CloudCath wins FDA approval for connected device for home dialysis

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End-stage renal disease (ESRD) patients awaiting transplant are burdened with expensive care and spend hours in a dialysis center to maintain some functionality in their kidneys. Approval of the CloudCath system may help some patients complete dialysis at home under the watchful eye of clinicians monitoring the device remotely, and at a significantly reduced cost. The company’s first home peritoneal dialysis (PD) system has obtained 510(k) clearance from the FDA and is expected to have a limited launch in 2022, followed by a full commercial launch in 2023.

Dialysis care can be extremely expensive, averaging around $89,000 per year, while home care can offer significant savings of around $53,000 per year, according to the American Journal of Kidney Diseases. from the National Kidney Foundation. Continuous home monitoring can also help prevent exacerbations, according to Aly Elbadry, chief executive of CloudCath.

Dialysis monitoring to avoid clinical deterioration

“The CloudCath device is designed to support the clinician/patient partnership for home PD therapy,” said Elbadry, adding, “In fact, the entire dialysis ecosystem has a current and urgent goal of maximizing the use of home modalities. Additional monitoring measures should prevent health decline. Through a cloud-based digital connection, the PD monitoring system continuously provides data that can alert a physician to a brewing health issue.

“Promising early data from the CloudCath system shows that patients and clinicians can be alerted to the need for assessment days before symptom onset, allowing patients to seek early medical intervention, diagnosis and treatment before progress to hospitalization, catheter removal or death. he said.

Integrates with current CCPD system

The continuous, low-profile nature of the device allows it to be added to ESRD care with minimal effort on the part of the patient or family. Patients can continue to use their current Continuous Cyclic PD (CCPD) device with CloudCath. The monitoring system is designed to integrate with a patient’s existing device, according to Elbadry. “Patients simply connect the CloudCath sensor and drain set, similar to their current drain set extensions, to their home CCPD cycler,” he said.

“As the dialysate fluid is drained, the CloudCath sensor uses advanced digital optical sensors to assess the turbidity of the fluid,” Elbadry said. “Changes in fluid turbidity are detected by CloudCath’s proprietary cloud-based algorithm and notifications are sent to clinicians and patients alerting them to seek further medical evaluation.”

CloudCath’s system has the potential to change the landscape of PD surveillance which, in its current state, is fragmented, with options ranging from paper-based testing, drain line assessment, or waiting for symptoms. Instead, CloudCath’s device system looks for signs of infection or complication indicated by cloudy dialysate fluid. When cloudy fluid is detected by the PD monitoring system, it is a trigger for the patient and physician to coordinate further care.

New standard of dialysis care with monitoring

CloudCath envisions the monitoring system could be part of the future standard of care in PD for patients with ESRD. This could extend to other settings as well. “While focused on in-home PD, the CloudCath system can also be used in healthcare settings such as long-term care facilities and, in the rare event a patient visits the hospital and pursuing PD treatment, the CloudCath system can be used in a hospital setting,” Elbadry said.

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