Innovators at KidneyX competition: Award winners look at access, hemodialysis process

WASHINGTON — HHS awarded more than $1 million in prize money last week during its first KidneyX Summit. Here is a summary of the recipients and their projects.

Vascular access

Researchers/Developers: Vinay Narasimha Krishna, MD, Department of medicine, division of nephrology, The University of Alabama at Birmingham; and Mohammad R. Haider, PhD, and Steven D. Gardner, Department of electrical and computer engineering, The University of Alabama at Birmingham

Device: A non-invasive, wearable telehealth device to detect thrombosis and monitor the health of arteriovenous fistulas and grafts in patients on hemodialysis. It uses a small sensor to monitor the patient’s vascular access in real time and sends the acquired data to a local microcontroller for signal processing. A machine learning algorithm then classifies the input data to identify hemodialysis vascular access clotting and automatically alerts patients and their health care teams.

Researchers/Developers: Dimitri Augustin, MD

Stanford University Nephrology fellow and Stanford Biodesign alumnus

Racquel Redwood Meng

Stanford Biodesign alumnus

Device: A wearable, real-time monitor of arteriovenous fistula attributes that identifies failing or properly maturing arteriovenous fistulas. Patients will benefit from real-time arteriovenous fistula data immediately postoperatively without requiring significant time, skills of a health care professional or concurrent connection to a hemodialysis machine. When early arteriovenous fistula maturation failures are identified, providers will be notified in order to evaluate if early interventions are necessary.

Researchers/Developers: Access for Life Inc., Daniel Nadis, Roger Mason, MD

Device: This smart sensor-enhanced needle guide is implanted in the subcutaneous tissue. It directs a blunt needle through an opening in the skin to an underlying fistula, reducing pain from large bore needles. A biosensor on the JEM cylinder with an audio-visual alarm will reduce risks of back wall perforation and needle dislodgement. The sensors also measure blood flow, allowing nephrologists to identify increased stenosis risk.

Researchers/Developers: Yael Vin, MD, MPH, FACS; and Matthew Phaneuf

Beth Israel Deaconess Medical Center in Boston

BioSurfaces LLC in Ashland, Mass.

Device: Beth Israel and BioSurfaces LLC are developing a drug-eluting electrospun hemodialysis graft. “We have the technology to incorporate drugs that reduce neointimal hyperplasia into the electrospun fibers and localize this attachment to a certain segment (venous edge) and layers of choice (inner layer, mid layer),” the researchers wrote.

Hemodialysis

Researchers/Developers: Outset Medical Inc. in San Jose, Calif.

Device: The proposed innovation provides for an integrated, automated means of monitoring of important physiological parameters during hemodialysis, including blood volume status (absolute and relative), vascular access function (flow rate and circulation) and ultrafiltration rate. “This is especially impactful in care settings such as in-home or in-center self-care hemodialysis, where patients take on greater ownership of their therapy,” the researchers wrote.

Researchers/Developers: Christian Schafmeister, PhD

Department of chemistry, College of Science and Technology, Temple University

Device: Schafmeister and colleagues are developing atomically precise membranes for high-flux and selective removal of blood toxins during hemodialysis. “We propose a solution to the problem of replicating kidney functions by creating chemically synthesized, atomically precise membranes that can be as thin as a single-molecule that mimic the highly permeable and selective membrane channels present in human cells,” Schafmeister wrote. “ ... This will open the door for renal replacement therapy to personalized/precise medicine beyond simple dialysis.”

Researchers/Developers: Peter Kotanko, MD; Stephan Thijssen, MD; Xia Tao, MD, PhD;

and Vaibhav Maheshwari, PhD

Renal Research Institute LLC in New York

Device: Kotanko and colleagues are developing a device to improve the intradialytic removal of protein-bound uremic toxins using binding competitors. Hemodialysis can remove uremic toxins, but protein-bound uremic toxins are the most difficult, the researchers wrote. They are infusing a displacer substance into the dialysis machine’s blood tubing upstream of the artificial kidney. The displacer binds to the same binding sites on albumin as the toxins. “Thus, it quite effectively competes with the toxins for their albumin binding, displaces them from the albumin molecule, and, once they are free, they can then be easily removed in the artificial kidney,” wrote the researchers. “In laboratory experiments, we have seen up to a three-fold increase in the removal rate of these toxins.” The plan with KidneyX funding is to develop an ideal displacer (or a combination of displacers) that can be used routinely in hemodialysis and study the impact on toxin removal.

