifestyle change platform to help patients delay dialysis. It uses and evidence-based curriculum, health coaching, and data analytics.
  2. Currently, we have had more than 850+ patients. However, after KidneyX, we're ramping up our efforts to fuel our growth through private/equity funding and will continue to forge partnerships with dialysis clinics and health organizations to increase clinical basis for RenalTracker.     
     

Stanford University

  1. Our product, the OpticLine, aims to detect infection at its earliest stages in peritoneal dialysis (PD) patients by using optical density to measure the white blood cell (WBC) concentrations of their waste fluid. Our device will help treat PD patients sooner and prevent peritoneal scarring. The peritoneum acts as a natural exchange barrier during PD and by preventing scarring, the OpticLine will allow patients to continue using PD and prevent hospitalization costs caused by infection. 
  2. We are very grateful for the support and opportunities KidneyX has granted us. Because the major risk with our device is not knowing if our benchtop experiments are translatable to a real-world setting, our future goals are to test our device with patient waste fluid samples, to make our device fully autonomous, and pursue clinical trials. These next steps will help deliver OpticLine to peritoneal dialysis patients and improve their outcomes by detecting infection earlier.

 

Improving Dialysis

University of Michigan

  1. We have discovered a way to make a tunneled dialysis catheter insert device that will elute nitric oxide (NO). NO is a gaseous molecule that will provide an anti-microbial and anti-thrombotic function at the hub and tip of the catheter. We hypothesize that this effect will diminish infection and improve catheter function over time. We plan to use the KidneyX prize to manufacture the catheter insert and test our hypothesis in a bioreactor, as well as a sheep model.
  2. Once our KidneyX phase 1 project is completed, we hope to test our tunneled dialysis catheter insert device in a chronic animal model. We intend to apply for the KidneyX prize phase 2, which would support our plan to test the insert device in man, with the ultimate goal of reducing infection and thrombosis in patients who dialyze by means of a catheter, and, as a result, improving the disease burden on dialysis patients and families.
     

Access for Life, Inc.

  1. Access for Life is developing a subcutaneous, stent-like device, JEM™, to reduce vessel damage, initially for dialysis patients. As a Smart sensor-enabled needle guide, it enables safe home dialysis while sleeping, eliminates needle entry pain, extends lives, and reduces costs. The sensors indicate the correct needle position while transmitting data about blood flow, core temperature, and hydration.  This data enables clinicians to provide precision, personalized care to manage blood vessel health as well as the patient’s overall condition.
  2. Our immediate target is a set of confirmatory large animal trials to validate encapsulation, lack of metal on metal contact, and ease of cannulation. Once completed, we will bring our technology to a clinical research partner to bring this breakthrough approach to dialysis into the ESRD world.
     

Temple University

  1. Our aim is to replicate kidney function by creating chemically synthesized, atomically precise membranes as thin as a single molecule to better replicate the selective membranes in human cells.
  2. Our ultimate goal is to create a compact multistage membrane system that can replicate the function of the proximal tubule to selectively recover small nutrients, salts, and water from the filtrate, reformulate, and return to the blood while excluding toxins, opening the door renal replacement personalized beyond simple dialysis.
     

Mount Sinai Renal Research Institute

  1. Protein-bound uremic toxins are associated with poorer outcomes in dialysis patients. These toxins are bound to albumin and cannot be removed with conventional hemodialysis. Through "displacer-enhanced dialysis” displacers substances are infused into the blood upstream of the dialyzer. They bind to the same albumin binding sites as the toxins, displace them from the albumin molecule and allow them to be easily dialyzed. Our previous laboratory and human studies have shown 3-times greater dialytic removal of protein-bound uremic toxins with displacers.
  2. Our treatment method requires displacer molecules that can be used chronically without acute and long-term negative side effects. Our first goal is to identify promising displacers using cheminformatic tools and to test their effectiveness utilizing high-throughput laboratory methods. We primarily envision the use of existing drugs with well-documented safety profiles. Secondly, we are planning a double-blind, randomized prospective trial of displacer-enhanced dialysis to study the effects of our method on protein-bound uremic toxins levels and patient-reported and clinical outcomes.
     

