CLOUDCATH RECEIVES FDA CLEARANCE FOR NOVEL PERITONEAL DIALYSIS (PD) AT-HOME PATIENT MONITORING SYSTEM
SAN FRANCISCO, Feb. 15, 2022 /PRNewswire/ — CloudCath Inc., a private medical device company advancing real-time fluid analytics and remote monitoring of infectious diseases, announced today it received U.S. Food and Drug Administration (FDA) clearance for the CloudCath System, the world’s first data-driven, cloud-based, remote monitoring platform for PD patients in the $74.5B end-stage renal disease (ESRD) market1. The company plans a limited launch of the CloudCath System in the coming months with several clinics in targeted regions of the U.S.
The CloudCath System delivers continuous analytics from the comfort of a patient’s home with state-of-the-art technology that integrates seamlessly into the patient’s daily PD protocol. The CloudCath PD monitoring platform sends real-time notifications to both clinicians and patients to facilitate the patient monitoring of dialysate fluid required for safe home use of PD. Promising early data show patients and clinicians may be alerted to the need for evaluation days before the onset of symptoms, enabling patients to seek early medical intervention, diagnosis, and treatment.
“The opportunity to remotely and proactively manage our PD patients’ addresses a major obstacle to greater PD adoption. Today’s standard-of-care for patient monitoring is subjective. It relies on patients to self-monitor their dialysate fluid with either a decades-old “newspaper test,” the ability to read text through fluid drainage lines, or waiting for signs of pain and discomfort in the abdomen,” stated Glenn Chertow, MD, MDH, Professor of Medicine in Nephrology at Stanford University School of Medicine. “With the CloudCath solution, automated fluid analytics and real-time notifications will enable us to monitor and follow up with patients quickly, so they can stay home and on PD until a successful transplant.”
Every year in the U.S., nearly 750,000 people are affected by kidney failure, which impacts 1% of the Medicare population but accounts for 7% of the Medicare budget due to the high cost of treatment.2 One factor driving this high cost of care is the large number of ESRD patients receiving in-center hemodialysis, which averages $89,000 per patient per year (PPPY). By comparison, at-home peritoneal dialysis is 40% less, or around $53,000 PPPY.3 In response, the Advancing American Kidney Health 2019 Executive Order set a goal for 80% of incident ESRD patients to receive either home dialysis therapy or a kidney transplant by 2025.4 To support this, CMS developed the ESRD Treatment Choices (ETC) Model to encourage greater use of home dialysis and transplant, offering incentives to centers that keep patients on PD for the first three years of dialysis.5
“FDA clearance of the CloudCath solution comes at a dynamic time in the dialysis market,” stated Aly ElBadry, CEO and Co-Founder of CloudCath. “With the 2019 Executive Order calling for increased use of at-home dialysis, CloudCath’s automated sensing and advanced PD care algorithm build a stronger connection between clinicians and patients to help dialysis providers meet these goals. We are excited to deliver new health insights and care algorithms that aim to eventually reduce hospitalizations and improve quality of life for PD patients.”
About CloudCath
CloudCath is a private medical device company advancing real-time fluid analytics and remote monitoring of infectious disease. By driving innovation at the intersection of biologic insights, machine learning algorithms, and remote monitoring IoT technologies, CloudCath solutions provide automated, powerful health analytics from human fluid assessment to healthcare providers. The company’s first solution addresses the needs of peritoneal dialysis patients. The CloudCath System is designed to activate the clinician/patient partnership through remotely monitoring patients’ dialysis fluid, supporting higher peritoneal dialysis utilization rates, reducing high-mortality hospitalizations, maximizing the functional and social quality of patients’ lives, and keeping ESRD patients on PD therapy longer.
1 https://www.grandviewresearch.com/industry-analysis/end-stage-renal-disease-market
2 United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018.
3 https://ajkdblog.org/2016/11/29/pd-versus-hd-do-i-have-a-choice/
4 https://aspe.hhs.gov/sites/default/files/private/pdf/262046/AdvancingAmericanKidneyHealth.pdf
5 https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model
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