Researchers/Developers: Ira Kurtz, MD, David Geffen School of Medicine at University of California, Los Angeles

Roland Ludlow, CEO and founder, Curion Research Corporation

Jamie Hestekin, MD, professor, department of chemical engineering, University of Arkansas

Device: The group is developing dialysate- and cell-free renal replacement technology that would not require the use of an external dialysate solution to drive the flux of ions and water across a membrane. The device couples multiple wafer electro deionization technology with pressure-driven ultrafiltration, nanofiltration and reverse osmosis modules specifically developed for this project.

CKD

Researchers/Developers: Kirby Binayao, RN, MBA; Karl Quint, MD; and Karen Naranjo

Renal Tracker, the Netherlands

Device: Renal Tracker delivers new or existing CKD self-management programs via digital platforms and uses behavior change elements to help patients modify progression risks.

Home dialysis

Researchers/Developers: Janelle Kaneda, Alisha Birk and Mark Buckup

Bioengineering department, Stanford University

Device: This device utilizes optical interrogation methods for early diagnosis of peritonitis.

The OpticLine will use spectrophotometry to analyze the optical density of whole blood counts (WBCs) in the dialysis waste fluid to gauge for infection. With a prototype, various WBC concentrations in Dulbecco’s phosphate-buffered saline were measured. “Our results from our works-like spectrophotometer prototype experiment indicate that we detect a significant difference in optical density between our two WBC concentrations of interest: 10 WBC/mm3 (normal) and 1,000 WBC/mm3 (infected) (P value = 1.47E-07),” the researchers wrote.

Infection control

Researchers/Developers: Alexander Yevzlin, MD

Director of interventional nephrology, division of nephrology

University of Michigan in Ann Arbor

Device: This is a nitric oxide-eluting, disposable hemodialysis catheter insert aimed at preventing infection and thrombosis. Nitric oxide (NO) is an endogenously formed gaseous molecule that is well known to play a key role in preventing infection and thrombosis. The disposable NO release insert will be replaced at each dialysis session (every 2 to 3 days).

Artificial kidney

Researchers/Developers: Shuvo Roy, PhD; William H. Fissell, MD; and Charles Blaha, MS

University of California, San Francisco; Vanderbilt University Medical Center in Nashville;

Silicon Kidney

Device: The researchers are developing a hemodialysis system (iHemo) that involves implanting a compact hemodialyzer (HemoCartridge) that creates a permanent internal vascular connection. “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 treatments, especially within the home setting,” they wrote.

Researchers/Developers: Jonathan Himmelfarb, MD; Buddy Ratner, PhD; Larry Kessler, ScD; Kassandra Thomson, PhD; Glenda V. Roberts; and Anna Galperin, PhD

University of Washington Center for Dialysis Innovation in Seattle

Device: The UW Center for Dialysis Innovation is developing the Ambulatory Kidney to Improve Vitality (AKTIV): a wearable, miniaturized dialysis system that “is low-cost, water-efficient, requires minimal anticoagulation, offers complication-free blood access and is patient-friendly,” the researchers wrote. “The AKTIV will provide sustained life, and higher quality, more productive lives for patients worldwide, allowing almost unlimited mobility, dramatically reduce pharmaceutical burden and reduce dietary restrictions.”

Researchers/Developers: Qidni Labs Inc.

Device: This is a project to develop an automatic air removal system that can be used safely in a wearable renal therapy device with minimal user intervention. This system uses an air removal filter of the design used in cardiopulmonary bypass and extracorporeal membrane oxygenation systems. This system can also determine and signal the patient with an alarm if the hydrophobic isolation filter element has been wetted and thus has reduced the accuracy of the integrated return blood pressure monitor.

Transplantation

Researchers/Developers: Jeff Ross; Joseph Uzarski

Miromatrix Medical Inc., Eden Prairie, Minn.

Device: Using multiple patented technologies, Miromatrix is working to bioengineer new kidney grafts that consist of human cells grown in pig extracellular matrix scaffolds. “Perfusion decellularization removes the native cells from pig kidneys while leaving behind a transplantable scaffold that provides the framework needed to grow a new kidney graft,” the developers wrote. Miromatrix’s perfusion software drives cells to regenerate kidney structures, including blood vessels and nephrons, in laboratory bioreactors. As an initial step, Miromatrix has developed a process to revascularize kidney grafts with consistent performance in vivo. Revascularized kidney grafts have shown sustained vascular patency on follow-up angiographies in chronic pig transplantation models without evidence of blood clotting.

Reference:

www.kidneyx.org/WhatWeDo/PrizeCompetitions/redesigndialysisphasei

Editor’s note: On May 7, 2019, the article was updated add Vinay Narasimha Krishna, MD, to the entry from the Department of electrical and computer engineering, The University of Alabama at Birmingham. Healio/Nephrology regrets the error.