Beth Israel Deaconess Medical Center and BioSurfaces, Inc.

  1. Use of an arteriovenous graft (AVG) is associated with high risk for failure due to uncontrolled cell growth at the outflow end. An artificial electrospun AVG (NuSpun) has been developed that has excellent kink-resistance, self-sealing after needle puncture, softness/ease of handling and ability to promote the body’s own cells to grow into the device. Using this device, our goal is to incorporate drugs into specific regions within the NuSpun fibers to control cell overgrowth within the outflow vein.
  2. Funds from KidneyX will be used to conduct early studies in which we plan to obtain detailed characterization of the drug release profile. We also will produce prototypes demonstrating different drug spatial localization and conduct initial preclinical assessment. Dr. Yael Vin stated, “[w]e have united a diverse multidisciplinary team of researchers that believe that developing a novel AVG that combines multiple benefits each demonstrated by certain grafts and devices may result in a significantly improved graft for hemodialysis patients.”

 

Engineering

Curion Research Corporation, UCLA and the University of Arkansas

  1. Our project involves the development of a novel technology for renal replacement therapy that does not utilize water/dialysate, nor are living cells used. The technology couples for the first time new multiple wafer electrodeionization devices with pressure driven ultrafiltration, nanofiltration and reverse osmosis modules. The technologic advances and approaches employed in this proposal can be potentially utilized in the future in various configurations that include standalone, wearable, and implantable renal replacement devices to treat patients with compromised kidney function.
  2. The future goals of the project are to demonstrate proof of concept of a portable device and to acquire investor funding. Over the next 4-6 months we will integrate all pressure driven membrane modules and electrodeionization subcomponents in the portable device. Software to control the device will also be integrated and tested. Functional tests will be performed including the sensing and modulation of transport of specific ions. Finally, the device will be tested in pigs for various lengths of time.
     

University of Washington, Center for Dialysis Innovation

  1. The University of Washington Center for Dialysis Innovation was launched in 2017 with the mission of transforming dialysis using state-of-the-art biomaterials and engineering technologies. We are focused on developing the AKTIV (Ambulatory Kidney to Improve Vitality): a wearable, miniaturized dialysis system that is water-efficient, lightweight, requires minimal anticoagulation, offers complication-free blood access, and is robust and patient-friendly. The AKTIV will not only sustain life, but provide higher quality, more productive lives for patients by giving them back their mobility.
  2. The KidneyX competition prize will accelerate our technology development and prototype evaluation timelines, and will help make the AKTIV a reality for patients that much sooner. We are aiming to have a device ready for clinical trials within 5 years. KidneyX is a truly exciting development this field sorely needs, and will spur development of innovations that will make a real impact on patients.
     

Qidni Labs, Inc.

  1. This is a system that will allow for the automated and easy removal of any accumulated air in the blood path for wearable dialysis machines at various orientations. Machines used in hospitals and clinics must have a vertical orientation to work safely. A pump and an accelerometer are used to reset the separation chamber level and inform the patient when it occurs. The accelerometer and vibration unit are similar to what is used in mobile phones.
  2. This project is part of our larger goal of designing and building a safe, effective system that is small enough to be worn on the body and be used for daily treatments instead of traditional hemodialysis. This will allow greater freedom and mobility for patients that need hemodialysis.
     

UC San Francisco, Vanderbilt University and Silicon Kidney

  1. The iHemo is a dialysis machine that will allow patients to receive the benefits of frequent and prolonged hemodialysis with the operational simplicity of peritoneal dialysis. The iHemo relies on an implanted hemodialyzer (HemoCartridge) to create permanent internal vascular connections, which eliminates needle-based vascular access. The iHemo will improve dialysis patient outcomes and their quality of life by eliminating risk of accidental blood disconnect and encouraging frequent and prolonged hemodialysis sessions, especially within the home setting.
  2. We hope that ASN will introduce us to investors and accelerators who have the ability to connect us with influential audiences. With their support, we hope to demonstrate the technical and clinical feasibility of the iHemo and raise its visibility to the dialysis patient and provider community.
     

