In Context
Chronic kidney disease (CKD) affects 10% of the global adult population and poses a significant public health challenge, driven by rising rates of underlying conditions and an ageing demographic. Effective management relies on early detection, long-term monitoring, and control to mitigate the impact on patients’ wellbeing and healthcare costs.
Renalyse is developing innovative biosensing technology to detect biomarkers in blood. They aim to create a low-cost point-of-care device capable of assessing key kidney function indicators using just a drop of blood, enabling remote health monitoring from home. In line with their mission to decentralise CKD diagnostic tools, Renalyse has partnered with Perdigó Medical to advance their product pipeline, focusing on end-stage renal disease (ESRD).
Patients progressing to ESRD often require dialysis, which can lead to complications such as electrolyte imbalances and inadequate waste removal due to insufficient monitoring. Furthermore, treatment adjustments for individual patients remain limited.
The Challenge
The biosensing device was designed as an external module that attaches directly to the blood circuit of dialysis machines, featuring a small, disposable microfluidics cartridge.
This cartridge uses Renalyse’s core electrochemical sensing technology to detect and measure changes in biochemical concentrations.
Key objectives for developing this dialysis add-on included:
- Monitoring biomarkers such as urea, creatinine, and electrolytes during haemodialysis sessions.
- Integrating with existing dialysis machines.
- Enabling wireless data communication to transmit real-time information to a cloud-based platform, accessible by healthcare providers through a secure web interface for concurrent patient monitoring.
- Enhancing safety for both patients and healthcare professionals.
Integrating the add-on device posed several challenges, including:
- Ensure compatibility with the fluidic systems of a variety of existing dialysis machines.
- Handle small fluid volumes accurately while preventing blockages and leaks.
- Minimise disruptions to established clinical workflows, featuring a simple interface that optimises usability for healthcare professionals.
- Consider costs and scalability from the concept stage to support future widespread use.
Perdigó's Approach
Recognising this unmet need, Perdigó collaborated with the dialysis team of Barcelona’s Hospital Clinic to develop an innovative point-of-care biosensing device as an add-on for existing dialysis machines.
This device is designed to monitor key biochemical markers in the blood during dialysis sessions, assessing efficiency and allowing for patient-specific treatment adjustments to enhance outcomes.
Delivered Value
The concept of this dialysis biosensing device shows huge promise in improving the quality of dialysis care. Real-time data will allow healthcare professionals to personalise treatments, reducing the risk of complications and allowing for shorter dialysis sessions.
Renalyse is expected to conduct a clinical investigation of the device at Hospital Clínic de Barcelona to assess its effectiveness and gather inputs for further development.