 

 

 

WASHINGTON — HHS awarded more than $1 million in prize money last week during its first KidneyX Summit. Here is a summary of the recipients and their projects.

Vascular access

Researchers/Developers: Vinay Narasimha Krishna, MD, Department of medicine, division of nephrology, The University of Alabama at Birmingham; and Mohammad R. Haider, PhD, and Steven D. Gardner, Department of electrical and computer engineering, The University of Alabama at Birmingham

Device: A non-invasive, wearable telehealth device to detect thrombosis and monitor the health of arteriovenous fistulas and grafts in patients on hemodialysis. It uses a small sensor to monitor the patient’s vascular access in real time and sends the acquired data to a local microcontroller for signal processing. A machine learning algorithm then classifies the input data to identify hemodialysis vascular access clotting and automatically alerts patients and their health care teams.

Researchers/Developers: Dimitri Augustin, MD

Stanford University Nephrology fellow and Stanford Biodesign alumnus

Racquel Redwood Meng

Stanford Biodesign alumnus

Device: A wearable, real-time monitor of arteriovenous fistula attributes that identifies failing or properly maturing arteriovenous fistulas. Patients will benefit from real-time arteriovenous fistula data immediately postoperatively without requiring significant time, skills of a health care professional or concurrent connection to a hemodialysis machine. When early arteriovenous fistula maturation failures are identified, providers will be notified in order to evaluate if early interventions are necessary.

Researchers/Developers: Access for Life Inc., Daniel Nadis, Roger Mason, MD

Device: This smart sensor-enhanced needle guide is implanted in the subcutaneous tissue. It directs a blunt needle through an opening in the skin to an underlying fistula, reducing pain from large bore needles. A biosensor on the JEM cylinder with an audio-visual alarm will reduce risks of back wall perforation and needle dislodgement. The sensors also measure blood flow, allowing nephrologists to identify increased stenosis risk.

Researchers/Developers: Yael Vin, MD, MPH, FACS; and Matthew Phaneuf

Beth Israel Deaconess Medical Center in Boston

BioSurfaces LLC in Ashland, Mass.

Device: Beth Israel and BioSurfaces LLC are developing a drug-eluting electrospun hemodialysis graft. “We have the technology to incorporate drugs that reduce neointimal hyperplasia into the electrospun fibers and localize this attachment to a certain segment (venous edge) and layers of choice (inner layer, mid layer),” the researchers wrote.

Hemodialysis

Researchers/Developers: Outset Medical Inc. in San Jose, Calif.

Device: The proposed innovation provides for an integrated, automated means of monitoring of important physiological parameters during hemodialysis, including blood volume status (absolute and relative), vascular access function (flow rate and circulation) and ultrafiltration rate. “This is especially impactful in care settings such as in-home or in-center self-care hemodialysis, where patients take on greater ownership of their therapy,” the researchers wrote.

Researchers/Developers: Christian Schafmeister, PhD

Department of chemistry, College of Science and Technology, Temple University

Device: Schafmeister and colleagues are developing atomically precise membranes for high-flux and selective removal of blood toxins during hemodialysis. “We propose a solution to the problem of replicating kidney functions by creating chemically synthesized, atomically precise membranes that can be as thin as a single-molecule that mimic the highly permeable and selective membrane channels present in human cells,” Schafmeister wrote. “ ... This will open the door for renal replacement therapy to personalized/precise medicine beyond simple dialysis.”

Researchers/Developers: Peter Kotanko, MD; Stephan Thijssen, MD; Xia Tao, MD, PhD;

and Vaibhav Maheshwari, PhD

Renal Research Institute LLC in New York

Device: Kotanko and colleagues are developing a device to improve the intradialytic removal of protein-bound uremic toxins using binding competitors. Hemodialysis can remove uremic toxins, but protein-bound uremic toxins are the most difficult, the researchers wrote. They are infusing a displacer substance into the dialysis machine’s blood tubing upstream of the artificial kidney. The displacer binds to the same binding sites on albumin as the toxins. “Thus, it quite effectively competes with the toxins for their albumin binding, displaces them from the albumin molecule, and, once they are free, they can then be easily removed in the artificial kidney,” wrote the researchers. “In laboratory experiments, we have seen up to a three-fold increase in the removal rate of these toxins.” The plan with KidneyX funding is to develop an ideal displacer (or a combination of displacers) that can be used routinely in hemodialysis and study the impact on toxin removal.