Miromatrix Medical, Inc

  1. Our unique perfusion decellularization process essentially washes out the cells from a discarded pig kidney, leaving all the vasculature or blood vessels and microstructures that define the kidney’s structure intact. The technology then introduces human vascular and kidney cells into the decellularized kidney matrix, under defined culture conditions, ultimately recellularizing it. The first step in the process is the introduction of vascular (endothelial) cells to revascularize the kidney matrix and demonstrate that it can be implanted and sustain long-term perfusion. This was our award-winning entry demonstrating we achieved a critical milestone because without an intact and functional vasculature, there is no way to bioengineer a whole kidney.
  2. We are now focused on introducing the functional kidney cells to next demonstrate renal function of the recellularized kidney, with our ultimate goal to develop fully functional transplantable kidneys.
     
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Kidney News Online reached out to all 15 winners of the KidneyX Redesign Dialysis Phase 1 competition to get more information on their projects.

All winners answered the following questions:

  1. Briefly summarize your project.
  2. What future goals do you have for your project after winning the KidneyX prize competition?
     

The winners were presented in three different categories based on their project’s basis. These include:

Diagnostics
Improving Dialysis
Engineering

Please keep up-to-date with KidneyX information and the rollout of future prize competitions on kidneyx.org.

Diagnostics

University of Alabama at Birmingham

  1. Our wearable telehealth device is worn over the patient’s arteriovenous fistula or graft. It detects dialysis vascular access clotting in real time by using sound wave data and machine learning algorithms. This proactive approach allows for early clot detection and early referral for intervention, thus avoiding missed dialysis related distress symptoms for the patient and related medical complications.
  2. We will now be working on miniaturizing the device and validating the algorithms before commercializing the device.  We are also working on devising machine learning algorithms to help detect vascular access stenosis.
     

Outset Medical, Inc.

  1. The Outset project focuses on personalizing dialysis treatments by using machine integrated sensors to automatically obtain physiologic measurements. These embedded sensors will monitor a patient’s vascular access health, volume status, and cardiac parameters without the need for manual steps or workflow interruption. This seamlessly collected data, and will allow physicians to customize a patient's treatment based on personal data history and provide an avenue for the clinical predictiveness needed to decrease intradialytic complications and dialysis related hospitalizations.
  2. This project will be incorporated as a key component of our data and analytics ecosystem. Incorporating the sensors into the device will not only reduce overall cost but also eliminate many of the barriers to collecting this data – additional equipment, manual measurement steps, and cross-platform communication. The application of machine learning and advanced analytical techniques to these large sets of high quality data will be used to focus on improving patient outcomes.
     

Stanford University, Fluo Medical

  1. The vision for the Fluo device is a wearable, real-time monitor of arteriovenous fistula attributes that identifies failing or properly maturing arteriovenous fistulas; patients would benefit from a reduction in fistula failures. To operate, the device would not require significant time, skills, or concurrent connection to a hemodialysis machine. When these failures are identified, providers may be notified in order to evaluate if early interventions are necessary for the patient.
  2. The future goals of Fluo Medical involve collaborating with field experts to develop a cost-effective works-like prototype, collecting patient and care team input to increase device adoption, enhancing clinical research and further developing intellectual property.
     

Binnovate Digital Health BV

  1. RenalTracker is a digitally-delivered lifestyle change platform to help patients delay dialysis. It uses and evidence-based curriculum, health coaching, and data analytics.
  2. Currently, we have had more than 850+ patients. However, after KidneyX, we're ramping up our efforts to fuel our growth through private/equity funding and will continue to forge partnerships with dialysis clinics and health organizations to increase clinical basis for RenalTracker.     
     

Stanford University

  1. Our product, the OpticLine, aims to detect infection at its earliest stages in peritoneal dialysis (PD) patients by using optical density to measure the white blood cell (WBC) concentrations of their waste fluid. Our device will help treat PD patients sooner and prevent peritoneal scarring. The peritoneum acts as a natural exchange barrier during PD and by preventing scarring, the OpticLine will allow patients to continue using PD and prevent hospitalization costs caused by infection. 
  2. We are very grateful for the support and opportunities KidneyX has granted us. Because the major risk with our device is not knowing if our benchtop experiments are translatable to a real-world setting, our future goals are to test our device with patient waste fluid samples, to make our device fully autonomous, and pursue clinical trials. These next steps will help deliver OpticLine to peritoneal dialysis patients and improve their outcomes by detecting infection earlier.

