Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

Inclusion Criteria:

• Are between 18 and 80 years of age and Care Partner is at least 18 years of age atthe time of signing consent.

• Have a diagnosis of end stage kidney disease (ESKD) adequately treated bymaintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and bedeemed stable by their treating nephrologist prior to the end of the ScreeningPeriod

• Have a well-functioning and stable vascular access (tunneled central venous catheterarteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/minprior to the end of Screening

• Can successfully complete a Skills and Comprehension Assessment with a Care Partnerprior to the completion of the Training Period.

Exclusion Criteria:

• Hgb level of < 9 g/dL at Screening

• Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during theRun-In period defined as:

1. Persistent pre-dialysis sitting SBP < 100 mmHg despite medical therapy,

2. Nadir intradialytic Systolic Blood Pressure (SBP) < 90 mmHg, if Subject'spre-HD SBP < 160 mmHg

3. Nadir intradialytic SBP < 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg

• Documented history of non-adherence to dialysis therapy that would preventsuccessful completion of the study

• Participant had an average ultrafiltration rate > 13 mL/kg/hour during the last 2weeks prior to Screening, per medical records.

• Had a significant cardiovascular adverse event within the last 90 days prior toScreening.