Researchers/Developers: Ira Kurtz, MD, David Geffen School of Medicine at University of California, Los Angeles

Roland Ludlow, CEO and founder, Curion Research Corporation

Jamie Hestekin, MD, professor, department of chemical engineering, University of Arkansas

Device: The group is developing dialysate- and cell-free renal replacement technology that would not require the use of an external dialysate solution to drive the flux of ions and water across a membrane. The device couples multiple wafer electro deionization technology with pressure-driven ultrafiltration, nanofiltration and reverse osmosis modules specifically developed for this project.

CKD

Researchers/Developers: Kirby Binayao, RN, MBA; Karl Quint, MD; and Karen Naranjo

Renal Tracker, the Netherlands

Device: Renal Tracker delivers new or existing CKD self-management programs via digital platforms and uses behavior change elements to help patients modify progression risks.

Home dialysis

Researchers/Developers: Janelle Kaneda, Alisha Birk and Mark Buckup

Bioengineering department, Stanford University

Device: This device utilizes optical interrogation methods for early diagnosis of peritonitis.

The OpticLine will use spectrophotometry to analyze the optical density of whole blood counts (WBCs) in the dialysis waste fluid to gauge for infection. With a prototype, various WBC concentrations in Dulbecco’s phosphate-buffered saline were measured. “Our results from our works-like spectrophotometer prototype experiment indicate that we detect a significant difference in optical density between our two WBC concentrations of interest: 10 WBC/mm3 (normal) and 1,000 WBC/mm3 (infected) (P value = 1.47E-07),” the researchers wrote.

Infection control

Researchers/Developers: Alexander Yevzlin, MD

Director of interventional nephrology, division of nephrology

University of Michigan in Ann Arbor

Device: This is a nitric oxide-eluting, disposable hemodialysis catheter insert aimed at preventing infection and thrombosis. Nitric oxide (NO) is an endogenously formed gaseous molecule that is well known to play a key role in preventing infection and thrombosis. The disposable NO release insert will be replaced at each dialysis session (every 2 to 3 days).

Artificial kidney

Researchers/Developers: Shuvo Roy, PhD; William H. Fissell, MD; and Charles Blaha, MS

University of California, San Francisco; Vanderbilt University Medical Center in Nashville;

Silicon Kidney

Device: The researchers are developing a hemodialysis system (iHemo) that involves implanting a compact hemodialyzer (HemoCartridge) that creates a permanent internal vascular connection. “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 treatments, especially within the home setting,” they wrote.

Researchers/Developers: Jonathan Himmelfarb, MD; Buddy Ratner, PhD; Larry Kessler, ScD; Kassandra Thomson, PhD; Glenda V. Roberts; and Anna Galperin, PhD

University of Washington Center for Dialysis Innovation in Seattle

Device: The UW Center for Dialysis Innovation is developing the Ambulatory Kidney to Improve Vitality (AKTIV): a wearable, miniaturized dialysis system that “is low-cost, water-efficient, requires minimal anticoagulation, offers complication-free blood access and is patient-friendly,” the researchers wrote. “The AKTIV will provide sustained life, and higher quality, more productive lives for patients worldwide, allowing almost unlimited mobility, dramatically reduce pharmaceutical burden and reduce dietary restrictions.”

Researchers/Developers: Qidni Labs Inc.

Device: This is a project to develop an automatic air removal system that can be used safely in a wearable renal therapy device with minimal user intervention. This system uses an air removal filter of the design used in cardiopulmonary bypass and extracorporeal membrane oxygenation systems. This system can also determine and signal the patient with an alarm if the hydrophobic isolation filter element has been wetted and thus has reduced the accuracy of the integrated return blood pressure monitor.

Transplantation

Researchers/Developers: Jeff Ross; Joseph Uzarski

Miromatrix Medical Inc., Eden Prairie, Minn.

Device: Using multiple patented technologies, Miromatrix is working to bioengineer new kidney grafts that consist of human cells grown in pig extracellular matrix scaffolds. “Perfusion decellularization removes the native cells from pig kidneys while leaving behind a transplantable scaffold that provides the framework needed to grow a new kidney graft,” the developers wrote. Miromatrix’s perfusion software drives cells to regenerate kidney structures, including blood vessels and nephrons, in laboratory bioreactors. As an initial step, Miromatrix has developed a process to revascularize kidney grafts with consistent performance in vivo. Revascularized kidney grafts have shown sustained vascular patency on follow-up angiographies in chronic pig transplantation models without evidence of blood clotting.

Reference:

www.kidneyx.org/WhatWeDo/PrizeCompetitions/redesigndialysisphasei

Editor’s note: On May 7, 2019, the article was updated add Vinay Narasimha Krishna, MD, to the entry from the Department of electrical and computer engineering, The University of Alabama at Birmingham. Healio/Nephrology regrets the error.

 

 

 

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