 

Improving Dialysis

University of Michigan

  1. We have discovered a way to make a tunneled dialysis catheter insert device that will elute nitric oxide (NO). NO is a gaseous molecule that will provide an anti-microbial and anti-thrombotic function at the hub and tip of the catheter. We hypothesize that this effect will diminish infection and improve catheter function over time. We plan to use the KidneyX prize to manufacture the catheter insert and test our hypothesis in a bioreactor, as well as a sheep model.
  2. Once our KidneyX phase 1 project is completed, we hope to test our tunneled dialysis catheter insert device in a chronic animal model. We intend to apply for the KidneyX prize phase 2, which would support our plan to test the insert device in man, with the ultimate goal of reducing infection and thrombosis in patients who dialyze by means of a catheter, and, as a result, improving the disease burden on dialysis patients and families.
     

Access for Life, Inc.

  1. Access for Life is developing a subcutaneous, stent-like device, JEM™, to reduce vessel damage, initially for dialysis patients. As a Smart sensor-enabled needle guide, it enables safe home dialysis while sleeping, eliminates needle entry pain, extends lives, and reduces costs. The sensors indicate the correct needle position while transmitting data about blood flow, core temperature, and hydration.  This data enables clinicians to provide precision, personalized care to manage blood vessel health as well as the patient’s overall condition.
  2. Our immediate target is a set of confirmatory large animal trials to validate encapsulation, lack of metal on metal contact, and ease of cannulation. Once completed, we will bring our technology to a clinical research partner to bring this breakthrough approach to dialysis into the ESRD world.
     

Temple University

  1. Our aim is to replicate kidney function by creating chemically synthesized, atomically precise membranes as thin as a single molecule to better replicate the selective membranes in human cells.
  2. Our ultimate goal is to create a compact multistage membrane system that can replicate the function of the proximal tubule to selectively recover small nutrients, salts, and water from the filtrate, reformulate, and return to the blood while excluding toxins, opening the door renal replacement personalized beyond simple dialysis.
     

Mount Sinai Renal Research Institute

  1. Protein-bound uremic toxins are associated with poorer outcomes in dialysis patients. These toxins are bound to albumin and cannot be removed with conventional hemodialysis. Through "displacer-enhanced dialysis” displacers substances are infused into the blood upstream of the dialyzer. They bind to the same albumin binding sites as the toxins, displace them from the albumin molecule and allow them to be easily dialyzed. Our previous laboratory and human studies have shown 3-times greater dialytic removal of protein-bound uremic toxins with displacers.
  2. Our treatment method requires displacer molecules that can be used chronically without acute and long-term negative side effects. Our first goal is to identify promising displacers using cheminformatic tools and to test their effectiveness utilizing high-throughput laboratory methods. We primarily envision the use of existing drugs with well-documented safety profiles. Secondly, we are planning a double-blind, randomized prospective trial of displacer-enhanced dialysis to study the effects of our method on protein-bound uremic toxins levels and patient-reported and clinical outcomes.
     

Beth Israel Deaconess Medical Center and BioSurfaces, Inc.

  1. Use of an arteriovenous graft (AVG) is associated with high risk for failure due to uncontrolled cell growth at the outflow end. An artificial electrospun AVG (NuSpun) has been developed that has excellent kink-resistance, self-sealing after needle puncture, softness/ease of handling and ability to promote the body’s own cells to grow into the device. Using this device, our goal is to incorporate drugs into specific regions within the NuSpun fibers to control cell overgrowth within the outflow vein.
  2. Funds from KidneyX will be used to conduct early studies in which we plan to obtain detailed characterization of the drug release profile. We also will produce prototypes demonstrating different drug spatial localization and conduct initial preclinical assessment. Dr. Yael Vin stated, “[w]e have united a diverse multidisciplinary team of researchers that believe that developing a novel AVG that combines multiple benefits each demonstrated by certain grafts and devices may result in a significantly improved graft for hemodialysis patients.”

 

Engineering

Curion Research Corporation, UCLA and the University of Arkansas

  1. Our project involves the development of a novel technology for renal replacement therapy that does not utilize water/dialysate, nor are living cells used. The technology couples for the first time new multiple wafer electrodeionization devices with pressure driven ultrafiltration, nanofiltration and reverse osmosis modules. The technologic advances and approaches employed in this proposal can be potentially utilized in the future in various configurations that include standalone, wearable, and implantable renal replacement devices to treat patients with compromised kidney function.
  2. The future goals of the project are to demonstrate proof of concept of a portable device and to acquire investor funding. Over the next 4-6 months we will integrate all pressure driven membrane modules and electrodeionization subcomponents in the portable device. Software to control the device will also be integrated and tested. Functional tests will be performed including the sensing and modulation of transport of specific ions. Finally, the device will be tested in pigs for various lengths of time.
     

University of Washington, Center for Dialysis Innovation

  1. The University of Washington Center for Dialysis Innovation was launched in 2017 with the mission of transforming dialysis using state-of-the-art biomaterials and engineering technologies. We are focused on developing the AKTIV (Ambulatory Kidney to Improve Vitality): a wearable, miniaturized dialysis system that is water-efficient, lightweight, requires minimal anticoagulation, offers complication-free blood access, and is robust and patient-friendly. The AKTIV will not only sustain life, but provide higher quality, more productive lives for patients by giving them back their mobility.
  2. The KidneyX competition prize will accelerate our technology development and prototype evaluation timelines, and will help make the AKTIV a reality for patients that much sooner. We are aiming to have a device ready for clinical trials within 5 years. KidneyX is a truly exciting development this field sorely needs, and will spur development of innovations that will make a real impact on patients.
     

Qidni Labs, Inc.

  1. This is a system that will allow for the automated and easy removal of any accumulated air in the blood path for wearable dialysis machines at various orientations. Machines used in hospitals and clinics must have a vertical orientation to work safely. A pump and an accelerometer are used to reset the separation chamber level and inform the patient when it occurs. The accelerometer and vibration unit are similar to what is used in mobile phones.
  2. This project is part of our larger goal of designing and building a safe, effective system that is small enough to be worn on the body and be used for daily treatments instead of traditional hemodialysis. This will allow greater freedom and mobility for patients that need hemodialysis.
     

UC San Francisco, Vanderbilt University and Silicon Kidney

  1. The iHemo is a dialysis machine that will allow patients to receive the benefits of frequent and prolonged hemodialysis with the operational simplicity of peritoneal dialysis. The iHemo relies on an implanted hemodialyzer (HemoCartridge) to create permanent internal vascular connections, which eliminates needle-based vascular access. The iHemo will improve dialysis patient outcomes and their quality of life by eliminating risk of accidental blood disconnect and encouraging frequent and prolonged hemodialysis sessions, especially within the home setting.
  2. We hope that ASN will introduce us to investors and accelerators who have the ability to connect us with influential audiences. With their support, we hope to demonstrate the technical and clinical feasibility of the iHemo and raise its visibility to the dialysis patient and provider community.
     

Miromatrix Medical, Inc

  1. Our unique perfusion decellularization process essentially washes out the cells from a discarded pig kidney, leaving all the vasculature or blood vessels and microstructures that define the kidney’s structure intact. The technology then introduces human vascular and kidney cells into the decellularized kidney matrix, under defined culture conditions, ultimately recellularizing it. The first step in the process is the introduction of vascular (endothelial) cells to revascularize the kidney matrix and demonstrate that it can be implanted and sustain long-term perfusion. This was our award-winning entry demonstrating we achieved a critical milestone because without an intact and functional vasculature, there is no way to bioengineer a whole kidney.
  2. We are now focused on introducing the functional kidney cells to next demonstrate renal function of the recellularized kidney, with our ultimate goal to develop fully functional transplantable kidneys.
     
Date:
Sunday, May 19, 2019